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
Response to Election/Restriction filed on January 14, 2026 is acknowledged. Claims 1-18 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group I, claims 1-16, drawn to a method for inhibiting bacteria growth and without traverse human SCGB1D2 protein from List I, B. Burgdorferi sensu lato from List II and an individual diagnosed with a Borrelia infection in the reply filed January 14, 2026.
The restriction is deemed proper and is made FINAL in this office action. Claims 4, 6-9, 12, 14, 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-3, 5, 10-11, 13, 15-16 are examined on the merits of this office action.
Claim Rejections - 35 USC § 112, First Paragraph
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 1-3, 5, 10-11, 13, 15-16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Scope of the claims
Claim 1 claims “A method for inhibiting the growth of Borrelia species, the method comprising: contacting the Borrelli sp. with an effective dose of a human secretoglobin family 1 D member 2 (SCGB1 D2) agent.” The instant application further claims wherein the agent is the SCGB1D2 protein (Claim 5), fragment thereof, variant thereof and mimetic thereof (claims 6-9) and also agent that competes for binding to a human SCGB1D2. Thus, the claim scope encompasses a vast number of differing agents with the required function of inhibiting growth of Borrelia species.
Therefore, to meet the written description requirement of 35 U.S.C. § 112, first paragraph, the specification must disclose a representative number of species that meet both the structural and functional limitations of the genus or the specification and/or the prior art must identify the structural elements that correlate to the claimed function in a manner that demonstrates to one of ordinary skill in the art that Applicant was in possession of the claimed genus at the time the application was filed.
Actual Reduction to Practice
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The specification provides experimental data demonstrating in vitro inhibition of growth of Borrelia burgdorferi using recombinant human SCGB1D2 reference protein and one specific variant (P53L). The working examples are limited to a recombinant human SCGB1D2 protein, a single identified missense variant, in vitro bacterial growth inhibition assays. No working examples are provided for SCGB1D2 mimetics, binding competitors, biologically active fragments, mutagenized libraries, screened candidate agents, non-protein competitors, multiple Borrelia species or prophylaxis. Thus, actual reduction to practice is limited to a single structural species (human SCGB1D2 protein) and one specific variant.
Therefore, the instant specification has failed to meet the written description requirement by actual reduction to practice of a representative number of species alone.
Sufficient relevant identifying characteristic
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination thereof.
The specification does not provide structural definitions of mimetics, structural requirements for competitors, sequence boundaries for active fragments, consensus motifs required for antibacterial activity or representative species across the claimed functional agent classes. Functional labels alone (i.e. mimetic, competitor, fragment) without structural guidance does constitute sufficient identifying characteristics.
Physical/Chemical Properties
The specification provides limited physical/chemical information for the human SCGB1D2 protein and one variant form. However, the specification does not describe physicochemical parameters required for antimicrobial activity, structure stability requirements, folding requirements, binding properties, charge/hydrophobicity constraints tied to activity and fragment size/activity relationships. No property is provided that would allow a skilled artisan to recognize which members of the broad claimed agent classes fall within the invention.
Functional characteristics when coupled with a known or disclosed correlation between function and structure:
While the specification attributes the functional property of inhibiting Borrelia burgdorferi growth to SCGB1D2 protein, it also indicates the mechanism of action is not yet determined, no conserved binding target is identified and no structural domain is correlated with antimicrobial function. There is no disclosed structure/function correlation enabling prediction that mimetics, fragments, competitors, mutagenized variants and screened candidates would share the claimed inhibitory activity. The specification lacks a structure function correlation or a representative number of species across the genus.
Method of Making
The specification describes methods for producing recombinant SCGB1D2 protein. However, the specification does not provide sufficient guidance for making mimetic compounds, non protein competitors, structurally distinct binding agents as claimed, variants and fragments of SCGB1D2.
Conclusion
In conclusion, only specific agents, i.e. human SCGB1D2 reduced to practice satisfies the written description requirements of 35 U.S.C. 112, first paragraph.
Claims 1-3, 5, 10-11, 13, 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating patients with B. burgdorferi infections via administering SCGB1D2 (human), does not reasonably provide enablement for treating/preventing any borrelia species with any SCGB1D2 agent encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To comply with the enablement requirements of 35 U.S.C. §112, first paragraph, a specification must adequately teach how to make and how to use a claimed invention throughout its scope, without undue experimentation. Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003). There are a variety of factors which may be considered in determining whether a disclosure would require undue experimentation. These factors include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The Nature of the Invention/ The breadth of the claims
Claim 1 claims “A method for inhibiting the growth of Borrelia species, the method comprising: contacting the Borrelli sp. with an effective dose of a human secretoglobin family 1 D member 2 (SCGB1 D2) agent.” The claims are broad in multiple respects. Claim 1 recites inhibiting growth of Borrelia species generally. Dependent claims further extend the scope to multiple Borrelia species, prophylactic and therapeutic administration, administration to at risk infected individuals, broad concentration ranges, SCGB1D2 proteins, variants, mimetics, fragments and competing agents. This represents a wide genus of organisms, agent types, dosing regimens, and clinical contexts. Regarding “Effective amount”, Applicant’s specification states “An “effective amount” refers to that amount which is capable of preventing infection or further bacterial growth. An effective amount can be determined on an individual basis and will be based, in part, on consideration of the symptoms to be treated and results sought. An effective amount can be determined by one of ordinary skill in the art employing such factors and using no more than routine experimentation” (see paragraph 0062).
