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 .
DETAILED ACTION
The amendment filed April 20, 2026 in response to the Office Action of January 20, 2026 is acknowledged and has been entered.
Claims 1, 3, and 8 have been amended.
Claims 12, 21, 29-31, 42, 43, 46, 48, 55, and 57-50 have been cancelled.
Claims 1, 3, and 5-8 are pending and under consideration.
In view of amendments on claims 1, 3 and 8, the Improper Markush Grouping rejection set forth in the previous Office Action of January 20, 2026 is hereby withdrawn.
In view of amendments on claims 1, 3 and 8, the 112(b) rejection set forth in the previous Office Action of January 20, 2026 is hereby withdrawn.
The amended claims 1, 3 and 8 recites specific dUTPase inhibitor, specific inhibitors of thymidylate biosynthesis and the immunotherapy agent. Accordingly, the 112(a) Written Description rejection and 112(a) Scope of Enablement rejection set forth in the previous Office Action of January 20, 2026 are hereby withdrawn.
In view of the claim amendments and applicant’s argument, the Double Patenting rejections over Pat. No. 10,858344 and Pat. No. 11,014,924 set forth in the previous Office Action of January 20, 2026 are hereby withdrawn, because Pat. No. 10,858344 and Pat. No. 11,024,924 are drawn to different dUTPase inhibitors from the dUTPase inhibitor recited by the amended claims.
MAINTAINED/MODIFIED REJECTIONS
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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.
Claims 1, 3, and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) in view of Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
Suzuki teaches a drug comprising a drug containing a DNA function inhibitor (such as dUTPase inhibitor and a fluorinated pyrimidine antimetabolite) and an immunomodulator (such as an anti-PD-1 antibody) ([0013], claims 1, 2 and 6).
Suzuki teaches that the fluorinated pyrimidine antimetabolite can be a combination drug containing tegafur, gimeracil, and oteracil potassium in a molar ratio of 1 : 0.4 : 1, or capecitabine (claim 5). As evidenced by [0023] of Suzuki, the combination of tegafur, gimeracil, and oteracil potassium is also called S-1. As evidenced by claim 1, S-1 and capecitabine are inhibitors of thymidylate biosynthesis. Suzuki also teaches other fluorinated pyrimidine antimetabolite and anti-tumor drug, such as 5-fluorouracil (5-FU) (the elected species) ([0004], [0009], [0023]). As evidenced by amended claim 1, 5-FU is an inhibitor of thymidylate biosynthesis.
Suzuki teaches a method of treating tumor by administering effective dose of a DNA function inhibitor (such as dUTPase inhibitor and a fluorinated pyrimidine antimetabolite) and an immunomodulator (such as an anti-PD-1 antibody) (claims 62, 63, 67, 68).
Suzuki teaches a specific dUTPase inhibitor: Compound I ([0021]).
Example 4 of Suzuki teaches that combination of S-1+Compound 1+anti-PD-1 antibody (the elected species) shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). It is noted that colorectal cancer is a type of gastrointestinal cancer (the elected species).
Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use of any other two drug combination ([0113], Example 4, Fig. 16, Table 10).
Suzuki teaches the invention is not limited to each of embodiments and examples described above, and various modifications can be employed ([0115]).
Taken together, Suzuki teaches a method of treating cancer, enhancing an immunotherapy efficacy, or inhibiting cancer cell growth in a subject by administering a combination of a deoxyuridine triphosphatase (dUTPase) inhibitor (such as Compound 1), an inhibitor of thymidylate biosynthesis (a fluorinated pyrimidine antimetabolite, such as S-1) and an anti-PD-1 antibody (the elected species). In addition, regarding the 5-FU (the elected species), Suzuki teaches S-1 and 5-FU as exemplary fluorinated pyrimidine antimetabolite and anti-tumor drug ([0004], [0009], [0023], and Example 4).
However, Suzuki does not teach a dUTPase inhibitor with a structure of instantly claimed (the elected species).
Spyvee teaches various dUTPase inhibitors of Formula I (claim 1).
Spyvee teaches the dUTPase inhibitor with the structure shown below (see Production Example Number 1 in Table 1 on page 83):
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This compound is identical to the compound recited by the amended claims 1, 3 and 8 (the elected species). This compound is the same as Compound A used in the Examples (see paragraph [0590] of the instant publication US 2023/0263773 A1).
Spyvee teaches method of production of the compound (§ Synthesis Examples, [0452]-[0453]).
Spyvee teaches a method of treating and inhibiting cancer using dUTPase inhibitors (claims 23-30).
Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to modified the methods taught by Suzuki by substituting the dUTPase inhibitor (compound 1) in the three-drug combination (e.g. compound 1 + S-1 + anti-PD1 antibody) with a dUTPase inhibitor (such as Compound A) taught by Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination of Compound A + S-1 + anti-PD1 antibody would be able to treat and inhibit cancer and cancer cells and to enhance the therapeutic efficacy because compound A and compound 1 have similar activity: inhibiting dUTPase and can be used in treating cancers, as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that three drug combination was found to have a statistically significant effect of combination use of any other two drug combination; the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
Regarding claim 5, Suzuki teaches that the triple combination can reduce the tumor size (Fig. 16).
Regarding claims 6 and 7, Example 4 of Suzuki teaches that the triple combination shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). It is noted that colorectal cancer is a type of gastrointestinal cancer (the elected species).
Response to Arguments
For the rejection of claims 1, 3, and 5-8 under 35 U.S.C. 103, Applicant argues:
Spyvee describes hydantoin-containing dUTPase inhibitors, and lists Compound A among a table of more than 170 compounds. Moreover, Spyvee provides no specific biological activity for these compounds. Accordingly, one of ordinary skill in the art would find no clear guidance to particularly choose Compound A from Spyvee and modify the methods of Suzuki to replace Compound I with Compound A other than by impermissible hindsight reasoning based on the instant Application.
Applicant’s arguments have been considered, but have not been found persuasive. First contrary to Applicant’s argument, Spyvee teaches that Compound A is an Exemplary dUTPase inhibitor (Table 1, and claim 21-26). Thus, one of ordinary skill in the art would have recognized that Compound A has the activity of inhibiting dUTPase. Soyvee explicitly teaches that these inhibitors can be used treating and inhibiting cancer using dUTPase inhibitors (claims 23-30). Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]). Suzuki teaches three drug combination was found to have a statistically significant effect of combination use of any other two drug combination; the method can be modified for different embodiments. In view of the references, one of ordinary skill in the art would recognize that there are other dUTPase inhibitors can be used in the three drug combination taught by Suzuki. One of ordinary skill in the art would have been motivated to try different inhibitors (from a limited number of options) in the combination for different and/or better therapeutic properties and to expand the options of the combinations.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant further argues that the claimed combinations shows unexpected results, as shown below:
Indeed, it is only the present application that discloses the methods involving the triple combination of Compound A, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody aa an immunotherapy agent. As discussed in the application and illustrated in the examples, the presently claimed combination demonstrates a surprisingly synergistic anti-tumor efficacy. This unexpected synergy is not taught or suggested by the cited references, and so further supports patentability.
Applicant further argues that unexpected results would overcome any prima facie obviousness. However, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.)”. MPEP 716.02
The results for Example 1 in para. [0588]-[0590] of the instant publication report that Compound A (the elected species) + 5-FU + anti-PD-1 led to significant improvement in the antitumor efficacy when compared to all other treatment groups including all other 5-FU and anti-PD-1 combinations (Figure 1 ). The combination of Compound A + 5-FU + Anti-PD-1 was the only treatment group that led to complete inhibition of tumor growth from day 1 to day 19. The results for Example 2 are given in par. [0610]-[0614] of the instant publication. In par. [0613], it is concluded that "these data unexpectedly demonstrate that a dUTPase inhibitor (e.g., Compound A) leads to a significant enhancement of the infiltration of both cytotoxic and regulatory T cells (measured by CDS+ CD4+ and CD3+), leukocytes (measured by CD45+) in tumor tissue when combined with an inhibitor of thymidylate biosynthesis (e.g., 5-FU) + an immunotherapy agent (e.g., an Anti-PD-1 antibody)". Examples 3-6 (par. [0615]-[0637] of the instant publication) relate to the combination of Compound A and FUdR, which is not a triple component combination as instantly claimed.
Taken together, the instant specification provided evidence of the enhanced therapeutic activity for only one triple combination: one compound of formula (I) (compound A) with one anti-PD1 antibody (CD279) and an inhibitor of thymidylate biosynthesis (5-FU) in only one tumor model: Murine MC-38 model. However, the claims encompass a broad genus combinations of Compound A plus different inhibitor of thymidylate biosynthesis and different anti-PD-1 antibody and various cancers/tumors. Accordingly, the data is not commensurate in scope with the claimed invention and does not demonstrate the non-obviousness of the claimed invention.
Applicant further argues that the references do not provide motivation to select and combine the claimed components, as shown below:
That one of ordinary skill in the art presented with Suzuki and Spyvee could have selected and combined specific components they disclose is not enough to establish a valid obviousness rejection; the mere disclosure of components recited in the present claims does not provide the requisite motivation to select and combine them to arrive at the claimed invention.
Applicant’s arguments have been considered, but have not been found persuasive. As set forth above, one of ordinary skill in the art would have had a reasonable expectation that the combination of Compound A + S-1 + anti-PD1 antibody would be able to treat and inhibit cancer and cancer cells and to enhance the therapeutic efficacy because compound A and compound 1 have similar activity: inhibiting dUTPase and can be used in treating cancers, as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that three drug combination was found to have a statistically significant effect of combination use of any other two drug combination; the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
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.
U.S. Patent No. 10,570,098
Claims 1, 3, 5-8, 21, 29, 31, 42, 43, 46, 48, 55 and 57-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,570,098 B2 (herein after Pat. 098, cited in IDS of 06/08/2023) in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Pat. 098 teach a method of a. one or more of inhibiting dUTPase or enhancing the efficacy of a dUTPase directed therapy; or b. reversing resistance to a dUTPase-directed therapy comprising contacting the dUTPase with a therapeutically effective amount of a compound of Formula (I):… (claim 1).
The claims of Pat. 098 teach 2. a method of treating a disease in a patient whose treatment is impeded by the expression or over expression of dUTPase, comprising:
administering to the patient in need of such treatment a therapeutically effective amount of a compound of Formula (I), or …; or
screening a cell or tissue sample from the patient; determining the expression level of dUTPase in the sample; and administering to a patient whose sample shows over expression of dUTPase, a therapeutically effective amount of the compound of Formula (I), or …(claim 2);
wherein the disease is a cancer (claim 5); wherein the cancer is selected from the group consisting of colon cancer, colorectal cancer, gastric cancer… (claim 6).
The claims of Pat. 098 teach a method of inhibiting the growth of a cancer cell comprising contacting the cell with a therapeutically effective amount of the compound of Formula (I), or …; and a therapeutically effective amount of a dUTPase directed therapeutic, thereby inhibiting the growth of the cancer cell; wherein Formula (I) … (claim 3)
The claims 19 and 20 of Pat. 098 teach the method of claim 1 or the method of claim 2, wherein the compound can be:
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It is noted that the compound above is identical to the compound recited by the amended claims 1, 3, and 8 (the elected species). This compound is the same as Compound A used in the Examples of the instant Application (see paragraph [0590] of the instant publication US 2023/0263773 A1). Thus, the compound of Pat. 098 reads on the dUTPase inhibitor of all pending claims, such as claims 1, 3, and 8.
Taken together, the claims of Pat. 098 teach methods of enhancing dUTPase directed therapy, or treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I), including the elected compound of the instant application. However, the claims of Pat. 098 do not teach using the dUTPase in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches the method of making Compound A. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor such as compound A to treat cancer or inhibit cancer cell growth as taught by the claims of Pat. 098 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as Compound A + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound A is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
U.S. Patent No. 10,562,860
Claims 1, 3, and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,562,860 B2 (herein after Pat. 860, cited in IDS of 06/08/2023) in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Pat. 860 teach a compound of structure shown below (see claim 10):
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It is noted that the compound above is identical to the structure of amended claims 1, 3 and 8 (the elected species). This compound is the same as Compound A used in the Examples of the instant Application (see paragraph [0590] of the instant publication US 2023/0263773 A1). Thus, the compound of Pat. 098 reads on the dUTPase inhibitor of all pending claims, such as claims 1, 3, and 8.
The claims of Pat. 860 teach the compound above. However, the claims of Pat. 860 do not teach the method of enhancing dUTPase directed therapy, or treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I), in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’ s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches the method of making Compound A. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to make the dUTPase inhibitor such as compound A as taught by the claims of Pat. 86011 and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as Compound A + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound A is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to develop a more powerful combination therapy for cancer treatment.
U.S. Patent No. 11,104,649
Claims 1, 3, and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,104,649 B2 (herein after Pat. 649, cited in IDS of 06/08/2023) in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Pat. 649 teach a compound of formula (I):
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Claim 7 of Pat. 649 teaches that the compound of claim 1, wherein L1 can be:
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…
which read on the instant claim 43.
Claim 9 of Pat. 649 teach that the compound of claim 1, wherein L2 is -S(O)2NH- wherein the sulfur is attached to L1.
Claim 12 of Pat. 649 teach that the compound of claim 1, wherein L3 can be:
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which read on the instant claim 46.
Claim 13 of Pat. 649 teach that the compound of claim 1, wherein B is
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Based on the definition of claim 1, R20 is CH2-R21; methyl optionally substituted with 2 or 3 fluorine atoms; C3-C6 cycloalkyl; or C1-C6 alkyl; and R21 is C1-C10 alkyl optionally substituted with one or more hydroxy or fluoro; or C3-C6 cycloalkyl. Taken together, the compounds taught by the claims of Pat. 649 encompass the compound recited by the amended claims 1, 3, and 8.
Claim 15 of Pat. 649 teaches a method of treating a disease in a patient whose treatment is impeded by the expression or over expression of dUTPase, comprising:
administering to the patient in need of such treatment a therapeutically effective amount of the compound of claim 1, wherein the disease is cancer (claim 16), wherein the cancer is selected from the group consisting of colon cancer, colorectal cancer, gastric cancer, esophageal cancer, head and neck cancer, breast cancer, lung cancer, stomach cancer, liver cancer, gall bladder cancer, pancreatic cancer and leukemia (claim 17).
Claim 18 of Pat. 649 teaches a method of inhibiting the growth of a cancer cell comprising contacting the cell with a therapeutically effective amount of the compound of claim 1; and a therapeutically effective amount of a dUTPase directed therapeutic, thereby inhibiting the growth of the cancer cell; wherein the cancer cell is selected from a colon cancer cell, a colorectal cancer cell, a gastric cancer cell, a head and neck cancer cell, a breast cancer cell, a lung cancer cell or a blood cell (claim 19).
Taken together, the claims of Pat. 649 teach methods of treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I). However, the claims of Pat. 649 do not teach using the specific dUTPase inhibitor (e.g. Compound A) in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches dUTPase inhibitors of Formula (I) (such as compound A) and the method of making these compounds. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor of Formula (I) to treat cancer or inhibit cancer cell growth as taught by the claims of Pat. 649 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as the compound of taught by the claims of Pat. 649 + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound of Formula (I) (such as compound A) is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing the dUTPase inhibitors (such as compound A) is known; dUTPase inhibitors can be used in treating and inhibiting cancers (e.g. colorectal cancer); dUTPase inhibitors can be used in combination with an inhibitor of thymidylate biosynthesis to enhance therapeutic efficacy. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
U.S. Patent No. 11,584,723
Claims 1, 3, and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,584,723 B2 (herein after Pat. 723) in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Pat. 723 teach a compound of formula (I):
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Claim 9 of Pat. 723 teaches that the compound of claim 1, wherein L1 can be:
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…
which read on the instant claim 43.
Claim 10 of Pat. 723 teach that the compound of claim 1, wherein L2 is -S(O)2NH- wherein the sulfur is attached to L1.
Claim 13 of Pat. 723 teach that the compound of claim 1, wherein L3 can be:
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which read on the instant claim 46.
Claim 7 of Pat. 723 teach that the compound of claim 1, wherein B is
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Based on the definition of claim 4, R20 is CH2-R21; methyl optionally substituted with 2 or 3 fluorine atoms; C3-C6 cycloalkyl; or C1-C6 alkyl; and R21 is C1-C10 alkyl optionally substituted with one or more hydroxy or fluoro; or C3-C6 cycloalkyl…. Taken together, the compounds taught by the claims of Pat. 723 encompass the compound recited by the amended claims 1, 3, and 8.
Claim 16 of Pat. 723 teaches a method of treating a disease in a patient whose treatment is impeded by the expression or over expression of dUTPase, comprising:
administering to the patient in need of such treatment a therapeutically effective amount of the compound of claim 1, wherein the disease is cancer (claim 17), wherein the cancer is selected from the group consisting of colon cancer, colorectal cancer, gastric cancer, esophageal cancer, head and neck cancer, breast cancer, lung cancer, stomach cancer, liver cancer, gall bladder cancer, pancreatic cancer and leukemia (claim 18).
Claim 19 of Pat. 723 teaches a method of inhibiting the growth of a cancer cell comprising contacting the cell with a therapeutically effective amount of the compound of claim 1; and a therapeutically effective amount of a dUTPase directed therapeutic, thereby inhibiting the growth of the cancer cell; wherein the cancer cell is selected from a colon cancer cell, a colorectal cancer cell, a gastric cancer cell, a head and neck cancer cell, a breast cancer cell, a lung cancer cell or a blood cell (claim 20).
Taken together, the claims of Pat. 723 teach methods of treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I). However, the claims of Pat. 723 do not teach using the specific dUTPase inhibitor (Compound A) in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches dUTPase inhibitors of Formula (I) (such as compound A) and the method of making these compounds. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor of Formula (I) to treat cancer or inhibit cancer cell growth as taught by the claims of Pat. 723 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as the compound of taught by the claims of Pat. 723 + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound of Formula (I) (such as compound A) is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing the dUTPase inhibitors (such as compound A) is known; dUTPase inhibitors can be used in treating and inhibiting cancers (e.g. colorectal cancer); dUTPase inhibitors can be used in combination with an inhibitor of thymidylate biosynthesis to enhance therapeutic efficacy. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
U.S. Patent No. 12,098,133
Claims 1, 3, and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,098,133 B2 (herein after Pat. 133) in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Pat. 133 teach a compound of Formula (I) of structure shown below (see claims 1 and 10):
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It is noted that the compound above is identical to the first compound listed in the instant claims 1, 3, and 8 (the elected species). This compound is the same as Compound A used in the Examples of the instant Application (see paragraph [0590] of the instant publication US 2023/0263773 A1). Thus, the compound of Pat. 133 reads on the dUTPase inhibitor of all pending claims, such as claims 1, 3, 8.
The claims of Pat. 133 teach a method of treating a disease in a patient comprising administering a compound of Formula (I) (a dUTPase inhibitor), such as the compound shown above (claims 1, 10 and 15); wherein the disease is a cancer (claim 16), wherein the cancer can be colon cancer, colorectal cancer, gastric cancer, esophageal cancer, head and neck cancer, breast cancer, lung cancer, stomach cancer, liver cancer, gall bladder cancer, pancreatic cancer or leukemia (claim 17).
The claims of Pat. 133 teach a method of inhibiting the growth of a cancer cell comprising contact the cell with a compound of Formula (I) (a dUTPase inhibitor), such as the compound shown above (claims 1, 10 and 18), wherein the cancer cell is selected from a colon cancer cell, a colorectal cancer cell, a gastric cancer cell, a head and neck cancer cell, a breast cancer cell, a lung cancer cell or a blood cell (claim 19).
