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 1-100 have been canceled. Claims 101-120 have been added and are examined on the merits.
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 101-120 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
(A)Claims 101-116 are reliant on a genus of making moieties “coupled to” the anti-CD166 antibody, through a cleavable moiety, wherein the masking moiety inhibits the binding of the antibody to CD166. The claims encompass any anti-CD166 antibody format, such as full length bi-valent antibodies and antibody fragments, wherein the masking moiety can be at the amino terminus or carboxyl terminus (claim 106). When given the broadest reasonable interpretation, the masking moieties can be of any substance The specification described masking moieties which are peptides of SEQ ID NO: 135-238. The specification fails to provide a correlation between a minimal structure of the masking moiety and the property of serving as a masking moiety when attached to the anti-CD166 antibody comprising the antibody paratope formed by the heavy chain CDR sequences of SEQ ID 127-19 and the light chain CDR sequences of SEQ ID NO: 130/131, 132/133 and 134. One of skill in the art would not envision a masking moiety which was not other than SEQ ID NO: 135-238 as one could with a well-defined genus. Further the description of SEQ ID NO: 135-238 fails to describe the genus of making moieties relied upon in the claims, wherein the masking moieties can be of any substance an attached to the N-terminus of a construct comprising MM-LP1-CM-LP2-AB or AB-LP2-CM-LP1-MM.
(B)Claims 101-120 are reliant on a genus of antibody constructs, MM-LP1-CM-LP2-AB or AB-LP2-CM-LP1-MM encompassing a genus of linkers, L1 and L2. It is noted that the genus of linkers, LP1 and LP2 are highly variant to allow for the non-covalent interaction between the masking moiety and the antibody paratope especially in the format of AB-LP2-CM-LP1-MM, wherein AB is a full-length antibody and LP2 is attached at the C-terminus of the antibody Fc region. Linkers allowing for the unimolecular interaction of the masking moiety with the antibody paratope at the N-terminus would be required. One of skill in the art could not envision the required linkers because in addition to the linker length, the linker structure influences the stiffness or flexibility of the linker which in turn influences the ability of the linker to allow the interaction between the masking moiety and the antibody paratope, especially critical in the format AB-LP2-CM-LP1-MM wherein the antibody is a full-length antibody. The specification fails to provide a correlation between linker length and substance for LP1 and LP2 which allows for the proper interaction between the antibody paratope and the masking moiety when the antibody is a full-length antibody and the format is AB-LP2-CM-LP1-MM.
One of skill in the art would reasonably conclude that applicant was not in possession of the conjugated activatable antibodies at the time of filing.
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.
Claims 101-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-64 of U.S. Patent No.11,753,466. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent either anticipate or render obvious the instant claims. Claim 1 of the patent anticipates instant claims 101, section (a), 112(e), and 113(b). Claim 7 of the patent anticipates instant claims 115 and claim 118 sections (i), (ii) and (iii). Claim 12 of the patent anticipates instant claim 101, section (b) and claim 105. Claim 13 anticipates instant claim 105. Claim 16 anticipates instant claim 106. Claim 8 of the patent anticipates claim 114. Claims 9-11 of the patent anticipate instant claims 108-111. Claim 1 of the patent teaches the limitations of claims 117 and 119, sections (a)(i), (ii) and (iii). Claim 9 of the patent teaches the structural format required in claims 117 and 119 of MM-CM-AB or AB-CM-MM, and the structural format of claim 118 and 120 of MM-LP1-CM-LP2-AB and AB-LP2-CM-LP1-MM, thus the combined teaching of claim 1 and claims 9 and 10 of the patent render obvious section (a) of claim 117 and 119 and claims 118 and 120.
Claim 12 of the patent teaches that the agent of the conjugate is a detectable or diagnostic agent. The claims of the patent do not specifically teach that the detectable or diagnostic agent is an imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, a metal ion, a ligand-based label, or a fluorescent or near infrared dye, required in claims 102-104, 117(b) and 118(b).
Section 804 IIb of M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)
In the instant case, the ‘466 specification teaches that detectable and diagnostic agents include
imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, one or more metal ions, or a ligand-based label; and
The detectable label may be a fluorescent dye, (e.g. a fluorophore, Fluorescein Isothiocyanate (FITC), Rhodamine Isothiocyanate (TRITC), an Alexa Fluor® label), a near infrared (NIR) dye (e.g., Qdot® nanocrystals), a colloidal metal, a hapten, a radioactive marker, biotin and an amplification reagent such as streptavidin, or an enzyme (e.g. horseradish peroxidase or alkaline phosphatase).
Thus, the detectable moiety of claim 12 of the patent encompasses an imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, one or more metal ions, or a ligand-based label required in claims 102 and 103 and the near infrared dye required in claims 117(b) and 119(b).
Regarding claim 107, claim 16 of the patent teaches that the linker of claim 13 is a cleavable linker. One of skill in the art would understand that the linker of claim 13 encompassed both cleavable and non-cleavable linkers because claim 16 further limits the scope of claim 13, thus rendering obvious instant claim 107.
Regarding claim 116, the claims of the patent are drawn o methods of treating a subject by administration of the activatable antibody of the invention to a subject.. It would have been prima facie obvious at the time prior to the effective filing date to administer the activatable antibody in the form of a composition comprising a pharmaceutically acceptable carrier. One of skill in the art would have been motived tondo so in order to facilitate accurate dosing and control the length of infusion to the subject in order to avoid potential side-effects of a bolus administration.
Claims 101-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25, 27, 28, 33 and 48-66 of U.S. Patent No.10,745,481. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent either anticipate or render obvious the instant claims.
Claim 19 of the patent teaches the limitations of instant claim 101, sections (a)(i), (ii) and (iii) and (b). Claim 60 anticipates instant claim 116. Claims 20, 23 and 24 of the p[patent anticipate instant claims 105-107. Claims 6, 11-15 of the patent render obvious instant claims 108-111, 118, 120 and the structural configuration of MM-CM-AB and AB-CM-MM in claims 117 and 119 and the antigen binding fragments in instant claim 114, because it would be obvious that the limitations of claims 6, 11-13, depending on claim 3 and claims 14 and 15, depending on claim 13 of the patent would be part of the conjugated activatable antibody of claims 18 of the patent. Claim 7 of the patent render obvious instant claims 115 and claims 119(a)(i). Claims 31 and 32 of the patent meets the limitations of claims 112(e), 113(b) and 119(ii) and (iii). Claim 25 of the patent teaches the limitations of instant claim 117(a)(i). Claim 25 teaches the limitations of claim 117(a)(ii); dependent claim 31 teaches the limitations of claims 112(e) and 117(a)(ii), and dependent claim 32 teaches the limitations of instant claims 113(b) and 117(a)(iii).
The claims of the patent do not specifically teach that the detectable or diagnostic agent is an imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, a metal ion, a ligand-based label, or a fluorescent or near infrared dye, required in claims 102-104, 117(b) and 118(b).
Section 804 IIb of M.P.E.P. states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)
In the instant case, the ‘466 specification teaches that detectable and diagnostic agents include
imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, one or more metal ions, or a ligand-based label; and
The detectable label may be a fluorescent dye, (e.g. a fluorophore, Fluorescein Isothiocyanate (FITC), Rhodamine Isothiocyanate (TRITC), an Alexa Fluor® label), a near infrared (NIR) dye (e.g., Qdot® nanocrystals), a colloidal metal, a hapten, a radioactive marker, biotin and an amplification reagent such as streptavidin, or an enzyme (e.g. horseradish peroxidase or alkaline phosphatase).
Thus, the detectable moiety of claim 19 of the patent encompasses an imaging agent, a contrasting agent, an enzyme, a fluorescent label, a chromophore, a dye, one or more metal ions, or a ligand-based label required in claims 102 and 103 and the near infrared dye required in claims 117(b) and 119(b).
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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, Julie Wu can be reached at 571-272-5205. 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.
KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights