DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Art Unit and Examiner of your application in the USPTO have changed. To aid in correlating any papers in this application, all further correspondence regarding this application should be directed to Art Unit 1646, Mark Halvorson.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 1-5, 7, 9, 11, 13-23, 25-32 are pending and under examination.
35 USC § 103 rejections withdrawn
The rejection of claims 1-5, 7, 9, 11, 13-23, and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over White (US Patent 9,714,289 B2) in view of Jun (WO 2004/091658 Al) are withdrawn in view of Applicant’s argument.
NEW REJECTIONS:
Claim Objections
The claims contains sequences that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below.
There are recitations of SEQ ID NOs in claims 1, 2, 4, 22 and 25-27. However, a Sequence Listing has not been submitted with the application.
In response to this office action, Applicant must comply with the sequence rules, 37 CFR 1.821 - 1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 CFR 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136(a). In no case may an applicant extend the period for reply beyond the SIX MONTH statutory period. The nature of the non-compliance did not preclude an examination of the elected invention on the merits, the results of which are presented below.
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.
Claims 1-5, 7, 9, 11, 13-23, 25-32 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 1, 4, 22 and 25-27 recite specific biological material. It is apparent that the recited plasmid is required to practice the claimed invention, because they are specifically required in the claims. As required elements they must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the cell lines listed in claim 7. See 37 CFR 1.802.
The specification does not provide a repeatable method for obtaining the plasmid and they do not appear to be readily available material. Deposit of the plasmid would satisfy the enablement requirements of 35 U.S.C. 112. While the specification states on page 125 that the plasmid have been deposited for patent purposes, the specification does not indicate the terms of the deposit.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7, 9, 11, 13-23, 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over White (WO 2018/033798 A1, published 2/22/2018, IDS) in view of Mhalasakant (WO 2018/116198 A1, published 6/28/2018, IDS) and further view of Balasubramanyam et al (US2021/0292851, published September 21, 2021, effective filing date July 29, 2019) and DuPont et al (US 2019/0284269, published September 19, 2019).
White teaches PVRIG antibody can be used to treat cancers, in particular CHA.7.518.1.H4(S241P) (paragraphs 330-332). White teaches PVRIG antibody (CHA.7.518.1.H4(S241P)) novel cancer immunotherapy agent either as monotherapy or in combination with either TIGIT or PD1 blockade such as nivolumab (paragraph 373; Example 18). White discloses a heavy chain comprising VH-CH1-hinge-CH2-CH3 (paragraph 425). White discloses that the CH1-hinge-CH2-CH3 is selected from human IgG1, IgG2 and IgG4 (Id). White disclose that the VL is either kappa or lambda (Id). White discloses doses of 10 mg/kg (paragraphs 561, 562; tables 9, 10).
However, White does not teach the formulation according to claim 1.
Mhalasakant teaches high concentration stable liquid formulation with optimal osmolality and low viscosity across different temperature excursions and devoid of aggregation. Mhalasakant teaches a pharmaceutical formulation comprising : a) 1-100 mg/ml of at least one antigen binding protein; b) 20-40 mM of Histidine; c) 50-100 mM Arginine; d) 0.002-0.02% Polysorbate 80 (w/v); e) 50-150 mM NaCl; f) not more than 2.5% Sucrose w/v; wherein pH of the formulation is 6.5±0.5 , and said formulation is stable at 2-8 ̊C for at least 9 months, at 25 ̊C for at least 1 months, at 40 ̊C for at least 40 days, at 50 ̊C for at least 2 days (claim 69), wherein the antigen binding protein is an antibody (claim 73).
Mhalasakant teaches that L-Arginine (75 mM) (as the Arginine) is used in the pharmaceutical formulation (Tables 12-18).
Mhalasakant teaches that antibodies are stable in the pharmaceutical formulation at various temperature conditions (Examples 4, 5, 6).
The formulation ranges for each component in the formulation of Mhalasakant are overlapping with the ranges recited by instant claim 1.
One of ordinary skill in the art would have been motivated to apply Mhalasakant liquid antibody formulation to White’s method of treating cancer with nivolumab and an anti-PVRIG antibody because both Mhalasakant and White disclose nivolumab and other inhibitory immune checkpoint antibodies as therapeutic antibodies for treating cancer. It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to treat cancer with an anti-PVRIG antibody CHA.7.518.1.H4(S241P) and nivolumab as taught by White in a formulation taught by Mhalasakant with a reasonable expectation of success, because antibodies in the formulation are stable under various temperature conditions, as taught by Mhalasakant. It would have been prima facie obvious to combine White’s method of treating cancer with nivolumab and an anti-PVRIG antibody with Mhalasakant antibody formulation to have a method of treatment for cancer comprising administering nivolumab and an anti-PVRIG antibody in a formulation comprising from 15 mM to 70 mM histidine, from 30 mM to 90 mM NaCl; from 50 mM to 120 mM L-Arginine, and from 0.005% to 0.007% to 0.09% w/v polysorbate 80, wherein the composition has a pH from 6.3 to 6.8, and wherein the anti-PVRIG antibody is at a concentration of from 10 mg/mL to 40 mg/mL.
Neither White nor Mhalasakant disclose nivolumab administered at a dosage of about 360 mg of nivolumab or 480 mg of nivolumab or that the anti-PVRIG antibody is administered 20 mg/kg every 4 weeks.
Balasubramanyam discloses the administration of nivolumab every 4 weeks at 480 mg (paragraph 5).
DuPont discloses administration of anti-TIGIT antibody from 10 mg to 50 mg/kg every 4 weeks (paragraphs 152-160).
One of ordinary skill in the art would have been motivated to apply Balasubramanyam and DuPont’s antibody treatment regimens to White’s method of treating cancer with nivolumab and an anti-PVRIG antibody because White, Mhalasakant, Balasubramanyam all disclose the treatment of cancer with nivolumab and other inhibitory immune checkpoint antibodies. Furthermore, DuPont discloses treatment of cancer with antibodies to TIGIT while White disclose the treatment of cancer with both PVRIG and TIGIT. PVRIG and TIGIT both function as co-inhibitory molecules on activated T cells and natural killer (NK) cells.
Furthermore, the therapeutic regimens and pharmaceutical formulations of the antibody are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 1-5, 7, 9, 11, 13-23, 25-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 16-23, 25-30 and 34-36 of copending Application No. 17/631,847 in view of White (WO 2018/033798 A1, published 2/22/2018, IDS).
The claims of Application No. 17/631,847 are drawn to a stable liquid pharmaceutical formulation of an anti-PVRIG antibody comprising:
(a) an anti-PVRIG antibody, wherein said anti-PVRIG antibody comprises:
i) a heavy chain variable domain comprising the vhCDRl, vhCDR2, and vhCDR3
from the heavy chain ofCHA.7.518.l.H4(S241P) (SEQ ID NO:8), and
ii) a light chain variable domain comprising the vlCDRl, vlCDR2, and vlCDR3
from the light chain of CHA.7.518. l.H4(S241P) (SEQ ID NO: 13);
(b) from 10 mM to 100 mM 20 mM to 30 mM histidine;
(c) from 30 mM to 100 mM 55 mM to 65 mM NaCl;
(d) from 20 mM to 150 mM 90 mM to 110 mM L-Arginine; and
(e) from 0.005% to 0.1% 0.006% to 0.02% w/v polysorbate 80,
wherein the composition stable liquid formulation has a pH from 5.5 to 7.0 6.5 +/- 0.2 and wherein the anti-PVRIG antibody is at a concentration of up to 40 mg/mL.
The specification discloses that the antibody may be used to treat cancer (paragraphs 45-52).
White teaches PVRIG antibody can be used to treat cancers, in particular CHA.7.518.1.H4(S241P) (paragraphs 330-332). White teaches PVRIG antibody (CHA.7.518.1.H4(S241P)) novel cancer immunotherapy agent either as monotherapy or in combination with either TIGIT or PD1 blockade such as nivolumab (paragraph 373; Example 18). One of ordinary skill in the art would have been motivated to apply White’s method of treating cancer with anti-PVRIG antibodies and nivolumab to the claims of Application No. 17/631,847 because both Application No. 17/631,847 and the present claims involve anti-PVRIG antibodies that may be used to treat cancer
In addition, and with regard to obviousness-type double patenting of a method over a patented composition, the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer. In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent.
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010). In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating: [i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
Therefore, claims 1-5, 7, 9, 11, 13-23, 25-32 of the instant application are not patentably distinct since Application No. 17/631,847 which claimed the same product and antibody formulations, disclosing its utility, treating cancer, in the specification.
This is a provisional nonstatutory double patenting rejection.
Summary
Claims 1-5, 7, 9, 11, 13-23 and 25-32 stand rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Halvorson whose telephone number is (571) 272-6539. The examiner can normally be reached on Monday through Friday from 9:00 am to 6:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at (571) 272-8149. The fax phone number for this Art Unit is (571) 273-8300.
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/MARK HALVORSON/ Primary Examiner, Art Unit 1646
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