DETAILED ACTION
Applicant’s amendment to the claims in the Response filed on 10/03/2025, materially changing the scope of the claims, is acknowledged.
The rejections of record under 35 U.S.C. § 102 are withdrawn in view of Applicant’s amendment to the claims in the Response filed on 10/03/2025
A new ground of rejection is set forth below, which was necessitated Applicant’s amendment to the claims in the Response filed on 10/03/2025.
The Action is made FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon as evidenced by A0A7I2V5Z8_HUMAN (Result 1, Search Result 20250610_081841_us-17-765-137-3.rup, 06/10/2025).
McKinnon teaches therapeutic methods, including treatment of Alzheimer's disease, comprising administering a therapeutic composition. See [0068] and [0122]. The therapeutic compositions of McKinnon are centered around CD28 antibodies (see abstract, [0012]). McKinnon also teaches combination therapies, which include a combination of CD28 antibody and soluble CD29. See [0065]. It is noted that “CD29” is an alternative name for integrin ß1, and that the soluble form of CD29 would correspond to the extracellular domain, such as that represented by instant SEQ ID NOs: 1-3. As evidenced by instant FIG. 1 (reproduced below), the extracellular domain of integrin ß1 is located in the N-terminal region and comprises the sequences of SEQ ID NO: 1 (Rs), 2 (Rd), and (Rw).
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As evidenced by A0A7I2V5Z8_HUMAN, SEQ ID NOs: 1, 2, and 3, correspond to the first 20, 140, and 371 amino acids of human integrin ß1, respectively. See alignment below. It is further noted that the claims recite open claim language and do not exclude combination therapies.
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As such, a polypeptide comprising SEQ ID NOs: 1, 2, or 3 is reasonably within the scope of the soluble CD29 taught by McKinnon. It is noted that the instant claims are not limited to a polypeptide with only SEQ ID NOs: 1, 2, or 3, but, rather, through the use of the transitional phrase “comprising,” a polypeptide with at least SEQ ID NOs: 1, 2, or 3. Finally, it is noted that a soluble CD29 would not comprise the complete transmembrane and intracellular domains of a complete sequence of a ß1 integrin.
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ product they exemplify. As such, the claimed method is within the scope of McKinnon, and thus McKinnon renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that McKinnon provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed 10/03/2025 have been fully considered but they are not persuasive. Applicant’s arguments are moot in view of the current grounds of rejection set forth above.
Conclusion
NO CLAIMS ARE ALLOWED
Applicant's amendment necessitated the new 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 THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
Examiner interviews are available via telephone 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, Yvonne Eyler can be reached at (571) 272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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