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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on May 18, 2026 is acknowledged. Claims 1, 3, 5, 10-11, 13, 15-16 were amended, claims 2, 4, 6-9, 12, 14, 17-18, were canceled, claims 19-24 were newly added and claims 1, 3, 5, 10-11, 13, 15-16, 19-24 are pending in the instant application.
The was restriction deemed proper and made FINAL in the previous office action.
Claims 1, 3, 5, 10-11, 13, 15-16, 19-24 are examined on the merits of this office action.
Declaration Under 37 C.F.R. 1.132
Applicant submitted a declaration stating that, although the cited publication includes additional co-authors not named as inventors, those individuals merely provided mentorship and data analysis and did not make an inventive contribution to the subject matter claimed in the present application. Pursuant to MPEP 717.01(1)(1), the declaration has been considered as a declaration under 37 CFR 1.130. However, the declaration is not persuasive because it does not sufficiently establish that the relied upon subject matter disclosed in the reference was made by or obtained directly or indirectly from the inventor or a joint inventor, as required to invoke the exception under 35 U.S.C. 102(b)(1). Accordingly, the rejection is maintained.
Withdrawn Rejections/Objections
The rejection of claims 1-3, 5, 10-11, 13, 15-16 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed May 18, 2026.
The rejection of claims 1-3, 5, 10-11, 13, 15-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, scope of enablement is withdrawn in view of the amended claim scope, the working examples and the guidance provided in the specification regarding the claimed methods and compositions. Furthermore, Applicants amendment limiting claim 3 to borrelia burgdorferi aligns the claim with the working examples, which demonstrates inhibition of Borrelia Burgdorferi strain B31 (B. burgdorferi sensu stricto). A person of ordinary skill in the art would understand that Borrelia Burgdorferi denotes the species B. burgdorferi sensu stricto, of which B31 is the type strain, whereas B. burgdorferi sensu lato refers to the broader Lyme disease species complex.
The rejection of claim(s) 1-2, 5 under 35 U.S.C. 102(a)(1) as being anticipated by Strausz (BioRxiv, published online 2022, pages 1-14) is withdrawn in view of amendment of the claims filed May 18, 2026. However, Claim 3 is now rejected due to amendment of the claim to remove Borrelia sensu lato species (see below rejection).
Maintained/Revised Rejections
Claim Rejections - 35 USC § 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.
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, 3, 5, 10-11, 13, 15-16, 19-24 are/remain rejected under 35 U.S.C. 103 as being unpatentable over Strausz (BioRxiv, published online 2022, pages 1-14) in view of Klatt (DE102018113988 A1, see attached English translation).*All references cited previously.
Regarding claims 3, 5, 19, Strausz teaches a method of inhibiting growth of B. burgdorferi (Bb) comprising contacting Bb with human SCGB1D2 (see Figure 3, pages 10-11, “growth inhibition assay”, pages 10-11). Strausz teaches of the therapeutic and prophylactic potential for treatment of lymes disease.
Strausz is silent to wherein the Borrelia species is B. Burgdorferi sensu lato species, systemic administration to an individual, topical administration , the amounts listed in instant claim 13, 22, administering to a patient with a Borrelia infection (instant claims 15 and 23) and administered to a patient with the variant allele (claims 16 and 24).
However, Klatt teaches antimicrobial peptides and fragments for treatment and prevention of microbial infections, including infections cause by Borrelia burgdorferi sensu lato (see claims 1, 5 and 7, also paragraph 0034). Klatt teaches systemic and topical administration (see paragraph 0036, systemic administration and use in lotions or pastes).
It would have been obvious before the effective filing date of the claimed invention to administer the SCGB1D2 antimicrobial protein shown by Strausz to inhibit Borrelia growth to a subject having a Borrelia infection using the antimicrobial protein administration approaches taught by Klatt because Strausz expressly demonstrates that SCGB1D2 directly inhibits growth of Borrelia burgdorferi and identifies SCGB1D2 as a host defense antimicrobial factor with therapeutic potential, while Klatt teaches that antimicrobial pathogens, including Borrelia Burgdorferi species, are administered to subjects to treat infection. One of ordinary skill in the art would have been motivated to translate the demonstrated in vitro antimicrobial activity of SCGB1D2 into therapeutic administration using known antimicrobial protein delivery methods in order to achieve predictable infection reducing effects. Combining these teachings involves the predictable application of a known antimicrobial agent to a known infection using known administration methods, which is a recognized rationale for obviousness under KSR (see MPEP 2143, I(A)).
There is a reasonable expectation of success because Strausz experimentally demonstrates dose dependent inhibition of Borrelia burgdorferi growth by SCGB1D2 protein, thereby establishing functional antimicrobial activity against the target pathogen (including other Borrelia burgdorferi spcies that cause lymes) prior to clinical administration.
Regarding claims 10 and 20, as stated above, Klatt teaches systemic administration of antimicrobial peptides for bacterial infections including Borrelia infections. Selecting systemic administration for SCGB1D2 to treat Borrelia infection would have been an obvious, routine and predictable delivery choice.
Regarding claims 11 and 21, Strausz teaches that SCGB1D2 is a skin/sweat AMP and Klatt teaches topical antimicrobial peptide formulations; topical administration would have been an obvious route based on the teachings of Strausz in view of Klatt.
Regarding claims 13 and 22, Strausz teaches concentrations in the range of 2-16 ug/ml (in vitro activity). Strausz teaches inhibition of Borrelia Burgdorferi in a dose dependent manner and reports antimicrobial activity at a tested range of 2-16 ug/mL. Strausz therefore establishes that antimicrobial effectiveness depends on concentration of the SCGB1D2 agent. Klatt teaches that antimicrobial peptides and proteins formulated and administered across a range of therapeutically effective concentrations depending on formulation type and delivery (see paragraphs 0037-0039, translation).
It would have been obvious before the effective filing date of the clamed invention to adjust and optimize the concentration of the SCGB1D2 protein for therapeutic use (in vivo) because concentration is a recognized result effective variable in antimicrobial treatment. Determining the effective concentration within a workable therapeutic range in subjects would have involved routine optimization based on the dose dependent teachings of Strausz (see MPEP 2144.05).
Regarding claims 15 and 23, Strausz in view of Klatt renders obvious treating a subject having a Borrelia infection with SCGB1D2 because Strausz teaches that SCGB1D2 inhibits Borrelia growth and Klatt teaches administering antimicrobial proteins to infected subjects and using a demonstrated antimicrobial agent to treat infection caused by the same pathogen would have been a predictable application of the prior art (see above motivation).
Regarding claims 16 and 24, Strausz in view of Klatt renders obvious administering the SCGB1D2 agent to the recited variant-allele subject subgroup because Strausz teaches SCGB1D2 genetic variants and their functional antimicrobial differences (see Discussion of Strausz, page 8), and Klatt teaches administering antimicrobial proteins to treat bacterial infection. It would have been obvious to apply antimicrobial treatment to subjects identified as having a relevant SCGB1D2 variant because treating genetically identified susceptible subpopulations represents a predictable and routine patient-stratification approach in antimicrobial therapy. See KSR Int’l Co. v. Teleflex Inc. MPEP2143).
Response to Applicant’s Arguments
Applicant’s declaration, although identified as a declaration under 37 C.F.R 1.132, has been considered as an affidavit/declaration under 37 CFR 1.130 in accordance with MPEP 717.01(a)(1). However, the declaration is insufficient to establish that the cited disclosure qualifies for the exception under 35 U.S.C. 102(b)(1). Accordingly the rejection is maintained. The declaration does not sufficiently establish that the relied upon subject matter disclosed in the reference was made by or obtained directly or indirectly from the inventor or a joint inventor of the instant application. Therefore, the requirements of 37 CFR 1.130(a) have not been met.
New Objection
Claim 15 is objected to for the following minor informality: the limitation “…individual diagnosed with a Borrelia infection” should be replaced with -…individual diagnosed with a Borrelia burgdorferi sensu lato infection-.
Claim 23 is objected to for the following minor informality: the limitation “…individual diagnosed with a Borrelia infection” should be replaced with -…individual diagnosed with a Borrelia burgdorferi infection-.
New Rejections
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 3, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strausz (BioRxiv, published online 2022, pages 1-14).
*Please note that inventor overlap alone does not establish applicability of the 35 U.S.C. 102(b)(1) exception on the present record.
Regarding claims 3, 19, Strausz teaches a method of inhibiting growth of B. burgdorferi (Bb) comprising contacting Bb with an effective amount of human SCGB1D2 to inhibit (see Figure 3, pages 10-11, “growth inhibition assay”, pages 10-11). Strausz teaches of the therapeutic and prophylactic potential for treatment of lymes disease.
Conclusion
No claims are 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 ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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