Silberg, Barry Neil.

Patent Trials and Appeals Board

Apr 28, 2020

14297110 - (D) (P.T.A.B. Apr. 28, 2020)

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.
14/297,110 06/05/2014 Barry Neil Silberg 97605-000121US-926458 3381
20350 7590 04/28/2020
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
PRICE, NATHAN R
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
04/28/2020 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):
KTSDocketing2@kilpatrick.foundationip.com
ipefiling@kilpatricktownsend.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte BARRY NEIL SILBERG
____________

Appeal 2019-005493
Application 14/297,110
Technology Center 3700
____________

Before BRETT C. MARTIN, WILLIAM A. CAPP, and
JILL D. HILL, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 22–24, 26, 28, 29, 33, 34, and 40–45 as unpatentable
under 35 U.S.C. § 112(a) for failure to satisfy the written description
requirement.2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Sonescence, Inc. as the real party in
interest. Appeal Br. 3.
2 A rejection under Section 112(b) has been withdrawn by the Examiner.
Ans. 5. Although such withdrawal appears to be silent as to rejection of
claim 41, the Examiner’s silence regarding the rejection of claim 41
throughout the remainder of the Answer leads us to believe that the
Examiner intended to also withdraw the rejection as to claim 41.
Appeal 2019-005493
Application 14/297,110
2
THE INVENTION
Appellant’s invention relates to administering antibiotics at an open
surgical site. Spec. ¶ 2. Claim 22, reproduced below, is illustrative of the
subject matter on appeal.
22. A method for treating a bacterial infection in a target
tissue in a subject with an antibiotic, where the bacterial
infection is resistant to the antibiotic such that a minimum
inhibitory concentration of the antibiotic with respect to the
bacterial infection is equal to or greater than 64 μg/ml, the
method comprising:
identifying the infected target tissue in the subject;
injecting subcutaneously in the subject a solution
comprising the antibiotic dissolved in the solution, wherein the
antibiotic is not encapsulated in vesicles;
applying a ultrasonic instrument to the subject, the
ultrasonic instrument comprising a handle and a ultrasonic
transducer head coupled with the handle, and wherein the
ultrasonic instrument is applied to the subject by placing the
ultrasonic transducer head against a skin of the subject; and
transcutaneously broadcasting ultrasonic energy from the
ultrasonic transducer head while the ultrasonic transducer head
is applied against the skin of the subject at a frequency within a
range of 0.5 to 5 MHz for 2-5 minutes so as to disperse the
dissolved antibiotic throughout the infected target tissue via
microstreaming to a concentration greater than the minimum
inhibitory concentration of the antibiotic with respect to the
bacterial infection when sampled, thereby treating the antibiotic
resistant bacterial infection.
OPINION
Claims 22–24, 26, 28, 29, 33, and 43
Claim 22 is an independent claim and claims 23, 24, 26, 28, 29, 33,
34, and 43 depend therefrom. Claims App. These claims are argued as a
group. Appeal Br. 6–7. We select claim 22 as representative. See 37 C.F.R.
§ 41.37(c)(1)(iv).
Appeal 2019-005493
Application 14/297,110
3
The Examiner rejects claim 22 as lacking written description support
for the full breadth of the claim. Final Act. 3. In essence, the Examiner
finds that there is insufficient support for claiming a method of treating all
bacterial strain infections, in all possible target tissues, with all possible
antibiotics. Id. “In other words, the specification does not provide support
for the result that all bacterial infections in any target tissue could be treated
with any antibiotic that they are resistant to, using these steps.” Id.
Appellant argues Section 112 does not require “explicit, verbatim”
support. Appeal Br. 6. Appellant further argues that the Specification states
“generally” that the invention relates to a method of administering
antibiotics to prevent infection at an open surgical site. Id. Appellant
further argues that the Specification discusses “examples” that include the
claimed features and concepts. Id.
As one of skill in the art of pharmaceuticals would understand,
the concepts described therein and depicted in the experimental
examples are applicable to other compounds, particularly in the
same group or class, for treatment of drug resistant bacterial
infections.
Id. at 6–7.
In response, the Examiner finds that, notwithstanding Appellant’s
arguments, the Specification fails to disclose a representative number of
species to support a claim to a broad genus. Ans. 6.
It is the Examiner’s position that the appellant has not provided
sufficient evidence for an ordinary skill in the art to recognize
that the invention would treat any bacterial infection with an
MIC greater than 64 μg/ml with any medication. In other
words: a broad genus claim (i.e. a method for treating a
