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 1-15 were originally filed March14, 2023.
The preliminary amendment received March 14, 2023 amended claims 3-8, 10-13, and 15.
Claims 1-15 are currently pending.
Claims 1-3, 8, 11, and 12 are currently under consideration.
Please note: present withdrawn claim 5 has indefinite “such as” language (see MPEP § 2173.05 (d)) and a combination of broad and narrow limitations in the same claim (see MPEP § 2173.05 (c)).
Please note: present withdrawn claim 7 has indefinite “such as” language (see MPEP § 2173.05 (d)).
Election/Restrictions
Applicant’s election without traverse of human tissue factor, cellulose, epoxide chemistry (particularly epichlorohydrim), and FVII/VIIa in the reply filed on December 4, 2025 is acknowledged.
Please note: human tissue factor is considered a subgenus and not a single, specific species (e.g. 100% identity to present SEQ ID NO: 2, etc.). Therefore, the subgenus was searched.
Please note: epichlorohydrin is not part of the present claims, therefore, any art rejection of record does not require epichlorohydrin.
Claims 4-7, 9, 10, and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 4, 2025.
Please note: claim 9 is withdrawn due to the dependency on withdrawn claim 7.
Priority
The present application is a 371 (National Stage) of PCT/EP2021/075533 filed September 16, 2021 which claims foreign priority to EP 20196512.6 filed September 16, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 1, 2023 and January 14, 2026 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See pages 16 and 17.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See page 39.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The present “system” is being interpreted as a product since only TF and a dressing material are part of the body of the claim (see independent claim 1).
Claim Objections
Claim 8 is objected to because of the following informalities: a single conjunction should be utilized in the Markush group (see lines 4 “or” and 6 “or” and “and”). Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “poly sulfone” should read “polysulfone” (see line 4). 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 1-3, 8, 11, and 12 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. One of skill in the art would not be able to determine the scope of the presently claimed product. For example, it is unclear if the “system” is a product or a method. A “system” can be interpreted as either “a set of things working together” or “an organized method”.
Claims 1-3, 8, 11, and 12 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. One of skill in the art would not be able to determine the scope of the presently claimed product. For example, it is unclear what the scope of “variant thereof” is. There is not a function associated with the variant or a common core structure required by the variant for function (i.e. the preamble does not “breath life” into the body of the claim). As presently claimed, the “variant thereof” could encompass a polypeptide with 0% identity to a tissue factor.
Claim 2 is 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. One of skill in the art would not be able to determine the scope of the presently claimed product. For example, it is unclear what “origin” requires. This is particularly the case since “variant thereof” is present in the claim. A TF could be of human origin and the variant could have 0% identity with the human TF.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the “system” as claimed can be either a product, a process, or a combination thereof.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 8, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS).
For present claims 1-3, 8, and 11, Farrell teaches human tissue factor (TF) impregnated in a wound dressing wherein the wound dressing can be cellulose and one or more hemostatic agents may additionally be impregnated into the wound dressing including FVIIa (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 4, 6-9, 12, 13, 20, 23, 24, 28-31, 35, 42, 54, 58, 59, 66, 67, 71, 72, 75, 76, 78, 83, 84, 98).
Therefore, the teachings of Farrell anticipate the presently claimed TF and dressing material composition.
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osther WO 2016/150449 published September 29, 2016 (provided in the IDS).
For present claims 1-3, 8, 11, and 12, Osther teaches recombinant soluble human tissue factor (RshTF) and the extracellular part of TF in combination with Factor VII/VIIa coated on and/or impregnated or embedded in a carrier or scaffold including Biatain™ (i.e. cellulose) (please refer to the entire specification particularly the abstract; pages 1-3, 5-7, 10-15).
Therefore, the teachings of Osther anticipate the presently claimed TF and dressing material composition.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS); Osther WO 2016/150449 published September 29, 2016 (provided in the IDS); and Morrissey et al. WO 2006/047684 published May 4, 2006 (provided in the IDS).
For present claims 1-3, 8, 11, and 12, Farrell teaches human tissue factor (TF) impregnated in a wound dressing wherein the wound dressing can be cellulose and one or more hemostatic agents may additionally be impregnated into the wound dressing including FVIIa (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 4, 6-9, 12, 13, 20, 23, 24, 28-31, 35, 42, 54, 58, 59, 66, 67, 71, 72, 75, 76, 78, 83, 84, 98).
However, Farrell does not teach the combination of TF, FVII, and FVIIa.
For present claims 1-3, 8, 11, and 12, Osther teaches recombinant soluble human tissue factor (RshTF) and the extracellular part of TF in combination with Factor VII/VIIa coated on and/or impregnated or embedded in a carrier or scaffold including Biatain™ (i.e. cellulose) (please refer to the entire specification particularly the abstract; pages 1-3, 5-7, 10-15).
Since coated, embedded, and impregnated may be interpreted several ways, Morrissey et al. is utilized to explicitly teach attachment of TF to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood (please refer to the entire specification particularly paragraph 11).
For present claims 1-3, 8, 11, and 12, Morrissey et al. teach human tissue factor (TF) incorporated, embedded, etc. into stable, soluble nanoscale particles, scaffolds, membranes, matrixes, etc. including cellulose and chemical crosslinking via esters (please refer to the entire specification particularly the abstract; paragraphs 7, 9, 11, 29, 39, 40, 76, 77). Morrissey et al. also teach that soluble TF is thousands of times more active when embedded in a suitable membrane (please refer to the entire specification particularly paragraph 7). Morrissey et al. teach attachment of TF to solid supports so that it will not be allowed to migrate freely into and/or throughout the bloodstream, and so that it will not be washed out of a wound by hemorrhaging blood (please refer to the entire specification particularly paragraphs 11, 77).
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; impregnating/embedding TF so that TF will not be allowed to migrate freely into and/or throughout the bloodstream and so that TF will not be washed out of a wound by hemorrhaging blood) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-3, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS); Osther WO 2016/150449 published September 29, 2016 (provided in the IDS); and Looney et al. U.S. Patent Application Publication 2004/0193088 published September 30, 2004.
For present claims 1-3, 8, 11, and 12, Farrell teaches human tissue factor (TF) impregnated in a wound dressing wherein the wound dressing can be cellulose and one or more hemostatic agents may additionally be impregnated into the wound dressing including FVIIa (please refer to the entire specification particularly the abstract; paragraphs 1, 3, 4, 6-9, 12, 13, 20, 23, 24, 28-31, 35, 42, 54, 58, 59, 66, 67, 71, 72, 75, 76, 78, 83, 84, 98).
However, Farrell does not teach the combination of TF, FVII, and FVIIa.
For present claims 1-3, 8, 11, and 12, Osther teaches recombinant soluble human tissue factor (RshTF) and the extracellular part of TF in combination with Factor VII/VIIa coated on and/or impregnated or embedded in a carrier or scaffold including Biatain™ (i.e. cellulose) (please refer to the entire specification particularly the abstract; pages 1-3, 5-7, 10-15).
Since coated, embedded, and impregnated may be interpreted several ways, Looney et al. is utilized to explicitly teach hemostatic agents (TF, FVII/VIIa) irreversibly bound to the aldehyde-oxidized polysaccharide/cellulose (please refer to the entire specification particularly paragraph 69).
For present claims 1-3, 8, 11, and 12, Looney et al. teach wound dressings including cellulose and aldehyde oxidized cellulose bound irreversibly to the aldehyde-oxidized polysaccharide/cellulose with Factor VII/VIIa and tissue factor (please refer to the entire specification particularly the abstract; paragraphs 1-7, 47, 51-53, 57, 60, 62, 64, 66, 67, 69).
The claims would have been obvious because the substitution of one known element (i.e. genus of hemostatic agents; FVIIa alone) for another (i.e. species of FVII, the combination of FVII and FVIIa) would have yielded predictable results (i.e. adding to benefits of TF by providing binding partners in the coagulation cascade) to one of ordinary skill in the art before the effective filing date of the claimed invention. The claims would have been obvious because a particular known technique (i.e. combining TF, FVII, and FVIIa in a wound dressing; hemostatic agents (TF, FVII/VIIa) irreversibly bound to an aldehyde-oxidized polysaccharide/cellulose) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regarding epichlorohydrin (EPH) crosslinking of cellulose, see:
Mirtaghavi et al., 2020 (online August 10, 2020), Crosslinked porous three-dimensional cellulose nanofibers-gelatine biocomposite scaffolds for tissue regeneration, International Journal of Biological Macromolecules, 164: 1949-1959.
Alam et al., 2019, Sustainable Production of Cellulose-Based Hydrogels with Superb Absorbing Potential in Physiological Saline, ACS Omega, 4: 9419-9426.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/ Primary Examiner, Art Unit 1658