DePuy Synthes Products, Inc.

Patent Trials and Appeals Board

Dec 1, 2021

2021001994 (P.T.A.B. Dec. 1, 2021)

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.
15/801,335 11/02/2017 Dominique Messerli 88041-343745SYN0952USCNT5 1017
173217 7590 12/01/2021
Barnes & Thornburg LLP (DEPUY)
11 S. Meridian Street
Indianapolis, IN 46204
EXAMINER
LAWSON, MATTHEW JAMES
ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
12/01/2021 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOMINIQUE MESSERLI
Appeal 2021-001994
Application 15/801,335
Technology Center 3700
Before DANIEL S. SONG, BENJAMIN D. M. WOOD, and
BARRY L. GROSSMAN, Administrative Patent Judges.
GROSSMAN, 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 39–50. An oral hearing in accordance
with 37 C.F.R. § 41.47 was held on November 15, 2021. 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 the real party in interest as DePuy Synthes
Products, Inc. of Raynham, Massachusetts, a Johnson & Johnson company.
Appeal Br. 1.
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CLAIMED SUBJECT MATTER
The claims are directed to an apparatus for augmentation of body
tissues. Claim 39, reproduced below, is illustrative of the claimed subject
matter:
39. An apparatus for augmentation of body tissues
comprising:
a flexible elongated member having a longitudinal length
substantially larger than its height or its width, the flexible
elongated member being formed as an integral monolithic
elongated member, wherein the member comprises:
a plurality of bodies, the bodies having a first cross-
sectional size;
a plurality of links interconnecting the bodies, the
bodies and links connected end-to-end to form the
elongated member, the links having a second cross-
sectional size, the first cross-sectional size being larger
than the second cross-sectional size; the elongated
member being formed of bone, wherein the links are
demineralized through their entire thickness and the
bodies are partially demineralized across the entire outer
surface thereof; and
a therapeutic agent adsorbed, sorbed or perfused
onto or into the elongated member
wherein the member has a first state with a first moisture
content where the member is sufficiently rigid to prevent contact
between two adjacent bodies and a second state with a second
moisture content that is higher than the first moisture content
where the member is sufficiently flexible to allow contact
between two adjacent bodies.
Appeal Br. App. A, i (Claims App.).
Independent claims 42 and 43 are substantively similar to claim 39.
Independent claim 42 also states that a coating, such as a therapeutic agent
or other coating, is on at least a portion of the flexible elongated member.
Id. at i–ii. Independent claim 43 states that at least one of the bodies is
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formed with at least one through bore, cavity, recess or depression in its
outer surface. Id. at ii. Appellant acknowledges, however, that
“[i]ndependent claims 42 and 43 parallel claim 39” on the issues involved in
this appeal. Appeal Br. 7.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Baumgartner US 5,702,454 Dec. 30, 1997
Reed US 5,868,749 Feb. 9, 1999
Bindseil et al. US 2004/0249464 A1 Dec. 9, 2004

REJECTIONS
Claims 39–50 are rejected: (1) for new matter (“Applicant has not
argued the merits of the new matter rejection and therefore it is
maintained.”) (Final Act. 2); (2) under pre-AIA 35 U.S.C. §112, first
paragraph, for failing to comply with the written description requirement
(id. at 3–4); and (3) under § 103(a) as being unpatentable over Bindseil,
Baumgartner, and Reed (id. at 4–13).
OPINION
New Matter Rejection
As noted above, the Final Action, mailed November 4, 2019, refers to
a “new matter rejection.” Final Act. 2 (“Applicant has not argued the merits
of the new matter rejection and therefore it is maintained.”). This reference
to a new matter rejection is confusing because neither Appellant nor the
Examiner’s Answer has directed us to a specific “new matter rejection” in
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the prosecution history, and we find none on our own review of the
prosecution history.
The prosecution history shows that a request for continued
examination under 37 C.F.R. § 1.114 was filed on December 10, 2018, after
a final rejection of a prior, pending application. See Office Action mailed on
July 12, 2019. As stated in the July 12 Office Action, the finality of the
previous Office action was withdrawn and the submission filed on
December 10, 2018, which included amended claims, was entered. Id.
The Examiner then issued a non-final Office Action on amended
claims 39–50. See Office Action mailed on July 12, 2019. Claims 39–50
were rejected under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement. Id. at 3. The July 12 Office
Action also rejected claims 39–50 under pre-AIA 35 U.S.C. § 103(a) based
on Bindseil, Baumgartner, and Reed. Id. at 4.
