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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on Feb. 11, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/11/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “1-methyl-5-(2'-methyl-[1,1'-biphenyl]- yl)-1H-benzo[d][1,2,3]triazole-7-carboxylic acid and R-CHOP combination therapy for the treatment of lymphomas.”
Drawings
The drawings are objected to because the compound of Formula I in the claims is referenced as both “compound 1” and “AG636” in Figures 1-3. The AG636 name is not referenced anywhere else in the spec. Applicant is required to use a single naming convention in the figures for clarity and consistency.
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.
Status of the Claims
Claims 1-17 are pending in this application.
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.
Claims 1-9 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nellore et al. (WO 2018/197997 A1 – From IDS and previously cited) (“Nellore”); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”).
Regarding claim 1, Nellore discloses a method of treating cancer (including lymphoma) (Nellore claim 1) comprising administration of an effective amount of the instantly claimed compound of Formula I (Nellore’s claim 14, page 55). Furthermore, Nellore explicitly discloses this compound can be used in combination with known antitumor compounds (page 2, lines 27-30).
While Nellore does not specifically teach co-administration of an anti-cancer therapy; the teachings of Svirskis are relied upon for these disclosures.
Svirskis teaches the EPOCH regimen for the treatment of various non-Hodgkin lymphoma, other aggressive forms of diffuse large B-cell lymphoma, and Burkitt’s lymphoma. The regimen comprising Etoposide, oral Prednisone, Oncovin (vincristine), Cyclophosphamide, and Hydroxydaunorubicin (doxorubicin) (page 2, col. 1, para. 1). Svirskis teaches doxorubicin hydrochloride and vincristine sulfate (page 2, col. 1, para. 2, lines 3-4).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Nellore’s compound in combination with Svirskis’ treatment regimen to arrive at the instant invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Nellore’s and Svirskis’ disclosure.
Applicant is advised, the courts have found that “[i]t 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 their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Regarding claim 2, Nellore teaches the instant compound of Formula I for the treatment of Hodgkin lymphoma (Nellore claim 1).
Regarding claim 3, Nellore teaches the instant compound of Formula I for the treatment of non-Hodgkin lymphoma (Nellore claim 1).
Regarding claims 4-8, Nellore teaches the instant compound of Formula I for the treatment of diffuse large B-cell lymphoma (DLBCL – reading on B cell lymphoma) (Nellore claim 1).
Regarding claim 9, Nellore teaches the instant compound of Formula I for the treatment of T-cell lymphoma (Nellore claim 1).
Regarding claim 11, Nellore teaches the instant compound of Formula I for the treatment of anaplastic large cell lymphoma (ALCL) (Nellore claim 1).
Regarding administration of the anti-cancer agent and anti-cancer therapy simultaneously, in the same or different formulation, as recited in claim 12, Svirskis discloses a three-medicine mixture comprising vincristine sulfate, doxorubicin hydrochloride, and etoposide, in 0.9% sodium chloride as part of the EPOCH regimen (page 2, col. 1, para. 2). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer the instant compound of Formula I, taught by Nellore as an effective treatment for lymphoma, simultaneously either in the same or separate formulation from doxorubicin hydrochloride. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Svirskis teachings on the EPOCH treatment regimen comprising a doxorubicin formulation for various lymphomas.
Regarding sequential administration of the anti-cancer agent and anti-cancer therapy, as recited in claim 13, Svirskis’s administration of a mixture comprising vincristine sulfate, doxorubicin hydrochloride, and etoposide, in 0.9% sodium chloride as part of the EPOCH regimen suggests sequential administration of the other components of the regimen, namely Prednisone and Cyclophosphamide. Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer the instant compound of Formula I, taught by Nellore as an effective treatment for lymphoma, and doxorubicin hydrochloride sequentially. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Svirskis.
Further regarding claims 12-13, applicant is advised, the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Therefore, the claimed order of steps is an obvious variant of the steps of the cited prior art.
Regarding claims 14-15, Nellore speaks to the instant compound of Formula I and pharmaceutically acceptable salts thereof for the treatment of lymphoma (Nellore claims 1 and 14).
Regarding claim 16, Svirskis discloses doxorubicin hydrochloride (page 2, col. 1, para. 2).
Regarding claim 17, Svirskis discloses vincristine sulfate (page 2, col. 1, para. 2).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nellore et al. (WO 2018/197997 A1, Pub. Date – From IDS and previously cited) (“Nellore”); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”); as applied to claims 1-9 and 11-17, further in view of Straus et al. (Annals of Oncology, 2014, 25: 206–210. – previously cited) (“Straus”).
The teachings of Nellore and Svirskis are disclosed above and incorporated herein.
While Nellore in view of Svirskis does not specifically teach the treatment of cutaneous T-cell lymphoma, the teachings of Straus are relied upon for these disclosures.
