Ex Parte MATHENY

Patent Trial and Appeal Board

Jan 23, 2019

13679978 (P.T.A.B. Jan. 23, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/679,978 11/16/2012
135206 7590 01/25/2019
Wick Phillips Gould & Martin LLP
5700 Granite Parkway, Suite 330
Plano, TX 75024
FIRST NAMED INVENTOR
Keith E. MATHENY
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.
5868-00101 4694
EXAMINER
BACHMAN, LINDSEY MICHELE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/25/2019 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):
jerry.harris@wickphillips.com
wppatents@wickphillips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEITH E. MATHENY 1
Appeal2018-004087
Application 13/679,978
Technology Center 3700
Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
LISA M. GUIJT, 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 1, 3---6, 13, 16-20, 22-27, and 29-31,
which constitute all the claims pending in this application. Final Act. 1
(Office Action Summary). We have jurisdiction under 35 U.S.C. § 6(b ).
For the reasons explained below, we do not find error in the Examiner's
rejections of these claims. Accordingly, we AFFIRM the Examiner's
rejections.
1 "The real part in interest is Matheny ENTerprises, assignee of record."
App. Br. 2. We thus proceed on the basis that, for purposes of this appeal,
Matheny ENTerprises is the "Appellant."
Appeal2018-004087
Application 13/679,978
CLAIMED SUBJECT MATTER
The disclosed subject matter relates to "a biodegradable nasal splint,
wherein the biodegradable nasal splint is configured for placement within a
nasal passage so as to stabilize a surgically-corrected septum." Spec. ,r 9.
Claims 1, 13, and 22 are independent.
Claim 1 is illustrative of the claims on appeal and is reproduced
below.
1. A biodegradable nasal splint comprising:
a tubular component at least partially defining a hollow
passageway and a flap extending outward from the tubular
component, wherein the tubular component and the flap are
formed from a degradable material, wherein the degradable
material comprises at least 50% chitosan by weight of the
degradable material, wherein the biodegradable nasal splint is
configured for placement between a septum and an inferior
turbinate so as to apply a horizontally opposing force between
the nasal septum and the inferior turbinate.
Eliachar
Patterson
Eaton et al.
Bradley
Slager et al.
Dubin
REFERENCES
us 5,350,396
US 6,186,965 B 1
US 2007/0005094 Al
US 2008/0249428 Al
US 2008/0038354 Al
US 2010/0106255 Al
Sept. 27, 1994
Feb. 13,2001
Jan.4,2007
Oct. 9, 2008
Feb. 14,2008
Apr. 29, 2010
Karatzanis, Alexander D., et al., Septoplasty outcome in patients with
and without allergic rhinitis, 47 RHINOLOGY 444--49 (2009).
THE REJECTIONS ON APPEAL
Claims 29-31 are rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement. Final Act. 4.
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Application 13/679,978
Claims 1, 3-5, and 29 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dubin, Patterson, and Slager. Final Act. 4.
Claim 6 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Dubin, Patterson, Slager, and Eaton. Final Act. 6.
Claims 13, 16, 19, 20, 22, 23, 26, 27, 30, and 31 are rejected under
35 U.S.C. § 103(a) as being unpatentable over Eliachar, Patterson, and
Slager. 2 Final Act. 7.
Claims 17 and 24 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Eliachar, Patterson, Slager, and Karatzanis. Final Act. 9.
Claims 18 and 25 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Eliachar, Patterson, Slager, and Bradley. Final Act. 10.
ANALYSIS
The rejection of claims 29-31
for failing to comply with the written description requirement
Each of claims 29-31 recites "the degradable material optionally
further comprises chitin, and wherein the degradable material comprises at
least 90% by weight of chitosan and chitin." App. Br. 24 (Claims App.).
The Examiner determines that paragraph 63 of the Specification is "a
'laundry list' disclosure of every possible moiety [that] does not constitute
a written description of every species in a genus because it would not
'reasonably lead' those skilled in the art to any particular species," and thus,
"the limitations of claims 29-31 are considered to be new matter." Final
Act. 4 (citing M.P.E.P. § 2163.05 II); Ans. 6-7.
