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 statements filed 17 July, 2025 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. While the IDS lists a number of non-patent literature and foreign patent citations, the documents that correspond to those citations were not submitted with the IDS. Thus, they were not considered.
Election/Restrictions
Applicants elected the formulation of claim 7 without traverse in the reply filed on 10 July, 2025.
Claims Status
Claims 1-5 and 7 are pending.
Claim 1 has been amended.
Claims 2-4 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Gatti (EP 3072401) is hereby withdrawn due to amendment.
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.
Claims 1 5, and 7 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 require a water soluble polymer. However, applicants have not defined “water soluble.” It clearly means that the polymer can dissolve in water, but it is not clear what solubility is the cutoff between water soluble and not water soluble. Note that solubility is a function of molecular weight (Kokv, 1chemistry blog, entry of 2 April, 2013, 1st page, near bottom). This means a low molecular weight polymer may be able to meet a solubility cutoff that a higher molecular weight of the same polymer cannot.
response to applicant’s arguments
Applicants argue that limiting the claims to PEG, PVA, PVP, and copolymers overcomes the rejection.
Applicant's arguments filed 1 Dec, 2025 have been fully considered but they are not persuasive.
The issue is that a person of skill in the art would not know what the solubility cutoff is between a water soluble polymer and a polymer that is not water soluble. While most grades of the claimed polymers are highly water soluble, it is not clear that high mw PVA with a low degree of hydrolysis is (or copolymers of it) is. Note that the definition of the polymer is open (comprising a polymer and/or polymeric mixtures), which allows for copolymers with other monomers.
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 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al (J. Appl. Microbiol. (2016) 120(6) 1449-1465) in view of Holmes et al (J. Mammary Gland Biol. Neoplasia (2011) 16 p373-382), Bisgnano et al (J. Pharm. Pharmacol. (1999) 51 p971-974), and Teodorescu et al (Polymer Plast. Thecnol. Engin. (2015) 54 p923-943).
Shin et al discusses the uses of nisin (title). There are several citations to nisin treating mastitis, which is caused by staphylococcal strains, including one that specifies nisin z, applicant’s elected nisin species, and topical administration (6th page, 1st paragraph).
The difference between this reference and the examined claims is that this reference does not discuss hydroxytyrosol or a water soluble polymer.
Holmes et al states that mastitis can be caused by Staphylococcus aureus (abstract), and is one of the most common causes (p375, 2nd column, 2nd paragraph). Interestingly enough, it is also found in the milk of about 30% of healthy mothers (p375, 2nd column, 2nd paragraph). While rare before the 1990s, there are increasing numbers of cases of mastitis caused by methicillin resistant strains (p375, 2nd column, 3d paragraph). This reference teaches S. aureus as a common cause of mastitis.
Bisgnano et al discuss the antimicrobial activity of hydroxytyrosol (title). Hydroxytyrosol was made up in sterile buffer (p972, 1st column, 3d paragraph) and placed onto 6 mm disks in a diffusion assay (p972, 2nd column, 3d paragraph). This material had activity against several strains of S. aureus at concentrations comparable to common antibiotics (tables 1 and 2, p973, bottom of page). The material ire generally accepted as non-toxic to people, and it is suggested that they can be used as antimicrobial agents in humans (p974, 1st column, 2nd paragraph). This reference discusses the antimicrobial activity of aqueous solutions of hydroxytyrosol, and suggest using in humans.
Teodorescu et al discuss PVP in the context of biomedical and other applications (title). The material is water soluble, non-toxic, and biocompatible (p925, 2nd column, 3d paragraph), and is readily soluble in cold water (p925, 2nd column, 5th paragraph). The material is adhesive to both hydrophilic and hydrophobic surfaces, forms stable associations compounds and complexes with many active agents, thickens solutions, and forms films (p928, 2nd column, 2nd paragraph), all useful properties for a topical formulation. It can be used as a solubilizer for topical formulations, a suspension stabilizer, and is specifically mentioned as useful in antimicrobial coatings for medical devices (table 2, p931, top of page). This reference teaches that PVP has a number of properties that are useful in a topical formulation.
Therefore, it would be obvious to add the hydroxytyrosol of Bisgnano et al to the nisin formulations of Shin et al, to make it more potent against the S. aureus strains discussed by Holmes et al. As Bisgnano et al mention use in humans, an artisan in this field would add this formulation with a reasonable expectation of success.
Furthermore, it would be obvious to formulate the material with PVP, for the stabilizing, solubilizing, adhesive, and film forming properties of the material, as described by Teodorescu et al. As the reference mentions using the material in topical pharmaceutical formulations, an artisan would add this material to the topical formulations of Shin et al with a reasonable expectation of success.
Shin et al discusses nisin for topical administration. Bisgnano et al renders obvious the addition of hydroxytyrosol. Teodorescu et al renders obvious PVP and water. Thus, the combination of references renders obvious claim 1 and 7.
Shin et al mentions nisin z for this application, rendering obvious claim 5.
response to applicant’s arguments
Applicants argue that nisin is ineffective against gram negative bacteria, and so it is not obvious to add hydroxytyrosol to overcome this limitation, that Bisigano et al discusses in vitro screening, that neither Bisigano et al nor Teodorescu et al anticipate the claims by reciting all the limitations, and argue synergy, presumably an unexpected result.
Applicant's arguments filed 1 Dec, 2025 have been fully considered but they are not persuasive.
Applicants argue that it is not obvious to add hydroxytyrosol to nisin to generate combinations that are active against gram negative bacteria. While this is applicant’s rationale, there is no reason that the rationale in the rejection matches the rationale applicants used when developing the invention (MPEP 2144(IV)).
Applicants argue that Bisigano et al discuss in vitro screening. It is not clear how this overcomes the rejection.
Applicants point to differences between what they claim and the teachings of Bisigano et al and Teodorescu et al. However, this is a rejection under 35 USC 103, not 35 USC 102; there is no reason that every limitation must be met by a single reference for the rejection to be proper.
Finally, applicants argue synergy in the formulation. This has not been demonstrated.
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, 5, and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 15, and 18 of copending Application No. 17/775,779 (US 20220387669 (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 water soluble synthetic polymer, water, and a component selected from a Markush group comprising hyroxytyrosol. Competing claim 10 specifies bacteriocins, with competing claim 15 giving a Markush group, including nisin z, applicants elected bacteriocin. Competing claim 18 lists a number of water soluble polymers, including PVA, PVP, and copolymers and mixtures.
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 argue that amendments to the copending application have overcome the rejection.
Applicant's arguments filed 1 Dec, 2025 have been fully considered but they are not persuasive.
The limitation of hydroxytyrosol was moved from claim 2 to claim 1; it is not clear how this amendment overcomes the rejection.
New Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicants have amended claim 1 to require that the polymeric component has a concentration that allows for the polymeric component to be water soluble. There is no discussion in the disclosure as filed linking the concentration of a polymer to water solubility. Thus, this limitation constitutes new matter.
Claim Rejections - 35 USC § 112(b)
The legal basis for rejections under this statute was given above, and will not be repeated here.
Claims 1 5, and 7 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.
Applicants have amended claim 1 to require that the polymeric component has a concentration that allows for the polymeric component to be water soluble. It is not clear what this means. It could mean that the polymer has to be dissolved, it could mean that the polymer is in the formulation, but that under some unspecified conditions, it will dissolve, or some other interpretation.
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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658