DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Application Status
This office action is in response to the claims filed 3/28/2025.
Claims 16-35 are currently pending and being examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 16 (and 30): “a connector [] providing a force on the first exterior side thereby attaching the first film layer to the deck-facing surface”; interpreted to be threads, stitching, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 25:
In claim 25, “pre-compressing the respective edges” lacks sufficient antecedent basis, and further renders the claim indefinite because it is unclear what is meant by respective edges without further clarification (i.e., respective to what?).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-24, 26-33, and 35 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vendely et al. US 2022/0061843.
Regarding claim 16:
Vendely teaches an implantable adjunct (FIGS. 13-16, 110/130) configured to be detachably adhered to a deck of a staple cartridge ([0194]), the implantable adjunct comprising:
a deck-facing surface (unnumbered, lower portion contacting 114);
an external surface (unnumbered, upper portion contacting 115);
a first film layer (114) contacting the deck-facing surface and comprising a first exterior side (unnumbered, lower portion contacting deck 16) facing away from the implantable adjunct; and
a connector (119/122) in contact with the first exterior side, the connector providing a force on the first exterior side thereby attaching the first film layer to the deck-facing surface (i.e., omitting connectors 119/122 would cause the first film layer 114 to be released, since the force, provided by connectors 119/122, would no longer be present. Thus, there exists a force provided by the connector, acting to attach the first film layer to the deck-facing surface).
Regarding claim 17:
Vendely teaches the implantable adjunct of Claim 16, wherein the connector extends at least partially through the implantable adjunct (shown in FIGS. 13 and 116; cf. [0255]).
Regarding claim 18:
Vendely teaches the implantable adjunct of Claim 16, wherein the connector is a thread extending through the first film layer ([0260]).
Regarding claim 19:
Vendely teaches the implantable adjunct of Claim 18, wherein a first surface segment (portion in direct contact with deck-facing surface) of the thread contacts the deck-facing surface to provide the force, and wherein the thread comprises transverse segments (the various 119a and 119b portions inside of the deck-facing surface extending through the adjunct) positioned at each side of the first surface segment, the transverse segments extending at least partially through the implantable adjunct.
Regarding claim 20:
Vendely teaches the implantable adjunct of Claim 16, wherein the connector comprises a first row of stitching comprising a first plurality of surface segments, the first plurality of surface segments providing the force on the first exterior side of the first film layer (grid comprising rows of surface segments envisaged in FIGS. 13 and 16).
Regarding claim 21:
Vendely teaches the implantable adjunct of Claim 20, wherein the first row of stitching is positioned proximate a first edge of the implantable adjunct (e.g., see row comprising 120 in FIG. 13).
Regarding claim 22:
Vendely teaches the implantable adjunct of Claim 20, wherein the connector comprises a second row of stitching comprising a second plurality of surface segments, the second plurality of surface segments providing the force on the first exterior side of the first film layer (e.g., any other row, as shown in FIGS. 13 and 16).
Regarding claim 23:
Vendely teaches the implantable adjunct of Claim 22, wherein the implantable adjunct comprises a second edge (see FIG. 15), the first row of stitching and the second row of stitching run parallel to each other and are proximate opposite edges of the implantable adjunct (e.g., parallel rows near numerals 137 and 119, respectively, in FIG. 15).
Regarding claim 24:
Vendely teaches the implantable adjunct of Claim 23, wherein the first plurality of surface segments and the second plurality of surface segments are aligned laterally with respect to each along a longitudinal axis of the implantable adjunct (shown in FIG. 15).
Regarding claim 26:
Vendely teaches the implantable adjunct of Claim 18, wherein the thread comprises an absorbable material ([0386]).
Regarding claim 27:
Vendely teaches the implantable adjunct of Claim 16, further comprising, a second film layer (115) contacting the external surface and comprising a second exterior side, the connector providing a force on the second exterior side thereby attaching the second film layer to the external surface (envisaged in FIG. 15).
Regarding claim 28:
Vendely teaches the implantable adjunct of Claim 16, further comprising the staple cartridge (12).
Regarding claim 29:
Vendely teaches the implantable adjunct of Claim 16, wherein the implantable adjunct is adhered to the deck by an attachment material positioned between the first film layer and the deck ([0194]).
Regarding claim 30:
Vendely teaches a method for assembling an implantable adjunct, the method comprising: placing a first film layer (114) on the implantable adjunct (110/130); inserting a connector (119/122) through the first film layer and at least partially through the implantable adjunct, leaving at least a portion of the connector contacting a first exterior side of the first film layer; and connecting the first film layer to the implantable adjunct by the at least a portion of the connector that contacts the first exterior side of the first film layer ([0255], “A fiber 119 can be passed through the first biocompatible layer 114 to form several loops 120.”; This is only possible if the first film layer 114 has been positioned (“placed”) on the adjunct).
Regarding claim 31:
Vendely teaches the method of Claim 30, wherein: the connector comprises thread; the step of inserting the connector through the first film layer and at least partially through the implantable adjunct comprises creating a first row of stitching along the first exterior side of the first film layer; and the at least a portion of the connector that contacts the first exterior side is a first plurality of surface segments of the thread (all shown in FIG. 15; addressed in claim ).
Regarding claim 32:
Vendely teaches the method of Claim 31, wherein:
the step of inserting the connector through the first film layer and at least partially through the implantable adjunct comprises creating a second row of stitching along the first exterior side of the first film layer; and the at least a portion of the connector that contacts the first exterior side is a second plurality of surface segments of the thread (rows of surface segments of 140shown in FIG. 15).
Regarding claim 33:
Vendely teaches the method of Claim 32, wherein the first row of stitching and the second row of stitching run parallel and along opposite edges of the implantable adjunct (shown in FIG. 15).
Regarding claim 35:
Vendely teaches a system comprising: an implantable adjunct (110/130) comprising: a first absorbable material ([0386]); and a film layer (114) attached to the implantable adjunct by a first row of stitching (e.g., FIG. 15, row of stitching 140 adjacent numeral 137) and a second row of stitching (row of stitching 140 adjacent numeral 119) that run parallel and proximate opposite edges of the implantable adjunct, the first row of stitching and the second row of stitching comprising a second absorbable material ([0386], the stitchings are absorbable since the adjunct is absorbable); a staple cartridge (12) comprising a deck (16); and an attachment material attaching the implantable adjunct to the deck (described in [0208]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Vendely, as applied above.
Regarding claim 25:
Vendely teaches the implantable adjunct of Claim 23, but does not teach wherein an edge thickness of the implantable adjunct is thinner than a center thickness responsive to the force provided by the first row of stitching and the second row of stitching pre-compressing the respective edges.
In another embodiment, Vendely teaches “the edges of a compressible adjunct can be configured to improve attachment with a cartridge deck 16 of a staple cartridge 12 and/or improve the structural performance of the compressible adjunct. As illustrated in FIG. 17, edges 151a and 151b of the portions 150a and 150b, respectively, of the compressible adjunct 150 are each formed down to an outer lip 153 which defines an outer perimeter of the compressible adjunct 150, and can be attached to the cartridge deck 16, for example.” ([0293]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the adjunct of Vendely, such that an edge thickness of the implantable adjunct is thinner than a center thickness responsive to the force provided by the first row of stitching and the second row of stitching pre-compressing the respective edges, in order to improve attachment with a cartridge deck of a staple cartridge and/or improve the structural performance of the compressible adjunct, as taught by Vendely.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Vendely, as applied above, and further in view of Neville et al. US 3,774,662.
Regarding claim 34:
Vendely teaches the method of any one of Claims 31 to 33, but does not teach wherein the first row of stitching and the second row of stitching are applied using a double needle sewing machine.
However, stitchings applied using double needle sewing machines are old and well-known in the art. For example, in a related method, Neville discloses “[a] suitable mechanism, e.g. a twin-needle sewing arrangement having side by side needles spaced from each other by less than the width of the strip [] to secure the cords to the strip” (col. 13, line 66 through col. 14, line 5).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method by utilizing a double needle sewing machine to apply the stitchings, as taught by Neville, since this would ensure the stitchings are properly and efficiently made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARIUSH SEIF whose telephone number is (408)918-7542. The examiner can normally be reached Monday-Friday 9:30 AM-6:00 PM PST.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731
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