Straus discloses doxorubicin HCl liposome injection (DLI) showed the highest overall response rate for single agents in cutaneous T-cell lymphoma (CTCL) (conclusions – abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to administer Nellore’s compound in combination with Svirskis’ EPOCH regimen comprising doxorubicin HCl, for the treatment of CTCL in view of Straus. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Nellore’s disclosure that the instant compound of Formula I is effective for the treatment of lymphoma; Svirskis’s disclosure of an EPOCH (comprising doxorubicin HCl) regimen for the treatment of lymphoma; and Straus’s disclosure that doxorubicin HCl showed the highest response rate for CTCL among single agents.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-17 of U.S. Patent No. 11,717,512 B2 (US ‘512); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”).
Regarding instant claims 1-9 and 11-17, US ‘512 claims a method of treating cancers (including B cell lymphoma, DLBCL, etc.) comprising administration of the instant compound of Formula I.
While US ‘512 does not specifically teach co-administration of an anti-cancer therapy; the teachings of Svirskis are relied upon for these disclosures.
Svirskis teaches the EPOCH regimen for the treatment of various non-Hodgkin lymphoma, other aggressive forms of diffuse large B-cell lymphoma, and Burkitt’s lymphoma. The regimen comprising Etoposide, oral Prednisone, Oncovin (vincristine), Cyclophosphamide, and Hydroxydaunorubicin (doxorubicin) (page 2, col. 1, para. 1). Svirskis teaches doxorubicin hydrochloride and vincristine sulfate (page 2, col. 1, para. 2, lines 3-4).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘512’s compound in combination with Svirskis’ treatment regimen to arrive at the instant invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘512’s and Svirskis’ disclosure.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-17 of U.S. Patent No. 11,717,512 B2 (US ‘512); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”); as applied to claims 1-9 and 11-17, further in view of Straus et al. (Annals of Oncology, 2014, 25: 206–210. – previously cited) (“Straus”).
The teachings of US ‘512 and Svirskis are disclosed above and incorporated herein.
While US ‘512 in view of Svirskis does not specifically teach the treatment of cutaneous T-cell lymphoma, the teachings of Straus are relied upon for these disclosures.
Straus discloses doxorubicin HCl liposome injection (DLI) showed the highest overall response rate for single agents in cutaneous T-cell lymphoma (CTCL) (conclusions – abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to administer US ‘512’s compound in combination with a doxorubicin HCl-containing regimen for the treatment of CTCL. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘512’s disclosure that the instant compound of Formula I is effective for the treatment of lymphoma; Svirskis’s disclosure of an EPOCH (comprising doxorubicin HCl) regimen for the treatment of lymphoma; and Straus’s disclosure that doxorubicin HCl showed the highest response rate for CTCL among single agents.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Claims 1-9 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,290,508 B2 (US ‘508); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”).
Regarding instant claims 1-9 and 11-17, US ‘508 claims a method of treating cancers (including DLBCL, etc.) comprising administration of the instant compound of Formula I.
While US ‘508 does not specifically teach co-administration of an anti-cancer therapy; the teachings of Svirskis are relied upon for these disclosures.
Svirskis teaches the EPOCH regimen for the treatment of various non-Hodgkin lymphoma, other aggressive forms of diffuse large B-cell lymphoma, and Burkitt’s lymphoma. The regimen comprising Etoposide, oral Prednisone, Oncovin (vincristine), Cyclophosphamide, and Hydroxydaunorubicin (doxorubicin) (page 2, col. 1, para. 1). Svirskis teaches doxorubicin hydrochloride and vincristine sulfate (page 2, col. 1, para. 2, lines 3-4).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘508’s compound in combination with Svirskis’ treatment regimen to arrive at the instant invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘508’s and Svirskis’ disclosure.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,290,508 B2 (US ‘508); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”); as applied to claims 1-9 and 11-17, further in view of Straus et al. (Annals of Oncology, 2014, 25: 206–210. – previously cited) (“Straus”).
The teachings of US ‘508 and Svirskis are disclosed above and incorporated herein.
While US ‘508 in view of Svirskis does not specifically teach the treatment of cutaneous T-cell lymphoma, the teachings of Straus are relied upon for these disclosures.
Straus discloses doxorubicin HCl liposome injection (DLI) showed the highest overall response rate for single agents in cutaneous T-cell lymphoma (CTCL) (conclusions – abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to administer US ‘508’s compound in combination with a doxorubicin HCl-containing regimen for the treatment of CTCL. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘508’s disclosure that the instant compound of Formula I is effective for the treatment of lymphoma; Svirskis’s disclosure of an EPOCH (comprising doxorubicin HCl) regimen for the treatment of lymphoma; and Straus’s disclosure that doxorubicin HCl showed the highest response rate for CTCL among single agents.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Claims 1-9 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16-22 of U.S. Patent No. 12,297,179 B2 (US ‘179); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”).
Regarding instant claims 1-9 and 11-17, US ‘179 claims a method of treating cancers (including DLBCL, etc.) comprising administration of the instant compound of Formula I.
While US ‘179 does not specifically teach co-administration of an anti-cancer therapy; the teachings of Svirskis are relied upon for these disclosures.
