Joshua Makower et al.

Patent Trials and Appeals Board

Sep 3, 2019

11743605 - (D) (P.T.A.B. Sep. 3, 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.
11/743,605 05/02/2007 Joshua Makower P003 7186
118733 7590 09/03/2019
Moximed, Inc
46602 Landing Parkway
Fremont, CA 94539
EXAMINER
PRONE, CHRISTOPHER D
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
09/03/2019 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):
acermak@cnmiplaw.com
ip@cnmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOSHUA MAKOWER, ANTON G. CLIFFORD, and
RICHARD G. VECCHIOTTI
__________

Appeal 2018-0053781
Application 11/743,6052
Technology Center 3700
__________

Before FRANCISCO C. PRATS, MICHAEL J. FITZPATRICK, and
ULRIKE W. JENKS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134(a) involves claims to implantable
devices for relieving knee pain, as well as claims to methods of using such
devices. The Examiner entered a rejection for failure to comply with the
written description requirement, and a rejection for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify six applications in which related appeals have been
filed. Appeal Br. 3.
2 Appellants identify Moximed, Inc., a Delaware corporation, as the real
party in interest. Appeal Br. 3.
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We affirm the Examiner’s written description rejection, but reverse
the obviousness rejection.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 25 and 58–61, under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (Final Act. 3–5
(entered February 22, 2017)); and
(2) Claims 25–37, 44–47, 49–55, and 57–61, under 35 U.S.C.
§ 103(a), as being unpatentable over Hauser3 and Manspeizer4 (Final Act. 5–
7).
Claims 25 and 26 are representative and read as follows:
25. An implantable device useful for relieving knee pain that
does not require modification of articular cartilage of a knee,
the implantable device comprising:
an implantable absorber configured to absorb at least a
portion of a compressive load normally experienced by a
natural knee joint, wherein the absorber includes first and
second ends configured to be connected to bones on opposite
sides of the knee below skin covering a side of the knee, and an
elastomeric element or a spring positioned between said first
and second ends, said elastomeric element or spring including
one end which is unattached to the absorber;
wherein said elastomeric element or spring is configured
and arranged to resist compression of the device between said
first and second ends and to exert no force between said first
and second ends when in tension.

3 US 2,632,440 (issued Mar. 24, 1953).
4 US 6,540,708 B1 (issued Apr. 1, 2003).
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26. A method for relieving knee pain, the method
comprising:
implanting under skin at a side of a natural knee joint a
device that does not require modification of articular cartilage,
wherein when implanted the device includes an elastomeric
element or a spring which absorbs at least a portion of a
compressive load normally experienced by the natural knee
joint, wherein said elastomeric element or spring includes one
end which is unattached to the absorber, and wherein said
elastomeric element or spring is configured and arranged to act
only in compression of the natural knee joint.
Appeal Br. 31.

