DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Group III (claims 16-19) with species, (a) the variation encoding a premature stop codon truncates the intracellular/cytoplasmic domain of the short isoform the human PCDHGA10 polypeptide after about amino acid 812 in the reply filed on February 19, 2026 is acknowledged. The traversal is on the ground(s) that “…the Examiner's search burden is not increased by searching and examining all the claims together, particularly, given the overlap in claim scope as relates to the diagnosis of [benign paroxysmal positional vertigo] BBPV and between an antibody that binds to a short isoform of the human protocadherin gamma A10 (PCDHGA10) polypeptide and related diagnostic methods including for example Group I, which is directed to determining that at least one allele of the human protocadherin gamma A10 (PCDHGA10) gene.”, see page 6, 2nd paragraph (para.).
Applicant further argues “[they do] not believe the Examiner's search is increased by the recited species. See MPEP § 808.01(a). Applicant traverses this election on the grounds that the Examiner has not established that the search burden would be increased. The alleged species each relate to variations encoding premature stop codons and three of the five specifically to NCBI Reference Sequence NM 032090.1 Accordingly, Applicant respectfully requests reconsideration and withdrawal of the species election restriction requirement.”, see para. bridging pages 7 and 8.
Applicant addresses an additional species election that is moot at this point in prosecution because Group II from which it stems is not examined at this time, see page 8.
This is not found persuasive because as cited in the Requirement mailed February 3, 2026, the product claims within Group III can be implemented in different and distinct assays and methods, see page 3, segment 3. Notwithstanding, Applicant has factually stated “[they reserve] the right to seek rejoinder of the withdrawn claims upon a notification of allowable subject matter pursuant to MPEP § 821.”, see page 6, last sentence.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 1-19 are pending.
Claims 1-15 and 19, drawn to non-elected inventions and non-elected species are not examined on the merits.
Claims 16-18 are examined with the species, a. the variation encoding a premature stop codon truncates the intracellular/cytoplasmic domain of the short isoform the human PCDHGA10 polypeptide after about amino acid 812.
Drawings
4. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "11B-2" and "11B" have both been used to designate the Homo sapiens protocadherin gamma A10 (PCDHGA10) cDNA. Moreover, the drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "12B-2" and "12B" have both been used to designate the Homo sapiens caspase 10 (CASP10) cDNA nucleotide sequence. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 16-18 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.
The claimed invention reads broadly on an antibody that specifically binds to a short isoform of the human protocadherin gamma A10 (PCDHGA10) polypeptide encoded by a variation encoding a premature stop codon within intracellular/cytoplasmic domain of the human PCDHGA10 polypeptide, wherein the antibody does not specifically bind to the wild type short isoform of the human protocadherin gamma A10 (PCDHGA10) polypeptide and does not specifically bind to the wild type long isoform of the human PCDHGA10 polypeptide.
The written description in this instant case does not sufficiently set forth an antibody that specifically binds to a short isoform of the human protocadherin gamma A10 (PCDHGA10) polypeptide encoded by a variation encoding a premature stop codon truncates the intracellular/cytoplasmic domain of the short isoform the human PCDHGA10 polypeptide after about amino acid 812, see sections 0019-0021 bridging pages 6 and 7; and Antibodies segment bridging pages 19-23.
This antibody has not been fully defined and characterized. It is solely described by function, the target it specifically binds and what the antibody should not specifically bind. In fact, Applicant’s specification states, “[h]uman and mouse vestibular cells expressing the various forms of PCDHGA10 will be mapped. In order to do that, antibodies that are specific for human long, short, and mutant short forms, and for mouse long and short forms, must be generated. These antibodies will be used to perform quantitative fluorescent immunostaining of the vestibular ganglia from human postmortem tissues of BPPV and non-BPPV cases, and to quantify sub-cellular distribution of the isoforms at various ages in both humans and mice. Quantitative Western blotting (described below) will be performed to confirm the quantitative differences in total cellular PCDHGA10 protein.
[0165] Antibodies for different isoforms will be raised in different species (including, for example, chicken, guinea pigs, and rats) by Novus or Chemicon International for double staining. Initial non quantitative Western blotting will be used to confirm the antibodies.”, see page 45, sections 0164 and 0165.
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the binding agents in the claims to demonstrate possession. See Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
Vas-Cath Inc. V. Mahurkar, 19 U5PQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 115). The skilled artisan cannot envision the detailed structure of the encompassed polypeptides and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The polypeptide itself is required. See Fiers v. Revel, 25 U5PQ 2d 1601 at 1606 (CAFC1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts. 18 U5PQ2d 1016.
Furthermore, In The Reagents of the University of California v. Eli Lilly (43 U5PQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(l), the court states that "An adequate written description of a DNA...'requires a precise definition, such as by structure, formula, chemical name, or physical properties', not a mere wish or plan for obtaining the claimed chemical invention".
At the time the application was filed Applicant does not have possession of the breadth of the antibodies claimed. The specification does not evidence the possession of all the said antibody that is undefined and uncharacterized falling within the potentially large genus to establish possession. There is insufficient to support the generic claims as provided by Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See
https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 U5PQ2d 1398.
The full breadth of the claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached on 8AM-8PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
10 March 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643