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
Applicant’s submission filed 13 July 2026 has been entered. Claims 1-4, 6-15, and 17-37 are pending. Claims 1, 3-4, 8, 17, 25, and 32-33 have been amended, while claims 5 and 16 have been cancelled without prejudice or disclaimer and claims 36-37 have been newly added. Therefore, prosecution on the merits continues for claims 1-4, 6, 29-34, and 36-37 as being drawn to the elected invention and species, with claims 7-15, 17-28, and 35 withdrawn for reading on the non-elected inventions and species. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 3-4
Applicant’s amendments to each of instant claims 3-4 correct the minor informalities, thus obviating the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 32-33 under 35 USC 112(b)
Applicant’s amendments to each of instant claims 32-33 correct the antecedent basis, thus obviating the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-2 and 6 under 35 USC 103 over McQueen et al in view of Brahm
Applicant’s amendments to independent claim 1 requiring the outermost amnion layers of the plurality of layers to be oriented such that the epithelial layer is facing outwards – which was previously presented in now cancelled claim 5 – obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-6, 29, and 31-34 under 35 USC 103 over McQueen et al in view of Brahm and Zawko et al
The cancellation of claim 5 renders the rejection moot for that claim. For the remaining claims, Applicant’s arguments filed 13 July 2026 have been fully considered but are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 14-15 of the Remarks filed 13 July 2026 that McQueen et al disclose that the epithelial layer present on the amnion is substantially removed in order to expose the basement layer of the amnion. In response, the Examiner respectfully submits that, while McQueen et al disclose some embodiments of the invention wherein the epithelial layer is substantially removed, McQueen et al also disclose some embodiments of the invention wherein the epithelial layer of the amnion is intact. See, for example, Paragraph [0086] of McQueen et al.
Applicant has further traversed the rejection, asserting in Pages 15-16 of the Remarks filed 13 July 2026 that the suggestion for epithelial layers facing outwards in Zawko et al is only when the final product is formed of two amnion layers. In response, the Examiner respectfully submits that the ordinary artisan would have reasonably understood that the outward orientation of the amnion epithelial layers detailed in Zawko et al can be translated to final products that have greater than two layers, as the outer layers are still amnion layers.
Applicant has further traversed the rejection, asserting in Page 16 of the Remarks filed 13 July 2026 that the disclosure of Zawko et al is directed to a hydrogel medium with embedded tissue segments rather than a dehydrated multi-layer amnion product, as required by the instant claims. In response, the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Zawko et al is a tertiary reference relied upon to teach the orientation of amnion layers. With that, the ordinary artisan would have recognized that, even though Zawko et al teach a product that is not dehydrated, McQueen et al teach that the dehydrated products are rehydrated prior to use. See, for example, Paragraphs [0106]-[0107] of McQueen et al. Therefore, the ordinary artisan would have recognized that the principles and orientations of hydrated amnion products can be applied to dehydrated amnion products, as they will be rehydrated prior to use.
Applicant has lastly traversed the rejection, asserting in Page 16 of the Remarks filed 13 July 2026 that the ordinary artisan would not have been motivated to combine the teachings of the cited references. In response, the Examiner first respectfully submits that McQueen et al do not teach away from the removal of the epithelial layer from the amnion, as McQueen et al teach that some embodiments – not all embodiments – of the invention have the amnion epithelial layer substantially removed. See discussion above. With that, the ordinary artisan would have been motivated to combine the teachings of the cited references since (i) they all pertain to the use of amnion products as therapeutics for the treatment of tissue wounds, and (ii) the final amnion product of all references can be in the shape of or comprise a mesh pattern. See, for example, Paragraph [0008] of McQueen et al, Columns 2, 5, and 9 of Brahm, and Paragraphs [0058] and [0139]-[0142] of Zawko et al.
Therefore, the rejection is maintained and amended to encompass the claims as written.
RE: Rejection of claims 29-34 under 35 USC 103 over Samaniego et al in view of Brahm
Applicant’s arguments filed 13 July 2026 have been fully considered but are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 16-17 of the Remarks filed 13 July 2026 that Samaniego et al fail to teach a dehydrated amnion product. In response, the Examiner respectfully submits that, although Samaniego et al teach that the amnion layers are not dehydrated during processing or prior to packaging in many instances, that allows for the dehydration of the amnion layers in some instances. See Paragraph [0050] of Samaniego et al.
Applicant has further traversed the rejection, asserting in Page 17 of the Remarks filed 13 July 2026 that Brahm is silent to the orientation or arrangement of the outermost amnion layers in a dehydrated multi-layer amnion product. In response, the Examiner respectfully submits that Samaniego et al was relied upon to teach the outermost amnion layer limitation. See, for example, Paragraphs [0005], [0033]-[0035], [0047]-[0048] and Figures 2-3, 6 of Samaniego et al.
Therefore, the rejection is maintained and amended to encompass the claims as written.
New/Maintained Grounds of Rejection
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.
The factual inquiries 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.
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 1-4, 6, 29, 31-34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over McQueen et al (US 2022/0133955 A1, of record on IDS filed 25 August 2023) in view of Brahm (US 10583219 B1, of record on IDS filed 25 August 2023), and further in view of Zawko et al (US 2019/0358366 A1, of record).
McQueen et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 05 May 2022. Brahm is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 10 March 2020. Zawko et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 1, 3-4, 29, and 32-33: McQueen et al disclose a dehydrated placental tissue allograft that can be used in the treatment of wounds (Abstract; Paragraph [0041]).
As such, McQueen et al disclose that the dehydrated placental tissue allograft is comprised of multiple layers of amnion and chorion, wherein the amnion layers each comprise an epithelial layer, a basement membrane, and a fibroblast layer, while the chorion layers each comprise a reticular layer and a basement membrane (Paragraphs [0003], [0008], [0012], [0015]-[0018], [0042], [0066], [0085]-[0087], [0092]). McQueen et al further disclose that the amnion and chorion layers of the dehydrated placental tissue allograft can be configured in any arrangement (Paragraph [0092]).
McQueen et al do not disclose that the dehydrated placental tissue allograft includes at least four layers and less than ten layers, nor that the amnion layers form the outermost layers of the dehydrated placental tissue graft such that the epithelial layer is facing outward, as required by instant claim 1.
Brahm, however, discloses a multilayer bioabsorbable construct comprising amnion and chorion layers (Abstract; Columns 1-2, 4, 8). Brahm further discloses that the multilayer bioabsorbable construct comprises at least four layers, with the outermost layers being amnion layers and the inner layers comprising at least one chorion layer and at least one support layer (Columns 5-6; Figure 1). Brahm further discloses that layers within the four-layer embodiment – including the amnion layer – can be repeated and stacked on top of one another, such that an embodiment is formed comprising four amnion layers with at least two amnion layers adjacent to each other (Column 5).
With that, Zawko et al disclose hydrogel scaffolds comprising multiple amnion and chorion layers, wherein the amnion layers can be oriented such that either the epithelial layer or stromal – fibroblast – layer is outward facing, and the alternative layer is inward facing (Abstract; Paragraphs [0058]-[0060], [0065]-[0068], [0096]-[0099]).
Therefore, it would have been prima facie obvious to have modified the dehydrated placental tissue allograft of McQueen et al such that it comprises at least four layers, with the outermost layers being amnion layers having the epithelial surface outward facing and fibroblast surface inward facing, wherein the adjacent inner amnion layers are oriented so that either the fibroblast or epithelial surface of the inner amnion layers faces the inward-facing fibroblast surface of the outer amnion layers, as detailed in Brahm and Zawko et al. One of ordinary skill in the art before the effective filing date of the instant invention would have been motivated to tailor the dehydrated placental tissue allograft to a substantial thickness and orientation for the desired therapeutic use and ensure that it is physically capable of serving as a therapeutic (Brahm: Column 6), and would have had a reasonable expectation of success given that the disclosures of McQueen et al, Brahm, and Zawko et al are concerned with the generation of a multilayered amnion and chorion graft for wound healing applications (McQueen et al: Paragraphs [0001], [0008], [0018], [0068]; Brahm: Columns 1, 6, 8-10; Zawko et al: Paragraphs [0003]-[0004],[0030], [0035]-[0038]). See MPEP § 2143(I)(G).
Consequently, McQueen et al as modified by Brahm and Zawko et al render obvious a dehydrated placental tissue allograft comprised of at least four layers, wherein the dehydrated placental tissue allograft comprises and inner chorion layer and two outer amnion layers with the epithelial surface outward facing and fibroblast surface inward facing, and further comprises an inner amnion layer adjacent to each of the outer amnion layers that is oriented so that either the fibroblast (claims 4, 33) or epithelial surface (claims 3, 32) of the inner amnion layer faces the inward-facing fibroblast surface of the outer amnion layers. As the amnion layers each comprise an epithelial layer, a basement membrane, and a fibroblast layer, while the chorion layers each comprise a reticular layer and a basement membrane, this therefore renders obvious the dehydrated multi-layer amnion product of instant claims 1 and 29.
Regarding claim 2: Following the discussion of claim 1, Brahm further discloses that layers within the four-layer embodiment can be repeated, such that a five-, six-, or seven-layer embodiment is formed (Column 5). This therefore renders obvious the dehydrated multi-layer amnion product of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claims 6 and 34: Following the discussion of claim 1, McQueen et al further disclose that the amnion (claim 34) and chorion layers (claim 6) are derived from a human donor (Abstract; Paragraphs [0008], [0043], [0074]). This therefore reads on the dehydrated multi-layer amnion product of the instant claims.
Regarding claim 31: As aforementioned in the discussion of claim 29, McQueen et al as modified by Brahm and Zawko et al render obvious a dehydrated placental tissue allograft comprising four amnion layers, a support layer, and a chorion layer. As there are six total layers, this therefore reads on the dehydrated multi-layer amnion product of the instant claim.
Regarding claim 36: As aforementioned in the discussion of claim 1, McQueen et al as modified by Brahm and Zawko et al render obvious a dehydrated placental tissue allograft comprising four amnion layers and an inner chorion layer, wherein the outermost layers are amnion layers that each have an adjacent inner amnion layer. Since that results to the dehydrated placental tissue allograft having a layer configuration of AACAA, this therefore renders obvious the dehydrated multi-layer amnion product of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 37: As aforementioned in the discussion of claim 1, McQueen et al as modified by Brahm and Zawko et al render obvious a dehydrated placental tissue allograft comprising four amnion layers and an inner chorion layer, wherein the outermost layers are amnion layers that each have an adjacent inner amnion layer. Since Brahm discloses that layers can be repeated and stacked on top of one another (Column 5), it would have been prima facie obvious to have modified the dehydrated placental tissue allograft of McQueen et al as modified by Brahm and Zawko et al such that the allograft has a layer configuration of AACCAA or AACAAA. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to duplicate layers of the dehydrated placental tissue allograft to arrive at a thickness that is substantial for the desired therapeutic use (Brahm: Column 6), and would have had a reasonable expectation of success given that the disclosures of McQueen et al, Brahm, and Zawko et al are concerned with the generation of a multilayered amnion and chorion graft. See MPEP § 2143(I)(G).
Claims 29-34 remain rejected under 35 U.S.C. 103 as being unpatentable over Samaniego et al (US 2012/0083900 A1, of record on IDS filed 25 August 2023) in view of Brahm (US 10583219 B1, of record on IDS filed 25 August 2023).
Samaniego et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 05 April 2012. Brahm is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2), with a publication date of 10 March 2020.
Regarding claims 29-31: Samaniego et al disclose anti-adhesion wound dressings including patches made from amnion tissue obtained from human birth tissue (Abstract).
As such, Samaniego et al disclose multilayered amnion patches comprising individual amnion tissue pieces that have been stacked together, wherein the amnion layers each comprise an epithelial layer, a basement membrane, and a fibroblast layer (Abstract; Paragraphs [0004]-[0005], [0009], [0011], [0057]). Samaniego et al further disclose that the outermost amnion layers have the epithelial surface outward facing, with the inward-facing fibroblast layers promoting adherence between the two adjacent layers (Abstract; Paragraphs [0005], [0033]-[0035], [0047]-[0048]; Figures 2-3, 6).
Samaniego et al further disclose that the amnion patches can be dehydrated (Paragraph [0050]).
Samaniego et al do not disclose that the amnion patches include at least four amnion layers, as required by instant claim 29.
Brahm, however, discloses a multilayer bioabsorbable construct comprising at least one basement amnion layer and at least one top amnion layer (Abstract; Columns 1-2, 4, 8). Brahm further discloses that layers can be repeated and stacked upon each other (Column 5).
Therefore, it would have been prima facie obvious to have modified the amnion patch of Samaniego et al such that it consists of five amnion layers, as detailed in Brahm. One of ordinary skill in the art before the effective filing date of the instant invention would have been motivated to tailor the amnion patch to a substantial thickness for the desired therapeutic use and ensure that it is physically capable of serving as a therapeutic (Brahm: Column 6), and would have had a reasonable expectation of success given that the disclosures of Samaniego et al and Brahm are concerned with the generation of a multilayered amnion tissue graft. See MPEP § 2143(I)(G).
Consequently, Samaniego et al as modified by Brahm render obvious a dehydrated amnion patch consisting of five layers (claims 30-31), wherein the amnion layers each comprise an epithelial layer, a basement membrane, and a fibroblast layer. As the outermost amnion layers are oriented such that the epithelial surface is outward facing, this therefore renders obvious the dehydrated multi-layer amnion product of instant claim 29.
Regarding claims 32-33: As aforementioned in the discussion of claim 29, Samaniego et al disclose that the outermost amnion layers of the amnion patch have the epithelial surface facing outwards, with the inward-facing fibroblast surface promoting adherence between the two adjacent layers (Abstract; Paragraphs [0005], [0033]-[0035], [0047]-[0048]; Figures 2-3, 6). Accordingly, the ordinary artisan would have been motivated to ensure that at least one fibroblast surface is between adjacent amnion layers, whether that be between an outermost amnion layer and an inner adjacent amnion layer, or two inner adjacent amnion layers. One of ordinary skill before the effective filing date of the instant invention would have recognized that the fibroblast surface promotes adherence to an adjacent amnion layer, and thereby would have had a reasonable expectation of success given that the disclosures of Samaniego et al and Brahm are concerned with the generation of a multilayered amnion tissue graft. See MPEP § 2143(I)(G).
Consequently, Samaniego et al as modified by Brahm render obvious a dehydrated amnion patch, wherein an inner amnion layer that is adjacent to each of the outer amnion layers is oriented so that either the fibroblast (claim 33) or epithelial surface (claim 32) of the inner amnion layer faces the inward-facing fibroblast surface of the outer amnion layers. This therefore renders obvious the dehydrated multi-layer amnion product of the instant claims.
Regarding claim 34: Following the discussion of claim 29, Samaniego et al further disclose that the amnion layers are derived from a human donor (Abstract; Paragraphs [0012], [0030]-[0031], [0033], [0041]). This therefore reads on the dehydrated multi-layer amnion product of the instant claim.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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