Ex Parte SAIDI

Patent Trial and Appeal Board

Oct 24, 2018

14331805 (P.T.A.B. Oct. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/331,805 07/15/2014
155317 7590 10/26/2018
Vista IP Law Group, LLP / Spirox
100 SPECTRUM CENTER DR STE 900
IRVINE, CA 926184974
FIRST NAMED INVENTOR
Iyad S. SAIDI
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.
SPRX-001.4 9064
EXAMINER
SHARMA, YASHITA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/26/2018 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):
msd@viplawgroup.com
jll@viplawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IYAD S. SAIDI 1
Appeal2017-007337
Application 14/331,805
Technology Center 3700
Before RICHARD M. LEBOVITZ, JOHN E. SCHNEIDER and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for changing the structure of a nose, which have been rejected by the
Examiner as anticipated and as obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
"The internal nasal valve is the narrowest point in the nasal airway
and is the point that often limits inspiration flow." Spec. ,r 6. "Narrowness
1 Appellant identifies the Real Party in Interest as Spirox, Inc. Appeal Br. 2.
Appeal2017-007337
Application 14/331,805
of the nasal valve may lead to difficulty in respiration and snoring as well as
other breathing related disorders such as sleep apnea." Id. According to the
Specification, while both internal and external nasal dilators are available,
there remains a need for improved methods and systems for repairing nasal
valves that eliminates the risks of surgery and the discomfort of external
dilators. Spec. ,r,r 7-12. The Specification describes an implant and a
method for placing the implant using an injection technique that does not
require surgical incisions. Spec. ,r 13.
Claims 18-31, 36, and 37 are on appeal. 2 Claim 18 is illustrative and
reads as follows:
18. A method for changing a structure of a nose, the
method comprising:
inserting an introducing needle into the nose, the
introducing needle comprising a hollow core;
controlling movement of an implant out of the hollow
core of the introduction needle and into nasal tissue of the nose,
the implant having a length, width, and a thickness sized for the
implant to reside within nasal tissue of the nose;
depositing the implant adjacent to a lateral cartilage of
the nose and the maxillary bone; and
applying force to the cartilage to stent a nasal valve open.
The claims stand rejected by the Examiner as follows:
Claims 18-20, 22-25, 27-31, 36, and 37 have been rejected under 35
U.S.C. § 102( e) as anticipated by van der Burg. 3
2 Claims 1-17 and 32-35 are pending in the application but have been
withdrawn from consideration. Final Act. 1.
3 van der Burg et al., US 2008/0027480 Al, published Jan. 31, 2008 ("van
der Burg").
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Application 14/331,805
Claim 21 has been rejected under 35 U.S.C. § I03(a) as unpatentable
over van der Burg in view of Hunter. 4
Claim 26 has been rejected under 35 U.S.C. § I03(a) as unpatentable
over van der Burg in view of Vassallo. 5
ANTICIPATION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's finding that the rejected claims are
anticipated by van der Burg.
The Examiner finds that van der Burg discloses a method for
changing the structure of a nose comprising: inserting an introducing needle
into the nose wherein the introducing needle comprises a hollow core;
controlling the movement of an implant out of the hollow core of the
introducing needle and into the nasal tissue; depositing the implant adjacent
to the lateral cartilage of the nose and the maxillary bone and applying force
to the cartilage to stent a nasal valve open. Ans. 2-3. The Examiner finds
that the implant has a length, width, and thickness sized for the implant to
reside within the nasal tissue of the nose. Ans. 3. The Examiner also finds
that van der Burg teaches that the implant can be made ofNitinol, which has
shape memory properties. Ans. 3--4.
Appellant contends
[ v Jan der Burg's implant is not sized to reside within
nasal tissue of the nose, and rather than apply force to the
4 Hunter et al., US 2005/0142162 Al, published June 30, 3005 ("Hunter").
5 Vassallo et al., US 2006/02768I 7Al, published Dec. 7, 2006 ("Vassallo").
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Appeal2017-007337
Application 14/331,805
cartilage to stent the nasal valve open, van der Burg suspends
the nasal tissue from a structure near the patient's eye. Van der
burg also does not deposit its implant adjacent to a lateral
cartilage of the nose and the maxillary bone.
