Ex parte WILK

Board of Patent Appeals and Interferences

Apr 30, 1999

08127319 (B.P.A.I. Apr. 30, 1999)

Application for patent filed September 27, 1993. According to the appellant, the application1
is a continuation of Application 07/913,601, filed July 14, 1992, now U.S. Patent 5,269,753, issued
December 14, 1993.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 31
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte PETER J. WILK
__________
Appeal No. 97-0939
Application 08/127,3191
___________
ON BRIEF
___________
Before STAAB, MARTIN, and GONZALES, Administrative Patent Judges.
STAAB, Administrative Patent Judge.
DECISION ON APPEAL
Appeal No. 97-0939
Application 08/127,319
2
This is a decision on an appeal from the final rejection of claims 1-7 and 20-29, all the claims
currently pending in the application. Two amendments have been filed subsequent to the final rejection.
The first, submitted on July 17, 1995 (designated amendment “E” in the file) has been entered. The
second, submitted July 31, 1997 (designated amendment “F” in the file) has been refused entry by the
examiner.
Appellant’s invention pertains to a method for use in laparoscopic hernia repair, and includes
inter alia the steps of inserting a balloon between the abdominal muscles and the parietal peritoneum,
and inflating the balloon to shift connective tissue between the abdominal muscles and the parietal
peritoneum to form a space for performing the laparoscopic hernia repair operation on the herniated
tissues. Independent claim 1, a copy of which is found in the appendix to appellant’s second substitute
brief (hereinafter, brief) filed March 19, 1996, is illustrative of the appealed subject matter.
The references of record relied upon by the examiner in support of rejections under 35 U.S.C.
§ 103 and 35 U.S.C. § 102(e) are:
Bonutti 5,163,949 Nov. 17, 1992
(Filing date Jul. 17, 1991)
Pena 5,178,133 Jan. 12, 1993
(Filing date Mar. 26, 1991)
Moll et al (Moll) 5,309,896 May 10, 1994
(Filing date Nov. 19, 1991)
Kieturakis et al (Kieturakis) 5,496,345 Mar. 5, 1996
(Effective filing date June 2, 1992)
Appeal No. 97-0939
Application 08/127,319
Rejections (b)-(d) and (g) are new rejections made for the first time in the examiner’s answer.2
3
The following rejections are before us for review:2
(a) claims 1-7 and 20-29 under 35 U.S.C. § 112, first paragraph, as being based on a
specification, as originally filed, that “does not provide support for the invention as is now claimed”
(answer, page 11);
(b) claim 25 under 35 U.S.C. § 112, second paragraph, “as being indefinite for failing to
particularly point out and distinctly claim the subject matter which [appellant] regards as the invention”
(answer, page 12);
(c) claims 1-7 and 20-29, “provisionally rejected under the judicially created doctrine of double
patenting over claims 1-20 of U.S. Patent Application No. 08/602,913” (answer, pages 12-13); and,
(d) claims 20 and 27, “provisionally rejected under 35 U.S.C. § 101 as claiming the same
invention as that of claim 18 of copending application Serial No. 602913” (answer, page 14).
(e) claims 1-3, 6, 7, 20, 21 and 24-29 under 35 U.S.C. § 103 as being unpatentable over
Bonutti in view of Moll;
(f) claims 4, 5, 22 and 23 under 35 U.S.C. § 103 as being unpatentable over Bonutti in view of
Moll and further in view of Pena;
(g) claims 20, 21, 24, 25, 27 and 28 under 35 U.S.C. § 102(e) as being anticipated by
Appeal No. 97-0939
Application 08/127,319
4
Kieturakis;
The rejections are explained in the final rejection (Paper No. 11, mailed June 5, 1995), the
examiner’s answer (Paper No. 21, mailed August 22, 1996), the advisory letter (Paper No. 27, mailed
November 12, 1997) in response to appellant’s reply brief, and the supplemental examiner’s answer
(Paper No. 30, mailed December 30, 1997).