Svirskis teaches the EPOCH regimen for the treatment of various non-Hodgkin lymphoma, other aggressive forms of diffuse large B-cell lymphoma, and Burkitt’s lymphoma. The regimen comprising Etoposide, oral Prednisone, Oncovin (vincristine), Cyclophosphamide, and Hydroxydaunorubicin (doxorubicin) (page 2, col. 1, para. 1). Svirskis teaches doxorubicin hydrochloride and vincristine sulfate (page 2, col. 1, para. 2, lines 3-4).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer US ‘179’s compound in combination with Svirskis’ treatment regimen to arrive at the instant invention. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘179’s and Svirskis’ disclosure.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16-22 of U.S. Patent No. 12,297,179 B2 (US ‘179); in view of Svirskis et al. (J. Oncol. Pharm. Practice, 2018, 0, 1-10. – previously cited) (“Svirskis”); as applied to claims 1-9 and 11-17, further in view of Straus et al. (Annals of Oncology, 2014, 25: 206–210. – previously cited) (“Straus”).
The teachings of US ‘179 and Svirskis are disclosed above and incorporated herein.
While US ‘179 in view of Svirskis does not specifically teach the treatment of cutaneous T-cell lymphoma, the teachings of Straus are relied upon for these disclosures.
Straus discloses doxorubicin HCl liposome injection (DLI) showed the highest overall response rate for single agents in cutaneous T-cell lymphoma (CTCL) (conclusions – abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to administer US ‘179’s compound in combination with a doxorubicin HCl-containing regimen for the treatment of CTCL. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘179’s disclosure that the instant compound of Formula I is effective for the treatment of lymphoma; Svirskis’s disclosure of an EPOCH (comprising doxorubicin HCl) regimen for the treatment of lymphoma; and Straus’s disclosure that doxorubicin HCl showed the highest response rate for CTCL among single agents.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant's arguments filed September 29th, 2025 have been fully considered but they are not persuasive.
Applicant cites In re Soni: “when applicant demonstrates substantially improved results … and states the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary” (emphasis added). Applicant states Soni does not impose any requirement that each individual component of a combination be separately tested. Applicant further cites MPEP 716.002 (c) – though it is believed Applicant intended 716.02 (c) – to say that “unexpected results can be established even if comparison data are not provided for every individual variable, and that a separate control is not mandated where the relevant properties of the comparison are already known in the art” (emphasis added). Applicant asserts the current spec. demonstrates unexpected results, citing Figs. 1-3, and states combination of Compound 1 with R-CHOP resulted in a range of moderate to high synergistic growth. Applicant further argues that R-CHOP is a well-established standard of care regimen and it’s expected therapeutic range is well understood by those in the art, and thus the data in Figs. 1-3 demonstrates synergistic growth inhibition which would not have been expected from R-CHOP alone, and asserts that the absence of R-CHOP in the figures does not negate the unexpected nature of the results, particularly where improvement over Compound 1 monotherapy is demonstrated. Applicant further argues that Straus does not cure the deficiencies of Nellore and Svirskis, and does not teach the claimed combination therapy.
As stated in the Final rejection mailed 11/13/2025; Figure 1 fails to show the percent change in tumor volume when treated with the R-CHOP regimen without compound 1. Such data is necessary when assessing whether synergy is actually observed after treatment with compound 1 + R-CHOP, or merely an additive effect of combined treatment. This is particularly important information when the percent changes in tumor mass with CHOP, rituximab, and AG636 (compound 1) alone, are so close in some cases (see Figure 1 below).
PNG
media_image1.png
624
823
media_image1.png
Greyscale
Similarly, Figures 2 and 3 fail to show R-CHOP treatment effects on its own.
In response to Applicant’s arguments that “when applicant demonstrates substantially improved results … and states the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary” and “unexpected results can be established even if comparison data are not provided for every individual variable, and that a separate control is not mandated where the relevant properties of the comparison are already known in the art”; Applicant is directed to MPEP 716.02(a), which states: "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. This result was persuasive of nonobviousness even though the result was equal to that of one component alone. Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).” (emphasis added).
Therefore, for Applicant’s arguments to be persuasive, as stated in Final rejection mailed 11/13/2025, Applicant would need to demonstrate an effect which is greater than the sum of each of the effects taken separately (i.e R-CHOP; Compound 1; then R-CHOP + Compound 1). While the R-CHOP regimen is known in the art, and while the absence of R-CHOP performance in Figures 1-3 does not negate unexpected results, as stated by Applicant, relevant comparative data is required demonstrate synergy and overcome the instant obviousness rejection. While improvement of compound 1 monotherapy is demonstrated after combination with R-CHOP, an additive effect is not an unexpected result, and the absence of an antagonistic effect is also not an unexpected result. The data, as provided by Applicant, does not demonstrate any more than an additive effect.
Applicant is reminded, the courts have found that “[i]t 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 their having been individually taught in the prior art. It is therefore obvious to administer a mixture of the aforementioned anti-cancer agent and anti-cancer therapy, which are known in the art for the treatment of various lymphomas, to arrive at a treatment for lymphoma.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights