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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on July 15, 2026 is acknowledged. Claim 1 was amended, claims 10-11 were canceled and claims 1-9 are pending in the instant application. The restriction was deemed proper and made final previous office action.
Claims 2-9 remain withdrawn from consideration as being drawn to non-elected invention/species.
Claim 1 is examined on the merits of this office action
Withdrawn Rejections/Objections
The rejection of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Hillman (US5906923 A1) is withdrawn in view of amendment of the claims filed July 15, 2026.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of co-pending Application No.18258577 (reference application) is withdrawn in view of amendment of the claims filed July 15, 2026.
Maintained/Revised Rejections
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.
Claim 1 remains rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim 1 does not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on MPEP2106.03-MPEP2106.05.
Claim Interpretation
Claim 1 claims “A peptide comprising an amino acid sequence represented by SEQ ID NO: 1 or 2”.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see MPEP
2106.03)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea
(see 2106.04)?
Yes, the claims are directed to a natural phenomenon, namely a naturally-occurring peptide or antibody. For example, SEQ ID NO:2 is a naturally occurring peptide fragment (see attached handout, protein accession Q9UII2, ATIF1_Human, see attached handout).
Accordingly, the pending claims are directed to naturally occurring peptides.
As the product is found in nature, consideration is given to whether it is integrated into a practical application or contains other elements that provide a marked difference as compared to the natural counterpart.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application? (see MPEP 2106.04 (d)) NO. This judicial exception is not integrated into a practical application because it does not provide a treatment that affirmatively recites an action that effects a particular treatment for a disease or medical condition.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see MPEP 2106.05))?
No, the claim does not recite additional elements that amount to significantly more than the judicial exception, as explained below. Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in MPEP 2106. Instant claim 1 is drawn to a naturally occurring peptide. Given the broadest reasonable interpretation, this could be water in combination with the inhibitor which is naturally occurring and there is no evidence that the combination of the peptide and water results in a different property or function of the peptide. The peptide of the instant claims (an in combination with water) does not amount to significantly more than the exception.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claim 1 does not qualify as eligible subject matter.
Response to Applicant’s Arguments
Applicants argue “The Examiner asserts that the amino acid sequence of SEQ ID NO: 2 corresponds to a naturally occurring ATPIF1 protein fragment, citing the UniProt handout of protein Accession No. Q9UII2, ATIFlHuman ("UniProt Q9UII2"), and as such finds the peptide of claim 1 to be a naturally occurring peptide and a natural phenomenon. See Action, page 3. Applicant respectfully disagrees with this interpretation of the peptide of SEQ ID NO: 2. SEQ ID NO: 2 is a fragment of 47 amino acids, while UniProt Q9UII2 merely shows alignment of this sequence with a full-length protein of 106 amino acids (see UniProt Q9UII2, first page top right). Thus, there is no indication in UniProt Q9UII2 that a fragment consisting of SEQ ID NO: 2 (or 1) exists in nature, and the Examiner provides no other reasoning or evidence to support the assertion that it does exist in nature. To the contrary, Applicant respectfully submits that while ATPIF1 is a naturally occurring full-length protein, the peptide as claimed herein is a specific peptide fragment consisting of SEQ ID NO: 1 or 2 that does not naturally occur in nature. The peptide of claim 1, while corresponding to a 47-amino acid sequence within ATFIFI, does not correspond to a naturally occurring proteolytic cleavage product, and as such is not itself found in nature. Furthermore, the peptide of claim 1 was artificially designed based on ATPIF1 and produced by recombinant techniques, as described in Example 1 of the present application as filed, in which a vector encoding the peptide was constructed, transformed into . coli, and expressed, isolated, and purified. Therefore, Applicant respectfully submits that the peptide of claim 1 is not directed to a naturally occurring product and thus is patent-eligible subject matter. Applicants further argue that the peptide fragments have superior activity and effects as compared to the full length protein (see Additional Experiments 1-2 on pages 3-4 in Applicants response). In view of the above, Applicant respectfully submits that the rejection of claim 1 under 35 U.S.C. § 101 has been overcome and respectfully requests its withdrawal.
Applicant’s arguments have been fully considered but not found persuasive. The fact that the claimed peptide is a fragment or truncated form of the naturally occurring ATIF1 protein does not, by itself, establish that the claimed subject matter possesses markedly different characteristics from its naturally occurring counterpart. Although fragmentation results in a structural difference in length, the eligibility analysis considers whether the claimed product possesses markedly different characteristics, including relevant structural, functional or other characteristics, as compared with the naturally occurring counterpart. Thus, just identifying the claimed peptide as a shorter fragment of ATIF1 is insufficient, without more, to establish markedly different characteristics.