Taken together, the claims of Pat. 133 teach methods of treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I), including the elected compound of the instant application. However, the claims of Pat. 133 do not teach using the dUTPase in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches the method of making Compound A. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor such as compound A to treat cancer or inhibit cancer cell growth as taught by the claims of Pat. 133 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as Compound A + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound A is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
Application No. 18/807,770
Claims 1, 3, and 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-9, and 12-19 of copending Application No. 18/807,770 (hereinafter Appl. 770) in view of in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Appl. 770 teaches a compound of Formula (I) (see claims 1, 2, 4-9 of Appl. 770) which has a scope overlapping with the instantly claimed compound recited by the amended claims 1, 3, and 8..
The claims of Appl. 770 teach a method of treating a disease in a patient comprising administering a compound of Formula (I) as a dUTPase inhibitor (claim 15); wherein the disease is a cancer (claim 16), wherein the cancer can be colon cancer, colorectal cancer, gastric cancer, esophageal cancer, head and neck cancer, breast cancer, lung cancer, stomach cancer, liver cancer, gall bladder cancer, pancreatic cancer or leukemia (claim 17).
The claims of Appl. 770 teach a method of inhibiting the growth of a cancer cell comprising contact the cell with a compound of Formula (I) as a dUTPase inhibitor (claim 18), wherein the cancer cell is selected from a colon cancer cell, a colorectal cancer cell, a gastric cancer cell, a head and neck cancer cell, a breast cancer cell, a lung cancer cell or a blood cell (claim 19).
Taken together, the claims of Appl. 770 teach methods of treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I) (a dUTPase inhibitor). However, the claims of Appl. 770 do not teach using the dUTPase in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed; or the specific dUTPase inhibitor: compound A (the elected species).
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor (compound I), an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches the specific inhibitor Compound A, the method of making Compound A. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor of Formula (I) to treat cancer or inhibit cancer cell growth as taught by the claims of Appl. 770 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as Compound A + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound A is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
This is a provisional nonstatutory double patenting rejection.
Application No. 19/065,805
Claims 1, 3, and 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/065,805 (hereinafter Appl. 805) in view of in view of Suzuki (Suzuki, EP3400963A1, Publication Date: 11/14/2018, cited in IDS of 12/15/2022) and Spyvee (Spyvee et al., WO 2017/006282 A1, Publication Date: 01/12/2017, cited in IDS of 12/15/2022).
The claims of Appl. 805 teach a compound of Formula (I) of structure shown below (see claims 1 and 10):
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It is noted that the compound above is identical to the first compound listed in the instant claim 57 (the elected species). This compound is the same as Compound A used in the Examples of the instant Application (see paragraph [0590] of the instant publication US 2023/0263773 A1). As set forth above, the compound of Pat. 098 reads on the dUTPase inhibitor of all pending claims, such as claims 1, 3, 8.
The claims of Appl. 805 teach a method of treating a disease in a patient comprising administering a compound of Formula (I), such as the compound shown above (claims 1, 10 and 15); wherein the disease is a cancer (claim 16), wherein the cancer can be colon cancer, colorectal cancer, gastric cancer, esophageal cancer, head and neck cancer, breast cancer, lung cancer, stomach cancer, liver cancer, gall bladder cancer, pancreatic cancer or leukemia (claim 17).
The claims of Appl. 805 teach a method of inhibiting the growth of a cancer cell comprising contact the cell with a compound of Formula (I) (a dUTPase inhibitor), such as the compound shown above (claims 1, 10 and 18), wherein the cancer cell is selected from a colon cancer cell, a colorectal cancer cell, a gastric cancer cell, a head and neck cancer cell, a breast cancer cell, a lung cancer cell or a blood cell (claim 19).
Taken together, the claims of Appl. 805 teach methods of treating cancers, or inhibiting cancer cell growth with dUTPase inhibitors of Formula (I) (a dUTPase inhibitor), including the elected compound of the instant application. However, the claims of Pat. 133 do not teach using the dUTPase in combination with inhibitor of thymidylate biosynthesis (such as S-1 or 5-FU) and an immunotherapy agent (such as anti-PD-1 antibody), as instantly claimed.
