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.
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 4, 6, 8, 10, 14, 18, 20, 23-30 and 32 are pending.
Claim 25 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Claims 4, 6, 8, 10, 14, 18, 20, 23, 24, and 27-30 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 1 and 31 under 35 U.S.C. 101 because they read on a judicial exception is hereby withdrawn due to amendment.
The rejection of claims 1, 25, 26, and 31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph due to uncertainty as to the particle size is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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) 25, 26, and 32 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. 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.
As Brown et al teaches that the neonatal material does not play well with the adult material, a person of skill in the art would reasonably assume that mixing the two (in the bandage and in the wound) would be detrimental to wound healing, rendering obvious claim 32.
response to applicant’s arguments
Applicants argue that the material of Brown et al is so different from the material of Kumar et al that the process will not work, and argue a number of alleged unexpected results.
Applicant's arguments filed 21 Aug, 2026 have been fully considered but they are not persuasive.
Applicants argue that the material of Brown et al is so different from the material of Kumar et al that it cannot be processed the same way. To demonstrate this, they point out the differences between the material of Brown et al and the material of Kumar et al, and say these differences make a simple substitution impossible. However, there is no linking the differences to the process – it is, in essence, a list of property differences and a statement that the two materials are too different. Without some link between the property differences and the process, this argument cannot be persuasive.
In addition, the Supreme Court has stated that “a person of skill in the art is also a person of ordinary creativity, not an automaton” (KSR). Even if the process of Kumar et al is too harsh for the material of Brown et al, as applicants have argued, it is not considered unreasonable that a person of ordinary skill in the art would be able to tweak or optimize the process to a successful conclusion.
Applicants argue unexpected results of improved cell migration and wound closure. It is applicant’s responsibility to establish that the results are of statistical significance (MPEP 716.02(b)(I)). Applicants have not shown statistical significance against adult fibrin (applicant’s specification, p32, 2nd paragraph, continues to p33).
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 25, 26, and 32 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.
first rejection
Claims 25, 26, and 32 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 25 has been amended to include the line “is in the form of particles having a particle less than or equal to 500 nm.” There is clearly at least one word missing as the phrase “particles having a particle less than” has no meaning. This makes it impossible to tell if applicants are claiming an average diameter size limitation, a cutoff limitation, or some other meaning.
second rejection
Claim 32 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.
Claim 32 requires that the neonatal fibrin scaffolds enhance wound healing outcomes compared to adult fibrin scaffolds. There are a number of issues with this limitation. First, it is not clear what outcome is compared; if a wound takes longer to heal but has less scaring, for example, it is not clear if the claim limitations have been met. The second is that it is not possible to heal the same wound twice; once it is healed, it is gone. This makes it unclear how it would be determined if this limitation has been met. Note that applicant’s experiments show a great deal of overlap between the neonatal and adult material, and are not statistically different (p32, 2nd paragraph, continues to p33, 1st paragraph), which suggests that, based on the measurement standard applicants used, this claim is not enabled.
Conclusion
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.
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.
Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. 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.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
Prosecution Insights