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.
Information Disclosure Statement
The information disclosure statement filed 21 March, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because one of the citations has no date associated with it.
Election/Restrictions
Applicant’s election without traverse of group I (formulations) in the reply filed on 21 Nov, 2025 is acknowledged.
Claims Status
Claims 31-53 are pending.
Claims 31, 32, 41, 43, 44, and 52 have been amended.
Claims 34-40 and 46-51 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 April, 2025.
Withdrawn Rejections
The provisional rejection of claims 31, 32, 41, 42, 44, and 52 on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7 of copending Application No. 18/977,212 in view of Belli et al (Dental Materials (2010) 26) is hereby withdrawn due to the amendment of the competing application.
The provisional rejection of claims 31-33, 41-45, 52, and 53 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, 8, 11, 15, 27, 31, and 33 of copending Application No. 17/642,764 (US 20240124521) is hereby withdrawn due to the amendment of the competing claims.
Maintained/Modified 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 31-33 and 43-45 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.
Claims 31 and 43, and claims dependent on them, consist essentially of a polypeptide, an optional anti-inflammatory agent, and an adjuvant, diluent, or carrier. Consisting essentially of limits the scope of the claim to the specified materials and those that do not materially affect the basic and novel characteristics of the claimed invention (MPEP 2111.03(III). However, applicants have not described what the basic and novel characteristics of the invention are in their disclosure. That makes it impossible to determine what embodiments are excluded by the transition phrase.
response to applicant’s arguments
Applicants point to sections of the spec discussing the sequence to state that the basic and novel characteristics of the invention are clear.
Applicant's arguments filed 21 Nov, 2025 have been fully considered but they are not persuasive.
Applicants clearly think that their invention comprises SEQ ID 2 and variants. But it is not clear what the basic and novel characteristics are. Note that Belli et al discusses either SEQ ID 2 or an isomer of it, which, even if we take applicant’s arguments as persuasive, shows that this is not novel.
second rejection
Claims 41, 42, 52, and 53 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.
The rejected claims consist of the peptide, an optional anti inflammatory agent, and an adjuvant, diluent, or carrier. Consisting of allows for nothing in addition to the named ingredients (MPEP 2111.03(II)). The issue is what is allowed by “adjuvant, diluent, or carrier.” Applicants have not defined these terms. Adjuvant is known in the art (Google dictionary) as a secondary therapy or a substance that enhances the body’s immune response to an antigen, neither of which appear to be relevant in the context of the invention. Diluent is something that dilutes or weakens. Carrier is a relatively inert material used as a base or bulk material with which a smaller amount of an active substance is mixed to enable its processing, application, or analysis. Note that applicants have called viscosity modulators, gelling agents, and foaming agents excipients (p17, most of page), and pH modifiers, moisturizing agents, and antioxidants all appear to be classified differently than what is allowed in the claim (p17, last paragraph). As it is not clear what is covered by these terms, it is not clear what the scope of the claims are.
response to arguments
Applicants state that the definition of these elements are understood, and that the specification gives examples.
Applicant's arguments filed 21 Nov, 2025 have been fully considered but they are not persuasive.
Applicants state that these elements are known, but provide no definition from the literature to back up that assertion. Applicants state that the disclosure gives examples, but it is not clear that this is enough to allow a person of skill in the art to know the metes and bounds of the claims, esp. as, as noted in the rejection, applicants discuss some embodiments that seem to contradict the definition given in a general use dictionary.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 31, 32, 41, 43, 44, and 52 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Belli et al (Dental Materials (2010) 26, cited by applicants).
Belli et al discuss the adhesive binding abilities of mussel foot protein based peptides (abstract). This involved both the native peptides, using DOPA, and their tyrosine analogs, as well as dimers (1st column, 2nd paragraph). The strongest bond of the monomeric peptides was the all tyrosine analog (unnumbered table, 2nd column, top of page), while dimers gave only slightly higher binding (unnumbered table, 2nd column, top of page). The peptides themselves were dissolved in water with small amounts of TFA (1st column, 2nd paragraph), considered a pharmaceutical diluent. Note that both Belli et al (as noted above) and applicants’ disclosure (4th page, 5th paragraph), suggest that the difference compared to the native mussel foot protein is due to the DOPA/Tyr residue, not the Hyp residues, suggesting that they are the same. If they are the same, this reference anticipates the claims. If they are different, position isomers, such as the different hydroxyproline isomers, are considered obvious over each other (MPEP 2144.09(II)).
response to applicant’s arguments
Applicants argue that Belli et al does not unambiguously disclose SEQ ID 2, and that the TFA in the formulations of the reference render the compositions toxic and corrosive, so not suitable for topical or pharmaceutical use. This is supported by a declaration by Prof Jan-Christer Janson, applicant.
Applicant's arguments filed 21 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that Belli et al does not unambiguously disclose SEQ ID 2. While true, this does not overcome the rejection. As noted in the rejection, there are two possibilities – 1) that the peptide in Belli et al is identical to SEQ ID 2 (with some evidence to that effect), in which case the reference anticipates. 2) the peptide in Belli et al is an isomer of SEQ ID 2, in which case it is not a patentably distinct variation, and is obvious.
Applicants argue that the TFA used in the formulations of Belli et al is toxic and corrosive. Applicants are relying on material safety data sheets to prove this. However, it is known in the art that these are more a legal protection than an accurate determination of risks, note Lowe (blog “In the pipeline,” entry of 20 May, 2009, 1st page, 5th paragraph). Examples are given of obviously overboard safety precautions for sea sand (3d and 4th paragraphs) and rust (5th paragraph). TFA salts are known in pharmaceuticals, note Wilson et al (US 20150283200, paragraph 160) for an example, so the inherent toxicity is not high enough to prevent pharmaceutical/cosmetic use. Applicants argue that it is corrosive, but the MSDS that applicants cite give a pH of 2. This is similar to that of lemon juice and Coke (Schein, Acidity chart, 2016), both of which are commonly placed on mucous membranes (mouth while consuming). In other words, applicant’s presentation is not sufficient to persuade a person of ordinary skill in the art that the formulations of Belli et al are too toxic or corrosive for use in pharmaceutical/cosmetic formulations.
Claim Rejections - 35 USC § 103
The legal basis for rejections under this statute was given above, and will not be repeated here.
Claim(s) 31-33, 41-45, 52, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Belli et al (Dental Materials (2010) 26, cited by applicants) in view of Gao (WO 2014186937, cited by applicants). Please note that Gao is in Chinese. A machine translation of this document (also provided by applicants) was used for this rejection, and the places in the reference cited in this rejection refer to the machine translation.
Belli et al discuss the adhesive binding abilities of mussel foot protein based peptides (abstract). This involved both the native peptides, using DOPA, and their tyrosine analogs, as well as dimers (1st column, 2nd paragraph). The strongest bond of the monomeric peptides was the all tyrosine analog (unnumbered table, 2nd column, top of page), while dimers gave only slightly higher binding (unnumbered table, 2nd column, top of page). The peptides themselves were dissolved in water with small amounts of TFA (1st column, 2nd paragraph), considered a pharmaceutical or cosmetic formulation. Note that both Belli et al (as noted above) and applicants’ disclosure (4th page, 5th paragraph), suggest that the difference compared to the native mussel foot protein is due to the DOPA/Tyr residue, not the Hyp residues, suggesting that they are the same. If they are the same, this reference anticipates the claims. If they are different, position isomers, such as the different hydroxyproline isomers, are considered obvious over each other (MPEP 2144.09(II)).
As noted above, this reference either anticipates or renders obvious claims 31, 32, 41, 43, 44, and 52.
The difference between this reference and the remaining claims is that this reference does not discuss a gel, lotion, paste, ointment, foam, powder aerosol, or liquid aerosol.
Gao discusses mussel adhesive proteins for adhesion (1st page, 2nd paragraph) in the context of medical and cosmetic products (1st page, 1st paragraph). The material is usually made as a freeze dried powder or a liquid state, which is smeared or sprayed onto the surface (1st page, 3d paragraph). However, this is problematic with irregularly shaped parts and rapid drying (1st page, 3d paragraph). A gel or emulsion latex liquid or semi-solid preparation solves these problems, and can be made as an emulsion or various gelling agents (1st page, 4th paragraph).
Therefore, it would be obvious to make a gel or emulsion or semi-solid preparation of the mussel adhesive material of Belli et al, to allow for adhesion to irregularly shaped parts and to prevent issues with rapid drying, as discussed by Gao et al. As Belli et al is using a derivative of the adhesive protein of Gao et al for the same purpose, an artisan in this field would attempt this modification with a reasonable expectation of success.
response to applicant’s arguments
Applicants argue that neither document discloses SEQ ID 2, and that there is no motivation to combine because Belli et al teaches that longer sequences give better adhesion.
Applicant's arguments filed 21 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that neither document discloses SEQ ID 2. As noted previously, Belli et al discusses either SEQ ID 2 or a sequence that is not patentably distinct.
Applicants argue that Belli et al teaches that longer sequences have better binding, so there is no motivation to substitute the sequences of Gao et al with the sequences of Belli et al. This is an argument that Belli et al teaches away from the combination. There are a few issues with this argument. First, Belli et al is discussing repeating units of a binding sequence. There is no evidence that Gao et al is talking about more repeats of the same binding sequence. Second, Belli et al shows that dimers give only slightly higher binding, as noted in the rejection. It is not clear that this small difference is a teaching away – A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use (MPEP 2145(X)(D)(1)). It is not clear that this small difference in binding would overcome advantages, such as accessibility of the peptide via chemical synthesis and lower cost of materials. Finally, applicants argument is that it is improper to modify Gao et al with the teachings of Belli et al. But that is not how the rejection is written; Belli et al is modified by the teachings of Gao et al.
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 31-33, 41-45, 52, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13, and 18-20 of copending Application No. 17/781,571 (US 20240218016).
Competing claim 1 describes a compound comprising the sequence W-Lys-X1-Ser-U-X2-Y-G, with the various letters associated with a Markush group of amino acids or sequences that allow for the sequence of the examined claims. Competing claim 2 specifies that G is absent, as it is in the sequence of the examined claims. Competing claim 3 specifies that X1=Pro, identical to the sequence of the examined claims. Competing claim 4 specifies that X2 his Hyp, same as the examined claims. Claims 6, 7, and 8 describe Y as a 4 amino acid sequence, down to claim 8 which describes a Markush group including Hyp-Thr-Tyr-Lys, identical with the examined claims. Competing claim 13 reinforces these potential choices by describing a Markush group of sequences, including SEQ ID 41, identical with SEQ ID 2 of the examined claims save it has an additional DOPA residue at the C-terminus, in position G of the competing claims. However, given that claim 2 explicitly allows for this to be deleted, and all of claims 1-8 point to a sequence with the features of the peptide of the examined claim, that sequence is obvious. Competing claims 18-20 describe a pharmaceutical formulation with a pharmaceutically or cosmetically acceptable diluent, adjuvant, or carrier, with competing claim 20 also describing the formulation in the form of a gel, spray, cream, ointment, or powder.
response to applicant’s arguments
Applicants argue that SEQ ID 2 of the examined application is excluded from the competing claims, and that the competing claims have a later filing date, so the rejection should be withdrawn.
Applicant's arguments filed 21 Nov, 2025 have been fully considered but they are not persuasive.
It is not clear that the competing claims exclude SEQ ID 2, and do not render it obvious. Note that the rejection clearly points out why SEQ ID 2 of the examined claims is obvious over the competing claims.
Applicants argue that, as the competing claims are later filed, the rejection should be withdrawn. This holds only when the double patenting rejection is the only rejection outstanding, which is not the fact pattern of this application.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658