The opposing viewpoints of appellant are set forth in the brief (Paper No. 20, filed March 19,
1996), and the reply brief (Paper No. 24, filed July 31, 1997). In addition, a declaration under 37
CFR § 1.131 by inventor Peter J. Wilk (Paper No. 26) has been submitted with the reply brief for the
purpose of “swearing behind” the Kieturakis patent that forms the basis for the newly entered § 102(e)
rejection.
Rejection (a)
The 35 U.S.C. § 112, First Paragraph, Rejection
Looking first at the rejection of claims 1-7 and 20-29 under 35 U.S.C. § 112, first paragraph,
we understand this rejection to be based upon the written description requirement of the first paragraph
of § 112. In general, the test for determining compliance with the written description requirement of §
112 is whether the disclosure of the application as originally filed reasonably conveys to the artisan that
the inventor had possession at that time of the later claimed subject matter, rather than the presence or
absence of literal support in the specification for the claim language under consideration. Further, it is
Appeal No. 97-0939
Application 08/127,319
5
also well settled that the content of the drawings may be considered in determining compliance with the
written description requirement. See Wang Lab., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26
USPQ 1767, 1774 (Fed. Cir. 1993); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1564, 19
USPQ2d 1111, 1117 (Fed. Cir. 1991). See also In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ
1089, 1096 (Fed. Cir. 1983).
It is the examiner’s view, as expressed on pages 2-3 of the final rejection, that the original
disclosure does not provide descriptive support for the steps of claims 1, 20 and 27 of (1) removing the
elongate instrument from the pre-peritoneal space, thereby permitting herniated tissue to project into
said pre-peritoneal space, (2) after removal of the instrument from the pre-peritoneal space, performing
a laparoscopic hernia repair operation on the herniated tissues, and (3) inflating the balloon any time
after disposition rather than upon disposition thereof into the pre-peritoneal space. In addition, the
examiner considers that the step of claims 2, 21 and 28 of (4) infusing a gaseous composition into the
space to expand and maintain the same in an expanded state during the operation is not described in the
original disclosure.
After reviewing appellant’s disclosure as originally filed, it is our determination that the
specification and drawings thereof, although somewhat incomplete, are sufficient to provide “written
description” support within the meaning of the first paragraph of 35 U.S.C. § 112 for the steps called
into question by the examiner. Support for step (1) is found, in our view, in a comparison of Figures 1
Appeal No. 97-0939
Application 08/127,319
See page 2, line 23, and page 4, penultimate line, of the specification.3
6
and 4 when considered in light of page 5, lines 4-7 and 22-23, of the specification, and from an
understanding of the intended end result of the invention as a whole. Support for step (2) is found, in
our view, in the first and third objects of the invention found on page 2 of the specification, and the
summarized description of appellant’s method as found on page 3, lines 14-18, when these portions of
the specification are read in conjunction with Figures
1, 2 and 4. Figure 4 is especially pertinent in this respect in that it shows the herniated tissue HT
projecting into the pre-peritoneal space PS formed by the balloon, the laparascope 12 positioned
through trocar sleeve 14 into the space PS, and the absence of the elongated instrument used to create
the space PS. Support for step (3) is found in the specification at page 2, lines 23-24, and page 4, last
two lines. In this regard, when read in context, an artisan would understand the word “upon” as used in
the specification and claims as indicating that the balloon is disposed between the abdominal tissue AM3
and the peritoneum PP and then inflated. Finally, support for (4) is found in the specification at page 3,
lines 4-7, and page 5, lines 14-17, especially in that these passages indicate that carbon dioxide gas is
used to “maintain” the space PS in a desired state of expansion.
In reaching these conclusions, we reiterate that the test for compliance with the written
Appeal No. 97-0939
Application 08/127,319
Although not rejected by the examiner on this ground, claim 27, line 21, contains a similar4
double inclusion of the word “said.”
7
description requirement of § 112 is not whether appellant’s original disclosure exactly describes the
subject matter claimed, but rather whether persons of ordinary skill in the art would have recognized
that appellant invented what is now claimed. In that we believe an artisan would recognize from a
review of the original disclosure as a whole that appellant invented what is now claimed, we will not
sustain the examiner’s rejection of the appealed claims under 35 U.S.C. § 112, first paragraph.
Rejection (b)
The 35 U.S.C. § 112, Second Paragraph, Rejection
The examiner has concluded that claim 25 is indefinite because of the double inclusion of the
word “said” in describing one of the steps (i.e., “said said step of inserting said distal tip of said
instrument including . . .” (claim 25, lines 3-4)). Appellant has failed to point out any error in the4
examiner’s position and instead has submitted a proposed amendment (Paper No. 25) filed with the
reply brief to overcome the rejection. The examiner, however, has refused to enter this proposed
amendment. Advisory letter (Paper No. 27, mailed November 12, 1997).
The rejection under the second paragraph of § 112 is therefore still before us, and claim 25 has
not been amended as set forth in the unentered proposed amendment. Under these circumstances, we
will sustain the examiner’s newly entered rejection of claim 25 under 35 U.S.C. § 112, second
Appeal No. 97-0939
Application 08/127,319
Appellant is apparently of the view that the filing of a terminal disclaimer would overcome5
rejection (g) as well. However, in that provisional rejection (g) is based on 35 U.S.C. § 101, a terminal
disclaimer would not be effective to overcome this rejection in the event the application upon which it is
based were to issue as a patent.
8
paragraph, since appellant has failed to point out any error in this rejection.
Rejections (c) & (d)
The Provisional Double Patenting Rejections
Each of the examiner’s provisional double patenting rejections is based on appellant’s
application Serial No. 08/602,913. With respect to provisional rejection (f), appellant states that “[he]
is prepared to submit a terminal disclaimer in accordance with current practice upon an
indication that any of the claims of the instant application or Application 08/602,913 are allowable”
(reply brief, page 5). No separate response is made with respect to rejection (g). 5
It has always been the policy of this Board to summarily affirm rejections that are not argued by
appellant. However, a review of the Patent Office records reveals that Serial No. 08/602,913 is now
abandoned. Therefore, the basis for the standing provisional double patenting rejections no longer
exists. Accordingly, we will not sustain these newly entered provisional double patenting rejections,
notwithstanding appellant’s failure to traverse them in the reply brief.
In the event Serial No. 08/602,913 is revived, the examiner should consider whether a new
provisional double patenting rejection based thereon would be appropriate.
Appeal No. 97-0939
Application 08/127,319
9
Rejections (e) & (f)
The 35 U.S.C. § 103 Rejections
We appreciate that Bonutti discloses a method of using a balloon retractor to create a space in
the body for a surgical procedure by first positioning the deflated balloon in the body at a desired
location, then inflating the balloon with fluid, and thereafter manipulating the balloon to separate body
tissue (column 7, lines 23-42). Bonutti also teaches that, depending on the application, the balloon can
be left in place during the operation, or deflated and removed and
another instrument put into the space created (column 3, lines 50-52; column 4, lines 53-58). We also
appreciate that Moll discloses the use of an inflated retractor to create a working space for a
laparoscopic hernia repair operation (Figures 20A, 20B, 21 and the portions of the specification
describing same). Our difficulty with the examiner’s rejection, however, stems from its implied position
that the combined teachings of these references would have suggested to one of ordinary skill in the art
a method of using the balloon retractor of Bonutti in a hernia repair operation that includes the step of
removing the balloon retractor instrument prior to performing the hernia repair operation on the
herniated tissue, as now required by each of the independent claims on appeal. Clearly, Moll teaches
that the retractor should in all instances remain in place during the operation. As to Bonutti, while the
balloon can be deflated and removed, and another instrument put into the space created (column 3,
Appeal No. 97-0939
Application 08/127,319
10
lines 50-52), whether or not this is done “depend[s] on the application” (column 4, line 53), and in
particular notes that “[s]ome tissues will stay in place to allow this latter function, after the space has
been created with the retractor” (column 4, lines 56-58). Missing from the combined teachings of the
references, in our view, is any teaching that in a hernia repair operation, the tissues in question will stay
in place so as to allow for removal of the retractor, or that, as a practical matter, the balloon of Bonutti
could be removed even if the tissues will not stay in place. In light of these deficiencies in the
disclosures of Bonutti and Moll, we will not sustain the standing § 103 rejection of claims 1-3, 6, 7, 20,
21 and 24-29 based on their combined teachings.
The Pena reference additionally applied in the § 103 rejection of claims 4, 5, 22 and 23 does
not render obvious what we have found to be lacking in Bonutti and/or Moll. Accordingly, the standing
§ 103 rejection of these claims also will not be sustained.
Rejection (g)
The 35 U.S.C. § 102(e) Rejection
Appellant does not appear to challenge the examiner’s position that the disclosure of Kieturakis
anticipates the subject matter of claims 20, 21, 24, 25, 27 and 28. Instead, appellant has submitted a
declaration under 37 CFR § 1.131 by inventor Peter J. Wilk for the purpose of “swearing behind” the
Appeal No. 97-0939
Application 08/127,319
The effective filing date of Kieturakis is June 2, 1992, which is the filing date of the6
grandparent SN 07/893,988 application thereof. See item [60] on the cover sheet of the Kieturakis
patent, as well as column 1, lines 5-7, of the specification.
11
effective filing date of the Kieturakis patent. Therefore, the dispositive issue with respect to this6
rejection is whether the Wilk declaration is effective to remove Kieturakis as a reference.
37 CFR § 1.131(b), in pertinent part, reads as follows:
[o
The showing of facts [required to overcome a reference cited against a claim] shall be
such . . . as to establish reduction to practice prior to the effective date of the reference,
or conception of the invention prior to the effective date of the reference coupled with
due diligence from prior to said date to a subsequent reduction to practice or to the
filing of the application.
In the present instance, appellant contends that the Wilk declaration and supporting exhibits
“establish a date of conception prior to the earliest effective filing date of Kieturakis et al., i.e., prior to
June 2, 1992 . . . [and] diligence from the conception date to a subsequent (constructive) reduction to
practice” (reply brief, page 2).
We have closely reviewed the Wilk declaration and supporting exhibits and have concluded,
based on exhibits A-D, that appellant has established conception of the invention prior to June 2, 1992,
the earliest effective date of the Kieturakis reference. However, we do not agree that appellant has
established diligence from just prior to Kieturakis’ entry into the field on June 2, 1992 to appellant’s
Appeal No. 97-0939
Application 08/127,319
The “self-adhered note” in question actually appears to be a hand drawn sketch intended to7
simulate a self-adhered note.
12
constructive reduction to practice on July 14, 1992. The activities referred to in exhibits A-D, while
pertinent to conception of the invention, do not show diligence in constructively reducing the presently
claimed invention to practice because they are not directly related to the filing of a patent application
directed to the presently claimed subject matter.
Turning to the remaining exhibits, exhibit E is a photocopy of the same sheet of appellant’s
notes and drawings as exhibit D, except that a portion of the sheet is obscured by what declarant Wilk
characterizes as a “self-adhered note sheet” . The writing within the bounds of the “note sheet”7
includes the initials “N.S.,” the date “6/17/92,” and several additional lines of text. Declarant Wilk
states:
I wrote the note on a self-adhering note sheet and attached the note to the drawing of
Exhibit D. The note has the initial “N.S.” of my patent attorney Neil Sudol, indicating
that I made the note during a meeting with my attorney on June 17, 1992. The note
says that the invention had been “discussed previously” - with my attorney - and carries
the words “same balloon as intussussception device” and “file separately” and “method
claims only.” [Declaration, paragraph 8.]
Exhibit F comprises photocopies of certain pages of an invoice from attorney Sudol dated July
1, 1992. The exhibit supports declarant Wilk’s statements regarding the note sheet of exhibit E in the
sense that it refers to a meeting between declarant Wilk and attorney Sudol on June 17, 1992 “re new
Appeal No. 97-0939
Application 08/127,319
13
inventions for May and June,” which new inventions include inter alia a “peritoneal balloon.”