Suzuki and Spyvee’s teachings are described above. In particular, Suzuki teaches a combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis (S-1), and an anti-PD-1 antibody, shows enhanced anti-tumor activity (Table 10), in a colorectal carcinoma model (CMT-93 tumor model). Suzuki teaches that the three drug combination was found to have a statistically significant effect of combination use to any other two drug combination ([0113], Example 4, Fig. 16, Table 10). Spyvee teaches the method of making Compound A. Spyvee teaches that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302]).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to use dUTPase inhibitor such as compound A to treat cancer or inhibit cancer cell growth as taught by the claims of Appl. 805 and to modify the method and to use the inhibitor in combination with an inhibitor of thymidylate biosynthesis (such as S-1, or 5-FU), and an anti-PD-1 antibody as taught by Suzuki and Spyvee. One of ordinary skill in the art would have had a reasonable expectation that the combination (such as Compound A + S-1 + anti-PD1 antibody) would be able to treat and inhibit cancer and to enhance the therapeutic efficacy because the combination of a dUTPase inhibitor, an inhibitor of thymidylate biosynthesis, and an anti-PD-1 antibody showed enhanced anti-tumor activity, Compound A is a well-known dUTPase inhibitor as taught by Suzuki and Spyvee. One of ordinary skill in the art would have a reasonable expectation to reach the claimed invention because references teaches that the method can be modified for different embodiments; the method of producing Compound A is known; Compound A can be used in treating and inhibiting cancers (e.g. colorectal cancer); Compound A can be used in combination with an inhibitor of thymidylate biosynthesis. The motivation would have been to expand the options of the three drug combination and to develop better combinations for cancer treatment.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
For the Double Patenting rejections of claims 1, 3, and 5-8, Applicant argues:
As an initial matter, Applicant notes that the '805 Application is a continuation of the '770 Application, which is a continuation of the '133 Patent, which is a continuation of the '723 Patent, which is a continuation of the '649 Patent, which is a continuation of the '860 Patent, which is a continuation of the '098 Patent, which is the national stage entry of international Patent Application No. PCT/IB2016/054091, which published as Spyvee (WO 2017/006282). Accordingly, the '805 Application, the '770 Application, the '133 Patent, the '723 Patent, the '649 Patent, the '860 Patent, the '098 Patent, and Spyvee all share the same application disclosure.
The Office Action relies on Spyvee for teaching "that the dUTPase inhibitor can be used in combination with an agent which is suitable for treating the disease ([0173]), such as 5-FU, capecitabine, S-1 ([0301] and [0302])." See Office Action at pp. 28, 30, 33, 37, 40, 44, 47, 49, and 52. However, the Office Action's reliance on the teachings of Spyvee is prohibited by the MPEP, which states that"[ w ]hen considering whether the invention defined in a claim of an application would have been anticipated by or is an obvious variation of the invention defined in the claim of a patent or copending application, no part of the reference patent or application may be used as if it were prior art." See MPEP 804(II)(B)(l). Accordingly, these seven rejections which rely on Spyvee are necessarily improper and should be withdrawn.
It is noted that the Double Patenting rejections over Pat. No. 10,858,344 and Pat. No. 11,014,924 set forth in the previous Office Action of January 20, 2026 are hereby withdrawn, because Pat. No. 10,858,344 and Pat. No. 11,014,924 are drawn to different dUTPase inhibitors from the dUTPase inhibitor recited by the amended claims.
For other Double Patenting rejections, the Applicant’s arguments have been considered, but have not been found persuasive. Spyvee has a publication date of January 12, 2017 and the instant application has a priority date of June 26, 2020. Thus, Spyvee is a qualified 102(a)(1) reference. MPEP 804(II)(B)(3) states: “Any secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102”. Accordingly, Spyvee can be used as prior art in the obviousness Double Patenting rejection.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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/CHENG LU/ Examiner, Art Unit 1642
/PETER J REDDIG/ Primary Examiner, Art Unit 1646
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