Ex Parte Schraga

Patent Trial and Appeal Board

Aug 28, 2017

13524742 (P.T.A.B. Aug. 28, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/524,742 06/15/2012 Steven Schraga P41961 5682
7055 7590 08/30/2017
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
EXAMINER
CERIONI, DANIEL LEE
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
08/30/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN SCHRAGA
Appeal 2016-000386
Application 13/524,742
Technology Center 3700
Before LINDA E. HORNER, ERIC C. JESCHKE, and
BRENT M. DOUGAL, Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Steven Schraga (“Appellant”) seeks review under 35 U.S.C. § 134(a)
of the Examiner’s decision, as set forth in the Final Office Action dated
January 2, 2015 (“Final Act.”), and as further explained in the Advisory
Action dated March 11, 2015 (“Adv. Act.”), rejecting claims 1—4 and 21—
31.1 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies Stat Medical Devices, Inc. as the real party in
interest. Appeal Br. 3.
Appeal 2016-000386
Application 13/524,742
BACKGROUND
The disclosed subject matter “relates generally to devices used to
collect fluid samples from and/or inject fluids into patients.” Spec. 12.
Claims 1, 22, 27, and 31 are independent. Claim 1 is reproduced below:
1. A fluid collection device comprising:
a body having a front end and a back end;
the back end being at least one of:
open; and
sized and configured to receive therein
a receptacle;
a movable needle holding member arranged
in an area of the front end of the body and having an
external side area releasably engaged by portions of
a releasable connection; and
the needle holding member comprising:
one side wherein there is arranged a
standard needle connecting interface adapted
to mate with a needle interface of a user-
installable needle; and
an opposite side wherein there is
arranged an internal needle of a double-ended
needle arrangement,
wherein, when the user-installable needle is
installed on the standard needle connecting
interface, a puncturing portion of the user-
installable needle functions as an external needle of
the double-ended needle arrangement and a
puncturing portion of the internal needle of the
double-ended needle arrangement is disposed inside
the body,
wherein the standard needle connecting
interface is visible and recognizable from outside
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the body when the needle holding member is
installed and prior to use.
REJECTIONS
1. Claims 22—30 stand rejected under 35U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
2. Claims 1—4 and 21—31 stand rejected under 35 U.S.C. § 112,
second paragraph, as failing to particularly point out and distinctly claim the
subject matter regarded as the invention.
3. Claims 1—4 and 21—31 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Shaw (US 5,810,775, issued Sept. 22, 1998) and
Donnan (US 2003/0236501 Al, published Dec. 25, 2003).
DISCUSSION
Rejection 1 — The rejection of claims 22—30 under
35 U.S.C. § 112, first paragraph
The Examiner rejected claims 22—30, finding that “the claim
limitation(s) ‘a puncturing portion of the needle holding member functions
as an internal needle of the double-ended needle arrangement’ [in
independent claims 22 and 27] do not appear to be supported in
[Appellant’s] written description.” Final Act. 3. The Examiner stated that
“the only support for the claim term ‘puncturing portion’ found by the
examiner in [Appellant’s] written description is at paragraph [0034], which
states ‘[a] typical vacutainer-type vial has an insertion end whose self­
sealing septum can be punctured by the needle.’” Id. According to the
Examiner, “this portion of [the] [Specification only provides support for the
needle to have a puncturing portion, not the needle holding member.” Id.
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Appellant argues that Figures 10 and 11 “show a fluid collection
device which utilizes a double-ended needle arrangement” and that “[t]his
double-ended needle arrangement is formed by, e.g., a needle holding
member 10 shown Fig. 4, and, e.g., one of the user-installable needles 20A—
20C shown in Figs. 5—7.” Appeal Br. 9. Appellant continues that “Fig. 4
clearly shows a puncturing portion 14 of the needle holding member 10 that
functions as an internal needle of a double-ended needle arrangement.” Id.
The Examiner states that “there are a few problems with th[e]
interpretation” that “the claim term ‘puncturing portion’ finds . . . support in
the [Specification’s term ‘internal hollow needle 14.’” Ans. 26. First, the
Examiner states that “a puncturing ‘portion’ seems to indicate only a part of
a structure, such as a face or edge, instead of an entire structure like a
needle” and thus, Appellant’s position as to support for “the claimed
‘puncturing portion’ is somewhat contradictory to the plain meaning of the
language.” Id. Second, the Examiner states that “the ‘internal hollow
needle’ is not a part of the ‘needle holding member 10.” Id. at 26.