The July 12 Office Action did not enter any rejection under 35 U.S.C.
§ 132 based on “new matter.”2
Following the July 12 Office Action, a telephonic interview was held
on September 20, 2019 between the Examiner and Appellant’s counsel, Mr.
Nagorniy. See “Applicant-Initiated Interview Summary,” mailed September
26, 2019. In this Summary, the Examiner states,
Both parties discussed amending the claims to recite that there is
a first mineralized state, a second demineralized state, and a third
state where the moisture content is adjusted. Amending the
claims in this manner would likely overcome the new matter

2 Title 35 U.S.C. § 132 states, “No amendment shall introduce new matter
into the disclosure of the invention.”
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rejection. However, it appears that the above amendment would
not overcome the rejection of record.
Interview Summary, Sept. 26, 2019 (emphasis added).
This summary clearly refers to a “new matter rejection,” although no
such rejection has been made.
Following the interview, Appellant filed on October 15, 2019, a
response to the July 12, 2019, Office Action. The October 15 Response
sought only “reconsideration” of the rejection of claims 39–50 under Section
103 in the July 12 Office Action. See Oct. 15, 2019, Response. No mention
was made of the Section 112 rejection or a “new matter” rejection. Claims
39–50 were not amended. The October 15 response also acknowledged that
during the interview the “art-based rejections” were discussed and that “[n]o
agreement was reached” at the September 20 interview. Id. at 5.
The Final Rejection, summarized above, followed.
In its Appeal Brief, Appellant argues “claims 39–50 do not constitute
new matter and should be entered, and the rejection of these claims pursuant
to pre-AIA 35 [ ] U.S.C. [§] 112, first paragraph, should be withdrawn.”
Appeal Br. 6.
It appears that both the Examiner and Appellant equate a prohibition
against new matter under Section 132 with the requirements of Section 112,
first paragraph. This is incorrect. They are separate and distinct
requirements.
Section 132 prohibits the introduction of new matter into the
disclosure of an application. Section 112, first paragraph, requires that claim
language be supported in the specification. In re Rasmussen, 650 F.2d 1212,
1214 (CCPA 1981) (opinion by C. J. Markey). Employment of Sections 132
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and 112 as interchangeable leads to confusion of two distinct concepts: (1)
adding new matter to the disclosure; and (2) broadening a claim. Id.
Broadening a claim does not add new matter to the disclosure. Disclosure is
that which is taught, not that which is claimed. Rasmussen, 650 F.2d 1214.
An applicant is entitled to claims as broad as the prior art and the disclosure
will allow. Id.
As stated in Rasmussen,
The proper basis for rejection of a claim amended to recite
elements thought to be without support in the original disclosure,
therefore, is § 112, first paragraph, not § 132. The latter section
prohibits addition of new matter to the original disclosure. It is
properly employed as a basis for objection to amendments to the
abstract, specifications, or drawings attempting to add new
disclosure to that originally presented.
Rasmussen, 650 F.2d at 1214–15. Rasmussen further explained,
Past opinions of this court, in cases in which a § 132 claim
rejection was reviewed on a § 112 analysis, should not in future
be viewed as having approved the employment of § 132 as a
basis for claim rejection. The amended claims involved in those
cases should have been rejected under § 112, first paragraph.
The claim rejections in those cases could then have been
explicitly affirmed or reversed on direct applications of § 112,
rather than on § 112 analyses applied to § 132 rejections.
Accordingly, such cases are overruled insofar as they approved
rejection of claims under § 132.
Rasmussen, 650 F.2d at 1215. See also, Gentry Gallery, Inc. v. Berkline
Corp., 134 F.3d 1473, 1480 (Fed. Cir. 1998) (“In [In re Rasmussen], our
predecessor court restated the uncontroversial proposition that ‘a claim may
be broader than the specific embodiment disclosed in a specification.’
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However, the court also made clear that ‘[a]n applicant is entitled to claims
as broad as the prior art and his disclosure will allow.’”) (Citations omitted).
Following Rasmussen, we disregard the Examiner’s reference to a
“new matter rejection” (see Final Act. 2) under Section 132, which, in fact,
was never made in this case. We consider below the rejection under § 112.
The § 112, First Paragraph Rejection
Independent claims 39, 42, and 43 require “a flexible elongated
member . . . formed as an integral monolithic elongated member.” The
independent claims also state that “the member comprises . . . a plurality of
bodies . . . [and] a plurality of links.” Additionally, the claims require that
“the bodies and links [are] connected end-to-end to form the elongated
member.” The claims also require that the links “are demineralized through
their entire thickness” and that the bodies “are partially demineralized across
the entire outer surface.”
The Specification states that demineralization affects the “pliability”
of bone material. As stated in the Specification, the “use of a demineralizing
agent on bone, e.g., cortical or cancellous bone, transforms the properties of
the bone from a stiff structure to a relatively pliable structure.” Spec. ¶ 59.
According to the Specification,
Any desired portions of bone components, e.g., link portions 220
or any other desired portion, may be demineralized or partially
demineralized in order to achieve a desired amount of
malleability, elasticity, pliability or flexibility, generally referred
to herein as “flexibility”. The amount of flexibility can be varied
by varying in part the amount of demineralization.
Spec. ¶ 59.
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Regarding moisture content, the Specification states that “[o]ptionally,
the flexibility or pliability of demineralized bone may be enhanced when the
bone is hydrated.” Spec. ¶ 59.
The claim language that is specifically at issue in the § 112 rejection
requires
the member has a first state with a first moisture content where
the member is sufficiently rigid to prevent contact between two
adjacent bodies and a second state with a second moisture
content that is higher than the first moisture content where the
member is sufficiently flexible to allow contact between two
adjacent bodies.
See, e.g., for claim 39, Appeal Br. App. A, i (all emphasis added). Thus, the
claims require the member, not the links or bodies forming the member, to
have two different “states” of “moisture content” that determine the
flexibility of the two different states. The first state is where the member has
a first moisture content where the member is “sufficiently rigid to prevent
contact between two adjacent bodies” forming the member. The second
state is where the member has a second moisture content where the member
is “sufficiently flexible to allow contact between two adjacent bodies”
forming the member.
This “member” flexibility based solely on “moisture content” is in
addition to the claimed demineralization or partial demineralization of the
“links” and “bodies,” which, as discussed above, also affects flexibility.
Spec. ¶ 59 (“The amount of flexibility can be varied by varying in part the
amount of demineralization.”).
Based on the claim language, the entirety of the “member” cannot be
in both the first state and the second state at the same time. It is possible,
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however, for the member to be in the first state at a first period of time, such
as when freeze-dried, and in the second state at a second period of time, such
as after being hydrated for use. See Spec. ¶¶ 60, 62. It also is possible that
different portions or regions of the member may be in different states. See
Spec. ¶¶ 59, 60, 67. This second possibility, however, is not what is
claimed.
The Examiner acknowledges that the Specification “has support for
the member having a first and second moisture content[ ].” Final Act. 4
(emphasis added). The § 112 rejection, however, is based on the
Specification not disclosing that the “member” has a “the first moisture
content being sufficiently rigid to prevent contact between two adjacent
bodies and the second moisture content being sufficiently flexible to allow
contact between two adjacent bodies,” as stated in independent claims 39,
42, and 43. Id.; see also Ans. 4 (asserting that the Specification “fails to
teach the functional parameters associated with the two claimed moisture
contents”).
Appellant’s Argument
Appellant argues that paragraphs 59, 60, 67, and 69 provide support
for the first and second “member states” recited in the claims. Appeal Br. 6.
We disagree.
As explained in paragraph 59 of the Specification,
Variation in the mechanical properties of bone sections is
obtainable through various amounts of demineralization.
Advantageously, use of a demineralizing agent on bone, e.g.,
cortical or cancellous bone, transforms the properties of the bone
from a stiff structure to a relatively pliable structure. Optionally,
the flexibility or pliability of demineralized bone may be
enhanced when the bone is hydrated. Any desired portions of
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bone components, e.g., link portions 220 or any other desired
portion, may be demineralized or partially demineralized in
order to achieve a desired amount of malleability, elasticity,
pliability or flexibility, generally referred to herein as
“flexibility”. The amount of flexibility can be varied by varying
in part the amount of demineralization.
Spec. ¶ 59 (emphases added). This paragraph refers to “bone sections,” or
“desired portions” of bone components, having various amounts of
flexibility. It does not support the “member” having the two “moisture
content” states required in the claims, one “moisture content” state that
allows contact of adjacent bodies; and one “moisture content” state that
prevents contact of adjacent bodies.
Paragraph 60 of the Specification states that “[i]n some embodiments,
flexibility of demineralized or partially demineralized regions may be
further enhanced by varying the moisture content of the implant or portions
thereof.” Spec. ¶ 60 (emphasis added). Again, this disclosure emphasizes
flexibility of “regions” or “portions” of the implant; it does not support the
entirety of the “member,” including all “bodies” and all “links,” having the
two moisture content states required in the claims.
Paragraph 67 of the Specification states that “[d]emineralization may
be allowed to occur for a specified amount of time, for example to allow the
smaller, lower volume portions 220 of the device 200 to become more
flexible or elastic, while the larger bodies 210 of the device remain
structurally intact and substantially rigid.” Spec. ¶ 67 (Emphasis added).
This paragraph also refers to two different portions or components, 210 and
220, of the “member,” or chain 200, having different degrees of flexibility
based on demineralization, not moisture content. This disclosure does not
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support the “member” itself, comprising bodies and links, having the two
states of flexibility based on “moisture content,” as required in the claims.
Paragraph 69 of Specification refers to a table “of four monolithic
chains having different strut configurations.” Spec. ¶ 69. Referring to
Figure 2, the Specification also explains that “a chain 200 (sometimes
referred to as an elongated member)” comprises one or more “bodies 210
(sometimes referred to as beads)” and “one or more linking portions 220,
also sometimes referred to as struts or links 220.” Spec. ¶ 50. Thus, the
table concerns only the “struts,” not the entire “member.”
Paragraph 69 also defines “full flexibility.” “Full flexibility is
considered to be the condition when the chain [i.e., member] can be bent
until two adjacent beads contact each other without the chain cracking or
breaking.” Spec. ¶ 69. According to the Specification, “other measures of
flexibility are also contemplated and the invention should not be limited by
such measure of flexibility.” Id. This disclosure, defining “full flexibility,”
does not support the “member” having two different flexibility states based
on moisture content, as required in the claims.
We recognize that Appellant is entitled to claims as broad as the prior
art and the disclosure will allow. In re Rasmussen, 650 F.2d at 1214. The
disclosure supports portions or regions of the “member,” such as links and
bodies, having different flexibilities based on demineralization, with
flexibility “optionally enhanced” by moisture content. Spec. ¶ 59
(“Optionally, the flexibility or pliability of demineralized bone may be
enhanced when the bone is hydrated.” (emphasis added)). We agree with
the Examiner that the disclosure does not support the two states of flexibility
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of the member, based solely on moisture content, stated in independent
claims 39, 42, and 43, as required by 35 U.S.C. § 112, first paragraph.
Based on the analysis above, we affirm the Examiner’s rejection
under Section 112, first paragraph.
The § 103 Rejection
Appellant argues that neither Bindseil, Baumgartner, nor Reed
discloses a bone implant having different states with different moisture
contents wherein the moisture content determines the different levels of
flexibility. Appeal Br. 7. We agree.
The Examiner acknowledges that Bindseil “fail[s] to expressly teach
or disclose” that the collagen links used with the partially demineralized
bone bodies are formed by demineralization of bone and “conversely fails to
expressly teach or disclose that the demineralized links can be used with the
partially demineralized bodies.” Final Act. 5. The Examiner also
acknowledges that Bindseil “fail[s] to teach or disclose that the plurality of
links and bodies are constructed as an integral monolithic elongated
member.” Id. at 6.
Additionally, the Examiner also acknowledges that Bindseil does not
disclose or suggest a
member [that] has a first state with a first moisture content where
the member is sufficiently rigid to prevent contact between two
adjacent bodies and a second state with a second moisture
content that is higher than the first moisture content where the
member is sufficiently flexible to allow contact between two
adjacent bodies.
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Final Act. 6. The Examiner relies on Baumgartner to teach an integral
monolithic elongated member, and on Reed for the “moisture content”
disclosure missing from Bindseil.
Baumgartner discloses an intervertebral prosthesis. As shown in
Figure 6, several support members can be disposed in the manner of “pearls
on a pearl necklace” on a flexible, ribbon-like or string-like support 20 and
be connected thereto to form a cohesive implant. Baumgartner, 5:22–25.
Figure 7 of Baumgartner shows an alternative approach wherein support
members 7 and support 20 are manufactured from the same material and are
connected to form a single-piece implant, whereby the support 20 acts as a
spacer. Id. at 5:35–38. The Examiner relies on the Figure 7 embodiment for
the disclosure of an integral monolithic elongated member. Final Act. 6.
The Examiner determined it would have been obvious to a person of
ordinary skill in the art “to substitute the separate ‘pearl necklace’
configuration of Bindseil . . . out for the integral monolithic chain structure
of Baumgartner” because they are “art-recognized equivalents.” Id.
Reed discloses a bone screw made from cortical bone tissue. Reed,
11:1–11.3 According to Reed, typically, aseptic bone tissue is frozen, freeze
dried or demineralized for long-term storage. Id. at 5:19–21. According to
Reed, freeze drying increases shelf life of the tissue and allows a convenient
form for fabrication. Id. at 5:21–22.
Reed also discloses that:
Since freeze dried bone tissue will have a moisture content of 5%
or lower, it may be desirable to soak the device in saline solution
or other suitable medium to restore moisture prior to insertion.
Restoration of the bone tissue moisture is desirable in bone

3 Citations are to column:line of Reed.
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grafting and will assist in acceptability if the bone device into the
body.
Id. at 12:2–8. The only benefit of increasing the moisture content in the
bone screw in Reed is because it is “desirable in bone grafting and will assist
in acceptability if the bone device into the body.” Reed, 12:6–8. Reed does
not mention that the moisture content affects flexibility of the bone screw.
The Examiner states that “[w]hile, the Examiner agrees that there is
no express teaching [in Reed] that the change in moisture content adjusts the
flexibility of the implant it is an inherent characteristic of the material,
demineralized bone.” Final Act. 3. After determining that the relationship
of moisture content and flexibility is inherent in Reed, the Examiner
concludes that
it would have been obvious to one of ordinary skill in the art at
the time of invention to have constructed the member of Bindseil
et al. to have a first moisture content in a first state and a second
moisture content in a second state as taught by Reed as it allows
the member to have an indefinite storage life when in the first
state and increases the likelihood of acceptability of the bone
device in the body when implanted.
Final Act. 7. We disagree.
Our reviewing Court recognizes that inherency may supply a missing
claim limitation in an obviousness analysis. In re Ikeda Food Research. Co.,
758 F. App’x 952, 955–56 (Fed. Cir. 2019) (citing PAR Pharm., Inc. v. TWI
Pharms., Inc., 773 F.3d 1186, 1194–95 (Fed. Cir. 2014) (citations omitted)).
The Federal Circuit, however, also explained that “the use of inherency, a
doctrine originally rooted in anticipation, must be carefully circumscribed in
the context of obviousness.” PAR Pharm., 773 F.3d at 1195 (citing In re
Rijckaert, 9 F.3d 1531, 1533–34 (Fed. Cir. 1993)) (“The mere fact that a
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certain thing may result from a given set of circumstances is not sufficient
[to establish inherency].” (Internal quotation omitted)).
In In re Oelrich, the Court held,
inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient. (Citations omitted.)
If, however, the disclosure is sufficient to show that the natural
result flowing from the operation as taught would result in the
performance of the questioned function, it seems to be well
settled that the disclosure should be regarded as sufficient.
In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v.
Kemmer, 102 F.2d 212, 214 (CCPA 1939)).
Thus, relying on its “early precedent, and that of [its] predecessor
court,” the Federal Circuit held “the concept of inherency must be limited
when applied to obviousness, and is present only when the limitation at issue
is the ‘natural result’ of the combination of prior art elements.” PAR
Pharm., 773 F.3d 1186, 1195 (Fed. Cir. 2014).
There is no disclosure in Reed that discloses or suggests that
flexibility of a “bone” is affected by its moisture content and that the
“wherein” claim limitation at issue is the “natural result” of the combination
of prior art elements. Based on the record before us, there is no basis in fact
or law that the claim limitation at issue is inherent in Reed. Accordingly, we
reverse the determination that claims 39–50 would have been obvious based
on Bindseil, Baumgartner, and Reed.
CONCLUSION
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 39–50 as unpatentable under 35 U.S.C. § 112, first paragraph, and
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reverse the Examiner’s rejection of claims 39–50 as unpatentable under
35 U.S.C. § 103.
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C.
§
References/Basis Affirmed Reversed
39–50 112 Written
Description
39–50
39–50 103 Bindseil,
Baumgartner,
Reed
39–50
Overall
Outcome
39–50
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