Applicant’s argument that the peptide was artificially designed and produced using recombinant techniques is likewise not persuasive. Patent eligibility of a product is determined based on the characteristics of the claimed product, rather than merely the manner in which the product tis produced. Claim 1 is directed to the peptide itself and does not require the particular recombinant production steps relied upon by Applicant.
Applicant’s additional experimental evidence also does not establish that the claimed peptide possesses a markedly different functional characteristic. Rather, the submitted results indicate that the peptide fragments and the full length wild type protein exhibit the same general type of biological activity. For example, additional Experimental 2 compares the full length wild type protein (substance 1) with the fragment corresponding to SEQ ID NO:1 (substance 3) with respect to UCP-1 expression. The results indicated that both the full length protein and the claimed fragment increase UCP-1 expression. Although differences in the magnitude of the measured response are observed, Applicant has not established that such quantitative differences represent a markedly different functional characteristic, rather than a difference in degree of the same biological activity (or significantly superior activity). The evidence does not establish a different type of biological function due to the fragment. Instead, the evidence indicates retention of the biological activity associated with the naturally occurring protein. Applicant has not established that fragmentation of the naturally occurring protein, recombinant production of the peptide or the quantitative differences presented in Additional Experiments 1 and 2 confer a markedly different characteristic on the claimed peptide. Applicants arguments thus do not overcome the rejection under 35 U.S.C. 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18861693 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a peptide comprising SEQ ID NO:1 or SEQ ID NO:2 (see claim 1).
Co-pending AN 18861693 claims a BBB peptide comprising instant SEQ ID NO:2 (see claim 2).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant argues “Applicant respectfully disagrees, as the present invention now recites a peptide consisting of SEQ ID NO: 2, and as such does not read on the peptide of the '693 Application. In addition, the peptide of the present invention was developed as an active therapeutic agent for anti-obesity and glucose metabolism-improving effects, whereas the peptide of the '693 Application comprising SEQ ID NO: 2 is directed to use as a delivery carrier for transporting a payload into the brain tissue.
Applicants arguments have been considered but not found persuasive. The copending claims reciting a peptide comprising instant SEQ ID NO:2 encompass a peptide consisting of SEQ ID NO:2. Thus, amendment of the present claims to “consisting of” does not establish patentable distinction. Further, Applicants reliance on different uses does not establish patentable distinctness where the claims encompass the same peptide. A different intended use or property of the peptide does not render the patenting claimed subject matter patentably distinct. Accordingly, the rejection is maintained.
Claim 1 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No.19471420 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a peptide consisting of SEQ ID NO:1 or SEQ ID NO:2 (see claim 1).
Co-pending AN 19/471420 claims a peptide comprising instant SEQ ID NO:2 (see claim 1, SEQ ID NO:10 consists of instant SEQ ID NO:2). It is further noted that SEQ ID NO:10 of the copending application is identical to instant SEQ ID NO:2 of the instant application. The copending claims expressly recite SEQ ID NO:10 as the peptide component of a fusion protein further containing a linker and an Fc sequence. Accordingly, the presently claimed peptide consisting of SEQ ID NO:2 differs from the peptide component expressly recited in the copending claims only in that it is claimed apart from the linker and Fc components. It would have been an obvious variation to provide the expressly recited peptide sequence independently of the linker and Fc components, absent evidence demonstrating that such separation results in a patentably distinct peptide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant respectfully disagrees, as the present invention now recites a peptide consisting of SEQ ID NO: 2, and as such does not read on the peptide of the '420 Application, which is directed to an Fc-fusion protein comprising a peptide linked to an Fc domain. The claims molecules differ at least in structure, molecular weight, in vivo stability, and pharmacokinetic properties, among other features.
Applicants arguments have been considered but not found persuasive. The copending claims expressly recite SEQ ID NO:10 as the peptide component of a fusion protein further containing a linker and an Fc sequence. Accordingly, the presently claimed peptide consisting of SEQ ID NO:2 differs from the peptide component expressly recited in the copending claims only in that it is claimed apart from the linker and Fc components. It would have been an obvious variation to provide the expressly recited peptide sequence independently of the linker and Fc components (each having its own role, active peptide, linker, Fc for enhancing half life), absent evidence demonstrating that such separation results in a patentably distinct peptide.
Conclusion
No claims are allowed.
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 ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 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, 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.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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