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 .
Claims 1-15 are pending and are under examination.
Claims 5-6, 8-15 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend on another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
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 1-4 and 7 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 1 is indefinite in the recitation of a “cold” tumor since the metes and bounds are not clear. The specification discloses that a “cold” tumor is characterized by a “low” amount or absence of lymphocytes or a “low” TMB. However, The term “low” is a relative term which does not adequately define the scope of the claim. The specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 2 is indefinite in the recitation of a “low” for the same reasons set forth above.
Claims 4 and 7 are indefinite since they recite, in the same claims, a broad range and a narrow range within the broad range. 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, claims 2 and 7 recite the broad recitation of about 30-40, and the claim also recites about 40 , about 35 and about 30, which is the narrower statement of the range/limitation. 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. Claim 7 also recites a level of about 2.5, and preferably about 2.3, which is also indefinite for the same reason set forth above.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) a dendritic cell vaccine. This judicial exception is not integrated into a practical application because said dendritic cells are products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
In the instant case, the claims are directed to a dendritic cell vaccine, which is a composition of matter as set forth in Step 1 of the subject matter eligibility test (see MPEP 2106). Regarding step2A, prong 1, dendritic cells are products of nature (see, for example, WO2019/145471, page 1, which describes the role of naturally occurring dendritic cells as a component of the immune system for inducing T cell responses). Thus, dendritic cells in the human body would be structurally identical to those recited in the present claims. Regarding step 2A prong two and step 2B, the claims do not recite additional elements that integrate the judicial exception into a practical application, nor do the claims recite any additional elements that amount to significantly more than the judicial exception. The only other limitation is the recitation of a “vaccine” and an intended use in a specific patient subset. However, these limitations, recited at a high level of generality amount to nothing more than field of use or insignificant extra-solution activity.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2019/145471 (of record).
WO2019/145471 teaches a dendritic cell vaccine (see page 2, in particular). Regarding the limitation of for use in a method of treating a tumor in a patient or treating cancer in a patient, wherein the patient is selected by determining that they have a cold tumor or certain amounts of CD8 T cells, this refers to an intended use of the claimed dendritic cell vaccine. In other words, the claims are directed to a product that is intended to be used in a method of treating cancer. Intended use limitation must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. See MPEP 2111.02. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the intended use is for treating a tumor in particular types of selected patients. The instant specification discloses on page 2 that “dendritic cell vaccine” refers to human DCs for therapeutic use that may be administered, being prepared without an antigen source or with an antigen source, and that preferably the DCs have been prepared by loading the DCs with an antigen sourced from tumor associated peptides, tumor lysate, or whole tumor cells, and that the loaded DCs may be matured with TLR agonists.
WO2019/145471 specifically teaches that the dendritic cell vaccine can be human DCs for therapeutic use being prepared without an antigen source or with an antigen source, and that preferably the DCs have been prepared by loading the DCs with an antigen sourced from tumor associated peptides, tumor lysate, or whole tumor cells, and that the loaded DCs may be matured with TLR agonists. Thus, the dendritic cell vaccines of the prior art are structurally identical to those of the instant claims and would be capable of performing the intended use recited in the instant claims, thus anticipating the claims.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0000899.
The ‘899 publication teaches a dendritic cell vaccine that can be used to treat a patient with a “cold” tumor, wherein the cold tumor has no infiltrating cytotoxic T cells (i.e. CD8 T cells, see paragraphs 26 and 33-35, in particular). Regarding the limitations explaining how the patients are selected, the claims are directed to a product and those limitations are features of the intended use of the claimed product. In other words. Intended use limitation must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. See MPEP 2111.02. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the dendritic cell vaccine in the prior art is structurally and functionally identical to that of the instant claims, i.e. it is a dendritic cell vaccine that can treat “cold” tumors that have absence of infiltrating cytotoxic CD8 T cells.
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 1-4, 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 and 31 of U.S. Patent No. 9,562,219, claims 1-18 of US 9,895,430, claims 12-14 of U.S. 10,550,033, or claims 1-19 of 10,561,717
Although the claims at issue are not identical, they are not patentably distinct from each other because the patents claim a method of producing a composition comprising dendritic cells and an immunogenic cancer cell for use in immunotherapy, i.e. methods of making and using a dendritic cell vaccine. The instant specification on page 2 discloses that the “dendritic cell Vaccine” of the instant claims encompasses dendritic cells that have been loaded with immunogenic cancer cells. Therefore, the dendritic cell compositions made and used in the conflicting patents are structurally identical to the claimed dendritic cell vaccine and the intended use limitations of the instant claims do not impart any structural difference compared to the dendritic cells of the conflicting patents.
Claims 1-4, 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US 10,905,751 or claims 1-22 of US 10,918,704. Although the claims at issue are not identical, they are not patentably distinct from each other because the patents claim a method of treating cancer by administering a dendritic cell loaded with immunogenic tumor cells, or a method of producing a dendritic cell loaded with immunogenic tumors cells, i.e. methods of making and using dendritic cell vaccines. The instant specification on page 2 discloses that the “dendritic cell vaccine” of the instant claims encompasses dendritic cells that have been loaded with immunogenic cancer cells. Therefore, the dendritic cell compositions made and used in the conflicting patents are structurally identical to the claimed dendritic cell vaccine and the intended use limitations of the instant claims do not impart any structural difference compared to the dendritic cells of the conflicting patents.
Claims 1-4 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/036,294 or claims 1, 4-7, 10-12, 15-16, 18-23 of 16/964,847 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘294 application and ‘847 applications claim a method of treating cancer comprising administering a dendritic cell vaccine, wherein the vaccine is loaded with tumor cells. This is structurally identical to the instant claims, and anticipates the instantly claimed dendritic cell vaccine since it is capable of performing the claimed intended use for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644