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 .
Priority
Acknowledgement is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional application 63/367940, filed 08 July 2022. Therefore, the effective filing date of the instant invention is 08 July 2022.
Election/Restrictions
Applicant’s election of Group I, encompassing claims 1-7 and 29-35 in the reply filed on 26 March 2026 is acknowledged. In addition, Applicant’s election of the multi-layer amnion product species as being derived from a human source is acknowledged. The requirement is still deemed proper and is therefore made FINAL. However, because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 7-28 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claim.
Therefore, claims 1-35, of record 05 July 2023, are pending. Claims 7-28 and 35 are withdrawn for reading on the non-elected invention and species. Prosecution on the merits commences for claims 1-6 and 29-34.
Claim Objections
Claims 3-4 are objected to because of the following informalities:
Regarding claims 3-4: The instant claims are each objected to for reciting “are adjacent one another” in Lines 2-3, rather than “are adjacent to one another”.
Appropriate correction is required.
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 32-33 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.
Regarding claims 32-33: The instant claims recite the limitation “wherein adjacent amnion layers” in Line 1 of each claim. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of an “adjacent amnion layer” in the instant claims or parent claim 29, nor are the amnion layers necessarily adjacent due to the parent claim’s “comprising” language – which allows for additional, unrecited elements within the claimed product. See MPEP § 2173.05(e) and 2111.03.
Appropriate correction is required.
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 1-2 and 6 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).
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.
Regarding claim 1: 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, 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).
Therefore, it would have been prima facie obvious to have modified the dehydrated placental tissue allograft of McQueen et al such that it comprises four layers, with the outermost layers being 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 dehydrated placental tissue allograft 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 McQueen et al and Brahm are concerned with the generation of a multilayered amnion and chorion graft. See MPEP § 2143(I)(G).
Consequently, McQueen et al as modified by Brahm render obvious a dehydrated placental tissue allograft comprised of four layers, wherein the outermost layers are amnion layers and an interior layer is a chorion layer. 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 the instant claim.
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 claim 6: Following the discussion of claim 1, McQueen et al further disclose that the amnion and chorion layers are derived from a human donor (Abstract; Paragraphs [0008], [0043], [0074]). This therefore reads on the dehydrated multi-layer amnion product of the instant claim.
Claims 1-6, 29, and 31-34 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).
The discussion of McQueen et al in view of Brahm regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. McQueen et al as modified by Brahm render obvious claims 1-2 and 6. Zawko et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 3-5, 29, and 32-33: Following the discussion of claim 1 above, 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).
The combination of McQueen et al and Brahm fail to teach the particular arrangement of the amnion layers with respect to the fibroblast layer and epithelial layer, as required by instant claims 3-5, 29, and 32-33.
Zawko et al, however, 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 as modified by Brahm such that the outer amnion layers have the epithelial surface outward facing and fibroblast surface inward facing, with the adjacent inner amnion layers 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 Zawko et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to configure the amnion layers in the orientation best-suited for the therapeutic use, 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, wherein the dehydrated placental tissue allograft comprises two outer amnion layers with the epithelial surface outward facing (claim 5) 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. This therefore renders obvious the dehydrated multi-layer amnion product of instant claim 29.
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 34: Following the discussion of claim 29, McQueen et al further disclose that the amnion layers are derived from a human donor (Abstract; Paragraphs [0008], [0043], [0074]). This therefore reads on the dehydrated multi-layer amnion product of the instant claim.
Claims 29-34 are 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
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights