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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 Jan, 2026 has been entered.
Election/Restrictions
Applicants elected polymerized human fibrinogen in the form of particles without traverse in the reply filed on 10 June, 2025.
Claims Status
Claims 1, 4, 6, 8, 10, 14, 18, 20, and 23-31 are pending.
Claim 1 has been amended.
Claims 4, 6, 8, 10, 14, 18, 20, 23, 24, and 27-30 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The provisional rejection of claims 1 and 31 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 10 of copending Application No. 18/904,336 (US 20250114302) (reference application) in view of Brown et al (Anesthesiology (2016) 124(5) p1021-1031) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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 and 31 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a 3 part test for eligibility under this statute
1) Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) Does a judicial exception apply?
2b) If a judicial exception applies, is there something beyond the judicial exception?
Applying the test
1) The claims are drawn to fibrin scaffolds, a composition of matter.
2a) Brown et al (Anesthesiology (2016) 124(5) p1021-1031) mentions clots in neonates (abstract), which are less than 1 year of age (abstract). The claim also requires a particulate structure, but it is still the same material. Either way, the material is a natural product, which is a judicial exception (natural phenomenon). Claim 31 describes a product by process limitation related to the polymerization step, but it does not distinguish from the naturally occurring material.
2b) Claim 1 is just the material. As an embodiment of just a neonatal fibrin will read on the claim, there cannot be anything in addition to the judicial exception. While the claim requires particulate structure, but there is no evidence of record that this will make a significant difference in properties. Nor is there any evidence of record that the limitations of claim 31 will make a difference compared to the natural product. Thus, the claims lack patent eligibility.
response to applicant’s arguments
Applicants argue that the claimed material is structurally and mechanically distinct from a naturally occurring blood clot, and that the natural product is not less than 500 nm in size.
Applicant's arguments filed 22 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue that there are differences between a blood clot and their invention. However, the relevant comparison is not the blood clot, but the protein itself. Note that in Ass’n for Molecular Pathology v Myriad Genetics, isolated DNA was found to be a natural phenomenon; the fact that the material has been separated from whatever matrix it occurs in naturally is not sufficient to render it patent eligible.
Applicants argue that the newly added limitation of 500 nm size limit renders the claims patent eligible. Applicants have provided no evidence that this provides any significant difference to the material.
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.
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) 1, 25, 26, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al (Anesthesiology (2016) 124(5) p1021-1031) in view of Kumar et al (RSC Adv. (2014) 4 65081) and Moharir et al (Paediatr. Child Health (2012) 17(9) p495-497), with evidentiary support from Paveen et al (Nanotechnol. (2012) 095102).
Brown et al look at fibrin networks in neonates (title). Humans produce neonatal fibrin until 1 year of age (abstract); presumably, adult fibrin is produced after that. The authors postulated that adult and neonatal fibrinogen does not integrate well, and tested the hypothesis by mixing neonatal and adult fibrinogen, followed by the addition of thrombin (4th page, 4th paragraph). These formulations formed clots very different than those of either adult or neonatal fibrinogen (7th page, 4th paragraph). These mixed clots are poorly degraded by neonatal patients, and could affect clinical outcomes (9th page, 3d paragraph). In other words, the neonatal and adult clots do not integrate well (abstract).
The difference between this reference and the examined claims is that this reference does not discuss formulations for application to wounds.
Kumar et al discusses nanofibrin composite bandages for treating burn wounds (title). Particles of fibrin were suspended in distilled water, sonicated for 20 min, then mixed with chitosan and gelatin to form a homogenous hydrogel, then lyophilized to make bandages (p65082, 1st column, 5th paragraph, continues to 2nd column). The material was applied to an animal model of burns (p65083, 2nd column, 2nd paragraph). Kumar et al cite Paveen et al for the method of making the fibrin particles (p65082, 1st column, 5th paragraph). That reference isolated fibrin from human plasma (2nd page, 1st column, 2nd paragraph), followed by thrombin polymerization in an emulsion at 5-10 U/mL (fig 1, p2, top of page), followed by sonication (2nd page, 2nd column, 2nd paragraph) to produce particles with an intensity weighted average diameter of around 240 nm, with a maximum of around 300 nm (fig 2, 5th page, 2nd column top of page). This reference discusses particulate formulations for wound healing.
Moharir et al discuss burn injuries in an 11 month old infant (title). The authors emphasize that a significant percentage of burns in young children are non-accidental (i.e. abuse) and to take care to distinguish between accidental and non-accidental burns (p496, 1st column, 2nd paragraph).
Therefore, it would be obvious to use the method of Kumar et al to treat the burns of Moharir et al, using neonatal fibrin, as Brown et al states that adult fibrin integrates poorly with neonatal fibrin. As this is the same material produced endogenously to clot the injury, an artisan in this field would use such a material with a reasonable expectation of success.
Kumar et al discusses particulate fibrin of less than 300 nm made by a donation from a human of unspecified age. Brown et al, renders obvious using neonatal fibrin for neonatal patients. Note that the method used by Kumar et al polymerized the fibrinogen with thrombin, and did not include platelets. Thus, the reference renders obvious claim 1.
Kumar et al uses the material to treat a burn wound, rendering obvious claim 25.
If the material is applied to the wound, it will be in contact with the fibrin, rendering obvious claim 26.
The procedure used by Kumar et al used thrombin at a concentration of 5-10 U/mL. While this is greater than the concentration of claim 31, there is no evidence that this will make a difference in the final product. Note that the kinetics of enzyme reactions are well known and have been for over a century (Srinivasan FEBSJ (2021) 289 p6086-6098, abstract); how this difference in concentration will affect the rate of reaction is well understood. The MPEP states that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113). Thus, the combination of references render obvious claim 31.
response to applicant’s arguments
Applicants argue that neonatal fibrin has a different structure than adult fibrin, so will not form particles under the conditions of Kumar et al, much less ones that meet the particle size limitation, and claim unexpected results of accelerated wound closure, increased epidermal thickness, and enhanced angiogenesis compared to adult fibrin scaffolds.
Applicant's arguments filed 22 Jan, 2026 have been fully considered but they are not persuasive.
Applicants argue that neonatal fibrin would not be expected to form particles under the conditions of Kumar et al. There are two issues with this argument. First, applicants have provided no evidence beyond pointing out some non-relevant differences between adult and neonatal fibrin. Fibrin is insoluble -- that is the point of the protein; to form an insoluble mass that reduces/prevents blood loss. There is no evidence that the material will not form particles under the conditions of Kumar et al. Second, a person of skill in the art is a person of ordinary creativity, not an automaton (MPEP 2141(II)(C)). Kumar et al discusses particulate material; if the method they used did not work for neonatal fibrin, it is reasonably assumed that they can optimize the method (or use another method) to form particles.
Applicants argue that they have unexpected results. However, unexpected results are compared with the closest prior art, which is Brown et al. That reference uses neonatal fibrin. In addition, Brown et al states that neonatal fibrin is less dense and more susceptible to fibrinolysis than adult fibrin (3d page, 2nd paragraph), which would reasonably lead to applicant’s unexpected results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
first rejection
Claims 1, 25, 26, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, 11, and 18 of copending Application No. 18/921,390 (US 20250205316) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes a colloidal (i.e. particulate) formulation comprising fibrin nanoparticles. and a blood cofactor. Competing claim 2 specifies that the blood cofactor is whole blood, plasma, or fibrinogen/thrombin. Note that fibrinogen/thrombin does not have platelets, making clear that the inventors contemplated platelet free embodiments. Competing claim 7 specifies neonatal fibrin, which reads on “scaffolds” in the examined claims (note p6, 1st paragraph). Competing claim 11 requires an average particle size that overlaps with that of the examined claims. Competing claim 18 specifies a method of treating a wound, comprising contacting the fibrin scaffold with the wound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
response to applicant’s arguments
Applicants request reconsideration due to applicant’s claim amendments. However, the rejection (suitably modified) still reads on the examined claims.
second rejection
Claims 1, 25, 26, and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, and 9 of U.S. Patent No. 11,786,477 in view of Brown et al (Anesthesiology (2016) 124(5) p1021-1031).
Competing claim 1 describes particles of fibrin between 100 and 10,000 nm, overlapping with the size range of applicants, while competing claims 8 and 9 describe a method of treating a wound, comprising administering the composition of claim 1 directly to the wound.
The difference between the competing claims and the examined claims is that the competing claims do not specify neonatal fibrin.
Brown et al look at fibrin networks in neonates (title). Humans produce neonatal fibrin until 1 year of age (abstract); presumably, adult fibrin is produced after that. The authors postulated that adult and neonatal fibrinogen does not integrate well, and tested the hypothesis by mixing neonatal and adult fibrinogen, followed by the addition of thrombin (4th page, 4th paragraph). These formulations formed clots very different than those of either adult or neonatal fibrinogen (7th page, 4th paragraph). These mixed clots are poorly degraded by neonatal patients, and could affect clinical outcomes (9th page, 3d paragraph). In other words, the neonatal and adult clots do not integrate well (abstract).
Therefore, for treating neonatal patients, it would be obvious to use neonatal fibrin, as Brown et al states that neonatal and adult clots do not integrate well. As this would be the same material endogenously formed in the child, an artisan in this field would attempt this modification with a reasonable expectation of success.
response to applicant’s arguments
Applicants request reconsideration due to applicant’s claim amendments. However, the rejection (suitably modified) still reads on the examined claims.
New Rejections
Claim Rejections - 35 USC § 112(b)
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, 25, 26, and 31 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.
Claim 1, and claims dependent on it has a limitation that the particle size be no greater than 500 nm. There are two issues with this limitation. First, it is not clear if this is an average particle size (i.e. the average particle size must be less than 500 nm) or a cutoff (no particle may be greater than 500 nm). Note that applicants have support for an average particle size of 500 nm or less (p9, 1st paragraph), but not a cutoff. The second is, if this is an average size, how is the average weighted. There are different accepted ways to weight individual particles in computing an average (Malvern sales literature (2015), 4th page, 4th paragraph), and these different weightings will give different average values (4th page, 8th paragraph, continues to 5th page, 1st paragraph and fig 3, 4th page, near top of page). This means that an average weighted one way may meet the 500 nm limitation, but weighted a different way, the same formulation may fail. This makes the claims indefinite.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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