Ex Parte Aasmul

Patent Trial and Appeal Board

Aug 23, 2016

12673847 (P.T.A.B. Aug. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/673,847 02/17/2010
23117 7590 08/25/2016
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Spren Aasmul
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PTB-141-588 1777
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/25/2016 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte S0REN AASMUL
Appeal2014-003469
Application 12/673,847
Technology Center 3700
Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
ERIC C. JESCHKE, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from the
Examiner's Final rejection of claims 29, 30, 32, 34, 36, 37, 49-54, 56, and
60-62. Final Act. 1 (Office Action Summary, mailed May 29, 2013).
Claims 31, 33, 35, 38--48, and 55 have been withdrawn. See Request for
Continued Examination (filed November 29, 2012). Claims 1-28 and 57-59
have been canceled. See Request for Continued Examination. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
Appeal2014-003469
Application 12/673,847
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to an injection apparatus and to a
method of injection." Spec. 1 :3--4. Claims 29 and 30 are independent.
Claims 29 and 30 are illustrative of the claims on appeal and are reproduced
below:
29. An injection apparatus for making an injection at a
predetermined depth in skin comprising:
a skin positioning member for positioning on a patch of
skin within an area of skin to hold the patch of skin in a defined
position,
an injection needle comprising a point having a tip at a
distal end thereof and a shaft portion immediately proximal to
said point, the shaft portion having a longitudinal axis, and
an injection needle movement guide proximate the
injection needle to guide said injection needle for movement
from a parking position above the skin beside said skin
positioning member to slide beneath said skin positioning
member to an injection position in which the distal end of the
needle lies at a predetermined distance below said skin
positioning member;
wherein:
the tip of the injection needle is closer to the longitudinal
axis of the shaft portion than is an outside of the shaft portion.
30. An injection apparatus for making an injection at a
predetermined depth in skin, comprising:
a skin positioning member for positioning a patch of skin
within an area of skin to hold the patch of skin in a defined
position;
an injection needle comprising a tip, at least one bevel
and a heel together forming a point at a distal end thereof, and a
shaft portion immediately proximal of said heel having a
longitudinal axis, including a lumen extending along the
longitudinal axis, wherein the at least one bevel is formed
between said tip and said heel such that a lumen opening is
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Application 12/673,847
defined from the tip to a proximal end of the lumen opening
located distal of the heel; and
an injection needle movement guide proximate the
injection needle to guide said injection needle for movement
from a parking position above said skin positioning member to
an injection position in which the distal end of the needle lies at
a predetermined distance below said skin positioning member;
wherein:
a length of the lumen opening of the needle from the tip
of the needle to the proximal end of the lumen opening is in a
range from 5 to 15 times an outer diameter of the shaft of the
needle and the length of the lumen opening of the needle is
measured parallel to the longitudinal axis of the needle.
REFERENCES RELIED ON BY THE EXAMINER
Saito
Ejlersen
Prais et al.
("Prais")
Ejlersen
("F11 er!':en '1 40") ' _J_______ - -- /
us 5,968,022
US 2003/0171716 Al
US 2004/0030303 Al
US 8,409,140 B2
THE REJECTIONS ON APPEAL
Oct. 19, 1999
Sept. 11, 2003
Feb. 12,2004
Apr. 2, 2013
Claims 29 and 61 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Ejlersen and Saito.
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Application 12/673,847
Claims 29, 30, 32, 34, 36, 37, 49-54, 56 and 60-62 are rejected under
35 U.S.C. § 103(a) as unpatentable over Ejlersen and Prais. 1' 2, 3
Claims 29, 30, 32, 34, 36, 37, 49-54, 56, 60, and 62 are rejected on
the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1-20 of Ejlersen '140.
ANALYSIS
The double-patenting rejection of
claims 29, 30, 32, 34, 36, 37, 49-54, 56, 60, and 62
In the Examiner's Answer, the Examiner maintains"[ e ]very ground of
rejection set forth in the Office action dated 5/29/13" (i.e., the Final Office
Action). Ans. 2. The Examiner seems to have overlooked Appellant's
Terminal Disclaimer submitted on July 15, 2013, and accepted on July 17,
2013. See Terminal Disclaimer review decision, Document Code DISQ; see
also Br. 22. The Examiner does not indicate that there is any deficiency
with Appellant's submitted disclaimer and accordingly, we do not sustain
the Examiner's double-patenting rejection of claims 29, 30, 32, 34, 36, 37,
49-54, 56, 60, and 62.
1 The Examiner listed claims 55 and 57-59 but these claims have either
been withdrawn or canceled. See supra.
2 The Examiner did not include claims 60 and 62 in the header that lists the
claims rejected. Final Act. 3. However, in the body of the rejection, the
Examiner references both claims "60 and 62" as being rejected. Final Act.
4. Appellant acknowledges, "the Office Action mentions claim 60 as
rejected on page 4" but is silent regarding the rejection of claim 62. Br. 16.
Because Appellant acknowledges the rejection of claim 60, we are of the
opinion that Appellant is likewise aware of the rejection of claim 62. We
treat the Examiner's omission of claims 60 and 62 in the header as
inadvertent error.
3 See infra regarding dependent claim 52.
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Application 12/673,847
The rejection of claims 29 and 61
as unpatentable over Ejlersen and Saito
Appellant presents separate arguments for independent claim 29 and
its dependent claim 61. Br. 19-22. We address each claim separately.
Claim 29
Claim 29 is directed to an injection apparatus comprising an injection
needle wherein "the tip of the injection needle is closer to the longitudinal
axis of the shaft portion than is an outside of the shaft portion." The
Examiner relies on the teachings of Ejlersen for disclosing an injection
apparatus having an injection needle, but relies on the teachings of Saito for
disclosing the claimed geometry of the needle tip. Final Act. 2-3. The
Examiner concludes that it would have been obvious "to modify the device
of Ejlersen with a tip of the needle" "as taught by Saito, for the benefits of
minimizing the pain incident to injection and reducing the risk of the
membrane cracking adjacent to the injection site." Final Act. 3. The
Examiner provides further elaboration on the reason to combine Ejlersen and
Saito in the Examiner's Answer. See Ans. 19 ("[I]nfl[i]cting less injury to
the skin, blood vessel or other tissue at the point of injection.").
Despite the reasons provided by the Examiner, Appellant contends,
"[t]he justification for obviousness is not supported" and "[t]he Office
Action lacks any explanation providing the basis for this assertion" (the
assertion being the minimization of patient pain and tissue damage). Br. 19;
see also Br. 21. Appellant further contends, "[t]here is no disclosure in
either reference related to a membrane cracking, and the only discussion of
minimizing pain is discussed in Saito' s prior art section." Br. 19. The
discussion in Saito referenced by Appellant (which the Examiner references
more specifically as Saito 1 :52-67 (Ans. 19)) states that if the tapering wall
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Application 12/673,847
thickness of the needle "is made very thin during manufacturing, the point is
very sharp and will inflict less injury to the skin, blood vessel or other tissue
at the point of injection." This statement in Saito tracks that expressed by
the Examiner (see Ans. 19), and the fact that this statement was made under
the heading "2. Prior Art" in Saito (see col. 1, 1. 30) does not diminish the
ability of such teachings to be relied upon by the Examiner when providing
articulated reasoning with rational underpinning to support the legal
conclusion of obviousness. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Appellant's contentions are not persuasive of Examiner error.
Appellant also contends, "Saito is not analogous art." Br. 20.
Appellant alleges that the invention relates to "a different field of endeavor
than injection into the bloodstream (Saito)" and that the Examiner "has not
demonstrated why [Saito] is reasonably pertinent to the problems related to
injection at a predetermined depth." Br. 20. The Examiner finds that "Saito
discloses a needle injection including bevels for reducing needle penetration
force" that reduces the risk of tissue damage. Ans. 19. "Therefore, Saito is
in the same field (e.g. needle injection for inserting into skin) with
applicant's endeavor." Ans. 19.
It is not disputed that Saito is directed to hollow needles for injection
into a patient, or that Saito is directed to manufacturing a needle with a very
sharp point so as to "inflict less injury to the skin." Saito Title, Abstract, and
1 :52-59. Hence, we are not persuaded that Saito pertains to a different field
of endeavor than the claimed invention (hollow needles that pierce skin), nor
are we persuaded that Saito is not reasonably pertinent to the particular
problem with which the inventor was involved (avoiding tissue damage).
Accordingly, Appellant's contention that "Saito is not analogous art" (supra)
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is not persuasive of Examiner error. In other words, we are not persuaded
the Examiner erred in relying on Saito for the reasons stated.
Appellant further contends, "One of Ordinary Skill Would Not
Modify Ejlersen Based On Saito." Br. 20; see also Br. 21. Appellant's basis
for this contention is that "[ n ]eedles used for injection into a bloodstream
will have different properties and considerations than needles used for
injection into an entirely different area of the body." Br. 20. The Examiner
disagrees, stating that a needle based on the teachings of Saito "would
provide the benefits of reducing needle penetration force, minimizing the
pain incident to injection, [and] reducing the risk of the membrane cracking
adjacent to the injection site." Ans. 19. Appellant is not persuasive that one
skilled in the art would fail to modify Ejlersen based on Saito so as to
achieve these features.
Appellant also contends that "Saito is unrelated to injection at a
predetermined depth" (Br. 21) but Saito was not relied on for this reason.
The Examiner relied on Ejlersen for this teaching. Final Act. 2.
Accordingly, based on the record presented, we sustain the
Examiner's rejection of independent claim 29 as unpatentable over Ejlersen
and Saito.
Claim 61
Claim 61 depends directly from claim 29 and includes the additional
limitation that the needle configuration of claim 29 is achieved "by bending
the tip of the injection needle." We agree with Appellant that the Final
Office action "has not addressed these features" (i.e., "bending the tip"). Br.
22. Appellant explains why "bending provides a structural difference over
other ways to form a needle tip (such as grinding)" and that "this product by
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process feature results in a structure that is different than other
manufacturing processes."4 Br. 22. The Examiner does not rely on claim 61
as employing a product by process limitation but instead, relies on Saito for
specifically disclosing a needle shaft that is formed "by bending the tip of
the injection shaft." Ans. 17; see also Ans. 18, 20. However, the Examiner
does not identify where Saito actually teaches "bending" to form the tip as
claimed. Instead, Saito is directed to grinding different bevels on the needle
so as to achieve a sharp tip. See, e.g., Saito Abstract, 2:39--45, 3: 1-3, and
4:3-6. Because the Examiner appears to rely on an express disclosure in
Saito of a bending of the needle tip (as contrasted with a rationale based on a
product by process), we do not sustain the Examiner's rejection of
dependent claim 61.
As an aside, we are instructed by our reviewing court that "[ w ]here a
product-by-process claim is rejected over a prior art product that appears to
be identical, although produced by a different process, the burden is upon
the applicants to come forward with evidence establishing an unobvious
difference between the claimed product and the prior art product." In re
Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983) (citations omitted). We make no
determination as to any unobvious differences that may arise from the
structural differences enumerated by Appellant supra in view of the
Examiner's rejection not being based on a product by process rationale.
4 "For example, bending may tend to form a smoother final surface and/or
may deform the grain structure of the needle differently than other methods
of manufacturing." Br. 22.
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The rejection of claims 29, 30, 32, 34, 36, 37, 49-54, 56 and 6()-62
as unpatentable over Ejlersen and Prais
Appellant argues independent claim 29 separately (Br. 8-9),
independent claim 30 separately (Br. 9-14), claims 29 and 30 together (Br.
14-16), dependent claim 60 separately (Br. 16), dependent claim 61
separately (Br. 16-17), and dependent claim 52 separately (Br. 17-19). We
address each of claims 29, 61, 30, 60, and 52 (in that order) with the
remaining claims standing or falling with their respective parent claim. See
37 C.F.R. § 41.37(c)(l)(iv).
Claim 29
As stated supra, claim 29 is directed to an injection apparatus
comprising an injection needle wherein "the tip of the injection needle is
closer to the longitudinal axis of the shaft portion than is an outside of the
shaft portion." In this rejection, the Examiner relies on Prais, and
particularly Figures 8 and 9 thereof, for disclosing this limitation. Final Act.
4. The Examiner also replicates Figure 8 of Prais, providing annotations as
to how this figure teaches this limitation by identifying distances "a" and "b"
and stating that distance "a" "is shorter than distance b." Ans. 9.
Appellant "submits that Figs. 8 and 9 of Prais are rotated views of the
needle" and that, because of such rotation, "the tip of the needle is not closer
to the longitudinal axis of the shaft portion than is an outside of the shaft
portion." Br. 8 (referencing Prais ,-i,-i 25 and 26). Indeed, these two
paragraphs in Prais state that Figures 8 and 9 show the needle as being
"rotated" about the central (longitudinal) axis. See also Prais ,-i,-i 44 and 45.
Consequently, the distances "a" and "b" provided by the Examiner (Ans. 9)
are not both in the same plane such that a visual comparison of their
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respective lengths can be made. Instead, distance "a" is to a tip of a needle
that has been rotated out of the plane of the paper (i.e., the plane in which
distance "b" is shown).
Accordingly, Appellant has shown the Examiner erred in relying on
rotated Figures 8 and 9 of Prais as depicting a difference in the respective
distances from the longitudinal axis. We reverse the Examiner's rejection of
claim 29 as being unpatentable over Ejlersen and Prais.
Claim 61
Claim 61 depends directly from claim 29. In addition to the reasons
for reversing parent claim 29 supra, we additionally disagree with the
Examiner's reliance on Prais for teaching a needle tip configuration that is
achieved "by bending the tip of the injection needle" as recited in claim 61.
Final Act 4; see also Ans. 17-18. Instead, we agree with Appellant that, "it
is clear from Fig. 6 of Prais ... that the tip of the needle in Prais is not bent."
Br. 1 7. The Examiner does not elaborate as to where Prais teaches that the
configuration of the needle tip is achieved by bending, only that it is. Final
Act. 4; Ans. 17-18. The Examiner's replication of Figure 8 of Prais (Ans.
18), which depicts a rotated needle, is not indicative of a bent needle tip as
much as it is an illustration of a tapered needle that is no longer in the plane
of the paper. Such a figure is not a disclosure of a needle tip configuration
that is achieved "by bending" as recited. Accordingly, and in addition to the
reasons discussed above regarding parent claim 29, we reverse the
Examiner's rejection of dependent claim 61.
Claim 30
Claim 30 includes a limitation directed to a range of the outer
diameter of the needle "and the length of the lumen opening of the needle"
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when this length "is measured parallel to the longitudinal axis of the needle."
The Examiner provides two rationales for the rejection of claim 30. The
first is to the effect that Prais discloses such a "length" and as a result of this
"length," the Examiner has calculated that Prais' ratio is within the cited
ratio. Final Act. 4; see also Ans. 9-14. Appellant addresses this first
rationale and argues how the Examiner's determination of Prais' "length"
differs from the claimed "length" (whose end-points are identified at Spec.
21 :32-34 and Figure 12). Br. 9-12.
The Examiner alternatively finds that it would have been obvious to
provide a lumen opening in the cited range "since it has been held that
discovering an optimum value of a result effective variable (e.g., the length
of the lumen opening defines a flow path) involves only routine skill in the
art." Final Act. 5; see also Ans. 12, 17. Appellant does not present any
argument to the effect that it is beyond the ability of one skilled in the art to
optimize the needle tip variables discussed in Prais. See e.g., Prais iii! 43, 45,
48, and 49 discussing variations in bevel length "L" and bevel angle "1340"
at the end of the needle. See also Prais Figs. 4 and 9. Further, Appellant's
Specification does not indicate that there is any criticality or significance
associated with this cited range. See, e.g., Spec. 7:5-6; 7:20-22; 12:24-26;
13:30-32, 20:14-16, and 21:34-36; see also Ans. 16. However, in
Appellant's Appeal Brief, Appellant sets forth reasons why "a needle with
the specified ratio" "may" be helpful, but these reasons are directed to the
position of the needle with respect to the patient, and to tissue damage, with
no elaboration as to how a needle outside this claimed range would be any
different. Br. 12.
