DETAILED 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 .
Claim Status
Claims 25 and 30 are pending. Claims 15-24 and 26-29 were canceled, and claims 25 and 30 were amended in the Reply filed 1/02/2026. Claims 25 and 30 are presently considered.
Election/Restriction
Applicant's election with traverse of Group II (products, claims 25-29) and the species of Figure 9, (i.e., hN13 having the sequence LARRSPRSSDGKL corresponding to SEQ ID NO: 2, 100 µM in PBS) in the reply filed on 9/10/2025 was previously acknowledged. The traversal was previously fully considered but not found persuasive for reasons of record (see, e.g., Action mailed 10/07/2025 at 2), and the requirement was deemed proper and made FINAL.
Following extensive search and examination, the originally elected species was deemed free of the prior art, wherein the novelty was found in the combination of the structure consisting of SEQ ID NO:2, at 100 µM (i.e., a substantially higher than naturally occurring concentrations), in the non-natural pharmaceutical carrier of PBS.
Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was previously extended to the non-elected species of GenBank: ABS31134.11, which was deemed to be anticipated and/or obvious in view of the prior art. In the Reply filed 1/02/2026, Applicant amended the claims to exclude the non-elected species, and to require a peptide “consisting of” LARRSPRS (SEQ ID NO: 1) or “LARRSPRSSDGKL” (SEQ ID NO: 2.
Following extensive search and examination, the amended claims have been deemed free of the prior art. However, the claims are not in form for allowance at this time as explained below.
Claims 25 and 30 are presently considered.
Priority
The priority claim to EP20305795.5 (filed 7/10/2020) is acknowledged.
Information Disclosure Statement
No IDS was filed in the Reply filed 1/02/2026.
Claim interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claims 25 and 30 are representative of the pending claim scope. The applicable claim interpretation is set forth below.
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
The phrase “consisting of an amino acid sequence….” at claims 25 and 30 are understood to require the complete sequence(s) recited. Accordingly, this language is not reasonably interpreted in view of the specification to read upon dipeptide, tripeptide, …. Etc. fragments shorter than the full-length sequences recited at SEQ ID NO: 1 and 2.
Claims 25 and 30 are directed to a product, namely a peptide consisting of SEQ ID NO: 1 or 2, and a claim 25 may additionally comprise a pharmaceutically acceptable carrier, which may be water, blood, or other conventional carriers (see, e.g., Spec. filed 12/22/2022 at 16 at lines 5-11) or additional components.
In view of the amendments filed 1/02/2026, the phrase “a TMEM16A peptide activator” is deemed to be fully satisfied by the structurally complete description set forth in the body of amended claim 25.
Additional claim interpretations are set forth below.
Withdrawn Claim Rejections
The rejection of claims 25-29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been overcome by the cancellation of claims 26-29, and the amendments to claim 25 limiting it to sequences consisting of SEQ ID NOs: 1 or 2.
The rejection of claims 27-28 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form, is withdrawn as moot in view of the cancellation of claims 27-28.
The rejection of claims 25-29 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, has been overcome by the cancellation of claims 26-29, and the amendments to claim 25 limiting it to sequences consisting of SEQ ID NOs: 1 or 2.
The rejection of claims 25-28 under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US5620892 (Apr. 15, 1997; Kurtz et al.), has been overcome by the cancellation of claims 26-28, and by the amendments to claim 25 limiting it to sequences consisting of SEQ ID NOs: 1 or 2, as the reference does not teach a sequence “consisting of” instant SEQ ID NOs: 1-2.
The rejection of claims 25-30 under 35 U.S.C. 102(a)(1) as being clearly anticipated by GenBank: ABS31134.12 has been overcome by the cancellation of claims 26-29, and by the amendments to claims 25 and 30 limiting such claims to sequences consisting of SEQ ID NOs: 1 or 2, as the reference does not teach a sequence “consisting of” instant SEQ ID NOs: 1-2.
The rejection of claims 25-30 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more, has been successfully traversed-in-part by the cancellation of claims 26-29 and the amendments to claims 25 and 30; however, the amendments have necessitated a new or revised rejection, as set forth below.
New or Revised Claim Rejections Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 25 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The applicable analysis is discussed at MPEP § 2106.
Claims 25 and 30 are directed to a statutory category of invention, namely products, and more specifically pharmaceutical compositions consisting of either SEQ ID NO: 1 (LARRSPRSS) or SEQ ID NO: 2 (LARRSPRSSDGKL). Claim 25 requires the presence of an unspecified pharmaceutically acceptable carrier (e.g., water, saline solution, etc.). Accordingly, the claims are to a composition of matter (see, e.g., MPEP § 2106(II)-(III)).
Claims 25 and 30 are directed to a natural phenomenon, namely a fragment of a naturally occurring protein. Specifically, claims 25 and 30 recite and read upon at peptides consisting of either SEQ ID NO: 1 (LARRSPRSS) or SEQ ID NO: 2 (LARRSPRSSDGKL). However, such peptides naturally occur as a portion of a full-length protein as evidenced by GenBank: ABS31134.13 (showing LARRSPRSS and LARRSPRSSDGKL starting at position 30 to position 42). Accordingly, the claimed products are directed to fragments of naturally-occurring proteins (see, e.g., MPEP § 2106(III)).
Regarding the limitation reciting “consisting of” language in the Reply filed 1/02/2026: As previously noted on record (see, e.g., Action mailed 10/07/2025 at 9-10 at bridging bullet point), MPEP § 2106.04(c)(II)(C)(2) and Myriad explicitly identify that the Court determined and clarified that fragmentation of biopolymers does not constitute a feature that renders biopolymers markedly different from what exists in nature. Even though fragmentation or truncation structurally changes a protein or nucleic acid from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render an isolated polynucleotide or peptide fragment markedly different, because the sequence of the biopolymer responsible for the intrinsic and inherent properties of the fragment has not been altered. See, e.g., Myriad, 133 S. Ct. at 2116-18. Here, the sequences are understood to correspond to naturally occurring protein domains that retain the functionality attributable to the naturally occurring structure, which is not altered by fragmentation or truncation (see, e.g., Myriad, 133 S. Ct. at 2116-18). Accordingly, the “consisting of” limitation added in the Reply filed 1/02/2026 does not render SEQ ID NOs: 1 and 2 “markedly different” relative to the naturally occurring protein domains.
The remaining issues are whether or not the claim recites additional elements that amount to significantly more than the judicial exception (see, e.g., MPEP § 2106(III)). “To be patent eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception” (79 FR 74624 col I). The additional elements and claim language are discussed below.
Claim 25 recites the preamble phrase “a TMEM16A peptide activator”. Per MPEP § 2111.02, the preamble is understood not further limit the structure of the claimed compound beyond the positively recited structural limitations set forth in the body of each claim, and is therefore fully satisfied by the naturally occurring protein domains and fragments considered above. Accordingly, such language does not amount to significantly more than the judicial exception.
Claim 25 recites an additional component, namely a “pharmaceutically acceptable carrier” (see, e.g., instant claim 25). Per MPEP § 2106.04(d)(2), recitations that a claimed product is a “pharmaceutical composition” (i.e., comprises a pharmaceutically acceptable carrier) is not amount to significantly more than the judicial exception because “a recitation that a claimed product is a ‘pharmaceutical composition’ . . . merely indicat[e] how the claimed invention might be used” (see, e.g., MPEP § 2106.04(d)(2)). This is relevant because the “pharmaceutically acceptable carrier” does not correspond to any specific composition, but may be any possible pharmaceutical carrier (e.g., hydrogel, water, blood, etc.)4, and therefore the specific identity of the carrier does not alter the claimed invention. Accordingly, such language does not amount to significantly more than the judicial exception.
Accordingly, amended claims 25 and 30 are rejected under 35 U.S.C. 101 because the claims are directed to naturally occurring proteins without significantly more.
Response to Arguments
Applicant's arguments filed 1/02/2026 have been fully considered but they are not persuasive. As an initial matter, all arguments directed to withdrawn rejections are moot. Remaining applicable arguments are addressed below.
The Applicant addresses the remaining rejection under 35 USC § 101 at page 5 of the Reply (see, e.g., Reply filed 1/02/2026 at 5 at 4th full ¶). It is the Examiner’s understanding that Applicant alleges that the claims are limited to sequences consisting of SEQ ID NOs: 1 or 2, and alleges that “the claims do not try to protect a product of the nature and respects pathway B of eligibility from Step 2A of the Alice/Mayo test” (see id). This argument is not persuasive for reasons of record (see, e.g., Action mailed 10/07/2025 at 9-10 at bridging bullet point), which are reiterated in the revised rejection above. Specifically, “consisting of” language limits the claim scope to fragments of a naturally occurring peptide, but the Court has clarified that fragmentation of a naturally occurring biopolymer does not constitute a feature that renders the biopolymer markedly different from what exists in nature (see, e.g., Myriad, 133 S. Ct. at 2116-18). Here, the claims read upon domains of a naturally occurring polypeptide, wherein such domains would be expected and predicted to exhibit the functionality attributable to the domain of the naturally-occurring polypeptide. Accordingly, such arguments have been fully considered but not found persuasive.
The remaining rejection could potentially be overcome by deleting claim 30 and amending claim 25 to recite specific non-natural concentrations of the peptides in combination with limitations requiring one or more non-natural pharmaceutical excipients. Such limitations must be supported by the originally filed disclosure.
Accordingly, all applicable arguments have been fully considered, but not found persuasive to place the claims in form for allowance. Therefore, the rejection is maintained as revised above, wherein all revisions were necessitated by Applicant’s amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US5620892 (Apr. 15, 1997; Kurtz et al.; cited in previous action) teaches and discloses SEQ ID NO: 6, which comprises the LARRSPRSSDGKL at positions 33-42 (see, e.g., US’892 at SEQ ID NO: 6, claims 1-10, Fig. 4).
GenBank: ABS31134.15 (cited in previous action) discloses a sequence comprising LARRSPRSSDGKL starting at position 30 to position 42.
US 6458542 at SEQ ID NO: 2, discloses a sequence sharing substantial sequence identity with instant SEQ ID NOs: 1-2.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new or revised ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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 G. 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.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 GenBank ABS31134.1, voltage gated potassium channel accessory subunit isoform 3, partial [Homo sapiens], ncbi.nlm.nih.gov, 1 page (July 23, 2016), also available at https://www.ncbi.nlm.nih.gov/protein/ABS31134.1 (last visited 9/29/2025).
2 GenBank ABS31134.1, voltage gated potassiun channel accessory subunit isoform 3, partial [Homo sapiens], ncbi.nlm.nih.gov, 1 page (July 23, 2016), also available at https://www.ncbi.nlm.nih.gov/protein/ABS31134.1 (last visited 9/29/2025).
3 GenBank ABS31134.1, voltage gated potassium channel accessory subunit isoform 3, partial [Homo sapiens], ncbi.nlm.nih.gov, 1 page (July 23, 2016), also available at https://www.ncbi.nlm.nih.gov/protein/ABS31134.1 (last visited 9/29/2025); cited in previous action.
4 See e.g., Spec. filed 12/22/2022 at 16 at lines 1-21, noting that the pharmaceutically acceptable carriers “are those conventionally used”.
5 GenBank ABS31134.1, voltage gated potassium channel accessory subunit isoform 3, partial [Homo sapiens], ncbi.nlm.nih.gov, 1 page (July 23, 2016), also available at https://www.ncbi.nlm.nih.gov/protein/ABS31134.1 (last visited 9/29/2025; cited in previous action).