DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-3, 5, 7-14, and 17-24 are currently pending.
Claim 1 is amended.
Claims 8-14 and 17-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 4, 6, and 15-16 remain cancelled.
Claims 1-3, 5, and 7 have been considered on the merits.
Claim Interpretation
Claim 1 contains the phrase “for use in a reconstructive surgical procedure” in line 2. This limitation recites an intended use of the product of “an ADM graft” which carried little patentable weight.
With respect to claim 1, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus or composition is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. For example, “so as to receive a breast implant” does not clearly define a structural limitation of the apparatus or composition. Consequently, this limitation is not considered in analyzing the patentability of the apparatus or composition.
With respect to claim 5, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus or composition is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. For example, “configured to receive a breast implant” does not clearly define a structural limitation of the apparatus or composition. Consequently, this limitation is not considered in analyzing the patentability of the apparatus or composition.
New and Maintained Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 contains the limitation of “further comprising, prior to the packaging, joining two of the semi-circular shapes together along a curving portion of each of the two of the semi-circular shapes to form an ADM graft pocket configured to receive a breast implant”. Claim 1 has been amended to include a step prior to the packaging step which includes “joining the first semi-circular shape graft portion and the second semi-circular shape graft portion together along a curving portion of each of the semi-circular shapes to form an ADM graft pocket…so as to receive a breast implant”. Therefore, all of the limitations recited in claim 5 are contained in the newly amended claim 1 and claim 5 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell et al (US20130013068A1), in view of Barere et al (US20180055624A1) and Wound Source (Wound Source Product Guide, AlloSkin™ AC, Accessed through Google Wayback Machine web archive from Oct. 31, 2015).
Regarding claim 1, Forsell teaches a method of making an acellular dermal matrix (ADM) graft through first obtaining donor derived skin ([0032]/[0033]) and then removing the epidermis and adipose (i.e. fat) layers ([0044]/[0040]). Next, Forsell teaches the decellularization of the tissue to form the graft material ([0032]). Forsell teaches verifying the thickness of the graft and that the thickness is between 1-2 mm ([0040]/[0053]). The graft is taught to be packaged with sterile saline in a sterilization vessel (claim 1 and [0062]). The packaged product is then irradiated to form a sterile product as required by claim 1 ([0062]/[0063]). Forsell teaches that the skin is placed on a cutting board, inspected and cut into pieces of the desired size and shape and that this could be small (1x1 cm) shapes for certain procedures like gingivitis treatment or large shapes (20x20 cm) for larger burns or wounds and that a surgeon will further shape the graft as needed prior to implantation ([0052]). Forsell teaches that the skin graft may be used for breast reconstructive surgery ([0073]).
Regarding claim 2, the packaged product can include antimicrobial agents as required by claim 2 ([0037]/[0077]).
Regarding claim 3, Forsell teaches verifying the thickness of the graft and that the thickness is between 1-2 mm ([0040]/[0053]).
Forsell does not teach fenestrating the skin graft into a mesh pattern as required by claim 1. Forsell does not directly teach cutting the skin into a first semi-circular predetermined shape graft portion in a first layer and a second semi-circular shape graft portion in a second layer as required by claim 1. Forsell does not teach joining the first and second semicircular shapes together along a curving portion to form a graft pocket having closed bottom and side portions to receive a breast implant as required by claims 1 and 5.
However, Barere teaches about acellular tissue matrixes having predefined shape for enhanced coverage of breast implants (abstract).
Regarding claim 1, Barere teaches that the acellular tissue can be fenestrated with slits or holes which are taught to be able to be arranged in number, size, and location based on a variety of factors ([0064]). Barere teaches cutting the acellular tissue into a pre-defined semi-circular shape with a notch and that the shape may include a basement membrane (Figure 3 and 9, [0038], [0069]). Barere teaches that the acellular tissue matrix can be a first and second flexible sheet where both include curved edges ([0006]). Barere teaches that the grafts may be joined together to form a graft pocket to receive the breast implant ([0045]/[0070]). Specifically, Barere teaches that the first flexible sheet/graft, section 104, and a second flexible sheet/graft, section 108, is joined at joining section 110 and 111/112 of Fig. 2 (see Fig. 2 and [0045]). The graft depicted in Fig. 2 when joined along sections 110-112 of Fig. 2 as described by [0045] would result in a “pocket” where there is a closed bottom, side portions, and an open top end to receive a breast implant.
Regarding claim 5, Barere teaches that the grafts may be joined together to form a graft pocket to receive the breast implant, referred to as “prepectoral implantation of an implant” ([0045]/[0070]).
One of ordinary skill in the art prior to the effective filling date of the instant application would find it obvious at the effective filling date of the instant invention to combine the graft product of Forsell with the meshing patterns and breast implant graft pocket taught by Barere to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Forsell teaches the use of the graft in breast implantation and Barere teaches an acellular tissue matrix having predefined shape for enhanced coverage of breast implants (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Forsell and Barere because both teach method of making acellular skin graft products for use in breast implantation.
Although Forsell teaches the packaging of the ADM in sterile saline, Forsell and Barere do not teach packaging the ADM in “sterile water without any additives” as required by claim 1.
However, Wound Source teaches about their ADM product which has been for sale since at least Oct. 31, 2015 and which contains information on storage requirements for the ADM. Wound Source teaches that the ADM tissue is packaged in sterile water as required by claim 1 (see pg. 1, “Storage Requirements”.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007)): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the present situation, rationales A, B, and E apply. The claims merely require the combining of known prior art methods as taught by Forsell and Wound Source to store the ADM in a sterile composition of water. Forsell teaches a method of making and packaging an ADM in sterile saline, and Wound Source teaches an ADM product which is packaged in sterile water as described in detail above. The combination of Forsell and Wound Source would lead to a predictable result absent results to the contrary. Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell et al (US20130013068A1), in view of Barere et al (US20180055624A1) and Wound Source (Wound Source Product Guide, AlloSkin™ AC, Accessed through Google Wayback Machine web archive from Oct. 31, 2015), as applied to claims 1-3 and 5 above, and in further view of Nikkhah et al (Burns, 2015).
With regards to claim 7, the limitations of the independent claim are taught above.
Although Barere teaches that the acellular tissue can be fenestrated with slits or holes which are taught to be able to be arranged in number, size, and location based on a variety of factors ([0064]). Forsell and Barere do not teach that the fenestrating comprises using a meshing tool with a ratio of ADM tissue:space of 1:1 as required by claim 7.
However, Nikkhah teaches about various meshing tools with different ADM tissue:space ratios. Nikkhah teaches the use of a Brennen mesher which has a 1:1 ratio (pg. 258, col. 1, para 3). Further, Nikkah teaches that the 1:1 mesh compares favorably in terms of cosmetic appearances with the sheet graft at 12 months and that the 1:1 ratio is of particular use in areas of difficult graft take (pg. 264, col. 1, para 2).
One of ordinary skill in the art prior to the effective filling date of the instant application would find it obvious to combine the graft product of Forsell and Barere with the meshing tool and ratio taught by Nikkhah to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Nikkah teaches that the 1:1 mesh compares favorably in terms of cosmetic appearances with the sheet graft at 12 months and that the 1:1 ratio is of particular use in areas of difficult graft take (pg. 264, col. 1, para 2). One of ordinary skill in the art would have a reasonable expectation of success when combining Forsell and Barere with Nikkhah because Barere teaches that the acellular tissue can be fenestrated with slits or holes which are taught to be able to be arranged in number, size, and location based on a variety of factors ([0064]) and Nikkhah teaches that the 1:1 ratio is of particular use in areas of difficult graft take (pg. 264, col. 1, para 2).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 10-11), in reference to the rejection of claims 1-3 and 5 under 35 U.S.C. 103, that the amended claim feature of claim 1 which now recites “a first semi-circular shape graft portion in a first layer and (2) a second semi-circular shape graft portion in a second layer, and joining the first semi-circular shape graft portion and the second semi-circular shape graft portion together along a curving portion of each of the semi-circular shapes to form an ADM graft pocket having a closed bottom end, closed side portions, and an open top end so as to receive a breast implant” is not taught by Barere because the material of Barere “is a covering, rather than a pocket, with no indication or reasoning to receive a breast implant in a surrounding configuration with support from the closed bottom end and the closed side portions” (Remarks, pg. 11).
In response, this argument is not found persuasive. Barere teaches that the acellular tissue matrix can be a first and second flexible sheet where both include curved edges ([0006]). Barere teaches that the grafts may be joined together to form a graft pocket to receive the breast implant ([0045]/[0070]). Specifically, Barere teaches that the first flexible sheet/graft, section 104, and a second flexible sheet/graft, section 108, is joined at joining section 110 and 111/112 of Fig. 2 (see Fig. 2 and [0045]). The graft depicted in Fig. 2 when joined along sections 110-112 of Fig. 2 as described by [0045] would result in a “pocket” where there is a closed bottom, side portions, and an open top end to receive a breast implant. Barere also teaches that the grafts may be joined together to form a graft pocket to receive the breast implant, referred to as “prepectoral implantation of an implant” ([0045]/[0070]). Therefore, the argument is not found persuasive.
Applicant argues (Remarks, pg. 12-15), in reference to the rejection of claims 1 and 7 under 35 U.S.C. 103, that the amended claim feature of claim 1 which now recites “a first semi-circular shape graft portion in a first layer and (2) a second semi-circular shape graft portion in a second layer, and joining the first semi-circular shape graft portion and the second semi-circular shape graft portion together along a curving portion of each of the semi-circular shapes to form an ADM graft pocket having a closed bottom end, closed side portions, and an open top end so as to receive a breast implant” is not taught by Barere because the material of Barere “is a covering, rather than a pocket, with no indication or reasoning to receive a breast implant in a surrounding configuration with support from the closed bottom end and the closed side portions” (Remarks, pg. 13).
In response, the argument is not found persuasive. Applicant arguments hinge on the alleged deficiencies of Barere regarding claim 1 which have been addressed at point 18 above. Applicant provides no other arguments as to the combination of Forsell, Barere, Wound Source, and Nikkhah. Therefore, the arguments are not found persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632