According to the Examiner, “a needle is separate from its needle holder,”
“[therefore, to say that an internal needle is a ‘puncturing portion’ would
just create ambiguity in the meaning and scope of the claim language and
when support creates confusion or a lack of clarity, such support is not
proper.” Id. at 27.2
The test for compliance with the written description requirement is
“whether the disclosure of the application relied upon reasonably conveys to
2 Although the Examiner discusses alleged “confusion” and “lack of
clarity,” the Examiner did not reject the claims at issue on this basis under
35 U.S.C. § 112, second paragraph.
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those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc). We agree with Appellant
that the relied-upon figures as well as paragraph 34 of the Specification
provide sufficient written description support for the limitations at issue. As
noted by Appellant, paragraph 34 “describes how the internal needle 14 can
puncture a septum of a vacutainer-type vial.” Appeal Br. 10; see also Spec.
134 (“A typical vacutainer-type vial has an insertion end whose self-sealing
septum can be punctured by the needle 14 and can cause retraction of the
flexible cover 15 during insertion of the vial.”).
Moreover, the same paragraph, as well as Figure 4, discussed therein,
support Appellant’s assertion that needle 14 is described as a portion—i.e., a
part within a larger structure—of needle holding member 10. See Spec. 134
(“Fig. 4 shows the needle holding member 10 of Fig. 3 in a configuration
wherein needle cover 15 is retracted to expose the inner needle 14.”). This
assertion is also supported by the freestanding arrow on the lead line from
reference numeral 10 in Figure 4, which indicates that needle holding
member 10 includes needle 14 also shown in the Figure. See 37 C.F.R.
§ 1.84(r)(l) (2014) (“On a lead line, a freestanding arrow to indicate the
entire section towards which it points[.]”); see also Koito Mfg. Co. v. Turn-
Key-Tech, LLC, 381 F.3d 1142, 1154 (Fed. Cir. 2004) (explaining that “the
written description requirement can be satisfied by words, structures,
figures, diagrams, formulas, etc.” (quotation omitted)).
For these reasons, we do not sustain the rejection of claims 22—30
under 35U.S.C. § 112, first paragraph.
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Rejection 2 — The rejection of claims 1—4 and 21—31
under 35 U.S.C. § 112, second paragraph
A. All Claims
A.i. “standard needle connecting interface”
Each of the four independent claims recites a “standard needle
connecting interface.” Appeal Br. 34—37 (Claims App.) (emphasis added).
The Examiner stated that “[i]t is unclear how the word ‘standard’ modifies
the term ‘needle connecting interface’ under the broadest reasonable
interpretation standard.” Final Act. 7—8. The Examiner stated that “what
may be considered as a ‘standard’ needle holding member to one skilled
artisan may be different from what another skilled artisan considers as a
‘standard’ needle holding member” because “the term ‘standard’ is
subjective to human understanding and there may even exist multiple
standards in the art (i.e., ISO vs. ANSI standards).” Id. at 8; see also Ans.
31 (stating that “it is unclear what standard is being referred to because there
are multiple standards in the fluid collection art, and more broadly in the
biomedical arts, such as, for example, the ISO standard versus the ANSI
standard”). The Examiner also stated that “what may be considered
‘standard’ by a skilled artisan is prone to change over time” in that
“standards are updated as technology evolves.” Final Act. 8.
For each claim, Appellant argues that “[t]he use of standard needle
connecting interfaces per se are well known.” Appeal Br. 14, 16—18.
Appellant contends to have “specifically stated [i]n paragraph [0041] of the
[Specification] that this term encompasses ‘any conventional standard type
interface.’” Id.
We are not apprised of error based on these arguments. As to the first,
Appellant does not support this contention with any evidence of record. See
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Ans. 32 (stating that “the first argument is merely a conclusory statement”).
Further, we agree with the Examiner that “the second argument does not
give any further clarity to the term ‘standard.’” Id.
