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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/15/2026 has been entered.
Status of the Claims
Claims 1-3, 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Claims 8-14 and 17-24 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 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.
Withdrawn Rejections
The 112(d) rejection made onto claim 5 is withdrawn in light of the amendments submitted on 07/15/2026 canceling claim 5.
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.
Claims 1-3 and 7 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the preamble “a method of manufacturing an acellular dermal matrix (ADM) graft product for use in a reconstructive surgical procedure”. The claim phrase “for use in a reconstructive surgical procedure” has been interpreted in the previously presented office action as an intended use of the product of “an ADM graft” which carried little patentable weight. Further, Applicant has amended claim 1 to include the following steps “to provide an ADM graft pocket with a geometry to (1) receive a breast implant in a surrounding configuration with support from the closed bottom end and the closed side portions, and (2) position the anterior portion adjacent the breast implant opposite the chest wall, (3) position the posterior portion adjacent the breast implant adjacent the chest wall, and (4) the curving portion of each of the semi-circular shapes is complimentary with one another from the closed bottom end and the closed side portions to provide a single layer of continuous coverage of the breast implant from a first point of the anterior portion, across a first one of the closed side portions, across the posterior portion, and across a second one of the closed side portions to the point of the anterior portion”. These additional steps appear to constitute a mismatch between the preamble and the body of the claim which is indefinite. The preamble is drawn to a method of making a graft product and not a method of using a graft product in a surgical setting, whereas the newly amended steps provided in claim 1 are drawn to steps of performing a breast surgery employing the graft formed by the method.
Claim 1 recites the limitation "the posterior position" in pg. 2, line 6. There is insufficient antecedent basis for this limitation in the claim.
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 remain 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). The following rejection has been amended to reflect the amendments made onto claim 1 by applicant in the reply filled on 07/15/2026.
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 claim 1. Forsell does not teach that the graft portions are sutured together as required by claim 1. Forsell does not explicitly teach that the provided ADM graft pocket has “a geometry to (1) receive a breast implant in a surrounding configuration with support from the closed bottom end and the closed side portions, and (2) position the anterior portion adjacent the breast implant opposite the chest wall, (3) position the posterior portion adjacent the breast implant adjacent the chest wall, and (4) the curving portion of each of the semi-circular shapes is complimentary with one another from the closed bottom end and the closed side portions to provide a single layer of continuous coverage of the breast implant from a first point of the anterior portion, across a first one of the closed side portions, across the posterior portion, and across a second one of the closed side portions to the point of the anterior portion” as required by claim 1.
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. Further, the pocket is joined together with sutures (see Fig. 1 and [0059]). Barere teaches that the ADM graft pocket containing a first and second semi-circular shape forms an anterior portion which “can cover substantially all of the anterior surface of a breast implant” ([0007]). Barere teaches that the implant “can be placed within the pocket, and remaining edges of the tissue matrix are sutured or otherwise attached to tissue to close the implant pocket” ([0072]). Barere teaches that the coverage of the tissue pocket can facilitate complete coverage of the anterior, superior, inferior, lateral and posterior portions of the implant ([0004] and Fig. 5A-C). Further, Barere teaches that after performing a mastectomy or other procedure a surgeon may then place the tissue matrix materials described in Barere within the space and affix portions of the tissue matrices to tissue such as the chest wall or muscle ([0071]). Therefore, Barere teaches the newly amended claim limitations of “provide the ADM graft pocket with a geometry to (1) receive a breast implant in a surrounding configuration with support from the closed bottom end and the closed side portions, and (2) position the anterior portion adjacent the breast implant opposite the chest wall, (3) position the posterior portion adjacent the breast implant adjacent the chest wall, and (4) the curving portion of each of the semi-circular shapes is complimentary with one another from the closed bottom end and the closed side portions to provide a single layer of continuous coverage of the breast implant from a first point of the anterior portion, across a first one of the closed side portions, across the posterior portion, and across a second one of the closed side portions to the point of the anterior portion” as required by newly amended claim 1.
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 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 07/15/2026 have been fully considered but they are not persuasive.
Applicant argues (Remarks, pg. 10, para 2) that the cited art does not teach an ADM graft pocket having a closed bottom end, closed side portions, and an open top end so as to receive a breast implant with support from the closed bottom end and the closed side portions.
In response, the argument is not found persuasive. The graft depicted in Fig. 2 of Barere 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. Further, the pocket is joined together with sutures (see Fig. 1 and [0059]). Barere teaches that the ADM graft pocket containing a first and second semi-circular shape forms an anterior portion which “can cover substantially all of the anterior surface of a breast implant” ([0007]). Barere teaches that the implant “can be placed within the pocket, and remaining edges of the tissue matrix are sutured or otherwise attached to tissue to close the implant pocket” ([0072]). Barere teaches that the coverage of the tissue pocket can facilitate complete coverage of the anterior, superior, inferior, lateral and posterior portions of the implant ([0004] and Fig. 5A-C). Further, Barere teaches that after performing a mastectomy or other procedure a surgeon may then place the tissue matrix materials described in Barere within the space and affix portions of the tissue matrices to tissue such as the chest wall or muscle ([0071]).
Therefore, the argument is not found persuasive.
Applicant argues (Remarks, pg. 11, para 1) that Nikkhah does not cure the alleged deficiencies described at point 20 above of the cited art.
In response, the argument is not found persuasive. The graft depicted in Fig. 2 of Barere 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. Further, the pocket is joined together with sutures (see Fig. 1 and [0059]). Barere teaches that the ADM graft pocket containing a first and second semi-circular shape forms an anterior portion which “can cover substantially all of the anterior surface of a breast implant” ([0007]). Barere teaches that the implant “can be placed within the pocket, and remaining edges of the tissue matrix are sutured or otherwise attached to tissue to close the implant pocket” ([0072]). Barere teaches that the coverage of the tissue pocket can facilitate complete coverage of the anterior, superior, inferior, lateral and posterior portions of the implant ([0004] and Fig. 5A-C). Further, Barere teaches that after performing a mastectomy or other procedure a surgeon may then place the tissue matrix materials described in Barere within the space and affix portions of the tissue matrices to tissue such as the chest wall or muscle ([0071]).
Therefore, the argument is not found persuasive.
Conclusion
No claims are allowed.
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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
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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