DETAILED ACTION
Election/Restrictions
Applicant’s election of species, filed March 11, 2026, is acknowledged and entered. The elected species are: a first and second arenavirus species, IV administration, and no administration of an immune checkpoint inhibitor. Applicant’s remarks concerning the election of a single sequence from SEQ ID NO: 3-5 are persuasive, thus SEQ ID NO: 3-5 are under examination. Further, since Applicant elected the species of a first and second arenavirus, SEQ ID NO: 1, 2 and 6-8 are also under examination. Thus, claims 43, 44, 47, 50, 51, 53, 56, 59, 77, 87 and 120-122 are under examination with regard to the elected species.
Drawings
The drawings are objected to because Figures 8-13 have sequences that need to be identified by a sequence identifier.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In lieu of filing corrected drawings, the specification may be amended to recite the sequence identifiers in the brief description of the figures.
Claims Summary
Claim 43 is directed to a method for treating cancer in a patient in need thereof comprising one or more sessions, each session comprising:
Administering to the patient an effective amount of engineered replication-competent tri-segmented arenavirus particles comprising two S-segments encoding a fusion protein of HPV16 E7/E6 derived from a first arenavirus species; and
Administering the same from a second arenavirus species at a time point around half of the session.
The effective amount for i) and ii) is about 5x105, 1x106, 5x106, 1x107, 5x107, 1x108, 5x108, or 1x109 replication-competent virus focus-forming units (RCV FFU). The cancer is HPV 16+ (claim 53). The patient had tumor progression or recurrence on at least one standard-of-care therapy prior to the method (claim 56). The method results in a change in level of a cytokine or chemokine in the serum of the patient as compared to the pre-treatment level of the patient, an increase of HPV16 E7/E6-specific T cells in the serum of the patient as compared to the pre-treatment level of the patient, more T cells infiltrating into tumor tissues as compared to the pre-treatment level of the patient or patients receiving placebo, and/or one or more improved efficacy endpoint using RECIST and/or iRECIST compared to the pre-treatment level of the patient or patients receiving placebo (claim 77).
The first arenavirus species is LCMV and the second is PICV, or vice versa (claim 44). According to claim 47, the particles of i) and/or ii) (above) comprise:
Construct 1 is LCMV-based and consists of two S-segments and one L-segment encoding a fusion protein of HPV16 E7/E6 with five amino acid mutations to abrogate the oncogenic potential of E7 and E6, or
Construct 2 is PICV-based and consists of two S-segments and one L-segment encoding a fusion protein of HPV16 E7/E6 with five amino acid mutations to abrogate the oncogenic potential of E7 and E6
The fusion protein of Construct 1 or 2 is encoded by SEQ ID NO: 1 or 2 (claim 120. Construct 1 comprises SEQ ID NO: 3-5, and/or Construct 2 comprises SEQ ID NO: 6-8 (claims 121 and 122, respectively). SEQ ID NO: 3 and 4 represent a first and second S segment from LCMV with an optimized ORF for the E7/E6 fusion protein, respectively. SEQ ID NO: 6 and 7 represents a first and second S segment from PICV with an optimized ORF for the E7/E6 fusion protein, respectively. SEQ ID NO: 5 and 8 represent LCMV and PICV L segments, respectively. Administration is IV (claim 59). Claim 87 is directed to embodiments A-F and J, detailing various multiple sessions protocols wherein administration is IV.
In the embodiment of claim 50, the particles of i) are Construct 2, and the particles of ii) are Construct 1. The effective amount of Construct 2 is about 1x106, 7, 8 or 9 RCV FFU, and the effective amount of Construct 1 is about 5x105, 6, 7 or 1x108 or 5x108 RCV FFU, wherein each session lasts for 6 weeks, and administration is IV (claim 51).
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.
Claims 43, 44, 47, 50, 51, 53, 56, 59, 77, 87 and 120-122 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 43 recites “derived from a first arenavirus species”, and “derived from a second arenavirus species”. Claim 47 recites “”LCMV-based” and “PICV-based”. The metes and bounds of the structures that are “derived from” or “based” on these viruses cannot be determined. There is no indication of what structures from the originals are retained in the derivatives. Removal of the term “derived” from claim 43 would overcome this rejection. Suggested language for claim 47 is “wherein Construct 1 consists of two LCMV S-segments and one LCMV L-segment”, or equivalent language.
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 47, 50, 51, 59 and 87 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.
The claims are directed to methods of treating cancer by administering two species of arenavirus, both expressing a fusion protein comprising HPV E7/E6, wherein the fusion protein has five amino acid mutations to abrogate the oncogenic potential of E7 and E6. The claims encompass a large genus of mutations anywhere along fusion protein, provided that the oncogenic potential of E7 and E6 is abrogated.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, Applicant has not provided any structure for the mutations, either by location or type of mutation. Applicant has provided a function for the mutated fusion protein, which is that the E6 and E7 oncogenic potential is abrogated. Figure 2A of the specification shows a schematic of a fusion protein of E7/E6 with five mutations (asterisks), however, the exact location and the type of mutation are not identified in the Figure. The specification indicates that Construct 1 comprises an E7E6 fusion protein having five mutations, referencing Cassetti et al., 2004, Vaccine. 2004; 22(3-4):520-27 (cited in the IDS filed 10/24/2023). Cassetti identifies the five mutations that abrogate oncogenic potential as C63G and C106G in E6, and C24G, E26G and C91G in E7 (see Figure 1). The instant specification does not appear to identify the mutations except by referencing Cassetti et al., which is an improper attempt to incorporate essential material (see 37 CFR 1.57(c)). It is presumed that these mutations are present in sequences encoded by SEQ ID NO: 1 and 2 (instant claim 120).
Even if the five mutations disclosed in Cassetti et al. could be incorporated into the instant specification, the only mutations are those five: C63G and C106G in E6, and C24G, E26G and C91G in E7. No other mutations have been provided. No structure-function correlation is given. Those five mutations are not representative of the large genus of mutations that could be made anywhere along the fusion protein E7/E6. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived.
Claim Rejections - 35 USC § 102
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.
Claims 43, 44, 47, 50, 51, 53, 59, 77 and 120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orlinger et al. (WO 2018/185307 A1, cited in the IDS filed 10/24/2023, “Orlinger”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Orlinger discloses methods of treating tumors by administering arenavirus particles from different arenaviruses expressing the same tumor antigen, such as a fusion protein of HPV16 E7 and E6 proteins (see abstract, paragraphs [0019] and [0042]) (claim 43). The particles are replication competent and comprise a tri-segmented genome of one L segment and two S segments (see paragraph [0020]) (claim 43). The first or the second arenavirus is LCMV or PICV (see paragraph [0059]) (claim 44). The fusion protein of E7/E6 has five mutations abrogating the oncogenic potential of E7 and E6 (see paragraph [00332]) (claims 47 and 50). Orlinger contemplates doses of 1x106, 7, 8, 9, and 5x105,6, 7, 8 FFU (see paragraph [00306]), administered, for example, as a single dose followed by a second dose three to six weeks later (claims 43 and 51). Although Orlinger does not name the time period as a session or describe the second administration as a halfway through a session, Orlinger’s timing qualifies since no particular parameters are given in claim 43. Although Orlinger does not state that the type of cancer/tumor is HPV 16+, it is expected that HPV 16+ cancer will be treated because HPV16 E7/E6 is administered (claim 53). Administration options include IV (see paragraph [0039]) (claim 59). An outcome of the method is a change in the level of the cytokine IFN-γ, for example (see paragraph [00274]) (claim 77). Addressing claim 120, directed to an embodiment wherein the fusion protein of HPV16 E7/E6 is encoded by SEQ ID NO: 1, Applicant’s SEQ ID NO: 1 (768-nt) is within Orlinger’s SEQ ID NO: 27 (2468-nt). Therefore, the claims are anticipated by Applicant’s own work.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Orlinger et al. (WO 2018/185307 A1, cited in the IDS filed 10/24/2023, “Orlinger”) as applied to claim 43 above. Claim 56 is directed to an embodiment wherein the patient had a tumor progression or recurrence on at least one standard-of-care therapy.
The teachings of Orlinger are outlined above. Orlinger does not specifically state that a patient receiving Orlinger’s method of treatment had a tumor progression or recurrence on at least one standard-of-care therapy. However, Orlinger does teach that their method is for subjects in remission, having a recurrent cancer, or for reducing the frequency of recurrence of cancer (see paragraphs [00270]-[00271]). It would have been obvious for patients in these categories to have received prior treatment with standard-of-care therapy, such as chemotherapy, with a reasonable expectation of success (see paragraph [00277]). Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 43, 44, 47, 50, 51, 53, 56, 59, 77 and 120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 10,669,315 B2 (cited in the IDS filed 10/24/2023) in view of Orlinger et al. (WO 2018/185307 A1, cited in the IDS filed 10/24/2023, “Orlinger”).
Patented claims 20 and 22-24, respectively, are directed to a method of treating or preventing an HPV infection in a patient, or inducing an immune response in a subject, by administering a first arenavirus viral vector and, after a period of time, a second, different, arenavirus viral vector, both vectors expressing the same antigen, a fusion protein of HPV16 E7/E6 (encoded by SEQ ID NO: 10, see patented claim 1). The arenavirus viral vector is tri-segmented, replication competent (see patented claim 5), comprising one L segment and two S segments, and a nucleotide sequence that expresses an HPV16 E7/E6 fusion protein. Although the patented claims do not state that the type of cancer/tumor is HPV 16+, it would have been obvious to have claimed such because the expressed antigen in the patented claims is from HPV16. Patented claim 15 indicates that antigen-specific T-cells are induced. Patented claim 19 is directed to a method that prevents manifestations of the HPV infection, including certain types of cancer. Patented claim 40 is directed to an embodiment wherein the arenavirus is from LCMV, and patented claim 49, PICV.
One difference between the instant claims and the patented claims is that the instant claims specify an effective amount and time period between the administration of the first arenavirus vector and the second. Orlinger discloses methods of treating tumors by administering arenavirus particles from different arenaviruses expressing the same tumor antigen, such as a fusion protein of HPV16 E7 and E6 proteins (see abstract, paragraphs [0019] and [0042]). The particles are replication competent and comprise a tri-segmented genome of one L segment and two S segments (see paragraph [0020]). Orlinger contemplates doses of 1x106, 7, 8, 9, and 5x105,6, 7, 8 FFU (see paragraph [00306]), administered, for example, as a single dose followed by a second dose three to six weeks later.
Another difference between the instant claims and the patented claims is that the instant claims specify LCMV and PICV, whereas the patented claims only identify LCMV. Orlinger discloses a similar method wherein the first or the second arenavirus is LCMV or PICV (see paragraph [0059]).
Another difference between the instant claims and the patented claims is that the instant claims specify intravenous administration. Orlinger discloses administration options, including IV (see paragraph [0039]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the fusion protein of E7/E6 has five mutations abrogating the oncogenic potential of E7 and E6. This feature is taught in Orlinger (see paragraph [00332]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the patient had a tumor progression or recurrence on at least one standard-of-care therapy. Orlinger does not specifically state that a patient receiving Orlinger’s method of treatment had a tumor progression or recurrence on at least one standard-of-care therapy. However, Orlinger does teach that their method is for subjects in remission, having a recurrent cancer, or for reducing the frequency of recurrence of cancer (see paragraphs [00270]-[00271]). It would have been obvious to have claimed this embodiment wherein patients in these categories have received prior treatment with standard-of-care therapy, such as chemotherapy, with a reasonable expectation of success (see paragraph [00277]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the fusion protein of HPV16 E7/E6 is encoded by SEQ ID NO: 1. Applicant’s SEQ ID NO: 1 (768-nt) is within Orlinger’s SEQ ID NO: 27 (2468-nt).
It would have been obvious to have claimed the features taught by Orlinger with a reasonable expectation of success, given the similarity of the methods and the details that the feature provide to the generic features of the patented claims.
Claims 43, 44, 47, 50, 51, 53, 56, 59, 77 and 120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,266,727 B2 (cited in the IDS filed 10/24/2023) in view of Orlinger et al. (WO 2018/185307 A1, cited in the IDS filed 10/24/2023, “Orlinger”).
Patented claims 8 and 9, respectively, are directed to a method of treating or preventing a neoplastic diseases in a subject, by administering a first arenavirus particle and, after a period of time, a second, different, arenavirus particle, both expressing the same antigen, an HPV E7 and E6 protein. The arenavirus viral vector is tri-segmented, replication competent (see patented claim 14), comprising one L segment and two S segments. Patented claim 17 is directed to an embodiment wherein the arenavirus is from LCMV.
One difference between the instant claims and the patented claims is that the instant claims specify an effective amount and time period between the administration of the first arenavirus vector and the second. Orlinger discloses methods of treating tumors by administering arenavirus particles from different arenaviruses expressing the same tumor antigen, such as a fusion protein of HPV16 E7 and E6 proteins (see abstract, paragraphs [0019] and [0042]). By administering HPV16 E7 and E6, one would have expected to treat an HPV16+ type cancer. The particles are replication competent and comprise a tri-segmented genome of one L segment and two S segments (see paragraph [0020]). Orlinger contemplates doses of 1x106, 7, 8, 9, and 5x105,6, 7, 8 FFU (see paragraph [00306]), administered, for example, as a single dose followed by a second dose three to six weeks later.
Another difference between the instant claims and the patented claims is that the instant claims specify LCMV and PICV, whereas the patented claims only identify LCMV. Orlinger discloses a similar method wherein the first or the second arenavirus is LCMV or PICV (see paragraph [0059]).
Another difference between the instant claims and the patented claims is that the instant claims specify an outcome, such as a change in the level of cytokine in the serum of a patient. An outcome of Orlinger’s method is a change in the level of the cytokine IFN-γ, for example (see paragraph [00274])
Another difference between the instant claims and the patented claims is that the instant claims specify intravenous administration. Orlinger discloses administration options, including IV (see paragraph [0039]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the fusion protein of E7/E6 has five mutations abrogating the oncogenic potential of E7 and E6. This feature is taught in Orlinger (see paragraph [00332]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the patient had a tumor progression or recurrence on at least one standard-of-care therapy. Orlinger does not specifically state that a patient receiving Orlinger’s method of treatment had a tumor progression or recurrence on at least one standard-of-care therapy. However, Orlinger does teach that their method is for subjects in remission, having a recurrent cancer, or for reducing the frequency of recurrence of cancer (see paragraphs [00270]-[00271]). It would have been obvious to have claimed this embodiment wherein patients in these categories have received prior treatment with standard-of-care therapy, such as chemotherapy, with a reasonable expectation of success (see paragraph [00277]).
Another difference between the instant claims and the patented claims is that the instant claims specify that the fusion protein of HPV16 E7/E6 is encoded by SEQ ID NO: 1. Applicant’s SEQ ID NO: 1 (768-nt) is within Orlinger’s SEQ ID NO: 27 (2468-nt).
It would have been obvious to have claimed the features taught by Orlinger with a reasonable expectation of success, given the similarity of the methods and the details that the feature provide to the generic features of the patented claims.
Conclusion
No claim is allowed.
SEQ ID NO: 2 is free of the prior art of record. SEQ ID NO: 2 differs from Orlinger’s SEQ ID NO: 27 (nt 79-846) at one position. SEQ ID NO:2, nt 525 differs from nt 603 of SEQ ID NO: 27.
A nucleotide sequence comprising the combination of SEQ ID NO: 3-5 is free of the prior art of record.
A nucleotide sequence comprising the combination of SEQ ID NO: 6-8 is free of the prior art of record.
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/STACY B CHEN/Primary Examiner, Art Unit 1672
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