In the Reply Brief, Appellant takes the position that “[a] proper
construction of the term ‘standard’ is one that is consistent with the term
‘common.’” Reply Br. 4. Defining “standard” as “common,” however, does
not resolve the lack of clarity identified by the Examiner. The terms
“standard” and “common” are, in the context of the claims here, terms of
degree. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370
(Fed. Cir. 2014) (identifying “unobtrusive manner” as a term of degree);
Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1372 (Fed.
Cir. 2008) (“Here, the term ‘anaerobic condition’ is in effect a term of
degree because its bounds depend on the degree of oxygen deficiency.”).
Our reviewing court has reaffirmed that terms of degree are not “inherently
indefinite” and that “[cjlaim language employing terms of degree has long
been found definite where it provided enough certainty to one of skill in the
art when read in the context of the invention.” Interval Licensing, 766 F.3d
at 1370 (citations omitted).3
As noted by the Examiner, the Specification here uses various terms
in conjunction with “standard.” See Final Act. 8 (discussing Spec. 110 (“a
standard interface and/or a universal interface”), 131 (“any conventional
standard type interface such as a luer-lok type interface”), 135 (“a common
standard connecting interface)); see also Appeal Br. 14, 16—18 (all citing
3 We view this guidance as applicable either when the term of degree
is recited in the claims at issue or when present in the proposed construction
of language in the claims.
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Spec. ^41 (“any conventional standard type interface such as a luer-lok type
interface”). Although these passages indicate a luer-lok type interface would
fall within the scope of the limitations at issue, Appellant has not provided
further guidance (and we do not discern any from the Specification) of the
“objective boundaries” as to “standard” or “common.” See Interval
Licensing, 766 F.3d at 1371.4 For example, Appellant has not provided (in
the Specification or in argument) objective boundaries as to how “common”
an interface must be to satisfy the limitations at issue. See In re Morris, 111
F.3d 1048, 1056 (Fed. Cir. 1997) (“It is the applicants’ burden to precisely
define the invention, not the PTO’s.”).
A.ii. Alleged Lack of a Prima Facie Case of Indefiniteness
For each of the independent claims, Appellant asserts that “the
[indefiniteness] rejection of this claim makes no reference to the
specification and drawings” and does not provide “any explanation
whatsoever as to how or why one having ordinary skill in the art would find
the noted claim features unclear.” Appeal Br. 13, 15—18. According to
Appellant, “[a]s such, this rejection is prima facie improper.” Id.
The Office establishes a prima facie case of indefiniteness by
adequately explaining why the metes and bounds of a pending claim are not
clear, thereby providing an applicant proper notice and the ability to
respond. See In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014) (per
curiam); see also MPEP § 2173.02(III)(B) (9th ed., Rev. 07.2105, Nov.
2015) (“The Office action must set forth the specific term or phrase that is
indefinite and why the metes and bounds are unclear. Since a rejection
4 Appellant has not proposed to define “standard needle connecting
interface” as encompassing solely a luer-lok type interface.
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Application 13/524,742
requires the applicant to respond by explaining why claim language would
be recognized by a person of ordinary skill in the art as definite or by
amending the claim, the Office action should provide enough information
for the applicant to prepare a meaningful response.”). Here, we determine
that the Examiner clearly identified the language at issue and adequately
explained the perceived lack of clarity. See Final Act. 4—8; Ans. 27—32.
B. Independent Claim 1
B.i. “therein”
Claim 1 recites “sized and configured to receive therein a receptacle.”
Appeal Br. 34 (Claims App.) (emphasis added). The Examiner stated that
“[i]t is unclear what the term ‘therein’ refers to” because “‘therein’ could
refer to the ‘back end,’ the ‘body,’ or the ‘fluid collection device.’” Final
Act. 4; see also Ans. 28 (stating that “because the antecedence is not explicit
(such as ‘a back end’ and ‘the back end,’ where antecedence is very clear),
the metes and bounds of the scope of the claim language is
unascertainable”).
Appellant argues that “[i]n this limitation, ‘therein’ clearly refers to
the ‘back end.’” Reply Br. 4.
A claim fails to comply with 35 U.S.C. § 112, second paragraph,
“when it contains words or phrases whose meaning is unclear.” Packard,
751 F.3d at 1310, 1314 (approving, for pre-issuance claims, the standard
from MPEP § 2173.05(e)); see also Ex parte McAward, Appeal 2015-
006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential)
(adopting the approach for assessing indefmiteness approved by the Federal
Circuit in Packard). A “satisfactory response” to a rejection under 35
U.S.C. § 112, second paragraph, “can take the form of a modification of the
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language identified as unclear, a separate definition of the unclear language,
or, in an appropriate case, a persuasive explanation for the record of why the
language at issue is not actually unclear.” Id. at 1311. Here, we consider
Appellant’s response to define “therein” in the limitation at issue, thereby
adequately addressing the Examiner’s position.
B.ii. “there”
Claim 1 recites “one side wherein there is arranged a standard needle
connecting interface adapted to mate with a needle interface of a user-
installable needle” and “an opposite side wherein there is arranged an
internal needle of a double-ended needle arrangement.” Appeal Br. 34
(Claims App.) (emphasis added). The Examiner stated that, for both
limitations, “[i]t is unclear where ‘there’ refers to.” Final Act. 4. The
Examiner also stated that each limitation is “broken up by the transitional
term ‘wherein,’ which connotes new limitation(s) being introduced in the
claim.” Id. at 4—5.
Addressing these limitations, Appellant states:
The needle holding member 10 comprises one side (i.e., the part
of member 10 located outside device 80) wherein there is
arranged a standard needle connecting interface adapted to mate
with a needle interface of a user-installable needle (see Figs. 8
and 9) and an opposite side wherein there is arranged an internal
needle of a double-ended needle arrangement (see Figs. 4 and
10).
Appeal Br. 14.
We determine that Appellant has not provided a “satisfactory
response” to the Examiner’s position because Appellant does not define the
unclear language or persuasively explain “for the record why the language at
issue is not actually unclear.” Packard, 751 F.3d at 1311. Instead,
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Appellant essentially recites the limitations at issue and identifies certain
figures depicting various recited features. See Ans. 29 (stating that “[t]he
ambiguity cannot be resolved without importing limitation(s) from
Appellant[’s] [Specification into the claim language”); see also Morris, 127
F.3d at 1056 (“It is the applicants’ burden to precisely define the invention,
not the PTO’s.”).
B.iii. “and having”
Claim 1 recites “a movable needle holding member arranged in an
area of the front end of the body and having an external side area releasably
engaged by portions of a releasable connection.” Appeal Br. 34 (Claims
App.) (emphasis added). The Examiner stated that “[i]t is unclear what has
an external side area releasably engaged by portions of a releasable
connection.” Final Act. 5. The Examiner also stated: “Does the movable
needle have [an] external side area releasably engaged by portions of a
releasable connection or does the front end of the body have [an] external
side area releasably engaged by portions of a releasable connection?” Id.
Appellant argues that “[a] movable needle holding member 100 is
arranged in an area of the front end of the body (see Fig. 14) and has an
external side area (see area 113 in Fig. 12) releasably engaged by portions
of a releasable connection.” Appeal Br. 14. Here, we consider Appellant’s
response to define “and having” as relating to the “movable needle holding
member,” thereby adequately addressing the Examiner’s position. See Ans.
30 (stating that “using the conjunction ‘and’ makes it seem like the needle
holding member has the external side area”).
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C. Independent Claim 22
C.i. “therein”
Claim 22 recites “sized and configured to receive therein a
receptacle.” Appeal Br. 35 (Claims App.) (emphasis added). The Examiner
determined that claim 22 is indefinite for the same reasons set forth above
with regard to claim 1. See supra, Rej. 2, § B.i; see also Final Act. 5. For
the same reasons discussed above, we consider Appellant to have defined
“therein” in the limitation at issue, thereby adequately addressing the
Examiner’s position. See Reply Br. 4.
C.ii. “and having”
Claim 22 recites “a needle holding member arranged in an area of the
front end of the body and having an external side area releasably engaged by
portions of a releasable connection.” Appeal Br. 35 (Claims App.)
(emphasis added). The Examiner determined that claim 22 is indefinite for
the same reasons set forth above with regard to claim 1. See supra, Rej. 2,
§ B.iii; see also Final Act. 5. For the same reasons discussed above, we
consider Appellant to have defined “and having” as relating to the “needle
holding member,” thereby adequately addressing the Examiner’s position.
See Appeal Br. 15.
C.iii. “the puncturing portion of the internal needle”
Claim 22 recites “the puncturing portion of the internal needle.”
Appeal Br. 36 (Claims App.) (emphasis added). The Examiner found that
this limitation lacks antecedent basis. See Final Act. 6. According to the
Examiner, “claim 22 does not actively claim an internal needle, but instead
recites ‘a puncturing portion . . . functions as an internal needle,”’
“[therefore, a comparison is made to an internal needle and not a recitation
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of an internal needle as part of the device of claim 22.” Id.; see also Ans. 30
(“Claim 22 fails to expressly recite an internal needle, but instead only
references the term ‘internal needle’ as a term of comparison.”).
Appellant argues “[antecedent basis is found on lines 11 and 12 of
claim 22 which recites ‘a puncturing portion of the needle holding member
is disposed inside the body and functions as an internal needle of the double-
ended needle arrangement. Appeal Br. 16.
We determine that Appellant has not provided a “satisfactory
response” to the Examiner’s position because Appellant has not provided “a
persuasive explanation for the record of why the language at issue is not
actually unclear.” Packard, 751 F.3d at 1311.
D. Independent Claim 27
Claim 27 recites “a movable needle holding member arranged in an
area of the front end of the body and having an external side area releasably
engaged by portions of a releasable connection.” Appeal Br. 36 (Claims
App.) (emphasis added). The Examiner determined that claim 27 is
indefinite for the same reasons set forth above with regard to claim 1. See
supra, Rej. 2, § B.iii; see also Final Act. 6. For the same reasons discussed
above, we consider Appellant to have defined “and having” as relating to the
“movable needle holding member,” thereby adequately addressing the
Examiner’s position. See Appeal Br. 17.
E. Independent Claim 31
E.i. “therein”
Claim 31 recites “a body having a front end and sized to receive
therein a fluid collection vial.” Appeal Br. 37 (Claims App.). The Examiner
determined that claim 31 is indefinite for two reasons. See Final Act. 6.
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First, the Examiner stated that “[i]t is unclear what is ‘sized to receive
therein a fluid collection vial.’ Is it the claimed ‘body’ or the claim[ed]
‘front end?’ Or is it another element in the claim?” Id. Second, the
Examiner stated “[i]t is unclear what ‘therein’ refers to. It appears that
‘therein’ could refer to the ‘back end,’ the ‘body,’ or the ‘fluid collection
device.’” Id.
Appellant argues that “Fig. 10 shows an open back end and also sized
and configured to receive therein a receptacle or vial.” Appeal Br. 18.
Appellant also contends to have “described such features as also being used
on conventional fluid collection devices in the application Background
section.” Id.
We determine that Appellant has not provided a “satisfactory
response” to the Examiner’s position because Appellant does not define the
unclear language or persuasively explain “for the record why the language at
issue is not actually unclear.” Packard, 751 F.3d at 1311. Instead,
Appellant recites aspects of the limitations at issue and asserts that Figure 10
depicts an “open back end,” which is not recited in claim 31. See Morris,
127 F.3d at 1056 (“It is the applicants’ burden to precisely define the
invention, not the PTO’s.”). As to the alleged disclosure in the
“Background” of the Specification, Appellant does not adequately identify
such alleged disclosure.
E.ii. “having a same connecting interface”
Claim 31 recites “a standard needle connecting interface that can
connect to different user-installable needle members having a same
connecting interface.” Appeal Br. 37 (Claims App.) (emphasis added). The
Examiner stated that “[i]t is unclear what is ‘having a same connecting
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interface.’” Final Act. 7. The Examiner stated, “[i]s it the claimed ‘standard
needle connecting interface’ that can have a same connecting interface or is
it the claimed ‘different user-installable needle members’ that can have a
same connecting interface?” Id.', see also Ans. 30 (“The claim language on
its face is ambiguous whether the standard needle connecting interface or the
user-installable needle members have the same connecting interface.”).
Appellant does not address this basis for the rejection of claim 31 as
indefinite. See Appeal Br. 17—18. Thus, we are not apprised of error in the
Examiner’s position. See Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI
2010) (precedential) (“If an appellant fails to present arguments on a
particular issue—or, more broadly, on a particular rejection—the Board will
not, as a general matter, unilaterally review those uncontested aspects of the
rejection.”).
E.iii. “said standard connecting interface at least one of’
Claim 31 recites “said standard needle connecting interface at least
one of.” Appeal Br. 37 (Claims App.). The Examiner stated that this
language “does not appear to be grammatically correct and therefore it is
unclear what the limitations of the claim language are.” Final Act. 7. The
Examiner also stated that “[i]t appears that the words ‘being’ or ‘is’ should
be included in the claim language, however clarification is needed.” Id.', see
also Ans. 31 (stating that the claim language “appears to need the word
‘being’ or ‘is’ between ‘interface’ and ‘at’”).
Appellant does not address this basis for the rejection of claim 31 as
indefinite. See Appeal Br. 17—18. Thus, we are not apprised of error in the
Examiner’s position. See Frye, 94 USPQ2d at 1075.
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E.iv. “thereon”
Claim 31 recites “a prior to use mode wherein the standard needle
connecting interface has no needle member installed thereon.” Appeal Br.
38 (Claims App.) (emphasis added). The Examiner stated that “[i]t is
unclear what ‘thereon’ refers to.” Final Act. 7; see also Ans. 31 (“‘Thereon’
could potentially find antecedence in many different claim terms.”).
Appellant does not address this basis for the rejection of claim 31 as
indefinite. See Appeal Br. 17—18. Thus, we are not apprised of error in the
Examiner’s position. See Frye, 94 USPQ2d at 1075.
E.v. Withdrawn Bases
In the Office Action, the Examiner found that certain limitations
recited or allegedly recited in claim 31 lacked antecedent basis. See Final
Act. 6 (]Hf 21, 24). In the Answer, the Examiner withdraws these bases for
the rejection of claim 31 as indefinite. See Ans. 30 (second full paragraph),
31 (second full paragraph).
Although we reverse some of the indefmiteness rejections above,
because at least one basis remains for the indefmiteness of each of the
independent claims, we sustain the rejection of claims 1^4 and 21—31 under
35 U.S.C. § 112, second paragraph.
Rejection 3 — The rejection of claims 1—4 and
21—31 under 35 U.S.C. § 103(a)
Appellant argues the patentability of independent claims 1, 27 and 31
based on the same arguments and argues the other independent claim (claim
22) based on a subset of those arguments. Appeal Br. 19-32; Reply Br. 5—7.
Appellant does not provide separate arguments for any dependent claims.
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We select independent claim 1 as representative, with the remaining claims
standing or falling with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv) (2014).
For claim 1, the Examiner relied on Shaw for certain limitations but
stated that Shaw does not expressly disclose certain limitations, including,
for example, (as phrased by the Examiner) “the needle holding member
comprising a standard needle connecting interface adapted to mate with a
needle interface of a user-installable needle” and “that the puncturing
portion of the user-installable needle functions as an external needle of a
double-ended needle arrangement.” Final Act. 9-10. The Examiner found,
however, that “Donnan teaches a needle holding member (Fig. 7) (paragraph
[0062]) comprising one side wherein there is arranged a standard needle
connecting interface (82) adapted to mate with a needle interface (87) of a
user-installable needle (88) (i.e., Tuer-lock fitting’; paragraph [0063])” and
teaches “that the puncturing portion of the user-installable needle functions
as an external needle of a double-ended needle arrangement” (citing Fig. 7).
Final Act. 10—11. According to the Examiner, it would have been obvious
for one of ordinary skill in the art at the time of the invention to modify
Shaw into a device satisfying the limitations of claim 1, “in view of the
teachings of Donnan, for the obvious advantage of providing means to fit
together in sealing engagement such that no leakage will occur from the
body (see paragraph [0063] of Donnan).” Id. at 11.
As an initial matter, we set forth our understanding of the modified
device as proposed by the Examiner. We understand the Examiner to
propose modifying the embodiment of Figure 1 of Shaw by (1) removing the
lower portions of double-ended needle 88 and threaded needle holder 74 (for
example, below the area of interface with hub 28), (2) modifying the
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remaining lower portion of threaded needle holder 74 to be similar to
forward end 87 of adaptor section 80 in Donnan (see Donnan, Fig. 1,1 63
(cited at Final Act. 10)), and (3) connecting to the modified structure
discussed in (2) separate auxiliary needle-carrying section 82 and needle 88
as shown in Figure 1 of Donnan (see also Donnan || 62—63 (cited at Final
Act. 10)). Thus, the modified device would include, inter alia, (1) a two-
piece double-ended needle rather than the one-piece double-ended needle of
Shaw (see Reply Br. 7 (bullets “A” and “B”)) and (2) a luer-lok type
interface (including needle 88 of Donnan) on the lower portion of the
modified needle holder 74 of Shaw (see Donnan | 63; see also Reply Br. 7
(bullet “C”)).
This view aligns with the understanding of the modified device
provided by Appellant. See Reply Br. 7 (discussing “modifying] the
double-ended needle arrangement 74 of SHAW so as to use a standard
connecting interface between the external needle 88 [of Shaw] and internal
needle covered by the retractable sheath 90” and arguing that “[t]o modify
SHAW in the manner of the invention would . . . require at least the above-
listed items A-C to all be changed and also apparently require the addition
of a standard connecting interface between portions of the body 74”). We
turn now to Appellant’s arguments.
First, Appellant argues that “the double ended needle arrangement 74
of SHAW utilizes a single needle 88 and thus lacks any connecting standard
interface on the member 74, much less, one which can receive a user
installable needle forming an external needle of a double-ended needle
arrangement.” Appeal Br. 20. Appellant also argues that “[i]n SHAW, the
entire double-ended needle arrangement 74 is installed on the body as a unit
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and cannot be separated into in internal needle portion and an external
needle portion.” Id. at 20—21. Appellant further argues that “DONNAN
fails to cure the noted deficiencies of SHAW” because “DONNAN clearly
lacks a double-ended needle arrangement” in that “the needle N of the
syringe B in no way constitutes or functions as an internal needle of the
double-ended needle arrangement.” Id. at 21; see also id. (bottom three
lines) — id. at 22 (top two lines) (arguing Donnan individually); Reply Br. 6—
7 (setting forth alleged “deficiencies of DONNAN” such as that “it does not
function as [a] double-ended needle arrangement”).
We are not apprised of error based on this set of arguments because
nonobviousness cannot be established by attacking references individually
when the rejection is based on a combination of prior art. See In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, by arguing that neither
Shaw nor Donnan, alone, teaches all aspects of claim 1, Appellant does not
address the rejection as articulated, in which the Examiner relies on certain
combined teachings of the prior art. For example, as noted by the Examiner,
“the rejection does not rely on Shaw for teaching a connecting standard
interface and does not rely on Donnan for teaching a double-ended needle
arrangement.” Ans. 33. As discussed above, however, a “standard needle
connecting interface” and “double-ended needle arrangement” would be
present in the modified device.
Second, Appellant argues that “SHAW teaches a needle unit 74 which
uses a single double ended needle 88 having opposite facing puncturing
portions supported in a one-piece body” but contends that “[i]n contrast, the
invention necessarily requires two needles connectable by a standard
connecting interface while continuing to have oppositely facing puncturing
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portions, i.e., an internal needle and an external needle whose puncturing
portions or ends are oriented in opposite directions.” Appeal Br. 21.
The Examiner responds that claim 1 “does not require that two
needles be connectable by a standard connecting interface” but instead,
claim 1 “states that a needle holding member comprises a side and an
opposite side with a standard needle connecting interface arranged
somewhere and an internal needle arranged somewhere (due to the
ambiguity of the language ‘there is arranged’ and ‘there’ not being specific
as to where).” Ans. 34.
In reply, Appellant argues that the Examiner’s position “is belied by
the claim language which recites two needles . . . that can function as a
double-ended needle arrangement and that are connectable together by a
standard connecting interface.” Reply Br. 5 (providing emphasis for certain
language in claim 1). Appellant also sets forth five alleged requirements of
claim 1 that, according to Appellant, “should be apparent [from] a fair
reading” of the claim. Id. at 5—6.
Even assuming that claim 1 implicitly requires, as argued by
Appellant, “two needles connectable by a standard connecting interface
while continuing to have oppositely facing puncturing portions” (Appeal Br.
21), such structures would be present in the modified device, as discussed
above. Moreover, as to the five alleged requirements of claim 1 (argued for
the first time in the Reply Brief), Appellant has not demonstrated why those
aspects would not be present in the modified device.
