Theresa Hermel-Davidock et al.

Patent Trials and Appeals Board

Nov 27, 2019

14805620 - (D) (P.T.A.B. Nov. 27, 2019)

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.
14/805,620 07/22/2015 Theresa Hermel-Davidock P-9514 5659
67309 7590 11/27/2019
Servilla Whitney LLC/BDX
33 Wood Ave South, Suite 830
Iselin, NJ 08830
EXAMINER
OLADAPO, TAIWO
ART UNIT PAPER NUMBER
1771
NOTIFICATION DATE DELIVERY MODE
11/27/2019 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):
docket@dsiplaw.com
ip.docket@bd.com
lmurphy@dsiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THERESA HERMEL-DAVIDOCK and LISA LIM
Appeal 2019-002611
Application 14/805,620
Technology Center 1700

Before ADRIENE LEPIANE HANLON, LINDA M. GAUDETTE, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1, 10, 11, 15–18, 21, and 23–27. See
Appeal Br. 9–16. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 This Decision includes citations to the following documents:
Specification filed July 22, 2015 (“Spec.”); Final Office Action mailed May
7, 2018 (“Final Act.”); Appeal Brief filed October 29, 2018 (“Appeal Br.”);
Examiner’s Answer mailed December 12, 2018 (“Ans.”); and Reply Brief
filed February 12, 2019 (“Reply Br.”).
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Becton,
Dickinson, and Company. Appeal Br. 3.
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CLAIMED SUBJECT MATTER
Appellant states the invention relates to a polymer resin composition
including a chemically attached lubricant structure, which may be used to
produce a self-lubricating medical device. Spec. ¶ 2. In particular, the
Specification states the polymer resin composition is a self-lubricating
polyurethane resin with a lubricant chemically attached within the
polyurethane resin. Id. ¶ 6. Claim 1, reproduced below, is illustrative of the
claimed subject matter (Appeal Br. 25, Claims Appendix):
1. A self-lubricating polyurethane comprising a reaction product
of:
a diisocyanate selected from the group consisting of 4,4-
diphenyl methane diisocyanate (MDI), toluene diisocyanate
(TDI), isophorone diisocyanate (IPDI), and methylene bis (4-
cyclohexyl isocyanate) (HMDI); and
a diol mixture containing:
a short chain diol selected from the group consisting of
ethylene glycol, 1,3-propylene glycol, 1,4-butane diol, neopentyl
glycol, and alicyclic glycols having up to 10 carbon atoms,
a long chain polyether diol comprising
poly(tetramethylene ether) glycol, and
a diol-containing lubricant comprising
polydimethylsiloxane diol;
the diol-containing lubricant being incorporated into a
backbone formed by the diisocyanate and the diol mixture;
wherein the diol-containing lubricant is present in an
amount ranging from about 1 to about 3 weight percent of the
polyurethane; and
the polyurethane comprises a weight average molecular
weight (Mw) in the range of from about 60,000 g/mol to 115,000
g/mol, and a number average molecular weight (Mn) in the range
of from about 30,000 g/mol to 50,000 g/mol.
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REFERENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Meijs et al.
hereinafter “Meijs”
US 2003/0018156 A1 January 23, 2003

REJECTION3
The Examiner rejected claims 1, 10, 11, 15–18, 21, and 23–27 under
35 U.S.C. § 103 as obvious over Meijs. Ans. 4–8.
Appellant presents separate arguments with respect to claims 1, 21,
and 23–25. Appeal Br. 7–16. We select claims 1, 21, and 23–25 as
representative for disposition of this appeal. 37 C.F.R. § 41.37(c)(1)(iv)
(2017).

OPINION
The Examiner’s Rejection
The Examiner found Meijs discloses a polysiloxane-containing
polyurethane elastomeric composition, where the polysiloxane component is
a lubricant component of the reaction product. Ans. 4. The Examiner found
Meijs discloses a polyether diol including polytetramethylene ether glycol.
Id. The Examiner found Meijs discloses amounts of polysiloxane of from
about 1 to about 60% of the composition, which overlaps the claimed range.
Id. at 4–5. The Examiner found Meijs discloses polyurethanes with number
average molecular weights from about 37,000 to about 90,000 and having a

3 In the Answer, the Examiner withdrew the rejections of claims 12, 13, 20,
28, 29, and 30. Ans. 8.
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polydispersity of from 1.87 to 2.08 such that polyurethanes having weight
average molecular weights of the claims would have been envisaged or at
least would have been obvious. Id. at 5.

Appellant’s Contentions
Appellant argues a polyurethane having the weight average molecular
weight (Mw) and number average molecular weight (Mn) recited in claim 1
would not have been obvious in view of Meijs, because the polyurethanes in
Meijs the Examiner relied on for the molecular weights are chemically
different from the recited polyurethanes. Appeal Br. 9–10. Appellant
contends Meijs fails to render obvious a lubricant in an amount ranging from
about 1 to about 3 weight percent, because Meijs teaches away from
amounts within the recited range, which are inconsistent with providing
materials that are suitable for long-term implantation. Id. at 11–13.
Appellant argues the present application demonstrates unexpected results
with respect to coefficient of friction and tensile at break properties with
polyurethanes including 1 to 3 weight percent polydimethylsiloxane. Id. at
20–23.

Issue
The dispositive issue is:
Considering the evidence as a whole, has Appellant identified
reversible error in the Examiner’s determination that a polyurethane having
weight average molecular weights, number average molecular weights, and a
polydimethylsiloxane diol component in an amount ranging from about 1 to
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about 3 weight percent of the polyurethane would have been obvious in view
of Meijs?

Discussion
Molecular Weights
We are not persuaded by Appellant’s arguments that the polyurethane
having the diisocyanate, short chain diol, diol-containing lubricant, and
poly(tetramethylene ether) glycol having a Mw in the range of 60,000 g/mol
to 115,000 g/mol and a Mn in the range of from about 30,000 g/mol to
50,000 g/mol recited in claim 1 is a non-obvious difference between the
claims in the prior art. Appeal Br. 9. In particular, we are not persuaded the
Examiner reversibly erred in relying on polyurethanes disclosed in Meijs
including polyhexamethylene oxide (PHMO) rather than polyurethanes
including poly(tetramethylene ether) glycol, also known as
polytetramethylene oxide (PTMO) (see Appeal Br. 10), as recited in claim 1.
Initially, according to Appellant, Meijs discloses polyurethanes
including PTMO are non-preferred. Id. However, Meijs discloses
polyurethanes may include PHMO or PTMO. Meijs, ¶ 68. Accordingly, we
agree with the Examiner that Meijs discloses polyurethanes including PTMO
are within the scope of the inventive polyurethanes disclosed therein. Ans.
8.
As to Appellant’s argument that Meijs discloses examples of
polyurethanes including PTMO that either fail to disclose molecular weights
or discloses Mn outside of the claimed range (Appeal Br. 9), as the
Examiner correctly explains, Meijs discloses useful ranges of molecular
weights based on exemplary embodiments disclosed therein, including Mw
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and Mn overlapping the ranges recited in claim 1. Ans. 9–10 (citing Meijs,
Table 10); Final Act. 4 (citing Meijs, Exs. 3, 9, Tables 2, 6). We further
agree with the Examiner that Meijs does not disclose a particular distinction
between molecular weights of those polyurethanes including PHMO and
those polyurethanes including PTMO. Ans. 10. Thus, we are of the view
the Examiner’s findings with respect to the molecular weight ranges
disclosed in Meijs are reasonable.
We observe also that the ranges of Mw and Mn recited in claim 1
appear to be derived from Table 1 of the Specification, and include
molecular weights from polymers prepared from the same diisocyanate,
short chain diol, long chain polyether diol, and the same
polydimethylsiloxane diol (PDMS) containing lubricant in amounts of 1%,
2%, and 3%. Spec. ¶ 21, Table 1. Claim 1 is not limited to such particular
components and the molecular weight ranges recited in claim 1 are from
different polymer examples and include endpoints outside those disclosed in
Table 1. For instance, the Mw range recited in claim 1 “about 60,000 g/mol
to about 115,000 g/mol” appears to be derived from the Mw of a polymer
containing 1% PDMS of 67,837 g/mol and the Mw of a polymer containing
3% PDMS of 110,300 g/mol. Further, the Mn range recited in claim 1 of
“about 30,000 g/mol to 50,000 g/mol” appears to be derived from the Mn of
a polymer containing 2% PDMS of 31,020 g/mol and the Mn of a polymer
containing 3% PDMS of 48,640 g/mol.
Accordingly, we are of the view that the Examiner’s findings with
respect to the molecular weights of the polyurethanes in Meijs mirror
Appellant’s own disclosure with respect to the Mw and Mn values in claim
1, and as such, are reasonable.
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Thus, we are not persuaded by Appellant’s argument that one of
ordinary skill in the art would have understood that the molecular weights of
polyurethanes in Meijs would be limited by the identity of the polyether
macrodiols used in forming the polymer.

Claim 21
Regarding claim 21, which recites the polyurethane comprises a
polydispersity (Mw/Mn) in the range of from about 1.8 to 2.3, similar to the
above argument, Appellant contends the Examiner’s reliance on Examples 3
and 6 of Meijs in determining the polydispersity recited in claim 21 would
have been obvious is not informative of the claimed polyurethanes because
the polyurethanes of claim 21 are chemically different than those in
Examples 3 and 6 of Meijs. Appeal Br. 14; Final Act. 4, 6.
We are not persuaded for similar reasons as discussed above with
respect to the weight average and number average molecular weights.

Amount of polydimethylsiloxane
We are not persuaded by Appellant’s arguments that Meijs teaches
away from amounts of PDMS recited in claim 1 or that the claimed PDMS
amounts would render Meijs’s composition unsatisfactory for its intended
purpose. Appeal Br. 10–13. In this regard, Meijs discloses expressly “the
weight ratio of polysiloxane to polyether and/or polycarbonate may be in the
range of from 1:99 to 99:1,” which the Examiner found to correspond to an
amount of about 1 to about 60% of the composition. Meijs ¶ 67; Final Act.
4. Although Appellant references a number of other disclosures in Meijs to
argue that when considered in context, Meijs would not lead one of ordinary
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skill in the art to the lower amounts of the disclosed range (Appeal Br. 10–
13, citing Meijs, Abstract,
¶¶ 8, 9, 28, 67, 68, 82, 84, 85, 89, 96, 99, 103, 105, 109; claims 8, 9), this
does not change the express disclosure in Meijs that all ratios of
polysiloxane to polyether/and or poly carbonate in the range of 1:99 to 99:1
form part of the invention, even if less preferred. See Ans. 11–12.
The prior art must be considered as a whole, including non-preferred
embodiments disclosed therein. See Merck & Co., Inc. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989)
(quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)). Indeed, as the
Examiner points out, Meijs discloses a wide range of applications, such that
usefulness of PDMS diol at lower amounts is not precluded. Ans. 12 (citing
Meijs, ¶ 27.)
To the extent Appellant’s argument is based on the position that the
ratios of polysiloxane to polyether/and or poly carbonate disclosed in
paragraph 67 of Meijs are in error, we observe that given the express
disclosure of Meijs of the ratios and the wide range of applications we
discern no apparent error in Meijs. See In re Garfinkel, 437 F.2d 1005, 1008
(CCPA 1971) (“Finally, appellant alleges that the analysis of 5.12%
AL(2)O(3) by Kistler [(the cited prior art publication)] is erroneous. An
affidavit was submitted to show that the glass Kistler used actually contained
only about 2% AL(2)O(3) . . . . We agree with the board that Kistler’s
disclosure would teach one of ordinary skill in the art to use up to 5.12%
AL(2)O(3) since the error, if it exists, is not apparent or obvious from
reading the publication. See, In re Yale, . . . 434 F.2d 666 (CCPA 1970)”).
In addition, Appellant has not provided sufficient evidence, such as
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declaration testimony to support the position that one of ordinary skill in the
art would have understood Meijs to be limited in the way Appellant argues.
Claims 23–25
Appellant contends Meijs does not disclose a polyurethane having the
tensile at the break properties recited in claims 23 and 24, or the coefficient
of friction property recited in claim 25, because Meijs does not disclose the
claimed polyurethanes. Appeal Br. 15–16. We are not persuaded because,
as discussed above, we do not agree that Meijs does not render obvious the
claimed polyurethanes. As pointed out by the Examiner, Appellant has not
provided any meaningful discussion beyond the identity of the polyurethanes
being different to rebut the Examiner’s position. Ans. 13.

Unexpected Results
We are not persuaded by Appellant’s arguments that the results
presented in the Specification are sufficient to demonstrate unexpected
results. Specifically, we are in complete agreement with the Examiner that
the inventive examples are not commensurate in scope with the claims.
Appeal Br. 14–15. As discussed above, the examples are limited to
polyurethanes prepared only with MDI as the isocyanate, 1,4-butane diol as
the short chain diol, a specific polytetramethylene ether glycol, and a
specific polydimethylsiloxane diol. Spec. ¶ 21. Thus, the polyurethanes
encompassed by the scope of the claims are considerably broader than the
polyurethanes tested in the examples. The scope of the “objective evidence
of non-obviousness must be commensurate in scope with the claims which
the evidence is offered to support.” In re Tiffin, 448 F.2d 791, 792 (CCPA
1971); see also In re Peterson, 315 F.3d 1325, 1329–31 (Fed. Cir. 2003).
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Moreover, we are not persuaded by Appellant’s arguments that the
Examiner’s position with respect to the Coefficient of Friction data results
being close and random are conclusory, unclear, and have no technical basis.
Reply Br. 3. That is, the coefficient of friction data in Table 3 demonstrates
that polyurethanes having amounts of PDMS within the range recited in
claim 1 have Coefficients of Friction that are both below and above
polyurethanes having amounts of PDMS outside the range recited in claim 1.
Compare Coefficients of Friction of polyurethanes with 1% PDMS (0.215),
2% PDMS (0.174), 3% PDMS (0.197) with polyurethanes with 4% PDMS
(0.202), 5% PDMS (0.190), 6% PDMS (0.204), 7% PDMS (0.286), and
10% PDMS (0.190). Thus, the Examiner’s reasoning is supported by the
Specification itself. In addition, we agree with the Examiner that the results
appear to relate to the intrinsic lubricating properties of
polydimethylsiloxane diol (Ans. 15), and thus it is not clear that the
Coefficient of Friction results would have been unexpected.
Regarding the tensile at the break properties, we emphasize that the
examples are not commensurate in scope with the claims. Appellant’s
argument that the values of tensile at the break of polyurethanes with
amounts of PDMS of 3% or less are significantly improved compared to 4%
or higher demonstrating criticality (Reply Br. 3–4) is also not persuasive as
Meijs discloses the addition of PDMS has poor mechanical properties
including tensile strength and elongation at break (Meijs, ¶ 6). Therefore, it
stands to reason that a decrease of the values of tensile at the break as the
amount of PDMS is increased does not appear to be unexpected, but rather
depends of the desired tensile at the break of the resulting polyurethane.
Indeed, the Specification allows for the presence of lubricant in amounts
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ranging from about 1 to 10 weight percent of the polyurethane composition.
Spec. ¶ 6, see also claim 24 (reciting a tensile at the break of about 3936 to
about 8210 psi, which encompasses values outside the ranges of
polyurethanes having amounts of PDMS of 1–3% in Table 2).
Thus, considering the evidence as a whole we are not persuaded the
Examiner erred in rejecting the claims as obvious over Meijs.
CONCLUSION
The Examiner’s rejection of claims 1, 10, 11, 15–18, 21, and 23–27
under 35 U.S.C. § 103(a) is affirmed.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 10, 11,
15–18, 21,
23–27
103 Meijs 1, 10, 11,
15–18, 21,
23–27

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED