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.
Status of Claims
Claims 1-6, 11, 17-19, 23-24, 28-29, 35, 41-42, 46, 52, and 58 are pending. Claims 11, 17-19, 28-29, 35, 41, 46, 52, and 58 are drawn to the nonelected invention. Claims 1-4, 23-24 and 42 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 23-24 and 42) in the reply filed on 09/08/2026 is acknowledged.
Claims 5-6, 11, 17-19, 28-29, 35, 41, 46, 52, and 58 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/07/2024 and 05/31/2024 have been considered by the examiner.
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 1-4, 23-24 and 42 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.
Scope of the invention
The claims are drawn to a diagnostic panel of amino acid sequences comprising SEQ ID NOs: 1-41 and variants thereof that retain the immunological binding profile of the corresponding non-variants. Th limitations of “variants thereof that retain the immunological binding profile of the corresponding non-variants” raise issues of written description because of the breadth of said limitations are not sufficiently supported in the disclosure as originally filed.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of an application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)) (emphasis added).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reitera
Disclosure of drawings or structural chemical formulas/ Actual Reduction to Practice
The specification discloses a variant may have any modification(s) of a specified amino acid sequence (e.g., SEQ ID NOs: 1-41)…and Such modifications may include insertions and deletions (internal or from the N- or C- terminus, or both) (at page 23, lines 19-28, as filed on 12/08/2023). Additionally, the specification also discloses a specific known Bartonella species (at Table 1) and only a total of 41 Bartonella recombinant proteins derived from Bartonella species (at Table 3)…were used to prepare antigen strips for Bartonella ImmunoBlots (at Example 1). Given a large number of possible different variants of sequences which fit within the limitations of claim 1 (each sequence is between 200-500 amino acids in length, meaning that there could be hundreds of thousands of the described variants for each of SEQ ID NOs 1-41 (also includes comprising SEQ ID NOs: 1-41)), the instant specification does not provide a representative number of species to support the claimed invention.
Relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation
The claims require that the variants have specific functional characteristics, namely that they retain the immunological binding profile of the corresponding non-variant. As stated above, the specification only describes SEQ ID NOs: 1-41 for binding affinity as immunoblots. The specification does not describe what other sequences within the genus of “variants” would possess the necessary functional characteristics. The specification does not describe which region of the amino acids within SEQ ID NOs: 1-41 are critical and which amino acids could be changed while still retaining the functional aspect of the same immunological binding profile of SEQ ID NOs: 1-41. For instance, the specification does not include identifications of regions of each sequence that would retain and preserve the necessary functional characteristics as claimed. Thus, the specification does not describe a structure-function correlation such that a skilled artisan in the art could visualize or recognize the identities of those variants to retain the immunological binding profile of the claimed SEQ ID NOs.
Additionally, the specification does not provide enough evidence of amino acid sequences comprising SEQ ID NOs: 1-41 (open-ended limitation) in its diagnostic panel. In particular, the recitation of “comprising” would include sequences that are much larger than SEQ ID NOs: 1-41 in the diagnostic panel and an infinite amount of possibilities containing the claimed sequences. As stated above, the specification only discloses a specific known Bartonella species (at Table 1) and only a total of 41 Bartonella recombinant proteins derived from Bartonella species (at Table 3)…were used to prepare antigen strips for Bartonella ImmunoBlots (at Example 1). Meanwhile, the specification does not describe what other sequences containing SEQ ID NOs: 1-41 would possess the necessary functional characteristics. For instance, the specification does not include identifications of regions of each sequence that would retain and preserve the necessary functional characteristics as claimed. Thus, the specification does not describe a structure-function correlation such that a skilled artisan in the art could visualize or recognize the identities of sequences that are much larger in length for binding affinity in a diagnostic panel.
Applicant merely discloses diagnostic panels with SEQ ID NOs: 1-41. The specification fails to disclose, for example, which amino acid residues individually conferring the desired functional property and such property is universal to a wide range of the Baronella genus. A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that would exhibit this functional property. The structural features common to the members of the genus are unknown in a wide range of variations.
A claimed invention may not be adequately described where an invention is described solely in terms of function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule defined solely by its ability to perform a function, such as recognizing a construct, without a known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”).
