DETAILED ACTION
Examiner acknowledges receipt of the reply filed 8/14/2026, in response to the non-final office action mailed 5/14/2026.
Claims 1-6, 8, 10-14, and 21-24 are pending and are being examined on the merits in this office action.
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 .
Terminal Disclaimer
The terminal disclaimer filed on 8/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 19/417321 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Specification- withdrawn
The objection to the abstract and specification is withdrawn in view of the amendment filed 8/14/2026.
Claim Objections- withdrawn
The objection of claims 1, 4-6, and 14 is withdrawn in view of the amendment filed 8/14/2026.
Double Patenting- withdrawn
The rejection of claims 1-6, 8, 10-14, and 21-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 10-16, 18, and 19 of copending Application No. 19/417321 (hereinafter referred to as the ‘321 application), is withdrawn in view of the terminal disclaimer (TD) filed 8/14/2026. The TD was approved 8/14/2026. See file wrapper.
The rejection of claims 1-6, 8, 10-14, and 21-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-14, 19, and 23-27 of copending Application No. 18/865678 (hereinafter referred to as the ‘678 application), is withdrawn in view of the amendment filed 8/14/2026 in the ‘678 application. The claims of the ‘678 application now recite a polypeptide comprising the amino acid sequence pf SEQ ID NO:101, a protein that is distinct from instantly claimed SEQ ID NO:87.
Response to Arguments
Applicant’s amendment and arguments, filed 8/14/2026, with respect to the above objections and rejections have been fully considered and are persuasive. Therefore, the objections and rejections have been withdrawn.
Applicant's amendment and arguments filed 8/14/2026 have been fully considered with respect to the maintained rejection but they are not persuasive. An action on the merits is set forth herein.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 1-6, 8, 10-14, and 21-24 remain/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. This rejection is maintained from the office action mailed 5/14/2026 but has been amended to reflect claims filed 8/14/2026.
The metes and bounds of claims 1 and 14 are deemed to be indefinite.
Claim 1 recites: a method of treating age-related macular degeneration (AMD), the method comprising administering to a subject in need thereof, a polypeptide in an amount sufficient to reduce an amount of drusen in the subject, wherein the polypeptide comprises the amino acid sequence having at least 85% identity to SEQ ID NO: 87, and wherein the AMD is treated.
Claim 14 recites: a method of treating age-related macular degeneration (AMD), the method comprising administering to a subject in need thereof, a polypeptide in an amount sufficient to reduce an amount of drusen in the subject, wherein the polypeptide comprises the amino acid sequence of SEQ ID NO: 87, and wherein the AMD is treated.
The term “an amount of drusen in the subject” is not expressly defined.
Yeager (AARP article, published 10/19/2020 at URL aarp.org/health/conditions-treatments/drusen- previously cited) states:
A few drusen are normal and are not a sign of disease, Awh says. “Most people don't have drusen that are big enough, widespread enough or in a location in the eye that presents any risk to vision."
Drusen become troublesome only when they start growing in size or number or developing in a problematic location. Specifically, if you develop too many drusen, if they get too large or if they develop beneath the macula — the bull's-eye focal point of the retina that processes sharp, clear, straight-ahead vision — you're at risk for developing dry AMD.
Yeager at p. 2. The reference further discloses that it is not uncommon to see drusen in younger individuals eyes and that some people are more genetically susceptible (p. 1).
The prior art teaches drusen can be found in individuals with normal/healthy eyes. Drusen can also be found in younger individuals, it is not limited to older adults with AMD.
The term “reduce an amount of drusen in the subject” in claims 1 and 14 is a relative term which renders the claim indefinite. The term “reduce an amount of drusen in the subject” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Specifically, the claims and specification do not provide a correlation between the amount of drusen present in an eye to distinguish between a patient with AMD vs healthy eyes. Thus, the claims and specification do not provide guidance to the skilled artisan as to the “amount of drusen” that should be reduced in order to provide treatment of a patient with AMD, as opposed to an individual with normal/healthy wherein in drusen is present, albeit at lower levels.
