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
This office action is in response to applicant’s reply filed on November 12, 2025.
Status of Claims
Amendment of claims 1 and 168 is acknowledged.
Claims 1 and 168-189 are currently pending and are the subject of this office action.
Claims 172-175 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 11, 2019.
Claims 1, 168-171 and 176-189 are presently under examination.
The following cancer species are under examination: anal cancer and NSCLC.
Priority
The present application is a 371 of PCT/US2020/025018 filed on 03/26/2020 and claims priority to provisional application No. 62/825,275 filed on 03/28/2019.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (Modified Rejection Necessitated by Amendment).
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 1, 168-169 and 176-189 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of NSLC, does not reasonably provide enablement for the treatment of anal cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1, 168-169 and 176-189 recite a method for treating anal cancer and NSCLC comprising the administration of a composition comprising effective amounts of Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and durvalumab (an immune checkpoint inhibitor).
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
A search of the literature revealed that neither Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and durvalumab (an immune checkpoint inhibitor). are effective in treating anal cancer either in vitro or in vivo.
4. The breadth of the claims
Although only anal cancer and NSCLC being examined, the instant claims encompass an enormous number of diseases: basically, any type of cancer is encompassed by the instant claims. As it is well known, there is no known drug or combination of drugs that shows efficacy in all types of cancer.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification provides the following data:
1- some pharmacokinetic, toxicology and maximum tolerated dose data for compound SRA737 (See Examples 1-5),
2- Phase 1/2 clinical data to confirm efficacy of SRA737 monotherapy in different types of cancer. The procedure is written in present tense, so it is considered a prophetic example, and no experimental data was provided (see example 6).
3- Phase 1/2 clinical data to confirm efficacy of SRA737 combination therapy with gemcitabine in different types of cancer. The procedure is written in present tense, so it is considered a prophetic example, and no experimental data was provided (see example 7).
4- In vitro data showing the ability of SRA737 to inhibit CHk1 in human and murine cancer cells (SCLC, NSCLC, pancreatic, colon and bladder). There is no mention of anal cancer cells (see Example 9).
5- In vivo (mice) data showing that SRA737 augmented an ICB-induced anti-tumor response in SCLC cells in mice (see example 10).
6- In vivo (mice) data showing that SRA737 in combination anti PD-L1 treatment in MC38 tumor cells (colorectal tumor cells) implanted in mice. (see example 11). Again, no data for anal tumor cells.
7- In vitro effect of triple combination therapy (SRA737, Gemcitabine and durvalumab) in SCLC cancer cells (see example 12). No data for anal cancer.
In summary, no in vivo or in vitro data for anal cancer was provided for the compounds: Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and durvalumab (an immune checkpoint inhibitor) either alone or in combination, and none of the data provided in the above examples can be correlated with efficacy in treating anal cancer comprising the administration of a composition comprising: Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and durvalumab (an immune checkpoint inhibitor).
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of anal cancer, is required for practice of the claimed invention.
6. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is absolutely no data correlating the claimed compounds individually or in combination with anal cancer treatment either in vitro or in vivo. Based on this, and in the absence of experimental evidence commensurate in scope with the claims (see: 5. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that a combination of Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and an immune checkpoint inhibitor as claimed, will be effective in treating anal cancer inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single example that correlates with the treatment of anal cancer.
So, determining if a combination of Gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and durvalumab (an immune checkpoint inhibitor) will be effective in treating anal cancer, will require assaying in vitro each of these compounds in an assay that correlates with the treatment of anal cancer, then determining if the combination is effective in treating anal cancer and then further determine their efficacy in vivo in a validated animal model for anal cancer.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
7. Conclusion
Accordingly, the inventions of claims 1, 168-169 and 176-189 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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.
1) Claim(s) 1, 168-171, 183-186 and 189 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feltquate et. al. (US 2017/0158776, cited in previous office action), Zangarini et. al. (Bioanalysis (2017) 9:1001-1010, cited in previous office action) and Walton et. al. (Oncotarget (2015) 7:2329-2342, cited in previous office action).
For claims 1 and 168-170, Feltquate teaches that that immune checkpoint inhibitors, like anti-PD-L1 inhibitors: Nivolumab (see [0006] and [0068]), Pembrolizumab (see [0069]) and Durvalumab (see [0077]) are each individually effective in treating NSCLC (see also [0011]).
Feltquate also teaches that gemcitabine and cisplatin are chemotherapeutic agents effective to treat NSCLC (see [0008]).
Walton teaches that the CHK1 inhibitor CCT245737 (SRA737) is also effective in treating NSCLC (see title, abstract and entire document).
Further, Feltquate teaches that combinations of anti-PD-L1 inhibitors (like Nivolumab, Pembrolizumab or Durvalumab) in combination with chemotherapeutic agents like gemcitabine and/or cisplatin are effective in treating NSCLC (see [0084], [0119] and claims 1-2, 8, 10, 13-15).
Zangarini teaches that SRA737 (formerly known as CCT245737) is a Chk1 inhibitor that was known to improve gemcitabine antitumor activity (see page 1001, right column, second paragraph). Walton further teaches that CCT245737 (SRA737) is effective in treating NSCLC in combination with a composition comprising gemcitabine (see title, see Figure 4 and see page 2335, right column under “A novel quantitative and sensitive biomarker assay CHK1 activity”).