Level of skill and knowledge in the art/predictability in the art
As evidenced, Araujo et al. (“Development of a multiplex serological assay to detect immunoreactivity against a novel Bartonella species in military working dogs”, Microbiology Spectrum, volume 13, issue 10, pgs. 1-17, published October 2025) teach the serodiagnosis of Bartonella infections is challenging and although the laboratory diagnosis is mainly based on serology (IFA or ELISA) and PCR testing, the sensitivity and specificity of these serological assays and PCR are often reported to be low (at pg. 11, last para). Araujo further teaches there is no “gold standard” assay for bartonellosis (in dogs or humans), and a combination of culture, serology, and molecular tests with variable or undetermined sensitivity and specificity is currently used diagnostically. Isolation of Bartonella species in dogs can be challenging due to the low bacterial concentration in the blood (at pg. 13, para. 2). Araujo also teaches the new multiplex assay assessed IgG antibodies to several Bartonella species, including CBm, but the observed cross-reactivity in antibody responses between the B. bacilliformis and B. bovis peptide antigens necessitates individual validation of responses to each antigen to maximize specificity and the impact of antibody reactivity to cross-reactive bacterial antigens is a clinical diagnostic challenge in bartonellosis (at pg. 13, para. 3).
Additionally, Shah et al. (US20210325393A1, published 10/21/2021) teach a panel of tagged, labeled or bound amino acid sequences (at para. [0005]). Shah teaches detecting Lyme disease with IgM or IgG-class antibodies (at para. [0006]). Shah also teaches the genetic diversity and the symptoms of infection that are as diverse as the organism causing them, makes it challenging to diagnose because it is a continuous spectrum of organisms rather into well-defined genetically distinct groups that are easily categorized (at para. [0077]).
In view of the above, one cannot visualize or recognize the identities of the members of the genus (as claimed) based from the disclosure of SEQ ID NOs: 1-41. Although Applicants have disclosed a reduction to practice to the full-length sequences of SEQ ID NOs: 1-41, given the unpredictability of diagnosing Lyme disease through diagnostic panels with IgM and IgG class antibodies, one cannot envision the structures of variants (e.g., including sequences that “comprise” the claimed SEQ ID NOs) as stated above to be part of a diagnostic panel without reduction to practice.
The level of skill in the art is high. In particular, methods for making and/or screening antibodies with desired binding properties were well known in the art at the time of the invention. At the same time, however, it was not within the skill of the art to predict whether a given sequence would bind specifically to a particular chemical structure. As stated above, Araujo (published 2025) has recognized the impact of antibody reactivity to cross-reactive bacterial antigens is a clinical diagnostic challenge in bartonellosis. Furthermore, there is substantial variability within the genus given the diversity in structure of variants and the lack of correlation between structure and function to be a diagnostic panel for Lyme disease.
In summary, the specification fails to provide adequate written description for the claimed genus of sequences, as the sequences are either described only in terms of desired functional properties or infinite sequence structures containing the SEQ ID NOs: 1-41 to define the desire diagnostic panel. Meanwhile, the skill artisans have indicated that there is no concrete art-recognized correlation between the structure of the sequences and antibodies. A single antigen can be bound by a very large and structurally diverse genus of antibodies (i.e., crosslinking). Meanwhile, the specification does not describe the structural characteristics common to the SEQ ID NOs: 1-41 for antibodies in a diagnostic panel. The specification does not provide any guidance as to what essential structures of antibodies would confer the necessary function of binding to SEQ ID NOs: 1-41. The specification provides no specific guidance as to what modification could be made or added while preserving function in a diagnostic panel and does not allow skill artisan to visualize or recognize the members of the genus as claimed. Therefore, the specification does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 1-4, 23-24 and 42 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 1, 23, 24, and 42 recite the limitations of “variants thereof that retain the immunological binding profile of the corresponding non-variant” lack antecedent basis for the phrase “the immunological binding profile”. Even though SEQ ID NOs: 1-41 are recited in these claims, the claims have not identified which regions are the immunological binding profiles for these sequences. Therefore, the claims are unclear to the metes and bounds of the structures to the phrase “immunological binding profile of the corresponding non-variant”. As stated in the 112(a) rejection, structure-function relationship is important to establish the claimed variants. Claims 2-4 are rejected as being dependent from claim 1.
With respect to claim 2, the claim recites that the amino acid sequences are bound to one or more substrates. It is unclear to the structure of these sequences binding to two claimed substrates in the diagnostic panel. Therefore, what is the structure of the claimed diagnostic panel for all 41 sequences and variants thereof to bind to two or more claimed substrates as a diagnostic panel.
Free of Prior Art
The closest prior art refernence of record is Plesch et al. (US2014/0325709A1 a divisional application of Application No. 11/644015). The reference discloses the claimed SEQ ID NOs: 1-2. However, the reference fails to teach or reasonably suggest SEQ ID NOs: 3-41.
Conclusion
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