2 The Examiner also listed claim 28, but claim 28 is canceled. See App.
Br. 24 (Claims App.).
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Application 13/679,978
The written description requirement is satisfied when the disclosure of
the application reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.
Ariad Pharmaceuticals v. Eli Lilly, 598 F.3d 1336, 1351 (Fed. Cir. 2010).
Here, the Examiner recognizes, "the specification discloses the use of
chitosan and chitin in constructing the nasal splint and further discloses the
nasal splint can be at least 90% by weight degradable material." Final Act.
4; see also Spec. ,r,r 62---63. Thus, Appellant has shown possession of the
subject matter of claims 29-31. Although paragraph 63 of the Specification
lists a number of degradable polymers that may be used for a BSS/BAIESS
(biodegradable structural support/biodegradable, active ingredient-eluting
structural support), contrary to the Examiner's assertion, nothing in this
paragraph implies that the list is intended to represent a "laundry list" of
every possible degradable polymer, or is a reference to "every species in a
genus." Final Act. 4; Ans. 7.
For these reasons, we do not sustain the rejection of claims 29-31
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
The rejection of claims 1, 3-5, and 29
as being obvious over Dublin, Patterson, and Slager
Appellant argues claims 1, 3-5, and 29 together. App. Br. 5-18;
Reply Br. 2-7. We select claim 1 for review, with claims 3-5 and 29
standing or falling therewith. See 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that Dubin discloses a nasal splint comprising a
tubular component (body 12) defining a hollow passageway 36 and a flap
(retention member 20). Final Act. 5 ( citing Dubin Fig. 4; ,r 1 ); see also
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Dubin Fig. 2. The Examiner acknowledges that Dubin "fails to disclose the
splint is made of a degradable material." Final Act. 5. The Examiner relies
on Patterson as disclosing a nasal splint constructed out of a biodegradable
material. 3 Final Act. 5 ( citing Patterson 1: 5-10). The Examiner concludes
that it would have been obvious to modify the nasal splint of Dubin to be
constructed of an absorbable material, as taught by Patterson, to "eliminate[]
the need for a patient to have a follow-up visit with a doctor for splint
removal and because removal can be sometimes be difficult and painful."
Final Act. 5 (citing Patterson 1:38-50).
The Examiner also acknowledges that "Dubin '255 and Patterson '965
fail to disclose the splint is constructed from chitosan." Final Act. 5. The
Examiner, however, concludes that it would have been obvious as a matter
of design choice, to modify the nasal splint of Dubin and Patterson to be
made of chitosan "because [Appellant] has not disclosed that this particular
absorbable material provides an advantage, is used for a particular purpose,
or solves a stated problem" and because an ordinary artisan would have
expected the nasal splint, made from materials disclosed in Patterson, "to
perform equally [as] well" as a nasal splint made of chitosan. Final Act. 5-
6.
Alternatively, the Examiner finds that Slager discloses "an absorbable
nasal splint (paragraph [0170]) and teaches [that] the splint can be made of
chitosan (paragraph [0108])." Final Act. 6. The Examiner concludes that it
would have been obvious to modify the nasal splint of Dubin and Patterson
3 The Examiner points out that Patterson discloses that its nasal splint can be
completely made of a biodegradable material, and thus, its nasal splint is at
least 50% by weight of a degradable material, as claimed. See Ans. 5.
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to be made of chitosan, as taught by Slager, "since it has been held to be
within the general skill of a worker in the art to select a known material on
the basis of its suitability for the intended use as a matter of obvious design
choice." Final Act. 6 (citing In reLeshin 277 F.2d 197 (CCPA 1960)).
Appellant seems to agree with both of the above "design choice"
rationales because when addressing the written description issue, Appellant
states "that the skilled artisan would have been 'reasonably led' to a
degradable material that includes both chitosan and chitin." App. Br. 19.
However, Appellant contends, "Patterson's disclosure would not have
caused the skilled artisan to believe that [] the device disclosed by Dubin []
might be improved by making [Dubin's] device[] degradable." App. Br. 8.
As support, Appellant argues that Patterson's device has a different shape
and that Dubin's design "must have sufficient mechanical activity to"
remain operational. App. Br. 9 (referencing Patterson 3:52--4:20).
According to Appellant, "[t]he skilled artisan would appreciate that the
materials employed in making Dubin 's stent [] biodegradable are critical to
the way in which those device[s] perform" and "[t]he fact that Patterson
might disclose a biodegradable nasal splint does not demonstrate the
obviousness of making[] Dubin 's stent [] biodegradable." App. Br. 10; see
also Reply Br 2-7. To be clear, Appellant contends that based on
Patterson's disclosure, there is no "reasonable expectation of success in
attempting to make [Dubin's] device[] biodegradable." Reply Br. 3.
These arguments are unpersuasive. Appellant does not provide
evidence or persuasive argument to show that the shape of, or the
mechanical activity relating to Dubin's nasal splint, would preclude the use
of a degradable material since Patterson clearly discloses that a degradable
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material is suitable for use in making nasal splints. See Patterson Abstract.
Further, "attorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness." In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997).
Appellant also argues that modifying Dubin' s device to be made of
chitosan would not have been a design choice because "the skilled artisan
must first have recognized that a nasal splint formed from a degradable
material including chitosan would be functionally equivalent to known nasal
splints" and that "the Examiner has not demonstrated the suitability of
chitosan for making an absorbable nasal splint." App. Br. 10-11. This
argument is also unpersuasive. The Examiner points to paragraphs 108 and
170 of Slager which disclose that "degradable polymers can include
modified polysaccharides such as ... chitosan" and that the devices
contemplated by Slager include "ear[,] nose[,] and throat devices such as[,]
nasal buttons [and] nasal and airway splints." See Final Act. 6; Slager ,r,r
108, 170. Accordingly, the Examiner has demonstrated the suitability of
using chitosan in making nasal splints.
Further, we note that Appellant discusses "a biodegradable, active
ingredient-eluting structural support (BAIESS)" (Spec. ,r 42) and that Slager
similarly discloses "polymeric matrices for the controlled release of a
hydrophilic bioactive agent" or an "elution control matrix" (Slager Abstract
( emphasis added)). Such common functionality of Appellant's and Slager' s
devices, and Appellant's earlier statement regarding how a "skilled artisan
would have been 'reasonably led"' to chitosan (App. Br. 19), further support
the Examiner's position that it would have been obvious to modify the
device of Dubin to be made of chitosan.
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Appellant next contends that "Slager does not disclose an absorbable
nasal splint made from chitosan and, therefore, does not demonstrate the
suitability of chitosan for making a biodegradable nasal splint." App. Br.
12; emphasis omitted. Appellant argues that Slager only discloses that some
devices might be "composed of the matrix itself' and "only some of the
multitude of devices listed in" Slager' s paragraph 170 might be formed from
the elution controlled matrix because "the skilled artisan would not read
Slager to suggest that a pace-maker or battery [ which are disclosed in
paragraph 170] might be formed from chitosan" or because "the disclosed
matrix-forming composition may [only] be used as a coating applied to these
devices." App. Br. 13; emphasis omitted. As such, Appellant argues that
the rejection is based on impermissible hindsight reconstruction. See App.
Br. 13-15.
Appellant's arguments ignore the explicit disclosure in Slager's
paragraphs 108 and 170 as reproduced above. Contrary to Appellant's
contention, the Examiner's rationale for modifying the device of Dubin is
based on evidence and sound technical reasoning rather than impermissible
hindsight reconstruction.
We also note that "[t]he combination of familiar elements according
to known methods is likely to be obvious when it does no more than yield
predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416
(2007). "If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." KSR, 550 U.S. at 417. In this case, we
find that the strong evidence demonstrating that the claimed subject matter is
nothing more than the application of a known technique to a known device
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ready to yield predictable results, and that there is reasonable expectation of
success in making Dubin's device biodegradable. See also Ans. 4.
Lastly, Appellant argues that "[t]he Matheny Declarationl41
demonstrates that the claimed biodegradable nasal splint formed from a
degradable material that comprises chitosan meets a long-felt, unresolved
need in the art." App. Br. 16. Appellant contends that the Declaration
shows that there are "numerous problems associated with conventional nasal
splints, like the Doyle Splint, for which a patent application was filed over
40 years ago," "[t]hese problems have existed for a substantial period of
time and continue to the present," and "[t]hus, there is clearly a 'long-felt'
and continuing need to overcome the problems associated with conventional
nasal splints." App. Br. 17; see also Reply Br. 5---6.
