DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
The instant application is a 371 of PCT/US2020/055633 filed on 10/14/2020 and claims domestic benefit to US provisional application no. 62/914,881 filed on 10/14/2019.
Status of the Claims
The preliminary claim amendments and remarks filed on 09/05/2025 is acknowledged. Claim 19, 42, and 51-53 are amended. Claims 7-9, 16-18, 25-41, 43-50, and 54-56 are cancelled.
Accordingly, claims 1-6, 10-15, 19-24, 42, and 51-53 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(b) rejection over claim 53 is withdrawn in view of the previously recited “inaccessible for intratumoral administration” being changed to “distal to the primary or secondary tumor”.
The 35 USC 102 rejection over Zhong for claim 42 is withdrawn in view of claim 42 now being dependent upon claims 15, 10, and 1.
Drawings
The drawings are objected to because the data in all of the graphs for FIG. 1-10 have poor resolution and are difficult to discern the different types of lines and symbols.
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.
The following grounds of rejections are maintained from the previous Office Action with amendments to address the amendments in instant claims 19 and42 as well as new rejection over claim 53 as necessitated by Applicant’s amendments.
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.
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.
Claims 1-6, 10-15, 19-24, 42 and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (WO 2017161349 in IDS filed 04/14/2022) in view of Cemerski et al. (US 20190328762 in IDS filed 04/14/2022)).
Zhong et al. teaches the recited compound in instant claim 1, 19, and 53 as a STING agonist for treating cancer in a patient in need thereof (see paragraph [031] and [055]). Furthermore, Zhong et al. discloses administering in combination with immune checkpoint inhibitors, such as humanized antibodies against PD1, PD-L1, CTLA4 and other molecules that block effective anti-tumor immune responses (see paragraphs [064-065]). Lastly, Zhong et al. discloses that only a small percentage of cancer patients benefit from the checkpoint inhibitor therapies because of insufficient number of anti-tumor immune cells are generated into the tumors, which is being interpreted as a cancer patient who is unresponsive to PD-1 or PD-L1 inhibition. Zhong et al. also discloses that cGAMP analogues are expected to function synergistically with immune checkpoint inhibitors and the combination therapies are likely to bring therapeutic benefits to a larger percentage of cancer patients (see paragraph [0164]).
In regards to instant claim 1, Zhong et al. teaches the recited compound in instant claim 1 as a STING agonist for treating cancer in a patient in need thereof (see paragraph [031] and [055]). However, Zhong et al. does not necessarily teach the administering cycle recited in claim 1.
Cermerski et al. discloses similar cyclic dinucleotides STING agonists for treating cancer (see compounds in paragraph [0206] and treating cancer in paragraphs [0220-0242]). Cermerski et al. specifically discloses that their cyclic dinucleotide STING agonist compounds can be administered once every 3, 7, 14, 21, 28 days. Furthermore, Cermeski et al. discloses the compound can be administered in various time intervals such as once every 3, 7, 14, 21, or 28 days for up to 3 months, followed by a period, lasting at least 2 months, in which the time interval between doses is increased by at least two-fold (see paragraphs [0211-0213]).
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have applied the administering cycle recited in instant claim 1 within the scope of Cermerski et al. for the STING agonist compounds disclosed by Zhong et al. to arrive at the claimed invention because both prior arts teach the same genus of cyclic dinucleotide STING agonist compounds useful for the same purpose (treating cancer).
In regards to instant claims 2-6 and 51-52, Zhong et al. discloses their compositions can be administered in an amount from about 0.01 mg to about 1 g per day (see paragraph [0152]).
Cemerski et al. discloses administering the cyclic dinucleotide STING compounds intratumorally, systemically, or subcutaneously (see paragraph [0083] and paragraph [0210]), which meet the limitations of examined claims 2-4. Cermerski et al. discloses administering the cyclic dinucletodie STING agonist compounds in amounts ranging from 10 ug to 3000 ug (see paragraph [0273]), which overlap with the disclosed ranges recited in examined clams 5-6. Cermerski et al. discloses that their method can be used to treat all of the recited cancers in examined claim 51 as well as cancers that have metastasized recited in instant claim 52 (see paragraphs [0220-0242]).
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to select the narrower range of administering disclosed by Cermeski et al. within the range of Zhong et al. because Cermeski et al. discloses a method to identify a maximum tolerated dose for their compounds (see paragraphs [0295-0301]) and would therefore be obvious to select the smallest effective dose to minimize side effects. Furthermore, it is also obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the compounds intratumorally, systemically, or subcutaneously for treating cancers as disclosed by Cermeski et al. because both prior arts teach the same genus of cyclic dinucleotide STING agonist compounds that can be effectively administered for treating cancer.
In regards to instant claims 10-15 and 42, Zhong et al. discloses further administering immune checkpoint inhibitors, such as humanized antibodies against PD1, PD-L1, CTLA4 and other molecules that block effective anti-tumor immune responses (see paragraphs [064-065]), which meet the limitations of instant claims 10 and 15.
However, Zhong et al. does not necessarily disclose the immune checkpoint inhibitor is administered prior / after the first cycle, initiated after the patient’s cancer has stabilized, or undergone at least 1 cycle of immune checkpoint inhibitor prior to the first cycle as recited in examined claims 11-14.
Cermeski et al. discloses similar cyclic dinucleotide STING agonist compounds which can be administered in combination with a PD-1 antagonist (see Abstract). Cermeski et al. discloses their combination therapy may be used following surgery to remove a tumor and may be used after radiation treatment (see paragraph [0215]), which is being interpreted as stabilization of a patient’s cancer. Furthermore, Cermeski et al. discloses their combination therapy is administered to a patient who has not previously been treated with a biotherapeutic or chemotherapeutic agent, targeted therapy, or hormonal therapy, i.e., is treatment-naïve and in other embodiments, the combination therapy is administered to a patient who failed to achieve a sustained response after prior therapy with the biotherapeutic or chemotherapeutic agent, i.e., is treatment-experienced (see paragraph [0216]).
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have administered the claimed compound by any of the limitations recited in instant claims 11-14 within the scope of Cermeski et al. for the compounds disclosed by Zhong et al. to arrive at the claimed methods because both prior arts teach the same genus of cyclic dinucleotide STING agonists that are useful for the same purpose of treating cancer.
In regards to claims 19-24, Zhong et al. discloses the claimed compound recited in examined claim 19 as a STING agonist for treating cancer as described above. However, Zhong et al. does not necessarily disclose a priming or maintenance dose.
Cermeski et al. teaches similar STING agonist compounds for treating cancer with administering cycles that read within the limitations recited in examined claim 21-23 as described above. Furthermore, Cermeski et al. discloses in their Example 2 (paragraphs [0293-0305]) a dose escalation of their CDN STING agonist compound in which dosing in the first three cycles is once a week and once every three weeks beyond cycle four (see paragraphs [0294-0295]). The dose escalation recited in Cermeski et al. is being interpreted as a priming and maintenance dosing cycle because the dose escalation example recites a small initial dose and subsequent larger amount dose cycles.
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date to have modified the method taught by Zhong et al. with the dose escalation method taught by Cermeski et al. to arrive at the claimed invention with a reasonable expectation of success because the dose escalation example disclosed by Cermeski et al. reads functionally the same as the recited “priming” and “maintenance” doses (see specification as published, paragraph [0062]), and Cermeski et provides a motivation to modify based on patients failing to achieve a sustained response after therapy as described above. Furthermore in regards to examined claim 24, Cermeski et al. discloses their CDN can be administered in amounts ranging from 10 ug to 3000 ug (see paragraph [0273]), and specifically in their dose escalation example, an initial dose of 10 ug and subsequent 90 ug or 270 ug doses (see paragraph [0295-0296]]). Therefore, it is also obvious to a select a dose escalation regimen within the scope of Cermeski et al. such that the first dose (or priming dose) is 2- to 100-fold less by weight than each subsequent escalation doses or maintenance doses, for example, a 10 ug initial “priming” dose and either 90 ug or 270 ug subsequent “maintenance” doses.
Lastly, the recited “wherein the amount of the compound in each maintenance dose is better tolerated in a subject after administration of the priming dose than when administered without the priming dose” would flow naturally from the combined teachings of Zhong and Cemerski described above because the combined references provide guidance of administering the same “priming” and “maintenance” dose within the same effective amounts (10-3000 ug and an initial 10 ug dose followed by subsequent 90 or 270 ug doses as described above). MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
In regards to instant claim 53, even though the combined teachings of Zhong and Cemerski described above do not necessarily teach providing sufficient cytokine activation to promote an immune response by the patient against occurrences of the cancer that are distal to the primary or secondary tumor, this result would flow naturally from the combined teachings of Zhong and Cemerski described above because the combined references teach the same intratumoral administration for the same compound at a primary tumor with the same effective amounts and dosing cycles as described above.
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Response to Arguments
Applicant’s arguments filed on 09/05/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that Cemerski fails to teach any specific dosing protocol and provides no evidence that the disclosed cGAMP analogues actually work using any specific dosing protocol. Applicant points to paragraph 0211 of Cemerski and states that this teaching does not provide a specific teaching to guide a skilled artisan to select a specific dosing regimen and arrive at the recited dosing regimen cycle.
Applicant’s arguments above were not found persuasive because MPEP 2143.02 I states “Conclusive proof of efficacy is not required to show a reasonable expectation of success … reasoning that "the expectation of success need only be reasonable, not absolute". Therefore, the prior art does not need to provide conclusive evidence that the compounds work but rather a reasonable expectation of success. Here, the combined teachings of Zhong and Cemerski provide this reasonable expectation of success in arriving at the recited dosing regimen cycles because Cemerski teaches weekly administration up to 3 months followed by every two week administration for up to two years for STING agonist compounds, and both prior arts teach the same genus of cyclic dinucleotide STING agonist compounds useful for the same purpose (treating cancer).
Applicant states that Cemerski provides no evidence that any of the disclosed cGAMP analogues would show any efficacy when administered by this dosing regimen and further points to the results from Clinical Trials NCT02675439, in which ADU-S100 (a different cGAMP analogue) was administered intratumorally on days 1, 8, and 15 of a 28-day cycle, and where the trial was terminated due to lack of efficacy. Therefore, Applicant states that without further experimentation, a skilled artisan would not know the recited compound would have the anti-tumor effect as disclosed in the instant application. It is noted that a supplemental IDS was not filed for the referenced NCT02675439. For purposes of compact prosecution, the NCT02675439 reference is attached in PTO-892 and used as the basis for the response below.
Applicant’s arguments above were not found persuasive because the NCT02675439 study only discloses this lack of efficacy was for a different type of cGAMP analogue compound and further does not disclose that it was due to the dosing regimen. Therefore, NCT02675439 does not necessarily teach away from optimizing the dosing regimen for the compounds in Zhong using the regimen cycles disclosed in Cemerski to arrive at the claimed invention.
Applicant states that the teaching of Zhong encompasses dosages ranging across 5 orders of magnitude and fails to provide the specific teaching to a guide a person of skill in the art to arrive at the claimed ranges. Applicant points to MPEP 2144.08 that “disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds”.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the combined teachings of Zhong and Cemerski described above provide guidance of arriving the claimed ranges because as described above, Cemerski teaches a narrower amount range (10 – 3000 ug) and further discloses a method to identify a maximum tolerated dose for their compounds (see paragraphs [0295-0301]) and would therefore be obvious to select the smallest effective dose to minimize side effects for the method of Zhong. Furthermore, the example referenced from MPEP 2144.08 is directed towards compound species within a prior art genus and not toward a range of dosages. Instead, MPEP 2144.05 recites “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” Therefore, Zhong discloses an overlapping range with dosages as low as 10 ug being effective, and Cemerski provides guidance to select with the lower narrower range (10-3000 ug) as described above.
Applicant states that for independent claim 1, both Zhong and Cemerski fail to teach the key surprising discovery that when administering according to the dosing regimen cycle recited in instant claim 1, the low dose amount recited in instant claims 5 and 6 resulted in a powerful anti-tumor effect without concurrent side effects often associated with excessive cytokine production.
In response to this alleged unexpected result, Applicant demonstrates in Examples 5-6 that twice weekly injection of the recited compound for two weeks was efficacious in a dose-dependent manner from 0.1 ug to 10 ug (0.005-0.50 mg/kg) (see paragraph 0085). Furthermore, Applicant demonstrates in Example 3 that these low dosages induce low levels of cytokines, indicating that these dosages will not cause systemic cytokine problems (see paragraph 0083). Applicant also demonstrates in Example 7 that the recited compound alone or in combination with 200 ug PD-L1 antibody suppressed tumor growth and prolonged mouse survival in all tested tumor models (paragraph 0090-0091). Applicant shows here an effective dosage of 0.5 mg / kg (10 ug) and dosing days as shown below:
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Here, while Applicant has demonstrated an effective dosage of 0.1-10ug for the recited compound that also will not cause concurrent side effects due to low levels of cytokines produced at this dosage, Applicant has not necessarily demonstrated that the dosing regimen cycle recited in instant claim 1 is critical for this result. Applicant has only shown that the dosage amount is critical for the surprising result of “powerful anti-tumor effect without concurrent side effects” but does not provide data or suggestions that the cycling regimen is also necessary in order to produce this effect. In fact, the dosing regimens disclosed in the examples are not commensurate from what is recited in instant claim 1.
Lastly, Applicant has not demonstrated that this alleged surprising result is commensurate in scope with the claims as required in MPEP 716.02(d) because independent claim 1 does not specify a dosage amount, and as described above, Applicant demonstrates that an effective dosage without concurrent side effects is 0.1-10 ug. Furthermore, the recited ranges in instant claims 5 and 6 also do not appear to be commensurate because the disclosed Examples in the instant specification only disclose efficacious administration without concurrent side effects at dosages of 0.1 ug to 10 ug (see Example 5 paragraph 0085 on page 27), which are outside of the ranges disclosed in instant claims 5 and 6 (50-6500 ug and 500-3000 ug).
Applicant states that for independent claim 19, Cemerski fails to teach a priming and maintenance dose to increase the tolerance of the body for the recited compound. Applicant states that the dose escalation method in Cemerski is a method for determining the highest dose that can be tolerated by a population of patients in order to establish a standard dosing amount. Applicant states that Cemerski provides no evidence that their dose-escalation method can potentially mitigate any negative effects of higher doses later in the dose-escalation protocol.
Applicant’s arguments above were not found persuasive because while the dose escalation example of Cemerski is to initially determine a maximum tolerated dose (MTD), Cemerski also discloses a confirmation study once the MTD is determined (see paragraph 0298 in Cemerski), which states that if the MTD for monotherapy (Arm 1, Part A) is 90 ug, then the starting dose for combination therapy (Arm 2, Part C), if no dose-limiting toxicity (DLTs) occurred in monotherapy, may be 10 μg, with a maximum dose escalation to 90 μg. Therefore, the dose escalation method disclosed here in Cemerski et al. reads functionally the same as the recited “priming” and “maintenance” doses (initial dose and subsequent escalation dosages). Furthermore, the amended wherein clause “wherein the amount of the compound in each maintenance dose is better tolerated in a subject after administration of the priming dose than when administered without the priming dose” would flow naturally from the combined teachings of Zhong and Cemerski described above because the combined references provide guidance of administering the same “priming” and “maintenance” dose as described above within the same effective amounts (10-3000 ug and an initial 10 ug dose followed by subsequent 90 or 270 ug doses as described above). MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Applicant states a surprising result that a higher dose can be tolerated when administered after a priming dose, which is not taught or suggested by Cemerski or Zhong. Applicant points to Example 10 in the instant specification, in which a 1 mg/kg/dose was tolerated with a priming dose compared to a 0.6 mg/kg/dose weekly without a priming dose.