The invention concerns antimicrobial activity of a host secreted protein (SCGB1D2) against Borrelia organisms and methods of treatment and prevention. Antimicrobial effects of proteins and peptides across microbial species are generally considered biologically complex and not highly predictable, particularly where mechanism of action is not established. The specification itself indicates that the mechanism of antimicrobial action requires further investigation.
The State of the Prior Art
The art recognizes antimicrobial peptides and host defense proteins, but their activity is known to vary significantly across bacteria strains and species. The specification does not establish that Borrelia species share a conserved susceptibility target for SCGB1D2 agents.
Franke (Ticks and Tick-borne Diseases 4 (2013) 11– 25) teaches lyme borreliosis complex is a heterogenous group of tick borne spirochaetes of the genus Borrelia (see abstract). Franke further teaches that “The current knowledge about the treatment of LB was recently summarized by Stanek. For EM and other cutaneous manifestations of LB, Lyme arthritis, and early neuroborreliosis doxycycline, amoxycillin, phenoxymetylpenicillin, and cefuroxime axetil are recommended as oral first-line therapy. Alternatively, macrolides can be applied as second-line option. Patients with late neuroborreliosis and cardiac involvement should be treated with intravenous ceftriaxone, cefotaxime, or penicillin…. Thus far, drug resistance has only been noted in vitro . For recently defined species like B. spielmanii, B. bavariensis, or B. kurtenbachii there are only few or no data about antibiotic susceptibility available so far” (see page 19, left column). Thus, there are many Borrelia species and variability in treatment of different species. The state of the art therefore does not supply predictability sufficient to fill the gaps in the disclosure.
The Predictability or Unpredictability of the Art/ The Relative Skill of Those in the Art
While a person of ordinary skill in the art could perform bacterial growth inhibition assays, such skill would still require substantial experimental screening across Borrelia species, agent variants, and dosing regimens to determine operability across the full claim scope. Skill level does not eliminate the need for extensive experimentation here.
Biological antimicrobials effects of proteins across microbial species are unpredictable, especially where only one species is tested and no molecular target/mechanism is identified. The specification provides no technical rationale establishing that inhibition of B. burgdorferi growth would reasonably predict inhibition across Borrelia species. This factor weights strongly against enablement.
Amount of Guidance/ The Presence or Absence of Working Examples
The specification provides experimental guidance only for in vitro growth inhibition of B. burgdorferi, limited concentration testing, comparison of one variant protein. The disclosure does not provide guidance for other Borrelia species, prophylactic efficacy, in vivo treatment, dosing selection across the claimed range, mimetics, fragments and competitors beyond functional labeling or screening criteria predictive across species. Only one working antimicrobial example is provided. The example is inhibition of B. burgdorferi in vitro. No working examples provided for other Borrelia species, in vivo models, prophylaxis, treatment outcomes, variant or mimetic agents beyond limited comparison and the full dosing range. A single species in vitro example does not enable the full claimed genus and treatment scope.
The Quantity of Experimentation Necessary
To practice the full scope, a skilled artisan would need to perform substantial experimentation including testing SCGB1D2 agents across multiple Borrelia species, determining susceptibility variability, establishing effective dosing across a very broad concentration range, validating prophylactic and therapeutic efficacy, screening numerous variants, mimetics, and fragments, confirming operability in at risk and infected patient populations.
Considering the factors above, the skilled artisan would be burdened with undue experimentation in determining if one of the claimed agents would be effective at treating/preventing Borrelia species. Considerable experimentation would be required for a skilled artisan to determine which agents, at what doses and under what regimens, would successfully treat/prevent Borrelia infections.
The experimentation required represents years of inventive effort. When the above factors are weighed, it is the examiner's position that one skilled in the art could not practice the invention without undue experimentation.
Therefore, in view of the Wands factors, the claims appear to require undue experimentation to
use the full scope of the claimed invention.
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) 1-2, 5 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.
Strausz teaches a method of inhibiting growth of B. burgdorferi (Bb) comprising contacting Bb with SCGB1D2 (see Figure 3, pages 10-11, “growth inhibition assay”).
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 and 15-16 are 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).
Regarding claims 1-2 and 5, Strausz teaches a method of inhibiting growth of B. burgdorferi (Bb) comprising contacting Bb with SCGB1D2 (see Figure 3, pages 10-11, “growth inhibition assay”). Strausz teaches of the therapeutic and prophylactic potential for treatment of lymes disease.
Strausz is silent to wherein the Borrelia species is a B. Burgdorferi sensu lato species, systemic administration to an individual, topical administration , the amounts listed in instant claim 13, administering to a patient with a Borrelia infection and administered to a patient with the variant allele (claim 16).
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 prior to clinical administration.
Regarding claim 10, 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 claim 11, 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 claim 13, 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 claim 15, 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 claim 16, 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).
Conclusion
No claims are allowed.
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/Examiner, Art Unit 1654