Appeal Br. 7. With respect to claims 22-25 and 37, Appellant argues that
while van der Burg discloses the use ofNitinol, van der Burg discloses the
use ofNitinol for a different embodiment than the one recited by the
Examiner for the other claims. Appeal Br. 10-13. Appellant contends that
nothing in van der Burg teaches the use ofNitinol with the structure cited by
the Examiner. Id.
Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
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.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
[U]nless a [prior art] reference discloses within the four comers
of the document not only all of the limitations claimed but also
all of the limitations arranged or combined in the same way as
recited in the claim, it cannot be said to prove prior invention of
the thing claimed and, thus, cannot anticipate under 35 U.S.C.
§ 102.
Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
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Application 14/331,805
Analysis
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding the rejection of claims 18-20 and 27-31. We find the
Examiner has established that claims 18-20 and 27-31 are anticipated by
van der Burg. Appellants have not produced evidence showing, or
persuasively argued, that the Examiner's determinations on anticipation are
incorrect. Only those arguments made by Appellant in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015). We have identified claim
18 as representative; therefore, all claims fall with claim 18.
With respect to claims 22-25, 36, and 37, we find that the Examiner
has not established that the claims are anticipated by van der Burg.
We address the parties' arguments below.
Claims 18-20 and 27-31
Appellant contends that van der Burg does not anticipate claims 18-
20 and 27-31 for several reasons. Appellant argues that the implant of van
der Burg is not sized to reside within the nasal tissue of the nose. Appeal Br.
7, Reply Br. 2. Appellant also argues that van der Burg does not disclose
applying force to the cartilage to stent the nasal valve open. Appeal Br. 7.
Finally, Appellant contends that the implant of van der Burg is not deposited
adjacent to the lateral cartilage of the nose and the maxillary bone. Id.
We have considered Appellant's arguments and find them
unpersuasive.
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Appeal2017-007337
Application 14/331,805
Our analysis begins by noting that the claims are process claims and
that they do not actually require the implant to reside entirely within the
nasal tissue but only be sized to or be capable of residing in the nasal tissue.
See, e.g., Appeal Br. 17 (Claims App'x). Thus the claim only requires that
the at least part of the implant reside in the nasal tissue.;
Referring to Figure IA (reproduced below) van der Burg teaches that
the tether can be "attached to the orbital rim 112 or to any structures near
orbital rim 112 or between orbital rim 112 and nose 124 that are less mobile
than nose 124. For example, tether line 108 can be attached to bones,
periosteum, or soft tissue." Van der Burg ,r 88.
/
I
i
/.10
i
148
\
cl
\
\
120
FIG. lA
Figure IA of van der Burg showing a nasal suspension assembly
being deployed through the nostrils using a cannula containing a tether line
and collapsed anchor at the proximal end of the tether line.
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Application 14/331,805
Van der Burg also teaches that the anchor is deployed partly in the tissue of
the nasal passage. Van der Burg ,r 89. From this discussion it is apparent
that the implant of van der Burg is capable of residing in the nasal tissue.
With respect to the limitation calling for the implant to be located
adjacent to the lateral cartilage and the maxillary bone, as the Examiner
points out, van der Burg teaches that the anchor can be attached to the
cartilage of the nose and the tether can be attached to the orbital rim which is
part of the maxillary bone. Ans. 8, van der Burg ,r,r 88 and 89. Thus the
implant of van der Burg lies adjacent to the two structures.
Finally, while van der Burg does not explicitly call for force to be
applied to the cartilage, we agree with the Examiner that such teaching is
implicit. Ans. 8. Van der Burg teaches that by applying tension to the
tether, the nasal structures are suspended and the site of nasal collapse is
thereby opened. Van der Burg ,r 88. Absent persuasive evidence to the
contrary, suspending the nasal structures would apply force to the cartilage
in the nose thereby stenting the structure open.
Claims 22-25, 36, and 37
The Examiner relies on the teachings in van der Burg that Nitinol, a
shape memory material, can be used to prepare the implants of van der Burg
to support the rejection of claims 22-25, 36, and 37. Appellant contends
that the disclosure ofNitinol in van der Burg applies only to an embodiment
of van der Burg other than the one relied on by the Examiner in rejecting the
other claims. Appeal Br. 10-13, Reply Br. 3---6.
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Application 14/331,805
We agree with Appellant that van der Burg does not anticipate claims
22-25, 36, and 37. While van der Burg teaches that Nitinol can be used to
prepare an implant, that teaching is directed to an entirely different
embodiment than the one relied on by the Examiner. Paragraph 94 of van
der Burg refers to implant 192 which is shown in Figure 6 of van der Burg
(reproduced below). As can be seen from Figure 6, the implant is
significantly different from the implant shown in Figure 1 A above.
4r~~:::'.'??~~--
--------·-·--.------------ ;>--- / 76
-~~
FIG. 6
Figure 6 of van der Burg showing an implant deployed across the
bridge of the nose.
The Examiner has pointed to nothing in van der Burg to show that the
materials that can be used to make the implant shown in Figure 6 apply
equally, for anticipation purposes, to any of the other implants described in
van der Burg.
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Application 14/331,805
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's finding that claims 18-20 and 27-31 are anticipated by van der
Burg.
We conclude that a preponderance of the evidence does not support
the Examiner's finding that claims 22-25, 36, and 37 are anticipated by van
der Burg.
OBVIOUSNESS
Van der Burg combined with Hunter (claim 21)
Appellant's argument with respect to this rejection is that Hunter does
not cure the deficiencies of van der Burg. Appeal Br. 14--15. As discussed
above, van der Burg is not deficient as to claims 18 and 20, from which
claim 21 depends. We, therefore, affirm this rejection.
Van der Burg combined with Vassallo (claim 26)
In rejecting claim 26, the Examiner finds that Vassallo adds to the
teachings of van der Burg a stop mechanism that controls the movement of
the introducing needle when the needle arrives at the desired location. Ans.
6. The Examiner concludes
it would have been obvious to one of ordinary skill in the art at
the time of invention was made to modify the introduction
needle in van der Burg to include a stop mechanism that
controls movement of an advancement shaft after the
introduction needle arrives at a desired location in the nasal
tissue, the method further comprising stopping movement of the
advancement shaft with the stop mechanism, for the purpose of
allowing complete ejection of the implant out of the needle and
assuring proper placement of the implant at the implantation
site.
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Application 14/331,805
Id.
Appellant argues that van der Burg does not need a stop mechanism as
van der Burg uses two access points. Appeal Br. 15. Appellant contends
that the Examiner engaged in impermissible use of hindsight in making the
rejection.
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Answer regarding this
rejection. Ans. 6. We find the Examiner has established that the subject
matter of claim 26 would have been obvious to one of ordinary skill in the
art at the time the invention was made over van der Burg combined with
Hunter. Appellant has not produced evidence showing, or persuasively
argued, that the Examiner's determinations on obviousness are incorrect.
As the Examiner has pointed out, one skilled in the art would have
been motivated to add the stop mechanism of Vassallo to the system of van
der Burg to help ensure proper placement of the implant. Ans. 12.
With respect to Appellant's argument that the Examiner engaged in
the improper use of hindsight, we agree with the Examiner that the rejection
"is based on a proper understanding of the scope and content of the
combination of these references." Ans. 11. The court acknowledged in
McLaughlin that
[a]ny judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
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Appeal2017-007337
Application 14/331,805
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Appellant has not
pointed to any specific teaching in the present Specification that was relied
on by the Examiner in making this rejection.
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that claim 26 would have been obvious over van der
Burg combined with Vassallo.
SUMMARY
We affirm the rejection of claims 18-20 and 27-31 under 35 U.S.C.
§ 102(e).
We reverse the rejection of claims 22-25, 36, and 37 under 35 U.S.C.
§ 102(e).
We affirm the rejections under 35 U.S.C. § 103(a).
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).
AFFIRMED-IN-PART
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