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 .
Claims 2-10, 15, 21-24 and 29 have been cancelled.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not fully persuasive.
The rejection of claims 1, 16-18, and 29 under 35 U.S.C. 103 as being unpatentable over Garcia et al. (U.S. Patent Application Publication 2021/0206848) in view of Cooke et al. (WO 2020/146432, of record) is withdrawn in view of the claim amendments.
The “at least 80% identical” limitations in claim 12 must be outside the three CDR triad in claim 11 in order for claim 12 to be properly dependent (i.e. SEQ ID NOS: 3, 4, and 5 for SEQ ID NO: 2; SEQ ID NOS: 35, 36, and 37 for SEQ ID NO: 34; SEQ ID NOS 79, 80, and 81 for SEQ ID NO: 78; SEQ ID NOS: 83, 84, and 85 for SEQ ID NO: 82; SEQ ID NOS: 95, 96, and 97 for SEQ ID NO: 94; SEQ ID NOS: 107, 108, and 109 for SEQ ID NO: 106; SEQ ID NOS: 135, 136, and 137 for SEQ ID NO: 134; SEQ ID NOS: 127, 128, and 129 for SEQ ID NO: 126; and SEQ ID NOS: 139, 140, and 141 for SEQ ID NO: 138).
Claim 1 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 19-20, directed to the process of using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 25-28 are not subject to rejoinder.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups I and II as set forth in the Office action mailed on 8/27/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 25-28 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/24/2025.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 19 is directed to a method of treatment or prevention of a disease, disorder or condition in a mammalian subject, the method comprising administering to said subject a therapeutically effective amount of a CD45 binding molecule of claim 1 or a pharmaceutically acceptable formulation thereof. Claim 20 specifies that the disease, disorder or condition is a neoplastic disease, disorder or condition.
Claim 19 is directed to treating and preventing any disease. It requires administering a therapeutically effective amount where the therapeutic effect (other than prevention) is unknown. Claim 20 specifies a neoplastic disease, disorder or condition. None of the diseases, disorders, or conditions are required to involve CD45. The claims do not require a particular diagnosis of any disease, disorder, or condition.
Paragraph [0107] of the specification defines treatment as referring to a course of action that is initiated with respect to a subject in response to a diagnosis that the subject is suffering from a disease, disorder or condition, or a symptom thereof, the course of action being initiated so as to eliminate, reduce, suppress, mitigate, or ameliorate, either temporarily or permanently, at least one of: (a) the underlying causes of such disease, disorder, or condition afflicting a subject; and/or (b) at least one of the symptoms associated with such disease, disorder, or condition. In some embodiments, treating includes a course of action taken with respect to a subject suffering from a disease where the course of action results in the inhibition (e.g., arrests the development of the disease, disorder or condition or ameliorates one or more symptoms associated therewith) of the disease in the subject. All aspects of treatment and prevention must be enabled in the absence of a more specific therapeutic outcome being claimed
At least for example, there is no evidence of record nor reason to believe that administration of any of the claimed CD45 binding molecules will prevent or cure HIV infection or reduce the viral load in a patient with HIV. There is no evidence of record nor reason to believe that administration of any of the claimed CD45 binding molecules will reverse or ameliorate HIV symptoms such as weight loss or opportunistic infections associated with HIV such as herpes and thrush.
At least for example, there is no evidence of record nor reason to believe that administration of any of the claimed CD45 binding molecules will prevent or cure an inflammatory disease such as rheumatoid arthritis. There is no evidence of record nor reason to believe that administration of any the claimed CD45 binding molecules will reverse or ameliorate joint damage caused by rheumatoid arthritis.
At least for example, there is no evidence of record nor reason to believe that administration of any of the claimed CD45 binding molecules will prevent or cure a neoplastic disease such as glioblastoma. There is no evidence of record nor reason to believe that administration of any the claimed CD45 binding molecules will reverse or ameliorate brain tissue damage and any associated cognitive and/or motor deficits caused by the damage to the brain tissue.
The specification does not enable the claimed methods of treatment or prevention. There are no examples of administering any of the claimed CD45 binding molecules to any mammalian subject to treat or prevent any disease, disorder, or condition.
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 13 and 19-20 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.
Claim 13 is confusing in reciting “SEQ ID NO: 216,” “SEQ ID NO: 292,” and “SEQ ID NO: 364.” These sequences correspond to Chothia CDR2 sequences (see at least Table 5) and not sequences for sdAb (containing CDR1, CDR2, and CDR3 as recited in claim 1).
Claim 19 recites a “therapeutically effect amount” without specifying what therapeutic effect is required. The metes and bounds of the claim cannot be determined.
Claims 1, 11-12, and 16-18 are allowable.
Claim 14 is objected to as being dependent upon rejected base claim 13, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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