Third, Appellant argues that “it is not apparent how DONNAN can be
read by one having ordinary skill in the art to teach or suggest the
modification of SHAW” and that “DONNAN fails to provide any teaching
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or suggestion for modifying SHAW in a manner resulting in the invention.”
Appeal Br. 21; see also Reply Br. 7 (arguing that “[i]n short, there is no
teaching in the applied art, much less in DONNAN, which would prompt or
lead one of ordinary skill in the art to modify the double-ended needle
arrangement 74 of SHAW” as proposed).
Contrary to Appellant’s argument, the Supreme Court has made clear
that an express teaching, suggestion, or motivation in the prior art is not
required for an obviousness determination. See KSR Int 7 Co. v. Teleflex
Inc., 550 U.S. 398, 418—19 (2007) (holding that when the teaching-
suggestion-motivation test is applied as a rigid and mandatory formula, it is
incompatible with Supreme Court precedent). Here, Appellant has not
addressed or shown error in the reasoning articulated by the Examiner. See
Final Act. 11 (first full paragraph).
We are also not apprised of error based on, for example, the assertion
that “adapter 80 in DONNAN is not a needle holder of the type used in
SHAW” (Appeal Br. 21) or that “[t]he ability to perform skin injection and
their use of a user installable needle appears to be all that [Shaw and
Donnan] have in common”) (Reply Br. 6). Appellant has not shown that
such alleged differences undermine the factual findings or reasoning relied
on to support the conclusion of obviousness. See KSR, 550 U.S. at 420
(“[FJamiliar items may have obvious uses beyond their primary purposes,
and in many cases a person of ordinary skill will be able to fit the teachings
of multiple patents together like pieces of a puzzle.”).
Fourth, Appellant argues that (1) “SHAW teaches a thread connecting
interface between the double-ended needle 74 and the needle holder 60
which is inside the front end 84 of body and is not visible and recognizable
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(see Fig. 1 of SHAW)” and (2) “DONN[AN] lacks any double-ended needle,
much less, any standard interface between needle components of a double-
ended needle.” Appeal Br. 22. Thus, according to Appellant, “even if one
modifies SHAW into a two component needle, there is no basis for doing so
while also making the standard interface visible and recognizable from
outside the body when the needle holding member is installed and prior to
use.” Id.
As noted by the Examiner, “[t]he claim language [at issue] states that
it is the ‘standard needle connecting interface’ that is visible and
recognizable from outside the body.” Ans. 34. Thus, as further noted by the
Examiner, arguing that the “needle holder” does not satisfy this limitation
does not apprise us of error “because the claims do not recite that the needle
holder need to be visible outside the body.” Id.5 We also see no error in the
Examiner’s position that, in the modified device, the “standard needle
connecting interface” would satisfy the limitation at issue based on the
configurations of the relied-upon structures in Donnan. See id. (“Fig. 7 of
Donnan clearly shows element 82 (which is the structure of Donnan that is
relied upon as reading on the claimed ‘standard needle connecting
interface’) as being visible and recognizable outside the body of the needle
holding member.”).
As to the argument that “neither document provides any teaching or
suggestion for modifying SHAW so as to have a standard needle connecting
interface that” satisfies the limitation at issue (Appeal Br. 22), we again note
5 The Examiner does not rely on element 60—but rather element 74 in
Shaw—as the “movable needle holding member” that is modified in the
manner proposed. See Final Act. 9—10.
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that an express teaching, suggestion, or motivation in the prior art is not
required for an obviousness determination. See KSR, 550 U.S. at 418—19.
For the reasons set forth above, we sustain the rejection of
independent claim 1. Claims 2—4 and 21—31 fall with claim 1.
DECISION
We reverse the decision to reject claims 22—30 under 35 U.S.C. § 112,
first paragraph, we affirm the decision to reject claims 1—4 and 21—31 under
35 U.S.C. § 112, second paragraph, and we affirm the decision to reject
claims 1—4 and 21—31 under 35 U.S.C. § 103(a).6
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
6 See 37 C.F.R. § 41.50(a)(1) (“The affirmance of the rejection of a
claim on any of the grounds specified constitutes a general affirmance of the
decision of the examiner on that claim, except as to any ground specifically
reversed.”).
23