Ex Parte Perez-Cruet et al

Patent Trial and Appeal Board

Jul 10, 2018

14211802 (P.T.A.B. Jul. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/211,802 03/14/2014
68779 7590 07/10/2018
MILLER IP GROUP, PLC
MI4 SPINE, LLC
42690 WOODWARD A VE.
SUITE 300
BLOOMFIELD HILLS, MI 48304
FIRST NAMED INVENTOR
Miguelangelo J. Perez-Cruet
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
MI4-00022 2808
EXAMINER
LEGETTE-THOMPSON, TIFFANY
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
07/10/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MIGUELANGELO J. PEREZ-CRUET and JOHN R. PEPPER
Appeal2016-005984
Application 14/211,802
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
ARTHUR M. PESLAK, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Miguelangelo J. Perez-Cruet and John R. Pepper ("Appellants") 1
appeal under 35 U.S.C. § 134 from the Examiner's decision rejecting
claims 1, 2, 4--13, and 15-19 in this application. Claims 3 and 14 are
cancelled. Appeal Br. 16, 18 (Claims App.). The Board has jurisdiction
over the appeal under 35 U.S.C. § 6(b ).
We AFFIRM.
1 MI4Spine, LLC is an applicant as provided in 37 C.F.R. § 1.46. The
Appeal Brief identifies the same entity as the real party in interest. Appeal
Br. 4.
Appeal2016-005984
Application 14/211,802
CLAIMED SUBJECT MATTER
Claim 1 illustrates the subject matter on appeal, and it recites:
1. A regeneration device for annular disc regeneration of a
disc, said disc including an outer annulus fibrosus and an inner
nucleus pulposus, said device comprising:
a trocar having one end including a sharp tip, an opposite
end and an inner cavity therebetween;
a handle portion attached to the opposite end of the trocar;
a plunger mounted to the handle portion; and
a catheter having a plurality of ports coupled to the plunger
and extended through the inner cavity of the trocar, wherein the
plunger is operable to push the catheter through the cavity and
out of an opening in the tip of the trocar, said catheter being
structurally configured and flexible so that when the catheter
extends out of the trocar it bends in a circular manner to be
effective to follow along an inside surface of the outer annulus
fibrosus.
Appeal Br. 16 (Claims App.).
REJECTIONS ON APPEAL
Claims 1, 2, and 4 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Manzi (US 2005/0182414 Al, pub. Aug. 18, 2005) and
Krueger (US 2007/0142842, pub. June 21, 2007).
Claims 5 and 6 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Manzi, Krueger, and O'Neil (US 2007/0093905 Al, pub.
Apr. 26, 2007).
Claim 7 stands rejected under 35 U.S.C. § I03(a) as unpatentable over
Manzi, Krueger, and Yeung '600 (US 2006/0247600 Al, pub. Nov. 2,
2006).
Claim 8 stands rejected under 35 U.S.C. § I03(a) as unpatentable over
Manzi, Gharib (US 2010/0210997 Al, pub. Aug. 19, 2010), and Krueger.
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Application 14/211,802
Claim 9 stands rejected under 35 U.S.C. § I03(a) as unpatentable over
Manzi, Gharib, Krueger, and Yeung '600.
Claims 10 and 11 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Manzi, Gharib, Krueger, and O'Neil.
Claims 12, 13, 15, and 17 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Manzi, Yeung '425 (US 2012/0022425 Al, pub. Jan. 26,
2012), and Krueger. 2
Claim 16 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Manzi, Yeung '425, Krueger, and Schell (US 2011/0230965 Al, pub.
Sept. 22, 2011 ).
Claims 18 and 19 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Manzi, Yeung '425, Krueger, and O'Neil.
ANALYSIS
A. Obviousness based on Manzi and Krueger
(Claims 1, 2, and 4)
Appellants argue for the patentability of claims 1, 2, and 4 together in
one group, and do not argue for the patentability of any one claim from the
other claims. See Appeal Br. 9-12. Accordingly, we select claim 1 to
decide the present appeal as to all claims in this group. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
The Examiner finds Manzi discloses a device including each and
every limitation of claim 1, except Manzi' s catheter (i.e., injection
2 The statement of this rejection indicates claims 12-15 are subject to the
rejection. Final Act. 10. However, claim 14 is cancelled. Appeal Br. 18
(Claims App.). Also, the underlying analysis additionally considers pending
claim 17. Final Act. 13.
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Application 14/211,802
cannula 30) is not "structurally configured and flexible so that when the
catheter extends out of the trocar it bends in a circular manner to be effective
to follow along an inside surface of the outer annulus fibrosus," as claimed.
See Final Act. 3 ( citing Manzi, Fig. 6). The Examiner finds Krueger
discloses delivery cannula 1223 having orifices 130a-130c, and deflectable
segment 132 to make cannula 122 flexible. Id. at 3--4 (citing Krueger ,r,r 47,
61, 70); Krueger, Fig. 5 (illustrating delivery cannula 122).
The Examiner concludes it would have been obvious to substitute
Manzi's catheter 30 with Krueger's flexible catheter 122 having a pre-set but
flexible curve, because Krueger "teaches that the curved cannula [122]
enhances the surgeon's ability to locate and inject the appropriate materials
required for the procedure at a desired site." Final Act. 4 ( citing Krueger
,r 8). In the Examiner's view, due to deflectable segment 132 of Krueger's
curved and flexible catheter 122, the catheter is as claimed "configured and
flexible so that when the catheter extends out of the trocar it bends in a
circular manner to be effective to follow along an inside surface of the outer
annulus fibrosus." Id. at 4.
Appellants argue Manzi and Krueger both fail to disclose a device for
annular disc regeneration of a disc, as recited in claim 1. Appeal Br. 9-12.
Appellants contend the Manzi device is "for performing surgical procedures
on bone," such as "distracting opposite surfaces of a bone from inside the
3 The Examiner, confusingly, refers to delivery cannula 122 of Krueger's
Figure 5, and to delivery cannula 36 of Krueger's Figure 1. See Final
Act. 3--4. Krueger's disclosure concerning cannulas 122 and 36 is materially
the same as they relate to the Examiner's rejection. See Krueger ,r,r 54, 61-
62, 64, 70, 73. Therefore, our analysis focuses on delivery cannula 122 for
the sake of simplicity.
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Application 14/211,802
bone," or "removing an inoperative disc" and then fusing vertebral bodies
together without regenerating the disc. Id. at 9. According to Appellants:
"Krueger, like Manzi, teaches bone stabilization, and that is not disc
regeneration." Id. at 10.
In answer, the Examiner maintains the preamble of claim 1 "do[ es]
not limit the structure of the device but rather recite[s] purpose and/or
intended use of the device." Ans. 16-17. In reply, Appellants assert the
preamble of claim 1 does more than state an intended use of the claimed
device, "because it at least adds structural context and meaning to" the
limitation reciting the catheter is structurally configured to extend out of the
trocar and bend in a circular manner to follow an inside surface of the outer
annulus fibrosus. Reply Br. 3.
We determine the preamble of claim 1 is not limiting. There is "no
simple test for determining when a preamble limits claim scope," but rather
a determination is made on the facts of each case, in light of the claim and
the supporting patent specification. American Med. Sys., Inc. v. Biolitec,
Inc., 618 F.3d 1354, 1358 (Fed. Cir. 2010). Case law provides "some
general principles to guide that inquiry." Id. "Generally, the preamble does
not limit the claims." Georgetown Rail Equip. Co. v. Holland L.P., 867 F.3d
1229, 1236 (Fed. Cir. 2017) (quoting Allen Eng 'g Corp. v. Bartell Indus.,
Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002)). For example, "[a] preamble is
not a claim limitation if the claim body 'defines a structurally complete
invention . . . and uses the preamble only to state a purpose or intended use
for the invention." Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir.
1997)). Nonetheless, a preamble may be limiting if it recites essential
structure or steps; the claim body depends on a preamble phrase for
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Application 14/211,802
antecedent basis; the preamble is essential to understand limitations or terms
in the claim body; or the preamble recites additional structure or steps
underscored as important by the specification. Id. at 1236.
Applying those principles to claim 1, we conclude the claim body
defines a structurally complete invention, and the claim preamble recitation
of "disc regeneration" states only a purpose or intended use for the claimed
device. No limitation in the claim body refers back to the "disc
regeneration" function recited in the preamble, nor is the claim preamble
essential to understanding the claimed device. Appellants do not cite any
disclosure(s) in the Specification to support their position that the preamble
is limiting. See, e.g., Appeal Br. 11 (discussing Specification generally);
Reply Br. 3--4 ( discussing claim construction). Thus, because the "disc
regeneration" intended use recited in the preamble of claim 1 is not limiting,
the cited prior art need not disclose such functionality.
Appellants next contend that Krueger's catheter 122, while it may be
flexible as found by the Examiner, is not "structurally configured and
flexible so that when it is pushed out of the trocar it bends in a circular
manner to follow along an inside surface of an outer annulus fibrosus of a
disc," as required by claim 1. Appeal Br. 10, 11-12. Thus, Appellants
contend the Examiner errs in relying on Krueger's catheter 122 as disclosing
the claim requirement for a catheter that "automatically curves so that [it]
follows along an inside surface of the nucleus pulposus [ sic 'outer annulus
fibrosus']" when extended. Id. at 11.