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Instead, Appellant relies on a lack of a reason to combine, and
hindsight in an effort to show Examiner error. Br. 12; see also id. at 14.
These are not persuasive in view of the Examiner's expressed reasons (see
Final Act. 4; see also Ans. 15, 16) and in view of the Examiner's finding
that Prais addresses variations in the relationship between needle angle and
lumen length. Ans. 15; see also Prais iJ 49. Appellant further alleges non-
analogous art (Br. 13-16) but this allegation is not persuasive for similar
reasons discussed supra, i.e., "Prais discloses a needle injection including
bevels for reducing needle penetration force," and the like. Ans. 16. In
other words, we agree with the Examiner that "Prais is in the same field."
Ans. 16.
Accordingly, we are not persuaded the Examiner erred in rejecting
claim 30 as being unpatentable over Ejlersen and Prais. We sustain the
Examiner's rejection of independent claim 30 and its dependent claims 32,
34, 36, 37, 49-51, 53, 54, 56 and 62.
Claim 60
Claim 60 depends directly from claim 30 and further recites that the
ratio of the length of the lumen opening "is in a range from 8 to 12 times"
the outer diameter of the needle shaft. Appellant contends, "[a] ratio
between 5 and 6 is not within the range from 8 to 12 as recited in claim 60."
Br. 16. However, Appellant does not indicate how the Examiner erred in
finding that this recited ratio is obvious based on "discovering an optimum
value of a result effective variable." Final Act. 5. We sustain the
Examiner's rejection of claim 60.
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Claim 52
Claim 52 depends from claim 30 and includes the additional limitation
that a part of the needle's point "is formed substantially parallel to the
longitudinal axis of the needle." In making this rejection, the Examiner
references Saito for showing "that a part of the point of the injection needle
60170 is formed substantially parallel to the longitudinal axis of the needle."
Final Act. 5; see also Ans. 18. Appellant notes the Examiner's reliance on
Saito stating, "[ d]ue to reliance on Saito, Appellant believes that the
rejection is in fact a three-way combination of Ejlersen, Prais and Saito
despite no such rejection of claim 52 being explicitly set forth in the Office
Action." Br. 17. We agree that the Examiner, in rejecting claim 52, also
relies on the reference to Saito in view of statements made in the body of
this rejection. Final Act. 5. After acknowledging this "three-way
combination," Appellant argues, "[ n Jo justification for obviousness related
to such a three-way combination is present in the Office Action and
therefore the rejection is improper." Br. 17.
It is not disputed by Appellant that Saito (as well as Prais) discloses
the claimed parallel arrangement. See Br. 17; see also Ans. 18. However,
the Supreme Court has provided guidance that "in order to determine
whether there was an apparent reason to combine the known elements in the
fashion claimed ... this analysis should be made explicit." KSR, 550 U.S. at
418. The Examiner provides no further discussion or justification for this
rejection other than that this feature is taught by Saito and Prais. Final Act.
5; Ans. 18. In short, we agree with Appellant that the Examiner has not
provided any articulated reasoning with rational underpinning to support the
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conclusion of obviousness. We reverse the Examiner's rejection of claim 52
as being obvious over Ejlersen, Prais, and Saito.
DECISION
The Examiner's rejection of claims 29, 30, 32, 34, 36, 37, 49-54, 56,
60, and 62 on the ground of nonstatutory obviousness-type double patenting
is reversed.
The Examiner's rejection of claim 29 as unpatentable over Ejlersen
and Saito is affirmed.
The Examiner's rejection of claim 61 as unpatentable over Ejlersen
and Saito is reversed.
The Examiner's rejection of claims 29 and 61 as unpatentable over
Ejlersen and Prais is reversed.
The Examiner's rejection of claims 30, 32, 34, 36, 37, 49-51, 53, 54,
56, 60, and 62 as unpatentable over Ejlersen and Prais is affirmed.
The Examiner's rejection of claim 52 as unpatentable over Ejlersen,
Prais, and Saito is reversed.
In summary, the Examiners rejections of claims 29, 30, 32, 34, 36, 37,
49-51, 53, 54, 56, 60, and 62 are affirmed. Likewise, the Examiner's
rejections of claims 52 and 61 are reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED-IN-PART
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