Since the prior art teaches that chemotherapeutic agents like gemcitabine and cisplatin, CHK1 inhibitors like SRA737, and immune checkpoint inhibitors like anti-PD-L1 antibody compounds like Nivolumab, Pembrolizumab or Durvalumab, are each individually effective in treating NSCLC, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to treat NSCLC combining three compositions (Nivolumab, Pembrolizumab and/ or Durvalumab, Gemcitabine and/or cisplatin, and SRA737), each of which is taught by the prior art to be useful for the same purpose (treating NSCLC), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
The skilled in the art will be further motivated to treat NSCLC with combination of the above compounds, since Feltquate teaches that combinations of anti-PD-L1 inhibitors (like Nivolumab, Pembrolizumab or Durvalumab) with chemotherapeutic agents like gemcitabine and/or cisplatin are effective in treating NSCLC, and because Zangarini and Walton teach that the combination of SRA737 and gemcitabine, not only is effective in treating NSCLC, but SRA737 is known to improve gemcitabine antitumor activity and the combination is effective in treating NSCLC
All this would result in the practice of claims 1 and 168-170 with a reasonable expectation of success.
For claim 171 the prior art is silent regarding the reduction in tumor growth.
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating NSCLC comprising the administration of a composition comprising effective amounts of the chemotherapeutic agents gemcitabine and/or cisplatin, the Chk1 inhibitor SRA737 and the immune checkpoint inhibitors durvalumab, pembrolizumab and/or nivolumab".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the tumor growth in the subject is reduced by at least 1%, at least 5%, at least 10%, etc.” appear to be the result of the process made obvious by the prior art: “a method for treating NSCLC comprising the administration of a composition comprising effective amounts of the chemotherapeutic agents gemcitabine and/or cisplatin, the Chk1 inhibitor SRA737 and the immune checkpoint inhibitors durvalumab, pembrolizumab and/or nivolumab", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 171 with a reasonable expectation of success.
For claim 183 the prior art is silent regarding: “the method resulting in a regression of a tumor associated with the cancer relative to baseline measurement, etc.”
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating NSCLC comprising the administration of a composition comprising effective amounts of the chemotherapeutic agents gemcitabine and/or cisplatin, the Chk1 inhibitor SRA737 and the immune checkpoint inhibitors durvalumab, pembrolizumab and/or nivolumab".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the method results in a regression of a tumor associated with the cancer relative to baseline measurement, etc.” appear to be the result of the process made obvious by the prior art: “a method for treating NSCLC comprising the administration of a composition comprising effective amounts of the chemotherapeutic agents gemcitabine and/or cisplatin, the Chk1 inhibitor SRA737 and the immune checkpoint inhibitors durvalumab, pembrolizumab and/or nivolumab", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 183 with a reasonable expectation of success.
Similar arguments are presented for the wherein clauses in claims 184-186.
For claim 189, Feltquate teaches that the subjects can be human (see [0103], thus resulting in the practice of claim 189 with a reasonable expectation of success.
2) Claim(s) 176-181 and 187-188 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feltquate et. al. (US 2017/0158776, cited in previous office action), Zangarini et. al. (Bioanalysis (2017) 9:1001-1010, cited in previous office action) and Walton et. al. (Oncotarget (2015) 7:2329-2342, cited in previous office action) as applied to claims 1, 168-171, 183-186 and 189, further in view of Liu (Therapeutic Cancer Research (2017) 77:5068-5076, cited in prior office action)
For claims 176-181 and 187-188, the prior art does not teach the specific amounts and dose regimens for the Chk1 inhibitor SRA737 as disclosed in the instant claims. However, Liu teaches the administration of 25 mg/kg daily of the Chk1 inhibitor AZD7762 to mice carrying NSCLC tumors (see page 5074 under “AZD7762 and gemcitabine cotreatment reduces tumor size”).
The determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition to achieve a beneficial effect. As Liu et al. teach that a range of dosages of the Chk1 inhibitor AZD7762 is used to treat NSCLC, the dosage is considered a result effective variable. Thus, it would also have been obvious to have chosen a dosage for the Chk1 inhibitor SRA737 from among those known to be effective in methods of treating NSCLC, knowing the different potencies and pharmacokinetics of these Chk1 inhibitors.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular range, but teaches that the claimed parameters are known to affect results or properties
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
All these will result in the practice of claims 176-181 and 187-188 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Since a new rejection necessitated by amendment was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself, so only those arguments not addressed in the rejection are being considered below:
Applicant argues that: Unexpected Results
Examiner’s response:
The specification presents data for the treatment of SCLC comprising the administration of gemcitabine, SRA737 and B7-H1 in Example 12. However, even if the data were considered synergistic, the results are not commensurate in scope with the claims, since the claims encompass any type of cancer. There is no evidence that the results observed for SCLC will correlate with any other type of cancer.
Double Patenting (Maintained Rejection).
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.
1) Claims 1, 168-171 and 176-189 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 20, 31, 42, 48, 53, 64, 68-69, 74-76, 90, 101, 107, 112, 123, 137 and 176 of copending Application No. 17/610,198 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite a method of treating cancer comprising the administration of gemcitabine (a chemotherapeutic agent), SRA737 (a Chk1 inhibitor) and an immune checkpoint inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
This is not the only remaining rejection.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
November 17, 2025.
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