Exhibit G comprises photocopies of certain pages of an invoice from attorney Sudol dated
August 2, 1992. Under the heading “WO7-135 Peritoneal Clearance W/Balloon” are three entries
pertaining to the preparation of a patent application that was apparently filed on July 14, 1992.
The critical period for diligence under 37 CFR § 1.131(b) begins just prior to the effective date
of the reference (i.e., June 2, 1992) and ends with the date of constructive reduction to practice (i.e.,
July 14, 1992, the filing of application SN 07/913,601, the parent of the instant application). Appellant
must account for the entire period during which diligence is required. Gould v. Schawlow, 363 F.2d
908, 919, 150 USPQ 634, 643 (CCPA 1966).
A period lacking activity of as little as two days has been held to be fatal. In re Mulder, 716 F.2d
1542, 1545, 219 USPQ 189, 193 (Fed. Cir. 1983) (37 CFR § 1.131 issue).
On the record before us, the earliest indication that appellant thought to file a patent application
directed to the claimed method, and thus constructively reduce it to practice, is, at best, inventor Wilk’s
alleged discussion with attorney Sudol at some unspecified date prior to June 17, 1992 (Wilk
declaration, paragraphs 8 and 9; exhibits E and F). The record does not specify when the alleged
Appeal No. 97-0939
Application 08/127,319
14
discussion took place, or precisely what was discussed. Accordingly, even when viewed in a light most
favorable to appellant, appellant’s showing has not adequately accounted for the time from just prior to
Kieturakis’ entry into the field on June 2, 1992 up to the alleged discussion with attorney Sudol some
time prior to June 17, 1992, a period of time that could have been up to two weeks. This unaccounted
for period of time in appellant’s attempt to show diligence coupling his conception to the effective filing
date of the present application leaves a hiatus that is fatal to appellant’s showing. In re Mulder, 716
F.2d at 1545, 219 USPQ at 193. We therefore conclude that appellant’s evidence does not show
diligence in constructively reducing the presently claimed invention to practice for the critical period
beginning just prior to the effective filing date of Kieturakis to the filing date of the parent of the instant
application, as required by 37 CFR § 1.131(b). It follows that we simply do not agree with appellant
that “the short time between Appellant’s conception and the filing of parent application No. 07/913,601
on
July 14, 1996 [sic, 1992] itself is evidence of Appellant’s diligence in [constructively] reducing the
invention to practice” (reply brief, page 3).
Thus, on the record before us, Kieturakis is still applicable as prior art. In that appellant has not
specifically disputed the examiner’s position that the Kieturakis disclosure anticipates the subject matter
Appeal No. 97-0939
Application 08/127,319
15
of claims 20, 21, 24, 25, 27 and 28, the standing § 102(e) rejection will be sustained.
Summary
Rejection (a) of claims 1-7 and 20-29 under 35 U.S.C. § 112, first paragraph, is reversed.
Rejection (b) of claim 25 under 35 U.S.C. § 112, second paragraph, is affirmed.
Provisional double patenting rejections (c) and (d) of claims 1-7 and 20-29 are reversed.
Rejections (e) and (f) of claims 1-7 and 20-29 under 35 U.S.C. § 103 are reversed.
Rejection (g) of claims 20, 21, 24, 25, 27 and 28 under 35 U.S.C. § 102(e) as being
anticipated by Kieturakis is affirmed.
The decision of the examiner is affirmed-in-part.
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
Appeal No. 97-0939
Application 08/127,319
16
AFFIRMED-IN-PART
LAWRENCES J. STAAB )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
JOHN C. MARTIN )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
JOHN F. GONZALES )
Administrative Patent Judge )
LJS/pgg
Coleman & Sudol
Appeal No. 97-0939
Application 08/127,319
17
261 Madison Avenue
New York, NY 10016-2303