Claim clarification is required.
Because claims 2-7 and 10-13 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Because claims 21-24 depend from indefinite claim 14 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Response to Arguments
Applicant traversed the rejection at pp. 7-8. Applicant asserts claims 1 and 14 were amended to “clarify that administration of the claimed polypeptide results in treatment of age-related macular degeneration (AMD)”.
Applicant states at p 7:
Read in light of the claims as a whole, a person of ordinary skill in the art would understand that the recited amount is a therapeutically effective amount for treating AMD, and that the claimed reduction in drusen is the reduction associated with achieving that therapeutic result. Thus, the amendment provides an objective clinical context for interpreting the functional limitation and informs a person of ordinary skill in the art, with reasonable certainty, of the scope of the claimed invention.
Applicant alleges that the Office acknowledges that a reduction in drusen correlates with treating AMD (referring to p. 9 the office action dated 5/14/2026). It is noted that page 9 relates to an ODP rejection. Applicant asserts that the “claims do not encompass arbitrary reductions in physiological drusen present in healthy individuals. Instead, the claims are directed to administration of the claimed polypeptide in a therapeutically effective amount that treats AMD, thereby providing an objective boundary to the claimed functional language”. Id. Applicant asserts that the instant claims are method claims, further requiring that the AMD is treated, e.g., reduction in drusen is in context of treatment of AMD, thereby providing an objective boundary to the functional language (pp. 7-8). Applicant asserts the skilled artisan “would not interpret the claims as encompassing healthy individuals or reductions in incidental physiological drusen unrelated to treatment of AMD” (reply at p. 8).
Examiner has reviewed and considered Applicant’s arguments but is not persuaded.
Applicant incorrectly conflates a statement made in the unrelated ODP rejection as being the Office’s position that a reduction in drusen correlates with treating AMD. The statement was clearly made with regard to the ‘678 application ODP rejection at p 9 of the office action. An excerpt from the office action is provided for clarity of the record:
While the claims of the '678 application do not teach reducing an amount of drusen, they do perform the same method steps- delivering the claimed peptide (85% or greater homology to instant SEQ ID NO:87) to the same patient population (subject with age-related macular degeneration (AMD)) with the same treatment endpoint, treating AMD. Because the method steps are the same, the claims of the '678 application inherently teach the same process of reducing drusen as in the current application. The claims of the '678 application therefore anticipate reducing an amount of drusen as instantly claimed. It is noted that a reduction in drusen correlates with treating AMD.
Regardless, Applicant did not address the crux of the instant indefinite rejection.
The 112b issue relates to the amount of drusen. Yeager teaches that drusen can be found in individuals with normal/healthy eyes. Drusen can also be found in younger individuals, it is not limited to older adults with AMD. Applicants assertion relating to a boundary of treatment is misplaced. The “boundary” of “wherein the AMD is treated” occurs only after the step of administering the claimed polypeptide. The instant issue relates to the identification of patients and distinguishing between patients (healthy vs AMD) as relating to the amount of drusen. It is further noted that the claims and specification do not provide a standard for ascertaining the requisite degree by which a reduction of drusen is intended to occur, i.e. there is no comparative/baseline value.
The rejection is maintained for at least these reasons and those previously made of record.
Relevant Art Not Relied Upon
Amino acid positions 1-14 of instant SEQ ID NO:87 have 54.1% identity with positions 138-151 of SEQ ID NO:265 of Thompson et al (U.S. 2024/0324599; Appl No 18/615771- previously cited). See score results.
Amino acid positions 2-17 of instant SEQ ID NO:87 have 53.1% identity with positions 73-88 of SEQ ID NO:18603 of Wu et al (U.S. 2013/0333061; Appl No 12/864690- previously cited). See score results.
Conclusion
No claims are allowed.
Claims 1-6, 8, 10-14, and 21-24 are pending and are rejected.
THIS ACTION IS MADE FINAL. 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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA M HELLMAN/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654
Prosecution Insights