Establishing long-felt need requires objective evidence that an art-
recognized problem existed in the art for a long period of time without a
solution. In particular, the evidence must show that the need was a
persistent, yet unfulfilled one that was recognized by those of ordinary skill
in the art. In re Gershon, 372 F.2d 535,539 (CCPA 1967). "[L]ong-felt
need is analyzed as of the date of an articulated identified problem and
evidence of efforts to solve that problem." Texas Instruments, Inc. v. ITC,
988 F.2d 1165, 1178 (Fed. Cir. 1993).
The Declaration addresses a 40 year old Doyle device and does not
take into consideration the more current teachings of Patterson and Slager,
as discussed above. Further, Appellant does not present evidence that others
considered the lack of a chitosan nasal splint as undesirable, or as presenting
4 Declaration of inventor Keith E. Matheny filed on June 3, 2016.
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a problem in need of a solution. As such, Dr. Matheny' s testimony is not
sufficient to establish that an industry-recognized problem existed in the art.
Thus, we agree with the Examiner that the Declaration is unpersuasive in
that it does not cite sufficient objective evidence. See Ans. 6.
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claims 1, 3-5, and 29 as being obvious over
Dubin, Patterson, and Slager. We thus sustain the rejection of these claims.
The rejection of claim 6
as being obvious over Dubin, Patterson, Slager, and Eaton
Appellant does not present substantive arguments regarding the
rejection of claim 6, which depends from claim 1. App. Br. 5-18; Reply Br.
2-7. We thus sustain the rejection of claim 6 for the same reasons as
discussed above for claim 1.
The rejection of claims 13, 16, 19, 20, 22, 23, 26, 27, 30, and 31
as being obvious over Eliachar, Patterson, Slager, and Karatzanis
Appellant argues all these claims together. App. Br. 5-18; Reply Br.
2-7. We select claim 13 for review, with claims 16, 19, 20, 22, 23, 26, 27,
30, and 31 standing or falling therewith.
In regard to claim 13, the Examiner finds that Eliachar discloses "a
method of performing a corrective procedure with respect to a patient's nasal
passage and positioning a splint between the patient's septum and the
inferior turbinate." Final Act. 7-8 ( citing Eliachar Fig. 1; 1: 10-25). The
Examiner acknowledges Eliachar "fails to disclose the splint is
biodegradable" and "fail[ s] to disclose [a] biodegradable material [ made of]
chitosan." Final Act. 8. Similar to the rejection of claim 1 as discussed
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above, the Examiner relies on Patterson and Slager as disclosing these
missing limitations, respectively. See Final Act. 8-9.
Appellant's arguments parallel those presented above regarding claim
1. See App. Br. 5-18; Reply Br. 2-7. Because we find no deficiencies in
the Examiner's rejection of claim 1 as being obvious over Dubin, Patterson,
and Slager (see supra), for similar reasons, we likewise sustain the
Examiner's rejection of claims 13, 16, 19, 20, 22, 23, 26, 27, 30, and 31 as
being obvious over Eliachar, Patterson, and Slager.
The rejection of claims 17 and 24
as being obvious over Eliachar, Patterson, Slager, and Karatzanis
The rejection of claims 18 and 25
as being obvious over Eliachar, Patterson, Slager, and Bradley
Appellant does not present substantive arguments regarding the
rejections of claims 17, 18, 24, and 25, which depend either from claim 13
or claim 22. App. Br. 5-18; Reply Br. 2-7. Accordingly, we sustain the
rejections of claims 17, 18, 24, and 25 for the same reasons discussed above.
DECISION
The Examiner's rejection of claims 29-31 under 35 U.S.C. § 112, first
paragraph, for failing to comply with the written description requirement is
reversed.
The Examiner's art rejections of claims 1, 3---6, 13, 16-20, 22-27, and
29-31 under 35 U.S.C. § 103(a) are affirmed.
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
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