B.G. NEGEV TECHNOLOGIES AND APPLICATIONS LTD.

Patent Trials and Appeals Board

Oct 2, 2020

2020001299 (P.T.A.B. Oct. 2, 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.
14/198,701 03/06/2014 Joseph KOST GPK-4110-292 1043
23117 7590 10/02/2020
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
10/02/2020 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):
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 JOSEPH KOST, AHARON AZAGURI, and
YANA YUDILEVICH
__________

Appeal 2020-001299
Application 14/198,701
Technology Center 3700
__________

Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and
TARA L. HUTCHINGS, Administrative Patent Judges.

REIMERS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–14, and 16–22. Claims 2, 15, and
23 have been canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as B.G. Negev
Technologies and Applications, Ltd. Appeal Brief (“Appeal Br.”) 3, filed
June 20, 2019.
Appeal 2020-001299
Application 14/198,701

2
CLAIMED SUBJECT MATTER
The claimed subject matter relates to “methods of treating a subject
afflicted with cancer, neoplasms or metastatic cancer using ultrasound.”
Specification dated May 30, 2014 (“Spec.”)2 1:10–12.
Claim 1, the sole independent claim on appeal, recites:
1. A method of treating a subject suffering from a disease or
a disorder associated with hyperproliferating cells, said method
comprising non-invasively administering to said subject
ultrasound in a dose effective to selectively prevent the growth
of said hyperproliferating cells or to eliminate said
hyperproliferating cells in said subject, while substantially not
affecting the cell viability of normal cells of said subject,
resulting in a cell viability of less than 40% of said
hyperproliferating cells and a cell viability of more than 60% of
said normal cells,
wherein said ultrasound is administered at a transducer
frequency ranging from 20 kHz – 200 kHz and a transducer
intensity of between 4 W/cm2 and 100 W/cm2, wherein said
intensity is pre-determined such that said intensity is lower than
a cavitational threshold intensity for the selected frequency.

THE REJECTION
Claims 1, 3–14, and 16–22 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.3

2 Although the May 30, 2014 Specification is not the original specification
filed in the application, it appears identical in content with the original
specification. The May 30, 2014 Specification appears to differ from the
original specification only in that the May 30 Specification is printed in
darker type and without line numbers erroneously inserted into the text.
“Submission of Substitute Specification” dated May 30, 2014.
3 Rejections of claims 1, 3–14, and 16–22 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement, and
under 35 U.S.C. § 112, second paragraph, as indefinite, have been
Appeal 2020-001299
Application 14/198,701

3
ANALYSIS
The Examiner concludes that the Specification fails to enable the full
scope of independent claim 1. Non-Final Act. 3; Ans. 4.4 “Although not
explicitly stated in [35 U.S.C. §112, first paragraph], to be enabling, the
specification of a patent must teach those skilled in the art how to make and
use the full scope of the claimed invention without ‘undue
experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)
(citing In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991)). Procedurally, the
Patent and Trademark Office (“PTO”):
bears an initial burden of setting forth a reasonable explanation
as to why it believes that the scope of protection provided by the
claim is not adequately enabled by the description of the
invention provided in the specification . . . . [T]his includes, of
course, providing sufficient reasons for doubting any assertions
in the specification as to the scope of enablement. If the PTO
meets this burden, the burden then shifts to the applicant to
provide suitable proofs indicating that the specification is indeed
enabling.
Wright at 1561–62 (citing In re Marzocchi, 439 F.2d 220, 223–224 (CCPA
1971)); see also MANUAL OF PATENT EXAMINING PROCEDURE (“MPEP”)
§ 2164.04 (9th edition, rev. June 2020).5 Appellant contends that the
Examiner has not articulated a reasonable and persuasive explanation as to
why the scope of independent claim 1 is not adequately enabled by the
Specification. See generally Appeal Br. 12–17; Reply Br. 3–9.6

withdrawn by the Examiner in the Answer. Examiner’s Answer (“Ans.”) 3,
dated Oct. 3, 2019.
4 Non-Final Office Action (“Non-Final Act.”), dated Mar. 26, 2019.
5 All references to the MPEP will be to the most recent edition and revision,
unless otherwise noted.
6 Reply Brief (“Reply Br.”), filed Dec. 2, 2019.
Appeal 2020-001299
Application 14/198,701

