DETAILED ACTION
Applicant’s response filed 11/19/2025 has been received and entered into the application file. All arguments have been fully considered. Claims 5-6 are currently pending. Claims 1-4 have been cancelled. Claim 5 is currently amended.
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 .
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (FIG. 3) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Drawings
Although the corrected drawing sheets submitted 11/19/2025 have been amended to recite English text, it is noted as discussed above that FIG. 3 recites nucleic acid sequences that are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure, submitted 11/19/2025, is accepted.
REJECTION(S) WITHDRAWN
Claim Rejections - 35 USC § 112
RE: Rejection of claims 3-6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite:
It is noted that claims 3-4 are cancelled, thus obviating the previous rejection of claims 3-4.
Claim 5 has been amended to recite active method steps, thus providing appropriate clarification. Therefore, the previous rejection of record is withdrawn.
Claim Rejections - 35 USC § 101
RE: Rejection of Claims 3-4 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter:
Applicant’s amendment submitted 11/19/2025 has cancelled claims 3-4, thus obviating the previous rejection of record.
RE: Rejection of Claims 1-2 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more:
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-2, thus obviating the previous rejection of record.
Claim Rejections - 35 USC § 102
RE: Rejection of Claim(s) 1-6 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Baur Jr. (U.S. Patent No. 4,361,552):
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-4, thus obviating the previous rejection of claims 1-4. However, the rejection of claims 5-6 has been maintained and updated in view of Applicant’s amendment submitted 11/19/2025.
RE: Rejection of Claim(s) 1-2 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nikaido et al., (US 2010/0098743) (“Nikaido”):
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-2, thus obviating the previous rejection of claims 1-2.
RE: Rejection of Claim(s) 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Maral et al., (IDS 2/17/2023) (“Maral”):
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-4, thus obviating the previous rejection of claims 1-4. However, new ground of rejection are set forth below in view of Applicant’s amendment submitted 11/19/2025.
Claim Rejections - 35 USC § 103
RE: Rejection of Claim(s) 3 and 5 under 35 U.S.C. 103 as being unpatentable over Nikaido; and Rejection of Claim(s) 4 and 6 under 35 U.S.C. 103 as being unpatentable over Nikaido, and further in view of Baur:
The rejections have been withdrawn in view of Applicant’s amendment submitted 11/19/2025.
Double Patenting
RE: Rejection of Claims 1-2 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,246,109:
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-2, thus obviating the previous rejection of claim 1-2.
RE: Rejection of Claims 1-2 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/021113 (“US ‘113”) (reference application):
Applicant’s amendment submitted 11/19/2025 has cancelled claims 1-2, thus obviating the previous rejection of claim 1-2.
REJECTION MAINTAINED
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by as being anticipated by Baur Jr. (U.S. Patent No. 4,361,552, previously cited (“Baur”).
The rejection has been updated in view of Applicant’s amendment submitted 11/19/2025.
It is noted the limitations directed to the production of the restoration material are directed to the manner by which the claimed composition has been produced. Such limitations are product-by-process limitations which appear to define the restoration material. Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., it is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), and In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). See also MPEP § 2113.
In the instant case, if the product by process limitations are considered, the process imparts the feature of a hydrated amniotic membrane comprising epithelial cells, basement membrane and connective tissue that constitutes the raw (native) amniotic membrane.
Regarding claims 5-6, Baur is directed to restoration materials for treating burns (col. 1, lines 5-10). Baur teaches of amnion membranes being a dry amniotic membrane (col. 2, lines 45-68), for tissue in a living body (col. 4, lines 39-50)and being produced by drying a fresh amniotic membrane (col. 2, lines 45-50 and lines 60-65) including human (col. 2, line 63) Further, the dry amniotic membrane is dehydrated (col. 4, line 23) and dried so as to store it in dry air (col. 3, line 41) in a sterile state (col. 3, lines 1-2 and col. 4, lines 13-21) and contains epithelial cell, basement membrane and connective tissue (col. 3, lines 50-53 and col. 4, line 12) which makeup the fresh amniotic membrane when it is rehydrated (col. 4, line 39) by immersing in water or a buffer solution (col. 4, line 15). Also see col. 5, lines 1-35.
Baur teaches administering the hydrated amnion membrane and placing the membrane over the wound, wherein the amnion dermis is placed downward (col. 4, lines 39-44), thus the epithelium is facing up. Baur teaches treating full-thickness wounds caused by thermal injury, i.e., third degree burn (col. 4, lines 38-52).
As to the limitations that the amniotic membrane protects against infection by foreign substances from outside by holding infiltrating cells in the wound and promoting the secretion of inflammatory cytokines, then increases the secretion of anti-inflammatory cytokines in the wound and suppresses tissue damage due to scarring and prolongation of inflammation in the wound, it is noted that Baur does not further comment on said limitations. However, the fact that Baur employs the same amnion membrane as the instant application (page 3, lines 27-29 to page 4, lines 1-8) means that any and all results of the method of Baur, whether recognized at the time of publication or not, were inherently achieved by the reference method.
Thus, Baur’s teaching anticipates claims 5-6.
NEW GROUND(S) OF REJECTION, NECESSITATED BY AMENDMENT
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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Maral et al., (IDS 2/17/2023, previously cited) (“Maral”), in view of Baur Jr. (U.S. Patent No. 4,361,552; set forth above and previously cited).
Regarding claims 5-6, with regard to the limitations directed to the manner by which the hydrated amniotic membrane has been obtained, these limitations are considered to be a product-by-process limitation (i.e., the process by which the composition to be administered is made). There is no indication in the instant specification that the process by which the hydrated amniotic membrane that is to be administered is made provides any physical, structural or functional difference as compared to any hydrated amniotic membrane comprising epithelial cells, basement membrane and connective tissue that constitutes the raw (native) amniotic membrane.
Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., it is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), and In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). See also MPEP § 2113.
As discussed above, if the product by process limitations are considered, the process imparts the feature of a hydrated amniotic membrane comprising epithelial cells, basement membrane and connective tissue that constitutes the raw (native) amniotic membrane.
Maral is directed to using human amnion as a temporary biological dressing. Maral teaches treating split-thickness (second-degree) and full-thickness (third-degree) burns in rats, i.e., a method of treating burns. Maral teaches the glycerol-preserved amnion was as effective as fresh amnion in terms of decreasing bacterial levels in infected rat burn wounds (Abstract). Maral teaches preparing the amnion membranes by separation from the chorion, cleansing with copious amounts of water and placing the amnion in 85% glycerol solution, placing at 37°C overnight and then refrigerating at 48°C for over a year. Maral teaches that, prior to use, the stored amnion was rehydrated through immersion in phosphate buffered saline solution for at least 10 minutes (page 626, right col., 2. Materials and methods). Maral teaches the structural and cellular definitions of the preserved amniotic membrane were well maintained and there were no signs of cellular deterioration (page 630, 3.1.1 Behavior of materials on partial-thickness wounds; Fig. 2). Thus, Maral discloses a hydrated amniotic membrane comprising epithelial cells, basement membrane and connective tissue that is placed on a burn wound as a covering material for burns as recited in claim 5.
Maral teaches creating full-thickness scald burns on sixty rats, thereafter the wounds were covered with the preserved hydrated amnion (page 627, 2.3 Part 3 (60 rats). Maral teaches the preserved hydrated amnion was effective at decreasing bacteria levels in the rat burn wounds as compared to controls (Table 3; 3.3. Part 3). Maral further teaches the preserved amnion maintained its structural and cellular characteristics without disintegration for up to 2 days on rat wounds (page 633, left col, third full paragraph to right col, first paragraph).
Thus, Maral discloses using the hydrated amniotic membrane for treating third-degree burns, as recited in claim 6.
Maral teaches all the limitations of claims 5 and 6 except Maral does not comment on whether or not the epithelium is facing up. However, Baur (set forth above) teaches treating burn wounds by administering the hydrated amnion membrane and placing the membrane over the burn wound, wherein the amnion dermis is placed downward (col. 4, lines 39-44), thus the epithelium is facing up. Baur teaches successfully treating full-thickness wounds caused by thermal injury, i.e., third degree burn (col. 4, lines 38-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the amniotic membrane with the epithelium facing up when covering burns.
The person of ordinary skill in the art would have been motivated to modify the treatment method of Maral to include applying the amniotic membrane with the epithelium facing up when covering burns, as taught by Baur, for the predictable result of successfully treating full-thickness wounds caused by thermal injury, thus meeting the limitation of claims 5-6.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Maral and Baur because each of these teachings are directed at therapeutic uses of dried amniotic membrane.
As to the limitations that the amniotic membrane protects against infection by foreign substances from outside by holding infiltrating cells in the wound and promoting the secretion of inflammatory cytokines, then increases the secretion of anti-inflammatory cytokines in the wound and suppresses tissue damage due to scarring and prolongation of inflammation in the wound, it is noted that Maral, in view of Baur, does not further comment on said limitations. However, the fact that Maral employs the same amnion membrane as the instant application (page 3, lines 27-29 to page 4, lines 1-8) means that any and all results of the method of Maral, whether recognized at the time of publication or not, were inherently achieved by the reference method.
Response to Remarks
Claim Rejections – 35 USC 102 and 103:
Applicant’s remarks have been fully considered, but are not found persuasive in view of the new and updated rejections set forth above.
It is further noted that the claims do not recite any limitations regarding treatment without keloids.
Conclusion
No claim is allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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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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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633