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.
The amendment received May 4, 2026 amended claims 1-15.
Claims 1-15 are currently pending.
Claims 1-3, 8, 11, and 12 are currently under consideration.
Please note: withdrawn claims 10 and 15 now fail to further limit independent claim 1.
Please note: it is unclear how TF or the variant thereof could be covalently linked to some members of the Markush group of withdrawn claim 7 (e.g. gel, cream, ointment, etc.).
Election/Restrictions
Applicants elected, without traverse, human tissue factor, cellulose, epoxide chemistry (particularly epichlorohydrim), and FVII/VIIa in the reply filed on December 4, 2025.
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Claims 4-7, 9, 10, and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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Please note: claim 9 is withdrawn due to the dependency on withdrawn claim 7.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 statement (IDS) submitted on April 22, 2026 is being considered by the examiner.
Specification
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.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Withdrawn Objections
The objection to the disclosure regarding an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of the amendment received May 4, 2026.
The objection to claim 8 regarding a single conjunction should be utilized in the Markush group (see lines 4 “or” and 6 “or” and “and”) is withdrawn in view of the amendment received May 4, 2026.
The objection to claim 8 regarding “poly sulfone” should read “polysulfone” (see line 4) is withdrawn in view of the amendment received May 4, 2026.
Withdrawn Rejections
The rejection of claims 1-3, 8, 11, and 12 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 “system” is withdrawn in view of the amendment received May 4, 2026.
The rejection of claims 1-3, 8, 11, and 12 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 the “variant thereof” is withdrawn in view of the amendment received May 4, 2026.
The rejection of claim 2 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 “origin” is withdrawn in view of the amendment received May 4, 2026.
The rejection of claims 1-3, 8, 11, and 12 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (i.e. system) is withdrawn in view of the amendment received May 4, 2026.
The rejection of claims 1-3, 8, and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Farrell WO 2012/142317 published October 18, 2012 (provided in the IDS) is withdrawn in view of the amendment received May 4, 2026.
The rejection of claims 1-3, 8, 11, and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Osther WO 2016/150449 published September 29, 2016 (provided in the IDS) is withdrawn in view of the amendment received May 4, 2026.
New Objections
Claim Objections
Claim 1 is objected to because of the following informalities: “SEQ ID NO:2” should read “SEQ ID NO: 2” (i.e. a space is missing). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: a conjunction is missing between the bullet points in claim 1. Appropriate correction is required.
New Rejection Necessitated by Amendment
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 composition. For example, it is unclear if the “at least 59% identity to SEQ ID NO: 2” refers to the TF and variant or only the variant.
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 composition. For example, it is unclear if TF is directly covalently linked to the dressing material or if an intermediate may be present (e.g. in such a way that the TF or any variant thereof is prevented from dissociating from the dressing material when exposed to a physiological environment).
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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). Morrissey et al. teach covalent linkages (please refer to the entire specification particularly paragraphs 77-80).
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; covalent linkages) 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Farrell; Osther; and Morrissey et al. for claims 1-3, 8, 11, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that Farrell and Osther do not teach covalent linkages. Applicants contend that Morrissey et al. do not teach that TF is covalently linked to a dressing material.
Applicants’ arguments are not convincing since the teachings of Farrell; Osther; and Morrissey et al. render the composition of the instant claims prima facie obvious. Morrissey et al. teach that nanoparticles comprising TF and scaffold proteins can be covalently linked to a solid support. The scaffold protein can be covalently linked to the solid support. See the abstract; paragraphs 8, 9, 76, and 80.
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). Looney et al. also teach that hemostatic agents including TF can be covalently bound to wound dressings (please refer to the entire specification particularly paragraphs 66-70).
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; covalent linkages) 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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Farrell; Osther; and Looney et al. for claims 1-3, 8, 11, and 12 were considered but are not persuasive for the following reasons.
Applicants contend that Farrell and Osther do not teach covalent linkages. Applicants contend that Looney et al. do not teach any examples of how a dressing material to which TF is covalently linked may be prepared.
Applicants’ arguments are not convincing since the teachings of Farrell; Osther; and Looney et al. render the composition of the instant claims prima facie obvious.
Looney et al. also teach that hemostatic agents including TF can be covalently bound to wound dressings (please refer to the entire specification particularly paragraphs 66-70).
`"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Regarding SEQ ID NO: 2, see:
U.S. Patent Application Publication 2002/0142373 published October 3, 2002 (SEQ ID NO: 2 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2);
U.S. Patent 6,093,399 published July 25, 2000 (SEQ ID NO: 23 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2); and
WO 96/01653 published January 25, 1996 (SEQ ID NO: 23 is the same length – 219mer and has 100% identity with present SEQ ID NO: 2).
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.
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.
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
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