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 .
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn. This office action is Non-final rejection.
Claim Status
Claims 1-9 and 11-32 are pending.
Claim 10 is canceled.
Claims 7-9 are withdrawn as being directed to a non-elected species.
Claims 11-20 (group II) and 21-30 (Group III) are withdrawn as being directed to a non-elected invention, the election having been made on 1/16/2023.
Claims 1-6 and 31-32 have been examined.
Priority
This application is a CON of 16/249,748 01/16/2019
This application is a DIV of 14/818,662 08/05/2015 PAT 10258717
14/818,662 has PRO 62/033,599 08/05/2014
Withdrawn Rejection
The non-compliance amendment of claims 1 and 32 is withdrawn in view of the claims filed on 8/4/2026.
The rejection of claims 1-3, 5-6, and 31-32 under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. and evidenced by Godbole et al. is withdrawn because the arguments of hydrogel not a dry composition are persuasive.
Maintained Rejection
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 1-6 and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moavenian (GB 2519072 A, previously cited 5/5/2026) and evidenced by Godbole et al. (Interactive CardioVascular and Thoracic Surgery 14 (2012) 390–394, previously cited 5/5/2026).
Claim 1 is drawn to a dry composition comprising (i) a biodegradable protein polymer in an amount of 100 parts by weight and (ii) honey in an amount of from 1 to 300 parts by weight relative to the 100 parts by weight of the biodegradable protein polymer; wherein, the composition promotes tissue regeneration of soft tissue when in contact with the soft tissue in a subject.
Moavenian teaches a dry composition of porous sponge or membrane comprises honey and collagen made by a process of lyophilisation or freeze-drying (Abstract; Fig 2). Moavenian
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shows the weight ratio of collagen to honey as 1:1 and 1:2 as follows (p16, Table 2), reading on the limitations (i) and (ii).
Moavenian teaches the dry composition is used for treating skin damage including a sharp injury which damages the dermis of the skin or a burn which damages the skin (p12, para 2-3) and regeneration of epithelial layer (p13, para 2, #5), reading on wherein the composition promotes tissue regeneration of soft tissue (e.g., skin) when in contact with the soft tissue in a subject.
With respect to claim 2, Moavenian teaches the dry composition is a membrane (Abstract).
With respect to claims 3 and 5-6, Moavenian teaches the dry composition comprises protein polymer of collagen (Abstract; p16, Table 2), which can be degraded by matrix metalloproteinases (p1, Background of the invention, para 2).
With respect to claim 4, Moavenian teaches the honey comprises methylglyoxal (p4, Table 1, antimicrobial characteristics).
With respect to claim 31, Moavenian teaches a dry composition of porous sponge comprising collagen. Moavenian teaches the dry composition is used for treating skin damage including a sharp injury which damages the dermis of the skin or a burn which damages the skin (p12, para 2-3) and regeneration of epithelial layer (p13, para 2, #5), reading on wherein the composition promotes tissue regeneration of soft tissue (e.g., skin) when in contact with the soft
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tissue in a subject. Godbole et al. is cited as evidence to show collagen sponge is a surgically-implantable form (Title and Abstract).
With respect to claim 32, Moavenian teaches a dry composition comprising collagen and honey described above not repeated here. Moavenian shows the dry composition made by the process above (Fig 2).
Applicant’s Arguments
Moavenian does not anticipate the pending claims because Moavenian is not enabling on its face of a composition that includes a biodegradable protein polymer and honey and that promotes tissue regeneration of soft tissue when in contact with the soft tissue in a subject.
Response to Arguments
Applicant's arguments filed 8/4/2026 have been fully considered but they are not persuasive because (i) MPEP 2112.01 (I) states “Product and apparatus claims - When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent” and (ii) MPEP 2112.01 (II) states "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Finally, applicant failed to provide to show the prior art product cannot perform the function as argued by applicant.
Maintained Rejection
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.
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.
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.
Claims 1-6 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Knaepler et al. (International Journal of Surgery 10 (2012) S15-S20, previously cited 10/25/2023) in view of Godbole et al. (Interactive CardioVascular and Thoracic Surgery 14 (2012) 390–394, previously cited 5/5/2026) and Moavenian (GB 2519072 A, previously cited 5/5/2026).
Claim 1 is drawn to a dry composition comprising (i) a biodegradable protein polymer in an amount of 100 parts by weight and (ii) honey in an amount of from 1 to 300 parts by weight relative to the 100 parts by weight of the biodegradable protein polymer; wherein, the composition promotes tissue regeneration of soft tissue when in contact with the soft tissue in a subject.
Knaepler et al. teach a composition comprising an antibiotic and a biodegradable drug carrier matrix of collagen implant (sponge. See S17 col 1, Sec 3.2.1. Acute and chronic osteomyelitis), inherent as a dry and solid composition, in the prophylaxis and treatment of surgical site infection in orthopaedic surgery (Title and Abstract), reading on the limitation (i) a dry composition comprising a biodegradable protein polymer of collagen (a carrier protein of an antimicrobial agent). Godbole et al. is cited as evidence to show collagen sponge is a surgically-implantable form (Title and Abstract).
Knaepler et al. in view of Godbole et al. do not teach a honey as an antimicrobial ingredient in a collagen sponge implant composition or a weight ratio of honey to the collagen protein.
Similarly, Moavenian teaches beneficial combination of honey and collagen in the form of sponge and membrane to treat wound (Abstract). Moavenian teaches honey can be beneficial used for tissue regeneration (e.g., epithelial layer of skin. p12, para 2 and p13, para 2, #5) and promoting wound healing as well as an antibacterial and anti-inflammatory properties (p1, last para to p2, para 1-2). Because (i) Moavenian teaches honey can be beneficially used for tissue regeneration and promoting wound healing in addition to honey’s antibacterial and anti-inflammatory properties and (ii) Knaepler et al. teach beneficial combination of an antibiotic and a biodegradable drug carrier matrix of collagen sponge implant, one of ordinary skill in the art would have found it obvious to beneficially combine an antimicrobial agent of Moavenian’s honey and a collagen sponge taught by both Knaepler et al. and Moavenian in the prophylaxis and treatment of surgical site infection in orthopaedic surgery.
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Moavenian teaches a dry composition of porous sponge or membrane comprises honey and collagen made by a process of lyophilisation or freeze-drying (Abstract; Fig 2). Moavenian shows the weight ratio of collagen to honey as 1:1 and 1:2 as follows (p16, Table 2), reading on the limitations (i) and (ii). Moavenian teaches honey can be used for soft tissue regeneration, such as epithelial layer of skin,(p12, para 2; p13, para 2, #5), reading on the wherein clause in claim 1.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Knaepler et al. in view of Godbole et al. with (ii) Moavenian’s honey because (a) Knaepler et al. in view of Godbole et al. teach the use of collagen sponge (S17 col 1, Sec 3.2.1. Acute and chronic osteomyelitis) comprising an antibacterial agent as an implant in the prophylaxis and treatment of surgical site infection in orthopaedic surgery (Title & Abstract) and (b) Moavenian teaches honey can be used for tissue regeneration (e.g., epithelial layer of skin. p12, para 2 and p13, para 2, #5) and promoting wound healing in addition to its antibacterial and anti-inflammatory properties (p1, last para to p2, para 1-2) when honey is used together with collagen sponge or membrane (Abstract). The combination would have reasonable expectation of success because both references of Knaepler et al. and Moavenian teach a dry composition of collagen sponge comprising collagen and an antimicrobial agent.
With respect to claim 2, Knaepler et al. suggest the implant in the form of sponge (S17, col 1, Sec 3.2.1), reading on a solid form.
With respect to claim 3, collagen is a protein which is biodegradable by collagenase or other enzymes. The specification disclosed gelatin and collagen as a preferred biodegradable protein (p10, Scaffold, line 19-20).
With respect to claim 4, Moavenian teaches the honey comprises methylglyoxal (p4, Table 1, antimicrobial characteristics).
With respect to claims 5-6, collagen is a natural polymer.
With respect to claim 31, Knaepler et al. teach the use of a collagen sponge as an implant to treat surgery site infection (Title; See S17 col 1, Sec 3.2.1. Acute and chronic osteomyelitis).
With respect to claim 32, , Moavenian teaches a dry composition comprising collagen and honey described above not repeated here. Moavenian shows the dry composition made by the process as follows (Fig 2).
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Applicant’s Arguments
The combination of Knaepler, Godbole, and Moavenian likewise does not teach or suggest the dry composition of claims 1 and 32 because (A) the parent application (U.S. 14/818,662, now issued as US 10,258,717) to issuance. Thus, this application with different claim scope should also be allowed (Remarks, p13, para last three para to p14, para 1-2) and (B) The substitution of antibacterial honey from Knaepler for the antibiotic in the implant of Knaepler would be merely redundant (Remarks, p14, last 3 para to p15, para 1-2)
Response to Arguments
Applicant's arguments filed 8/4/2026 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (A) is NOT persuasive because the examiner has found more relevant prior art references properly rejecting the instant claims described above not repeating here. If applicant doubts the patentability of US 10,258,717, the examiner recommends filing reexamination of US 10,258,717 instead of making arguments in a separate application with different claim scope admitted by applicant in the instant Remarks (p15, IV. Double Patenting Rejections, para 2-3).
Applicant’s argument (B) is NOT persuasive because substitution of an antibiotic with honey can be more beneficial for tissue regeneration (e.g., epithelial layer of skin. p12, para 2 and p13, para 2, #5) and promoting wound healing as well as an antibacterial and anti-inflammatory properties (p1, last para to p2, para 1-2) than an antibiotic with a single function, NOR redundant as argued by applicant.
Modified Rejection
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.
Claims 1-6 and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,258,717 B2 (the ‘717 patent) in view of Knaepler et al. (International Journal of Surgery 10 (2012) S15-S20, previously cited 10/25/2023), Godbole et al. (Interactive CardioVascular and Thoracic Surgery 14 (2012) 390–394), and Moavenian (GB 2519072 A).
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Claim 1 of the ‘717 patent disclosed a composition comprising a gelatin/collagen and honey as follows.
Claim 1 of the ‘717 patent does not specify the implant composition in membrane form.
The relevancy of Knaepler et al., Godbole et al., and Moavenian is described above not repeated here.
Because Moavenian a dry and solid composition of porous sponge or membrane comprising honey and collagen can be beneficially made by a process of lyophilisation or freeze-drying (Abstract; Fig 2), one of ordinary skill in the art would have found it obvious to combine the composition taught by claim 1 of the ‘717 patent with Knaepler et al. in view of Godbole et al. and Moavenian.
Thus, claim 1 of the ‘717 patent in view of Knaepler et al., Godbole et al., and Moavenian are obvious to the instant 1-6 and 31-32.
Applicant’s Arguments
Applicant argues (A) The pending claims also recite a different honey range and (B) the pending claims recite that the composition is "dry," whereas claim 1 of the '717 patent requires that the composition be "a solid."
Response to Arguments
Applicant's arguments filed 8/4/2026 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s arguments (A) and (B) do not apply to the modified rejection.
Claims 1-3, 5-6, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 25, and 29-30 of copending Application No. 16/249,748 (the ‘748 application, 12/18/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘748 application is obvious to the instant application.
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Claim 2 of the ‘748 application disclosed a membrane comprising a biodegradable polymer and honey as follows.
Claim 25 of the ‘748 application disclosed honey is from 1 to 300 parts by weight to 100% by weight to the biodegradable polymer as follows.
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In search for the scope of membrane, the specification the ‘748 application disclosed a membrane made by a process comprising removal solvent comprising the biodegradable polymer and honey by evaporation or lyophilization to remove the solvent to form a dry composition encompassing the product-by-process limitation as claimed.
Thus, claims 2 and 25 of the ‘748 application are obvious to the instant claims 1-3 and 31-32.
Claims 29-30 of the ‘748 application disclosed the biodegradable polymer comprising collagen or gelatin, satisfying the instant claim 5-6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 8/4/2026 have been fully considered but they are not persuasive because applicant’s request abeyance of the double patenting rejection does not overcome the provisional rejection of record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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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.
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/J.L/Examiner, Art Unit 1658
17-August-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights