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
Claim Status
Claims 1, 3-6, 9-16 and 22-27 are pending. Claims 22-27 have been added. Claims 7-8 and 17-21 have been canceled. Claims 3-6 and 9-10 have been amended. Claims 3-6, 9-10 and 22-26 are being examined in this application. In the response to the restriction requirement, Applicants elected Group II, anti-CLTA4 antibody, anti-IL17B antibody, melanoma, and separate administration of the two agents. Claims 1, 11-16 and 27 are withdrawn as being drawn to a nonelected species/invention.
Claim Rejections - 35 USC § 112
The rejection of claim 5 under 35 USC 112(d) is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 3-6, 9-10 and 22-26 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 melanoma and colon cancer with the claimed composition, does not reasonably provide enablement for the treatment of each and every cancer and/or infection with the claimed composition. 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.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to: 1) a method of treating a cancer in a subject comprising administering a composition comprising a CTLA4 inhibitor and an IL-17B inhibitor; and 2) a method of increasing the sensitivity of a cancer to a CTLA4 inhibitor.
(C) The state of the prior art;
The state of the prior art does not indicate that each and every cancer can be treated. For instance, Costello et al. (Pancreat Disord Ther; Suppl 4; doi:10.4172/2165-7092.S4-002) teaches that pancreatic cancer is an untreatable cancer (abstract).
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that not all cancers can be treated, the unpredictability of treatment of each and every cancer with the claimed combination of inhibitors is very high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not provide any examples with respect to the treatment of any cancer, other than melanoma and colon cancer, with the claimed combination of inhibitors.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for the treatment of each and every cancer with the claimed combination of inhibitors.
Working examples are necessary since the art has indicated unpredictability of treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
Response to Arguments
Applicant’s arguments filed on 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that “[t]he Working Examples which deal not only with melanoma, but also with colon cancer (see, e.g., MC38 colon cancer model in Example 3). Applicant repeated the technical effect of combining inhibition of CTLA4 and IL-17B observed in Example 1 in a melanoma model, this time in MC38 colon cancer model mice, wherein administration of anti-CTLA4 mAb on an IL-17B knockout (KO) background led to improved survival, with one mouse (11 %) achieving a complete response (CR) having tumor cleared and long-term survival (see FIG. 3 of the present application). This example validates that the CTLA4 and IL-17B inhibitory approach according to the currently amended claims can be applied to other types of cancer besides melanoma”.
Applicant also argues that “[C]ostello, which was published in 2013 (whereas the present application was filed in 2021), has no link with the present invention (Costello is focused on zinc and zinc transporters) and merely states that pancreatic cancer is an untreatable cancer. In spite of this statement by Costello and the corresponding assertion of the Examiner, however, the two years prior to 2013 included two separate clinical trials which reported encouraging therapeutic benefits of chemotherapy for the treatment of prostate cancer”.
Applicant further argues that “[t]he currently amended claims are devoted to treating a subject having a cancer, subject-matter which is fully and unambiguously supported by the Working Examples of the present application. Given the validation of the technical effect of the present application in separate cancers (see, e.g., Examples 1 and 3 of the present application), and in view of the state of the art at the time of filing, Applicant respectfully requests that this rejection be withdrawn”.
Applicant’s arguments are not persuasive because the claims encompass treating any cancer. As discussed above, certain cancers (e.g. pancreatic cancer) are untreatable, and Applicant did not provide any guidance to allow for the treatment of each and every cancer with the claimed combination of inhibitors.
Therefore, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
For the reasons stated above the rejection is maintained.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
This is a new rejection.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 is drawn to the method according to claim 3, wherein the CTLA4 inhibitor is an inhibitor of CTLA4 or of B7-1 or of B7-2. In the instance where CTLA4 inhibitor is an inhibitor of CTLA4, the claim fails to further limit the subject matter of claim 3. Furthermore, an inhibitor of B7-1 or of B7-2 is not encompassed by a “CTLA4 inhibitor”. Therefore, the claim fails to include all the limitations of claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
This rejection has been modified.
Claims 3-5, 10, 22-23 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Punnonen et al. (US 2017/0137520).
With respect to claim 3, Punnonen et al. teach a method of treating cancer comprising administering a composition comprising a CTLA4 inhibitor and an IL-17 inhibitor (claim 26; paras [0052], [0057], [0079]-[0081], [0978]). Given the finite possibilities (i.e. IL-17A through IL17-F), one of ordinary skill in the art would have at once envisaged using an IL-17B inhibitor.
With respect to claim 4, Punnonen et al. teach administering the IL-17 inhibitor and the CTLA4 inhibitor at different times (para [1127]).
With respect to claim 5, increasing the sensitivity of a cancer to a CTLA4 inhibitor is inherent to the administration of a CTLA4 inhibitor and an IL-17 inhibitor, which is taught by Punnonen et al. Therefore, the claim is anticipated.
With respect to claim 10, Punnonen et al. teach that the cancer is melanoma (claim 27; para [0057]).
With respect to claims 22-23 and 25-26, Punnonen et al. teach that the CTLA4 inhibitor is ipilimumab (paras [0070], [1130], [1138], [1170]).
Response to Arguments
Applicant’s arguments filed on 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that “[P]unnonen is focused on bispecific inhibitors, especially antibodies, which target both PD1 and CTLA4, useful in therapy. Indeed, the cited paragraph 52 of Punnonen states that such a multispecific binder may also contain a binding moiety (e.g., an antibody) that binds to another target as listed, wherein said list includes the term "IL-17". In said document, the sole reference to "IL-17" is in said list of 44 potential additional targets. Therefore, this document merely suggests combining the simultaneous inhibition of PD 1 and CTLA4, and possibly IL-17, among other candidates”.
Applicant also argues that “[A]s well established in the art, however, and shown in the publication Li et al…….., however, the term "IL-17" unambiguously refers to "IL-17 A." As mentioned on page 9, lines 19-21 of the application as filed, the IL-17 family comprises six (6) different cytokines, including IL-17 A (IL-17), as well as IL-17B, IL-17C, IL-17D, IL-17E and IL-17F. As disclosed in Li and known to those of skill in the art at the time of filing the present application, "IL-17B ... differ[s] considerably from the established activities for IL-l 7[A]" (see page 778, left column, third paragraph of Li). Therefore, a person of skill in the art when viewing the disclosure of Punnonen in view of the common understanding at the time (e.g., Li) would understand the reference to IL-17 does not refer to IL-17B, which is currently claimed, or any other IL-17 cytokine family members, and instead refers only to the individual cytokine IL-17 A”.
Applicant’s arguments are not persuasive.
It is clear that the teachings of Punnonen et al. relate to the IL-17 family (see paras [0052], [0079]-[0081], [0978]), which comprises IL-17A to IL-17F.
Therefore, since Punnonen et al. teach a method of treating cancer comprising administering a composition comprising a CTLA4 inhibitor and an IL-17 inhibitor, one of ordinary skill in the art would have at once envisaged using an IL-17B inhibitor.
For the reasons stated above the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This rejection has been modified.
Claims 3-5, 10 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shew et al. (WO 2016/004045) in view of Punnonen et al. (US 2017/0137520).
With respect to claims 3 and 10, Shew et al. teach a method for treating cancer comprising administering a composition for treating an interleukin-17B (IL-17B) and/or an interleukin-17 receptor B (IL-17RB)-mediated proliferation disorder, the composition comprising an agent that is an antagonist of IL-17RB and/or IL-17B (claim 19), wherein the cancer is skin cancer (claims 9 and 50; paras [0019] and [0032]).
Shew et al. also teach that the active agent is administered either alone or in combination with one or more other active agents (claim 8; para [0166]).
Shew et al. do not teach further administering a CTLA4 inhibitor.
Punnonen et al. teach a method of treating cancer comprising administering a composition comprising a CTLA4 inhibitor (claim 26; paras [0052], [0057], [0079]-[0081], [0978]), wherein the cancer is melanoma (claim 27; para [0057]).
The MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that CTLA4 inhibitors and IL-17B inhibitors are effective in treating a skin cancer such as melanoma, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating skin cancer. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 4, Punnonen et al. teach administering the CTLA4 inhibitor and further administering an IL-17 binding domain (i.e. an IL-17 inhibitor) (claim 26; paras [0052], [0057], [0079]-[0081], [0978]), wherein the CTLA4 inhibitor and the IL-17 inhibitor are administered at different times (para [1127]).
With respect to claim 5, increasing the sensitivity of a cancer to a CTLA4 inhibitor is inherent to the administration of a CTLA4 inhibitor and an IL-17 inhibitor, which is taught by Shew et al. and Punnonen et al. Therefore, the claim is obvious.
With respect to claims 22-23 and 25-26, Punnonen et al. teach that the CTLA4 inhibitor is ipilimumab (paras [0070], [1130], [1138], [1170]).
With respect to claim 24, Shew et al. teach that the IL-17B inhibitor is an antibody directed against IL-17B (paras [0020]-[0022]; passim).
Response to Arguments
Applicant’s arguments filed on 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that “[S]hew merely contemplates use of antagonists of IL-17RB or IL-17B with chemotherapeutic agents or with a HER inhibitor (trastuzumab). Contrary to the assertion of the Examiner, and as remarked in detail above, it was not obvious to associate the use of an anti-IL-17B therapy with an anti-CTLA4 therapy in view of Punnonen et al. As mentioned on page 9, lines 19-21 of the application as filed, the IL-17 family comprises 6 different cytokines (IL-17 A, IL-17B, IL-17C, IL-17D, IL-17E and IL-17F) with corresponding receptors (IL-17RA, IL-17RB, IL-17RC, IL-17RD, and IL-17RE). Each of the interleukin cytokines have a similar protein structure but different biological activities. For example, Li teaches that while IL-17 A stimulates IL6 secretion in fibroblasts, the different interleukin cytokine IL-17B does not. On the contrary, IL-17B induces TNF production in THP-1 cells whereas IL-17 A does not. Li further discloses that IL-17B differs from IL-17 A in its biological role in the immune response (see, e.g., page 778, right column, first paragraph of Li). Indeed, the skilled person would consider the teachings of Punnonen to unambiguously refer to IL-17 A, and not the IL-17 family in general, and even less so the specific cytokine IL-17B”.
Applicant’s arguments have been discussed above under “Response to Arguments” on pages 8-9.
For the reasons stated above the rejection is maintained.
This rejection has been modified.
Claims 3-6, 9-10 and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shew et al. (WO 2016/004045) in view of Punnonen et al. (US 2017/0137520) as applied to claims 3-5, 10 and 22-26 above, and further in view of Fenton et al. (Cancer Drug Resist. 2019 Sep 19;2(3):744-761).
The teachings of Shew et al. and Punnonen et al. with respect to claims 3-5, 10 and 22-26 have been discussed above.
Shew et al. and Punnonen et al. do not teach that the subject (or the cancer) is resistant to treatment with the CTLA4 inhibitor.
Fenton et al. teach that “[a]s experience with checkpoint inhibitors has grown, populations of patients who are primary nonresponders or develop secondary resistance have been the majority of cases, even in melanoma (abstract).
Fenton et al. also teach that “[C]linicians and researchers are also improving the efficacy of checkpoint inhibitors by optimizing the immune response induced by PD-1 and CTLA-4 blockade. Essentially, these therapies are acting to turn a “cold” tumor microenvironment into a “hot” tumor microenvironment where the immune system is active against the malignant cells. Increasing the ability to upregulate effector T cells or downregulate Tregs would dramatically improve responses and decrease rates of resistance” (page 753, 2nd para).
One of ordinary skill in the art would have been motivated to administer the IL-17B inhibitor to patients resistant to treatment with the CTLA4 inhibitor because Fenton et al. teach that populations of patients who are primary nonresponders or develop secondary resistance have been the majority of cases, even in melanoma.
The skilled artisan would have been motivated, with a reasonable expectation of success, to further administer the IL-17B inhibitor to subjects resistant to treatment with the CTLA4 inhibitor because Fenton et al. teach the need to optimize combination therapies that improve responses and decrease rates of resistance.
