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 .
Status of the Claims/Application
Claims 1 and 10 are currently amended. Claims 1-18 are currently pending and are under examination on the merits herein.
Priority
The instant application, filed on 05/18/2022, claims priority to US Provisional applications 62/939,331 and 62/994,130 filed on 11/22/2019 and 03/24/2020 respectively.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2025 is acknowledged and is in compliance with the provisions of 37 CFR 1.97. It has been considered by the examiner.
Withdrawn Objections/Rejections
Claim Objection
The objections to claims 1 and 10 has been withdrawn in view of the amended claims (Remarks pg. 6 para 3-3).
Rejection Under 35 U.S.C § 112(b)
Applicant’s amendment/arguments, see Remarks pg. 6 para 4-5, filed 11/18/2025, with respect to claims 1 and 10 have been fully considered and are persuasive. The rejection of claims 1 and 10 has been withdrawn.
Maintained Rejections
Applicant’s arguments, see Remarks pg. 7 para 3, filed 11/19/2025, with respect to the rejections of claims 1-18 under 35 U.S.C § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amended claims and newly found prior art reference.
Rejections Under 35 U.S.C § 103
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.
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.
Claims 1, 7, 9-10, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150165016 A1 , and further in view of US 20150086601, Cywes-Bentley et al. Antibody to Poly-N-acetyl glucosamine provides protection against intracellular pathogens: Mechanism of action and validation in horse foals challenged with Rhodococcus equi. PLoS Pathog. 2018 Jul 19;14(7), and Hambuchen et al Combining Active Immunization with Monoclonal Antibody Therapy To Facilitate Early Initiation of a Long-Acting Anti-Methamphetamine Antibody Response. J Med Chem. 2015 Jun 11;58(11), herein further referred to as US’016, US’ 601, Cywes and Hambuchen respectively.
Regarding claims 1, 7, 9-10, 16 and 18, US’061 teaches a method whereby PNAG polysaccharides (vaccine) are administered in a subject to induce and active immune response and where PNAG-specific antibodies can be administered to induce passive immunity (US’016 pg. 5 para 0079-80 and pg. 11 para 0141). US’016 further teaches a generic formular for PNAG conjugate vaccine comprising: at least 5 N-acetyl beta (1-6) glucosamine (US’016 pg. 2 para 0011) conjugated to a carrier protein such as tetanus toxoid (US’016 pg. 7 para 0106) through a linker (US’016 pg. 2 para 13) such as Formula I (US’016 pg. 6 para 0087). US’016 further teaches that PNAG antibodies such as F598 can be delivered with secondary agents such as a dPNAG antigen (vaccine) in other to potentiate an antigen specific immune response (US’016 pg. 11 para 0139).
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Formula I (Linker).
US’011 does not teach a method for inhibiting biofilm formation by administering mAb F-598 and the conjugate vaccine. US’016 does not also teach about the ratio of saccharide to protein to be between 30-39:1.
US’601 teaches a method for using mAb 598 that specifically binds to PNAG and disrupts formation of PNAG-containing microbial biofilms (US’601 pg. 1para 0006 and para 0020).
Cywes, teaches a PNAG vaccine conjugate of 5 ß-(1->6)-glucosamine conjugated to tetanus toxoid at a ratio of 35-39:1 (saccharide to protein) (Cywes pg. 14 para 2) and that 5GlcNH2-TT has the ability to raise PNAG antibodies against a very broad range of microbial pathogens (Cywes pg. 13 para 1).
Hambuchen teaches a method for combining active immunity with monoclonal antibody therapy for early initiation of a long-acting antibody body response whereby the benefit of this method includes an immediate onset immune action (from the administration of the mAb) and timely increases in the immune response (from the combined therapy) and a duration of the antibody response that could last for months (due to the vaccine) (Hambuchen, Abstract).
Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of US’016 in view of US’601, Cywes and Hambuchen with a reasonable high degree of predictable success to provide continuous protection against a PNAG type microbial infection or to inhibit the formation of microbial biofilm by co-administering the conjugate vaccine and mAb F-598. As indicated by US’016, the mAb against PNAG (F598) can be administered to an individual to provide immediate immune response (where the response is sufficient to: (i) prevent infection by from
occurring in a subject that is exposed to the pathogen; (ii) inhibit the development of infection, i.e., arresting or slowing its development; and/or (iii) relieve the infection, i.e., eradication
of the microbe in infected subjects) (US’016 pg. 10 para 0128) and then the oligosaccharide conjugate vaccine administered subsequently as an adjuvant to provide a passive immune response, and together as suggested by the example of Hambuchen, provides continuous protection against PNAG infections. A skilled artisan would have wanted to use a conjugate vaccine whereby 30-29 units of 5GlcNH2 conjugated to 1 tetanus toxoid, because this formulation has been shown to raise PNAG antibodies against a broad range of microbial pathogens that exhibit PNAG. Therefore, artisan would have been able to use 30-39 5GlcNH2 units to 1 tetanus toxoid in the vaccine formulation and administer both vaccine and F598 to a subject in a similar manner as though by Hambuchen so as to provide the subject with continuous protection, treat or prevent an infection in a subject against PNAG microbial infections.
Claims 2-6 and 8, 11-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US’016, US’ 601, Hambuchen, Cywes as applied to claim 1 above, and further in view of Kroger et al. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), NCIRD, 2011, Retrieved from <www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm#Tab4> on 02/02/2026, herein further referred to as Kroger.
Regarding claims 2-6 and 8, 11-15 and 17, and incorporating the analysis of claims 1 and 10 above, US’016 teaches that PNAG polysaccharides (vaccine) are administered in a subject to induce and active immune response and that PNAG-specific antibodies can be administered to induce passive immunity (US’016 pg. 5 para 0079-80 and pg. 11 para 0141). US’016 also teaches that administering oligosaccharides conjugate vaccine might not be effective to a subject who is at risk of developing an infection by non-ica/pga PNAG positive pathogens and therefore it may be beneficial to simultaneously treat the subject with antibody specific to PNAG (US’016 pg. 10 para 0127). US’016 further teaches that the desired time intervals for delivering multiple doses of a particular vaccine or antibody can be determined by an ordinary skilled artisan through routing experimentation.
US’016 does not specifically teach a time spacing for the concurrent administration of the vaccine conjugate and the PNAG specific antibody (F-598).
Kroger teaches that antibody-containing products interact less with inactive vaccines, toxoids, recombinant subunit and polysaccharide vaccines the with live vaccines. Kroger further teaches that administering vaccines and toxoids either simultaneously with or at any interval before or after receipt of an antibody-containing product should not substantially impair development of a protective antibody response (Kroger pg. 9 para 5).
Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of US’016 in view of US’601, Cywes, Hambuchen and Kroger with a reasonable high degree of predictable success so as to concurrently administer the antibody specific to PNAG such as F-598 and the PNAG conjugate vaccine to a subject in need of protection against a PNAG microbial infection whereby, the antibody (F-598) will induce an passive immunity (where it can prevent infection from occurring, inhibit development of infection by arresting or slowing its development and/or finally relieve the infection, i.e., eradicate the microbe), and the conjugate vaccine will induce active immune response thereby producing a continuous protection to the individual as suggested by the method of Hambuchen. Kroger teaches that inactive vaccines such as the conjugate vaccine of the instant claim does not substantially impair the function of an antibody when administered concurrently and that the conjugate vaccine can be administered before or after the antibody administration at any time interval as determine by a skilled artisan. Therefore a skilled artisan would have been able to concurrently administer the PNAG specific antibody F-598 with the conjugate vaccine, or administer the vaccine after 2, 4 or 6 hours of administering the F-598 antibody as suggested by Kroger. They would have been able to determine through routine experimentation the antibody titer raised by the subject after the administration of the F-598 necessary to determine when at what time interval is beneficial to administer the conjugate vaccine.
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 9 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10828360 B1 in view of Cywes, herein referred to as US’360.
Regarding claims 9 and 18, of the instant application, US’360 teaches of a method for inhibiting biofilm formation by administering a conjugate vaccine of the formula (A-B)x-C where A comprises 3-12 units of repeating saccharide ß-(1->6)-glucosamine, B is a linker (Fig. 2 below) (US’360 col 4 ln 20) connecting A and C, x is and integer from 10 to 40 and C is tetanus toxoid (US’360 claim 1). US’360 further teaches that such vaccine can provide effective immunity to a subject against an infection such as biofilm formation (US’360 col 34-45).
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US’360 does not specifically teach a conjugate vaccine where A is 5 repeating units of saccharide ß-(1->6)-glucosamine, and x is from 30-39.
Cywes, teaches a PNAG vaccine conjugate of 5 ß-(1->6)-glucosamine conjugated to tetanus toxoid at a ratio of 35-39:1 (saccharide to protein) (Cywes pg. 14 para 2) and that 5GlcNH2-TT has the ability to raise PNAG antibodies against a very broad range of microbial pathogens (Cywes pg. 13 para 1).
Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of US’360 in view of Cywes with a reasonable high degree of predictable success to use a 5 ß-(1->6)-glucosamine conjugated to TT at a ratio of 35-39: 1 (saccharide to protein), as it has been shown by Cywes that 5GlcNH2-TT at this ratio, is able to raise PNAG antibodies against a very broad range of microbial pathogens which can cause and infection or which produces biofilms.
Response to Arguments
Applicant's arguments filed 11/19/2026 have been fully considered but they are not persuasive. The applicant remarks that neither of the references cited, recites all the limitations of the instant claim, specifically the pentameric glucosamine and the specific ratio of 31-39: 1 oligosaccharide to tetanus toxoid (Remarks pg. 7 para 3). The applicants claims submitted on 05/18/2022, did not specifically claim of pentameric glucosamine, which is also within the range of 3-12 glucosamine as thought by the prior art and as initially claimed. A noted by in MPEP 2145 VI, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In view of the amended claims to specifically recite a pentameric glucosamine, see the examiners new grounds for rejection above.
Secondly the applicant states that the prior art references do not singly teach the specific oligosaccharide to tetanus toxoid ratio of 31-39:1, but a ratio of 1: up to about 700:1 and would have taken about 245350 possibilities, and that it would have only be possible for a skilled artisan to make to 31-39:1 ratio in hindsight to the applicant’s own disclosure (Remarks pg. 8 para 4 – pg. 9 para 1). As noted in MPEP 2145 X(B), an "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. " [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). As indicated in the rejections above, a ratio of 35-39: 1 pentameric glucosamine to tetanus toxoid has being shown be potent to a large variety of microbial infections and therefore could have been a motivating factor for a skilled artisan to use this ratio. Examiner further argues that a skilled artisan would have expected a greater number of oligosaccharide to tetanus toxoid would provoke a substantial immune response (Remarks pg. 10 para 2 – pg. 11 para 1) and that a skilled artisan would not have been motivated to reduce the ratio (Remarks pg. 11 para 2). A skilled artisan would have been able to know that the ratio of oligosaccharide to tetanus toxoid plays a role in the potency, immunogenicity of the vaccine conjugate as illustrated by Paoletti et al. Effects of chain length on the immunogenicity in rabbits of group B Streptococcus type III oligosaccharide-tetanus toxoid conjugates. J Clin Invest. 1992 Jan;89(1):203-9, herein referred to as Paoletti. Paoletti showed a comparative example of 3 ratios of oligosaccharide to tetanus toxoid (Paoletti pg. 205 Tab. I, II, III, IV and V).
Conclusion
No claims allowed.
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 EMMANUEL LED YOUTCHOM PENDIE whose telephone number is (571)272-6313. The examiner can normally be reached Mon - Fri: 8AM - 5PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanna Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL LED YOUTCHOM PENDIE/ Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647