WRITTEN DESCRIPTION
The Examiner’s Position
In rejecting claims 25 and 58–61 for failing to comply with the written
description requirement, the Examiner determined that the “recitations of
claims 25 and 58–61 requiring the absorber to exert no force on the knee, is
still considered new matter.” Final Act. 4.
Specifically, the Examiner found, the Specification “fails to address
that no forces are exerted upon the joint when a tension force is applied.
Little or no offloading seems to occur, but all the other forces including
friction and/or gravity are not addressed.” Id.
As to friction and gravity, the Examiner reasoned that “at least a small
amount of frictional force is transferred and the weight of the device will
inherently be transferred through force to the knee regardless of the
configuration of the knee.” Id. at 4–5. Therefore, the Examiner determined,
“there is at least some force transferred between the absorber and the knee
even when the knee is in tension.” Id. at 5.
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The Examiner advised Appellants to amend the claims “to be more
consistent with how their invention actually works. More appropriate
language would be on the order of saying the unattached end of the absorber
does not apply any substantial tensional forces to the knee[].” Id.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
(citations omitted):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
As to the issue at hand, our reviewing court has explained:
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the
applicant adds a claim or otherwise amends his specification
after the original filing date . . . the new claims or other added
material must find support in the original specification.
TurboCare Div. of Demag Delaval Turbomachinery Corp. v. General Elec.
Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001).
We select Appellants’ claim 25 as representative of the claims subject
to the Examiner’s written description rejection. See 37 C.F.R.
§ 41.37(c)(1)(iv). Having carefully considered the arguments and evidence
advanced by Appellants and the Examiner, we find that the preponderance
of the evidence supports the Examiner’s determination that claim 25 does
not find adequate descriptive support in Appellants’ Specification.
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Claim 25 recites an implantable device useful for relieving knee pain.
Appeal Br. 31. The device is composed of an absorber that has two ends
configured to be connected to bones on opposite sides of the knee, and an
elastomeric element or spring disposed between the two ends, with one end
of the spring being unattached to the absorber. Id.
The language at issue in claim 25 recites that the “elastomeric element
or spring is configured and arranged to resist compression of the device
between said first and second ends and to exert no force between said first
and second ends when in tension.” Id. (emphasis added).
Appellants do not contend, nor do Appellants identify, any disclosure
in the Specification that provides word-for-word support for the language at
issue. Our reviewing court has advised, nonetheless, that “to satisfy the
written description requirement, the disclosure as originally filed does not
have to provide in haec verba support for the claimed subject matter at
issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed.
Cir. 2000).
As noted above, however, the disclosure in the Specification must
convey with reasonable clarity to those skilled in the art that the inventor
was in possession of the invention. See id. “Put another way, one skilled in
the art, reading the original disclosure, must immediately discern the
limitation at issue in the claims.” Id.; see also Hyatt v. Boone, 146 F.3d
1348, 1354–55 (Fed. Cir. 1998) (“[T]he written description must include all
of the limitations . . ., or the applicant must show that any absent text is
necessarily comprehended in the description provided and would have been
so understood at the time the patent application was filed.”) (emphasis
added).
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Appellants do not persuade us that, despite the lack of word-for-word
support for the language at issue in claim 25, a skilled artisan would have
immediately understood, or necessarily comprehended, the Specification as
describing a device configured in the manner required by the language at
issue in claim 25. In particular, we are not persuaded that Appellants have
explained persuasively where or how the Specification describes an absorber
device with a spring, in which the spring is configured and arranged to exert
no force between the first and second ends of the absorber when the spring is
in tension.
We first note that it is unclear how a spring under tension could
possibly exert no force on the end of the absorber to which the spring is
attached, as recited in Appellants’ claim 25. Appellants, moreover, identify
no disclosure that describes or shows specifically a situation in which a
spring in a device as claimed is in tension, such that a skilled artisan would
immediately and necessarily understand that the spring is exerting no force
between the two ends of the absorber, as required by claim 25.
We acknowledge Appellants’ citation to Figure 118, as well as ¶¶ 33,
244, and 249 of the Specification, as support for the limitation at issue.
Appeal Br. 20. We acknowledge, as Appellants contend, that Figure 118
and its accompanying disclosure in ¶ 244, support claim 25’s recitation of a
spring attached to only one end of the absorber, wherein the spring resists
compression of the two ends of the absorber to reduce the load imposed on
the knee joint:
The energy manipulation member 614 can include a spring 618
which slides within a slider 620 during normal motion. At first
the spring 618 does not engage but at some point after
implantation for example three weeks, a rotation tab 622 is
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locked within a slot 624. At that point, the sliding spring
engages the tab 622 at key stages of gait and absorbs desired
amounts of energy.
Spec. ¶ 244.
We acknowledge Appellants’ citation to Figures 112–118, as well as
¶¶ 219–224, and 244 of the Specification, as support for the limitation at
issue. Appeal Br. 4. Similar to the other portions of the Specification cited
by Appellants, ¶¶ 219–224 and 244 explain how the spring’s resistance to
compression reduces the load on the knee. See, e.g., Spec. ¶ 221 (“A piston
support assembly 400 can further include springs 406 to aid in the load
manipulation being sought (See FIGS. 62 and 63).”); see also id. ¶ 243 (“As
shown in FIG. 114, the energy manipulation assemblies can absorb energy
by a fixed proportion during a portion of the gait cycle. This is reflected by
curve 604.”).
We, thus, acknowledge that the portions of the Specification cited by
Appellants, summarized above, explain how the spring’s resistance to
compression reduces the load on the knee. Appellants, however, do not
identify any specific disclosures in any of the cited portions of the
Specification that describe when or how the spring is under tension, such
that a skilled artisan would immediately recognize, and necessarily
comprehend, that Appellants possessed a spring configured and arranged to
exert no force between the first and second ends of the absorber when the
spring is in tension, as recited in claim 25. Because Appellants do not
explain specifically how the cited portions of the Specification support the
disputed language in claim 25, we are not persuaded that Appellants have
shown that they were in possession of a device having all of the features
required by claim 25, including the disputed elements.
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As to the forces of gravity and friction cited by the Examiner, it
cannot be disputed that the spring has mass, and that the spring therefore
would exert at least some force against the end of the absorber to which it is
attached, due to gravity. Moreover, as seen in Appellants’ Figure 118, claim
25 encompasses an embodiment in which the spring “slides within a slider”
(Spec. ¶ 244), thus supporting the Examiner’s determination that, due to
friction, the spring will exert force against the end of the absorber to which it
is attached. Accordingly, because the spring necessarily exerts some force
on the end of the absorber to which it is attached, we are not persuaded that
the Specification supports the language at issue in claim 25.
We are not persuaded, moreover, that it is reasonable to interpret the
unqualified language requiring the spring to exert “no force” between the
two ends of the absorber to exclude the forces of friction and gravity that a
spring would exert on the ends of the absorber. We acknowledge the
disclosure in the Specification that a device encompassed by claim 25 can
reduce the load on the joint during a patient’s gait. See Reply Br. 3–4 (citing
Figs. 114–117).
The fact that the claimed device can reduce the load on a joint does
not persuade us that it is reasonable to interpret the unqualified claim
language “exert no force” to instead mean “exert no substantial force.” See
In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007)
(“[W]hile ‘the specification [should be used] to interpret the meaning of a
claim,’ courts must not ‘import[ ] limitations from the specification into the
claim.’ . . . [I]t is improper to ‘confin[e] the claims to th[e] embodiments’
found in the specification . . . .”) (quoting Phillips v. AWH Corp., 415 F.3d
1303, 1323 (Fed. Cir. 2005) (citations omitted, bracketed text in internal
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quotes in original); see also In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989)
(“[D]uring patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed”).
In sum, for the reasons discussed, Appellants do not persuade us that
the Examiner erred in determining that the full scope of claim 25 lacks
sufficient descriptive support in the Specification. We, therefore, affirm the
Examiner’s rejection of claim 25 for failure to comply with the written
description requirement. Claims 58–61 fall with claim 25. See 37 C.F.R.
§ 41.37(c)(1)(iv).
OBVIOUSNESS
The Examiner’s Position
In rejecting claims 25–37, 44–47, 49–55, and 57–61 over Hauser and
Manspeizer, the Examiner cited Hauser as describing a device having nearly
all of the elements required by the rejected claims, and differing from the
rejected claims in that “Hauser does not disclose that the entire device is
implanted below the skin covering a side of the natural knee joint.” Final
Act. 6.
To address that deficiency, the Examiner cited Manspeizer as teaching
that “it is well known in the field of treating knee joint pain that a variety of
support systems can be attached to the joint externally or implanted
internally for the purpose of providing a permanent implant securely
attached the joint under the skin.” Id.
Based on the references’ combined teaching, the Examiner concluded
that an ordinary artisan would have considered it obvious to “implant the
connection system (Figures 53-54) of Hauser such that portions 810 and 812
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are trimmed down and attach to the natural bones below the skin along the
side of the natural knee joint in order to provide a permanent implant which
will not extend outside of the skin.” Id.
Responding to Appellants’ arguments, the Examiner expanded on the
reasons why an ordinary artisan would have implanted Hauser’s device:
As explained in the office action the combination would result
in an implant which is permanent and would not extend outside
of the skin. Accordingly, unlike the original nature of the
Hauser device, the modified version is permanent. It does not
need to be removed or replaced during different activities such
as showering or changing clothes. It is permanent meaning
once it is implanted the patient no longer needs to change or
remove it. It is also fully below the skin, which means it is no
longer a bulky device located on the outside of the patient[‘s]
leg. Being fully implanted has old and well known benefits, it
does not attract attention from other people, it does not catch on
clothing or other objects, and it has a more secure attachment to
the joint directly rather than superficial attachment to
surrounding tissue. Therefore a person of ordinary skill in the
art of knee implant would clearly recognize the previously
provided motivation of providing a permanent implant which
will not extend outside of the skin. . . .
Manspeizer is relied upon to teach that people of ordinary
skill in the art of knees are well versed and would look to both
external and implanted knee braces for solving problems.
Manspeizer supports the conclusion that a person of ordinary
skill in the art would recognize with few modifications many
external braces could be made for internal use and vice versa.
Ans. 11.
Analysis
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, id. at 415, it also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
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elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis
added).
Thus, as the Federal Circuit has since explained, “obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015)
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We agree with Appellants that a preponderance of the evidence does
not support the Examiner’s conclusion of obviousness. In particular, we are
not persuaded that the cited references would have suggested implanting
Hauser’s device under a patient’s skin, or modifying Hauser’s to the degree
required to make under-the-skin implantation feasible.
Hauser discloses “an improved leg brace for assisting crippled
individuals of any degree of impaired functions to walk.” Hauser 1:28–31.
Rather than suggesting that its device should be implanted, Hauser discloses
that its leg brace is “easily applied and removed by the patient.” Id. at 1:33–
34.
Hauser’s leg brace, moreover, is a relatively large and complicated
device that includes extensive multi-jointed bracing elements that extend
from an attachment point 16 at the side of the patient’s shoe, to a padded
ring member 11 that encircles the patient’s thigh well above the knee. See
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id. at Fig. 1; see also id. at Fig. 52 (embodiment cited by Examiner). The
evidence of record, therefore, does not support the Examiner’s contention
that Hauser’s device would be rendered implantable by making only a “few
modifications.” Ans. 11.
We acknowledge Manspeizer’s disclosure of “an internal or external
knee brace having a polycentric joint that enables control of a predetermined
helicoidal motion and which permits compression and distraction of the knee
joint.” Manspeizer, abstract.
The fact that a device having the relatively simple configuration
disclosed in Manspeizer (see id. at Fig. 1) could be employed internally as
well as externally does not persuade us that a skilled artisan would have
been motivated to perform the extensive modifications required to make
Hauser’s large and complicated device implantable, particularly given the
available option of simply using Manspeizer’s brace. Nor are we persuaded
that the Examiner has explained where or how the cited combination of
references teaches or suggests, specifically, what modifications would even
be required to make implantation of Hauser’s device feasible.
In sum, for the reasons discussed, Appellants persuade us that the
preponderance of the evidence does not support the Examiner’s conclusion
of obviousness. We, therefore, reverse the Examiner’s rejection of claims
25–37, 44–47, 49–55, and 57–61 over Hauser and Manspeizer.

SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 25 and 58–61, under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement.
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For the reasons discussed, we reverse the Examiner’s rejection of
claims 25–37, 44–47, 49–55, and 57–61, under 35 U.S.C. § 103(a), as being
unpatentable over Hauser and Manspeizer.

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

AFFIRMED-IN-PART