Response to Arguments
Applicant’s arguments filed on 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that “[F]enton is further cited merely to assert that it was obvious to administer the IL-17B inhibitor therapy to patients resistant to anti-CTLA4 therapy (see claim 9). Fenton, however, cannot rescue the defects of Punnonen and Shew which do not account for all the features of the currently amended claims individually, and there would be no motivation to combine their teachings as remarked above. Now here in Fenton is it disclosed nor suggested that an IL-17B inhibitor can treat populations of patients who are primary nonresponders or develop secondary resistance to immune checkpoint inhibitors”.
Applicant’s arguments have been discussed above under “Response to Arguments” on pages 8-9.
For the reasons stated above the rejection is maintained.
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.
This rejection has been modified.
Claims 3-5, 10 and 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10351623 in view of Liu et al. (Front Pharmacol. 2019 Feb 1:10:65).
With respect to claims 3-4, 10 and 24, ‘623 teaches a method for treating cancer in a patient comprising: administering to the patient a composition, the composition comprising at least one interleukin 17 (IL-17) antagonist of one human IL-17 isoform, wherein: the one human IL-17 isoform is IL-17B, the IL-17 antagonist is an antibody or an antigen-binding antibody fragment, and the cancer is adrenocortical carcinoma, endometrial cancer, cervical cancer, neuroblastoma, rectal cancer, bladder cancer, bone cancer, esophageal cancer or Ewing sarcoma (claim 1).
‘623 also teaches further administering a therapeutic agent (claim 2).
‘623 do not teach further administering a CTLA4 inhibitor.
Liu et al. teach that the CTLA-4 inhibitor ipilumumab is effective for melanoma, colorectal cancer and renal cell carcinoma.
The MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that CTLA4 inhibitors and IL-17B inhibitors are effective in treating cancers such as melanoma, colorectal cancer and renal cell carcinoma, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating melanoma, colorectal cancer and renal cell carcinoma. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 5, increasing the sensitivity of a cancer to a CTLA4 inhibitor is inherent to the administration of a CTLA4 inhibitor and an IL-17 inhibitor, which is taught by ‘623 and Liu et al. Therefore, the claim is obvious.
Response to Arguments
In the response filed on 11/25/2025, Applicant requested the rejection to be held in abeyance until the indication of allowable subject matter.
For this reason, the rejection is maintained.
This rejection has been modified.
Claims 3-5, 10 and 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-10, 15-16 and 19-26 of copending Application No. 17/600235 in view of Liu et al. (Front Pharmacol. 2019 Feb 1:10:65).
With respect to claims 3-4 and 10, ‘235 teaches a method for treating cancer or an infectious disease in a subject, comprising administering to the subject a composition comprising an inhibitor of PD1 or of a ligand thereof and an inhibitor of IL-17B or of a receptor thereof (claim 3), wherein the cancer is selected from the group consisting of: melanoma, sarcoma, Cutaneous Squamous Cell Carcinoma (CSCC), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Microsatellite Instability-High Cancer (MSI-H), Hepatocellular Carcinoma (HCC), Small Cell Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), ovarian cancer, Merkel Cell Carcinoma (MCC), Head and Neck Squamous Cell Carcinoma (HNSCC), Cervical Cancer, gastric cancer, esophageal cancer, urothelial carcinoma, Renal Cell Carcinoma (RCC), bladder carcinoma, anal cancer, triple negative breast cancer (TNBC), mesothelioma and Hodgkin's lymphoma (cHL) (claim 10).
‘235 do not teach further administering a CTLA4 inhibitor.
Liu et al. teach that the CTLA-4 inhibitor ipilumumab is effective for melanoma, colorectal cancer and renal cell carcinoma.
The MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that CTLA4 inhibitors and IL-17B inhibitors are effective in treating cancers such as melanoma, colorectal cancer and renal cell carcinoma, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating melanoma, colorectal cancer and renal cell carcinoma. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 5, increasing the sensitivity of a cancer to a CTLA4 inhibitor is inherent to the administration of a CTLA4 inhibitor and an IL-17 inhibitor, which is taught by ‘235 and Liu et al. Therefore, the claim is obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the response filed on 11/25/2025, Applicant requested the rejection to be held in abeyance until the indication of allowable subject matter.
For this reason, the rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658