bacterial infection) is presented but the disclosure only
describes a narrow species . . . with no evidence that the genus
is contemplated. [cit. omitted]. The claimed method assumes
Appeal 2019-005493
Application 14/297,110
4
that the method would treat any bacterial infection that could
have an MIC higher than 64 μg/ml, and the applicant has not
provided support in the specification for that conclusion, since
it has not been discussed in the specification.
Id.
The specification of a patent as filed must “contain a written
description of the invention.” 35 U.S.C. § 112. A specification has an
adequate written description when it “reasonably conveys to those skilled in
the art that the inventor had possession of the claimed subject matter as of
the filing date” of the patent. Ariad Pharm., Inc. v. Eli Lilly & Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). That requirement is satisfied
only if the inventor “convey[s] with reasonable clarity to those skilled in the
art that, as of the filing date sought, he or she was in possession of the
invention,’ and demonstrate[s] that by disclosure in the specification of the
patent.” Nuvo Pharmaceuticals (Ireland) Designated Activity Company v.
Dr. Reddy’s Labs Inc., 923 F.3d 1368, 1377 (Fed. Cir. 2019). “The essence
of the written description requirement is that a patent applicant, as part of the
bargain with the public, must describe his or her invention so that the public
will know what it is and that he or she has truly made the claimed
invention.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759
F.3d 1285, 1298 (Fed. Cir. 2014). The written description requirement
prevents an applicant from later asserting that he invented that which he did
not; the applicant for a patent is therefore required to recount his invention in
such detail that his future claims can be determined to be encompassed
within his original creation. Amgen Inc. v. Hoechst Marion Roussel
Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003) (citing Vas-Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991)).
Appeal 2019-005493
Application 14/297,110
5
The dispute between Appellant and the Examiner is a familiar one and
centers on the question as to how much disclosure is necessary to support
claims to a broad genus. Claim 22 recites four functional limitations,
namely: (1) identifying . . . tissue; (2) injecting subcutaneously . . . a
solution; (3) applying an ultrasonic instrument . . . ; and (4) transcutaneously
broadcasting ultrasonic energy . . . Claims App. Otherwise, the claim is
limited to: (1) bacterial infections that are resistant to the antibiotic at an
open-ended concentration above 64 μg/ml; and (2) the application of
ultrasonic energy within a range of 0.5 to 5 MHz for 2–5 minutes. Id. The
claim is broad enough to cover any infectious bacteria and any antibiotic.
Appellant’s Specification discloses species related to the use Cefazolin in
treating a list of certain organisms. Spec. ¶ 44, Table 1.
The Federal Circuit maintains that a sufficient description of a genus
requires the disclosure of either a representative number of species falling
within the scope of the genus or structural features common to the members
of the genus so that one of skill in the art can “visualize or recognize” the
members of the genus. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119
F.3d 1559, 1568–69. In that regard, an adequate written description requires
a precise definition, such as by structure, formula, chemical name, physical
properties, or other properties, of species falling within the genus sufficient
to distinguish the genus from other materials. Id. at 1568. Merely drawing a
fence around the outer limits of a purported genus is not an adequate
substitute for describing a variety of materials constituting the genus and
showing that one has invented a genus and not just a species. Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en
banc). The level of detail required to satisfy the written description
Appeal 2019-005493
Application 14/297,110
6
requirement varies depending on the nature and scope of the claims and on
the complexity and predictability of the relevant technology. Id. at 1351.
With respect to generic claims, the Federal Circuit has set forth a number of
factors for evaluating the adequacy of the disclosure, including the existing
knowledge in the particular field, the extent and content of the prior art, the
maturity of the science or technology, and the predictability of the aspect at
issue. Id. The written description requirement ensures that when a patent
claims a genus by its function or result, the specification recites sufficient
materials to accomplish that function – a problem that is particularly acute in
the biological arts. Id. at 1352–53. However, it is the specification itself
that must demonstrate possession. Id. at 1352. A written description that
merely renders the invention obvious does not satisfy the requirement. Id.
Having reviewed the arguments of Appellant and the Examiner and
also having reviewed Appellant’s Specification and claim 22, we agree with
the Examiner that Appellant has claimed a broad genus that lacks adequate
written description support. For example and without limitation, there is no
written description support for a method that uses an antibiotic other than
Cefazolin.
We sustain the Examiner’s Section 112 written description rejection
of claims 22–24, 26, 28, 29, 33, and 43.
Claims 34, 40, and 44
Appellant fails to argue these claims under a separate heading or sub-
heading. See 37 C.F.R. § 41.37(c)(1)(iv) (“any claims(s) argued separately
or as a subgroup shall be argued under a separate subheading that identifies
the claim(s) by number”). Appellant provides no explanation or excuse for
failing to comply with our rules. In the absence of appropriate headings in
Appeal 2019-005493
Application 14/297,110
7
the Appeal Brief, we will endeavor to consider Appellant’s arguments that
are apparently directed to these claims as best understood, which arguments
appear to be limited to the first two paragraphs on page 8 of the Appeal
Brief.
Claim 34 is an independent claim that is substantially similar in scope
to claim 22, except that it is limited to treating bacterial infection with the
antibiotic Cefazolin. Claims App. The Examiner finds that Appellant’s
written description is inadequate to support claim limitations directed to
resistance to bacterial infections equal to or greater than 64 μg/ml. Final
Act. 3.
[T]he specification ONLY provides support for four strains of
MRSA with a MIC up to 512 μg/ml to Cefazolin (See table 1).
Also the specification does not provide support for a method of
treating all bacterial strain infections, where the bacterial
infection is resistant to cefazolin such that a MIC with respect
to the bacterial infection higher than “64 μg/ml”, in all possible
target tissues, as claimed.
Id.
Appellant argues that Table 1 in the Specification identifies 20 strains
of bacterial infection having an MIC of 64 μg/ml or greater. Appeal Br. 8.
In response, the Examiner states, in pertinent part, as follows:
[I]t is the examiners position that the appellant has not provided
sufficient evidence for an ordinary skill in the art to recognize
that the invention would treat any bacterial infection with an
MIC greater than 512 μg/ml with Cefazolin. In other words: a
broad genus claim (i.e., a method for treating a bacterial
infection) is presented but the disclosure only describes a
narrow species . . . with no evidence that the genus is
contemplated [cit. omitted]. The claimed method assumes that
the method of using Cefazolin as claimed would treat any
bacterial infection that could have an MIC higher than 64
μg/ml, however the specification as originally filed only
Appeal 2019-005493
Application 14/297,110
8
provides evidence of Cefazolin treating some MRSA organisms
with a MIC’s up to 512 μg/ml. In other words, an ordinary skill
in the art would not understand appellant to have invented, and
been in possession of, the invention as broadly claimed.
Ans. 8.
The Examiner’s position, which is unrebutted by Appellant, is
persuasive. Accordingly, we sustain the Examiner’s Section 112(a) rejection
of claim 34. Claims 40 and 44, which depend from claim 34 (see Claims
App.), do not appear to be argued separately and fall with claim 34. See 37
C.F.R. § 41.37(c)(1)(iv).
Claims 41, 42, and 45
Appellant fails to argue these claims under a separate heading or sub-
heading. 37 C.F.R. § 41.37(c)(1)(iv). Once again, Appellant provides no
explanation or excuse for failing to comply with our rules. As before, we
will endeavor to consider Appellant’s arguments that are apparently directed
to these claims as best understood, which appear to be limited to the first two
paragraphs on page 8 of the Appeal Brief. Claims 42 and 45, which depend
from claim 41 (see Claims App.), are not argued separately and fall with
claim 41. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 41 is an independent claim that is substantially similar in scope
to claim 34. Claims App. As with claim 34, the Examiner finds that
Appellant’s written description is inadequate to support claim limitations
directed to resistance to bacterial infections equal to or greater than 64
μg/ml. Final Act. 4.
Appellant argues claim 41 in the same two paragraphs on page 8 of
the Appeal Brief as were advanced in traverse of the rejection of claim 34,
Appeal 2019-005493
Application 14/297,110
9
which arguments are no more persuasive with respect to claim 41 as they
were with respect to claim 34. Appeal Br. 8.
In response, the Examiner essentially repeats the position espoused
with respect to claim 34 which is unrebutted by Appellant, and which we
consider to be equally persuasive as to claim 41. Accordingly, we sustain
the Examiner’s Section 112(a) rejection of claims 41, 42, and 45.
CONCLUSION
Claims
Rejected
§ Basis Aff’d Rev’d
22-24, 26,
28, 29, 33,
34, 40-45
112 Written Description 22-24, 26,
28, 29, 33,
34, 40-45

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