In the Answer, the Examiner points out that claim 1 does not recite the
catheter "automatically" curves to follow along an inside surface of the outer
annulus fibrosus. Ans. 18. The Examiner interprets the claim limitation at
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issue ("said catheter being structurally configured ... ") as a functional
limitation, met by the structure of the Manzi device as modified in light of
Krueger because that device is capable of performing the recited function.
Id. at 18-19. Specifically, in the Examiner's view, Krueger's catheter 122 is
capable of extending out of Manzi's trocar to bend in a circular manner to
follow along an inside surface of the outer annulus fibrosus, as claimed. Id.
In reply, Appellants accuse the Examiner of ignoring the claim
limitation at issue. Reply Br. 3--4. According to Appellants, the Examiner
"has apparently not given this language any patentable significance," and
"the Examiner cannot merely dismiss language in the claims without
considering it." Id.
We agree with the Examiner's conclusion that the claim limitation
reciting the "catheter [is] structurally configured and flexible so that when
the catheter extends out of the trocar it bends in a circular manner to be
effective to follow along an inside surface of the outer annulus fibrosus" is a
functional limitation. This claiming strategy, while permissible, "carries
with it a risk." In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997).
When an Examiner has reason to believe that a functional limitation asserted
to be critical may in fact be an inherent characteristic of the prior art, the
Examiner possesses the authority to shift the burden to the applicant to show
otherwise. Id.; see also In re Simpson, 102 Fed. Appx. 675, 678 (Fed.
Cir. 2004) (unpublished) (as in Schreiber, existence of claimed structural
elements in prior art gave the Office reason to believe those elements could
perform the claimed function, thereby shifting burden to applicant to show
lack of inherency of claimed functionality). The Examiner may do this by
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Application 14/211,802
establishing that the structure disclosed in the prior art is capable of
performing the recited function. Schreiber, 128 F.3d at 1478-79.
A preponderance of the evidence supports the Examiner's finding that
Krueger's catheter 122 is capable of performing the claimed function.
Krueger's catheter 122 "includes a deflectable segment 132 forming a
pre-set curve 134." Krueger ,r 70, Fig. 5. Segment 132 has a shape memory
material, whereby segment 132 can be forced from the pre-set curve 134,
and will naturally revert back to curve 134 upon removal of the force. Id.
,r,r 54, 62, 64. Appellants do not persuasively rebut the Examiner's finding
that Krueger's catheter 122, if released from external forces as it is extended
from a trocar within a disc, will bend in a circular manner to follow along an
inside surface of the outer annular fibrosus. See, e.g., Appeal Br. 10-11
( discussing Krueger disclosure); Schreiber, supra. Appellants' contention
that the Examiner ignored the pertinent claim limitation is not accurate; the
Examiner addressed the claim limitation by finding that the Krueger catheter
is capable of performing the recited functionality. Further, we agree with
the Examiner that Appellants incorrectly characterize the claim as reciting
"the catheter automatically curves" to follow the inside surface of the outer
annulus fibrosus. Appeal Br. 11; Ans. 18.
For the foregoing reasons, we sustain the rejection of claims 1, 2, and
4 as unpatentable over Manzi and Krueger.
B. Obviousness based on Manzi, Krueger, and
one of O'Neil or Yeung '600
(Claims 5-7)
Appellants argue for the patentability of dependent claims 5-7 on the
sole basis that O'Neil and Yeung '600 "cannot provide the teaching missing
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from Manzi and Krueger" Appellants asserted in relation to the parent,
independent claim 1. Appeal Br. 12-13. For the reasons provided above,
we discern no deficiency of Manzi and Krueger for O'Neil or Yeung '600 to
cure in relation to claim 1. We, therefore, sustain the rejections of claims 5-
7 as unpatentable over Manzi, Krueger, and one of O'Neil or Yeung '600.
C. Obviousness based on Manzi, Gharib, and Krueger
(Claim 8)
Claim 8 is an independent claim reciting a regeneration device similar
to the device recited in claim 1. 4 See Appeal Br. 17 (Claims App.). In
rejecting claim 8, the Examiner relies on Manzi and Krueger in a
substantially similar fashion as with the common subject matter of claim 1,
and relies on Gharib in relation to the claimed rod being coupled to the
catheter. Final Act. 6-8. Appellants argue for the patentability of claim 8
on the sole basis that Gharib "cannot provide the teaching missing from
Manzi and Krueger" Appellants asserted in relation to claim 1. Appeal
Br. 13. For the reasons provided above, we discern no deficiency of Manzi
4 Appellants sought to amend claim 8 by an amendment filed with the
Notice of Appeal. See Response to Final Office Action (filed Sept. 24,
2015). The Examiner then entered an Advisory Action, including a copy of
the front page of the preceding amendment initialed "DO NOT ENTER:
/T.L./." See Adv. Act. (mailed Oct. 7, 2015). Nonetheless, the Appeal Brief
takes the position that "[i]t is unknown whether the amendment was
entered," and presents the amended version of claim 8 in the Claims
Appendix. Appeal Br. 4, 1 7. We conclude the record establishes the
amendment was not entered, because after-final amendments are not entered
as a matter of right (see 37 C.F.R. § 116(b}-(c)), and the Examiner initialed
the after-final amendment as being not entered. Thus, the version of claim 8
on appeal is the version which was pending at the time the final office action
on appeal was mailed.
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and Krueger for Gharib to cure in relation to the common subject matter
between claim 1 and claim 8. We, therefore, sustain the rejection of claim 8
as unpatentable over Manzi, Gharib, and Krueger.
D. Obviousness based on Manzi, Gharib, Krueger, and
one of O'Neil or Yeung '600
(Claims 9-11)
Appellants argue for the patentability of dependent claims 9-11 "[f]or
at least the reasons discussed above" in connection with independent
claims 1 and 8. Appeal Br. 13-14. For the reasons provided above, we
sustain the rejections of claims 9-11 as unpatentable over Manzi, Krueger,
and one of O'Neil or Yeung '600.
E. Obviousness based on Manzi, Yeung '425, and Krueger
(Claims 12, 13, 15, and 17)
Appellants argue for the patentability of claims 12, 13, 15, and 17
together in one group, and do not argue for the patentability of any one claim
from the other claims. See Appeal Br. 14. Accordingly, we select claim 12
to decide the present appeal as to all claims in this group. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
Claim 12 is an independent claim that, unlike the "device" claims 1
and 8 discussed above, recites a "method for ... disc regeneration." See
Appeal Br. 18 (Claims App.).
In rejecting claim 12, the Examiner relies on Manzi and Krueger in a
substantially similar fashion as with the common subject matter of claim 1.
See Final Act. 10-12. The Examiner relies on Yeung '425 in relation to the
claimed steps of "inserting the tip of the trocar into the intervertebral disc,"
and "extending the catheter within the intervertebral disc by pushing the
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plunger so that the catheter bends in a circular manner to follow along an
inside surface of the annulus fibrosus." Id. at 11; Ans. 19. In particular, the
Examiner finds Yeung '425 "teaches inserting a disc injecting needle (276B)
into an intervertebral disc (100); (see Fig. 9) and an annulus layer (378),"
and concludes it would have been obvious to insert Manzi' s device into a
disc as taught by Yeung '425. Final Act. 11 (citing Manzi ,r 22 and
Yeung '425, Abstract, ,r 67).
Appellants argue for the patentability of claim 12 on the same bases as
set forth above in relation to the parent, independent claim 1. See, e.g.,
Appeal Br. 11-12, 14; Reply Br. 4. That is, Appellants fail to address the
Examiner's reliance on Yeung '425 in relation to the claimed steps of
inserting a trocar into a disc, and extending a catheter within the disc. We
are, therefore, not apprised of error in that regard. See 37 C.F.R.
§ 4I.37(c)(l)(iv) ("any arguments or authorities not included in the appeal
brief will be refused consideration by the Board for purposes of the present
appeal"); In re Baxter Int'!, Inc., 678 F.3d 1357, 1362 (2012) (argument
waived when not timely presented in briefing to the Board, absent
exceptional circumstances); Ex Parte Frye, 94 U.S.P.Q.2d 1072, 1075
(BP AI 2010) (precedential) ("Filing a Board appeal does not, unto itself,
entitle an appellant to de nova review of all aspects of a rejection. If an
appellant fails to present arguments on a particular issue - or, more
broadly, on a particular rejection-the Board will not, as a general matter,
unilaterally review those uncontested aspects of the rejection."). We sustain
the rejection of claims 12, 13, 15, and 17 as unpatentable over Manzi,
Yeung '425, and Krueger.
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F. Obviousness based on Manzi, Yeung '425, Krueger, and
one of Schell or O 'Neil
(Claims 16, 18, and 19)
Appellants argue for the patentability of dependent claims 16, 18, and
19 on the sole basis that Schell and O'Neil "cannot provide the teaching
missing from Manzi and Krueger" Appellants asserted in relation to the
parent, independent claim 12. Appeal Br. 14. For the reasons provided
above, we sustain the rejections of claims 16, 18, and 19 as unpatentable
over Manzi, Yeung '425, and one of Schell or O'Neil.
DECISION
The various rejections of claims 1, 2, 4--13, and 15-19 are each
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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