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 .
Acknowledgement is made of applicant’s election without traverse of the species (xi).
Claims 1-64 have been canceled. Claims 65-90 have been added and are examined on the merits.
Claim Rejections - 35 USC § 112
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.
(A) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 65 recites the broad recitation “physiological pH”, and the claim also recites “~7.5” which is the narrower statement of the range/limitation. It is noted that the art teaches that pH varies with specific anatomical compartment, such as the peritoneum, interstitial fluid and peripheral blood. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
(B) Claim 65 is vague and indefinite in the recitation of “budesonide derivative”. It is unclear how much structural alteration of budesonide applicant is intending to encompass in the derivative.
(C) Claim 65(6), 76, 77 are vague and indefinite in the recitation of “ADC internalizes VISTA expressing immune cells”, “ADC internalizes VISTA-expressing Tregs” because the ADC has no internal compartment with which to internalize anything. For purpose of examination, the claims will be read as “the ADC is internalized by VISTA expressing immune cells” in claims 65 and 76 and “the ADC is internalized by VISTA-expressing Tregs” in claim 77.
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 65-90 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.
Claims 65-90 are reliant on a genus of ADC of formula A-(Q-L-AI)n or (AI-L-Q)n-A, wherein AI is a budesonide derivative.
Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
The specification fails to provide a written description of the derivatives in terms of what portions of the structure can be modified and still qualify as a budesonide derivate. The specification fails to provide representative number of species of budesonide derivatives by actual reduction to practice, It is noted that the specification discloses :
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as alternatives for glucocorticosteroids of the ADC (page 4). The specification does not define budesonide derivatives as encompassing the five structures in addition to budesonide.
The specification does not describe functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. One of skill in the art could not envisage if a compound belonged to the genus of budesonide derivates a one could do with a well-described genus.
One of skill in the art would reasonably conclude that applicant was no in possession of the ADCs comprising the genus of budesonide derivates as 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.
Claim 65-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 158-161 of copending Application No. 18/271,106 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the application anticipate the instant claims.
Claim 158 of ‘106 meets the limitation of A1 being a budesonide derivative Claim 159 meets the limitation of a linker comprising a cleavable moiety which is covalently bound to the anti-VISTA antibody, and Q being a heterobifunctional group which comprises different reactive groups for covalent attachment of the linker in claim 65, sections 3 and 4. Claim 159 also discloses that the number of budesonide derivatives, represented by “n” is 2-8 which meets the limitation of claim 65 , section 5. And claims 74 and 75. Claim 160 discloses that the ADC is preferentially delivered to VISTA expressing immune cells, including monocytes, myeloid cells, T cells, Treg cells NK cells, and neutrophiles which meets the limitations of claim 65, section 6, and claims 76 and 77. Claim 160 discloses that the ADC preferentially binds to VISTA expressing cells at physiological pH and has a pK of at most 70 hours in a human VISTA knock-in rodent, which meets the limitations of claim 65, sections (1)(i) and (ii). Claim 160 discloses that the VH CDRs of the anti-VISTA antibody are SEQ ID NO: 200, 201, and 202 and the VL CDRs are SEQ ID NO: 203-205 (xi, page 42), which meet the limitations of claim 65(1)(iii). Claim 160 further discloses that the VH of the anti-VISTA antibody is SEQ ID NO: 206 and the VL is SEQ ID NO: 208 (xi, page 46) which meets the limitations of claims 66-69.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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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.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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