In response to this alleged unexpected result, Applicant has not demonstrated that this alleged result is commensurate in scope with the claims as required in MPEP 716.02(d) because independent claim 19 does not specify a tolerated dosage amount, and Applicant has only shown a tolerated dose of 1 mg/kg/dose after an initial priming dose.
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 instant 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 1-6, 10-15, 19-24, 42, and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 11-12, 16, and 18-21 of U.S. Patent No. 10,519,188 (‘188) in view of Zhong et al. (WO 2017161349 in IDS filed 04/14/2022)) and Cemerski et al. (US 20190328762 in IDS filed 04/14/2022)).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of ‘188 discloses the same compound as recited in the instant claims. However, the claims of ‘188 do not necessarily teach a method of treating cancer with the recited administering cycles or any of the additional limitations of the method recited in the instant claims.
Zhong et al. is a WIPO PCT version of ‘188 and recites an identical disclosure as seen in ‘512. Therefore, the compound recited in claim 18 of ‘512 is also used to treat cancer and all of the limitations disclosed by Zhong et al., which are described above in the prior art rejections.
Cemerski et al. teaches similar cyclic dinucleotide STING agonist compounds for treating cancer and all of the limitations recited in the method of the instant claims such as the administration cycles and amounts, etc., which are described above in the prior art rejections.
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have used the compound recited in claim 14 of ‘188 to arrive at any of the instant claims with further guidance from Zhong et al. and Cemerski et al., which teaches the same genus of cyclic dinucleotide STING agonist compounds useful for the same purpose (treating cancer) and makes obvious all of the limitations of the instant claims as set forth in the prior art rejections.
Claims 1-6, 10-15, 19-24, 42, and 51-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 28-30, 32, 58, 83, 85-86, 88, 94, 96, and 110 of copending Application No. 17/814,824 (‘824) in view of Cemerski et al. (US 20190328762 in IDS filed 04/14/2022)).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of ‘824 recites the same compound as disclosed in the instant claims. Furthermore, claim 1 of ‘824 recites that the compound can be used in a method of treating tumors in a cancer in need thereof by conjointly administering effective amounts of a STING agonist, cytokine, and an immune checkpoint inhibitor such as anti-PD-1 antibody. Also, claim 3 of ‘824 recites intratumoral administration of the disclosed compounds.
However, the claims of ‘824 do not necessarily teach the administering cycle as recited in instant claim 1 or any of the specific administering method limitations such as priming and maintenance dosing regimen, systemically, or subcutaneously.
Cemerski et al. teaches similar cyclic dinucleotide STING agonist compounds for treating cancer and all of the limitations recited in the method of the instant claims such as the administration cycles and amounts, etc., which are described above in the prior art rejections.
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have applied the compound recited in claim 9 of ‘824 to arrive at any of the instant claims with further guidance from Cemerski et al., which teaches the same genus of cyclic dinucleotide STING agonist compounds useful for the same purpose (treating cancer) and makes obvious all of the limitations of the instant claims as set forth in the prior art rejections.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant requests the nonstatutory double patenting rejections be held in abeyance until allowable subject matter is found. Since allowable subject matter has not been found, the nonstatutory double patenting rejections are maintained.
Conclusion
No claim is currently found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693