4
An examiner must weigh eight factors identified by our reviewing
court in order to determine whether the Specification adequately enables a
claim. These factors include the breadth of the claim, the nature of the
invention, the state of the prior art, the relative skill of those in the art, the
predictability or unpredictability of the art, the amount of direction or
guidance presented, the presence or absence of working examples, and the
quantity of experimentation necessary. In re Wands, 858 F.2d 731, 737
(Fed. Cir. 1988); see also MPEP § 2164.01(a). The Examiner need not
make explicit findings as to each of the eight factors. Nevertheless, the
Examiner must reach a conclusion as to whether the Specification enables
the claim based on a consideration of the evidence of record as a whole,
viewed through the prism of these factors. MPEP § 2164.01(a).
As noted earlier,
there must be sufficient disclosure, either through illustrative
examples or terminology, to teach those of ordinary skill how to
make and how to use the invention as broadly as it is claimed.
This means that the disclosure must adequately guide the art
worker to determine, without undue experimentation, which
species among all those encompassed by the claimed genus
possess the disclosed utility.
Vaeck, 947 at 496. In making this determination, the Examiner must
consider not only the breadth of the claim at issue, but also the relative skill
of those in the art, as well as the predictability or unpredictability of the art.
See id. (affirming an enablement rejection of claim to a chimeric gene, at
least in part, because the art was unpredictable and the class of bacteria by
which the gene might be expressed was not yet thoroughly researched);
Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1536–37 (Fed. Cir.
1987) (reversing an enablement rejection of a claim directed to a method of
Appeal 2020-001299
Application 14/198,701

5
fabricating a laser structure where the particular process alleged not to have
been enabled, namely, brazing, was a predictable, well understood,
mechanical process).
In this case, the Examiner has made findings concerning at least three
of the Wands factors as those factors apply to independent claim 1, namely,
the breadth of the claim, the amount of direction or guidance presented, and
the presence or absence of working examples. In particular, the Examiner
finds the amount of direction or guidance presented by the Specification
inadequate compared with the breadth of claim 1. Non-Final Act. 3 (“[T]he
[S]pecification does not disclose detail that [would have] enable[d] one of
ordinary skill in the art to produce the claim[ed] result for the wide range of
parameters in the claim.”); Ans. 4. Furthermore, the Examiner finds that all
the working examples described in the Specification were performed using
ultrasound radiation having a frequency of 20 kHz; and that, in addition, the
examples discussed on pages 24–27 of the Specification, and summarized in
Figures 2–3 of the subject application, used ultrasound radiation having
intensities of either 4.15 W/cm2, 4.38 W/cm2, or 5.09 W/cm2. Non-Final
Act. 3; Ans. 5. As the Examiner correctly finds, these examples are
restricted to the lower portions of the ranges of 20 kHZ–200 kHz and 4
W/cm2–100 W/cm2 recited in claim 1. Non-Final Act. 3; Ans. 6.
However, the Examiner’s findings relating to the state of the prior art,
the relative skill of those in the art, and the predictability or unpredictability
of the art, are less persuasive. The Examiner finds, for example, that
because claim 1 was not rejected as unpatentable under 35 U.S.C. § 103,
there is no prior art. Ans. 5. As Appellant correctly points out, obviousness
under 35 U.S.C. § 103 and enablement under 35 U.S.C. § 112, first
Appeal 2020-001299
Application 14/198,701

6
paragraph, are separate inquiries. Reply Br. 2. Because they are separate
inquiries, the absence of a rejection under 35 U.S.C. § 103 does not imply
that there is no prior art or otherwise evidence the relative skill of those in
the art. Furthermore, the Examiner finds that the art is unpredictable based
on the alleged non-linearity of the experimental results summarized in
Figures 2–3 of the Specification. This finding is not persuasive, because
non-linearity alone, especially in a sample consisting of just three-to-six
working examples, is not probative of a high degree of unpredictability.
Here, the Examiner concludes that the Specification fails to enable
claim 1 based on findings regarding the breadth of the claims, the amount of
direction or guidance presented, and the presence or absence of working
examples, without adequately articulating persuasive findings as to the state
of the prior art, the relative skill of those in the art, or the predictability or
unpredictability of the art. Because the Examiner has not provided us with
reliable findings as to the state of the prior art, the relative skill of those in
the art, or the predictability or unpredictability of the art, we are not
persuaded that an unreasonable amount of experimentation would have been
required to make and use the subject matter of claim 1. In other words, the
Examiner has not articulated a reasonable and persuasive explanation as to
why the scope of independent claim 1 is not adequately enabled by the
Specification.
Accordingly, for the foregoing reasons, we do not sustain the
Examiner’s rejection of claims 1, 3–14, and 16–22 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the enablement requirement.

Appeal 2020-001299
Application 14/198,701

7
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. §  Reference(s)/Basis Affirmed Reversed
1, 3–14, 16–
22
112, first
paragraph
Enablement 1, 3–14,
16–22

REVERSED