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 .
Request for Continued Examination
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/21/26 has been entered.
Claim Status
3. The amendment, filed 01/21/26, has been entered. Claims 1-6 are pending. Claim 7 is cancelled. Claim 6 is amended. Claims 1-5 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 in the reply filed on 06/25/25. Claim 6 is under examination.
Withdrawal of Objections/Rejections
4. The following are withdrawn from the Office Action, filed 10/23/25:
The rejection of claim 6 under 35 U.S.C. 112(b) second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps, found on page 6 at paragraph 8, is withdrawn in light of Applicant’s amendments thereto.
Maintained Objection to Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
5. Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
5. Specific deficiencies and the required response to this Office Action are as follows: Please see CRFD posted 09/23/25.
Reproduced, in part:
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Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the CRF of the “Sequence Listing” is defective.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3)
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, Applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR 1.825(a)(5); and
A statement according to item 2) a) or b) above.
6. NOTE: As stated in the Final Office action, filed 10/23/25, the limitation “… heavy chain variable domain (VH) comprising the CDRs as set forth in SEQ ID NOs: 3-5 and a light chain variable domain (VL) comprising the CDRs as set forth in SEQ ID NOs: 7-9” cannot be searched until the sequence compliance issues are rectified.
Applicant’s Arguments and Response to Arguments
7. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the objection is maintained for reasons of record. For example:
With regards to the argument that to overcome this deficiency, Applicants have filed a Sequence Listing Statement which incorporates by reference a Sequence Listing which was submitted September 23, 2025, electronically in a computer readable form as the .txt file ISIS031828USORD-text-segeunce.listing.txt as required by 37 C.F.R. 1.825(a); see Remarks, page 5 (emphasis added); the Office notes that no new CRF was filed and the CRF filed on 09/23/25 was deemed defective because, as clearly indicated in the CRFD of 09/23/25, it was in the wrong format. Therefore, the argument is not persuasive because the “incorporation by reference” for a defective CFR, does not negate that the 09/23/25 CRF was indeed defective and therefore this action does not resolve the issue. Once again, because this application is a CON of a PCT with a controlling date of 08/04/22 (i.e. based on the CON), the ST.26 formatting is required (see CRFD posted 09/23/25). Thus, an XML sequence listing (i.e. not TXT) must be filed to be compliant.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
New Rejection: Claim Rejections - 35 USC § 112
9. 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.
10. Claim 6 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 is indefinite because the limitation “… heavy chain variable domain (VH) comprising the CDRs as set forth in SEQ ID NOs: 3-5 and a light chain variable domain (VL) comprising the CDRs as set forth in SEQ ID NOs: 7-9” is meaningless without defined sequences corresponding to SEQ ID NO: 3, 4, 5 and 7, 8, 9.
Therefore the metes and bounds cannot be ascertained and clarification is required to remove scope ambiguity.
New Rejection: Claim Rejections - 35 USC § 112
11. 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.
12. Claim 6 is rejected under 35 U.S.C. 112(a) 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, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Instant claims are drawn to method(s) for differentially diagnosing keratitis of a patient with Acanthamoeba keratitis comprising detecting an antigen-antibody reaction … wherein the antibody … comprises “… heavy chain variable domain (VH) comprising the CDRs as set forth in SEQ ID NOs: 3-5 and a light chain variable domain (VL) comprising the CDRs as set forth in SEQ ID NOs: 7-9”.
However, the sequences for the CDRS corresponding to SEQ ID NO 3, 4, 5 and 7, 8, 9 have not been described with sufficient particularity, such that one skilled in the art would recognize that Applicant had possession of the claimed invention, at the time of filing, because of a lack of sequence information properly incorporated into the specification (see Defective CRF above). Therefore, the specification does not provide sufficient written description to support the genus encompassed by the claims; see Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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.).
Therefore, without a proper CRF to provide adequate written description for the antibody’s structure, including sequences for each of its 6 CDRs, it is the Office’s position that Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Conclusion
13. No claims are allowed at this time.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
February 10, 2026