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
Claims 1-12, 14-16, 18-20 and 22-25 are presented for examination.
Applicant’s Amendment filed August 27, 2025 has been received and entered into the present application.
Claims 1-12, 14-16, 18-20 and 22-25 are pending. Claims 1, 3, 6, 10, 12 and 19-20 are amended. Claims 24-25 are newly added.
Applicant’s arguments, filed August 27, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Requirement for Restriction/Election
Applicant is reminded of his election without traverse of (i) an androgen receptor signaling inhibitor as the single disclosed species of second agent to be administered, (ii) enzalutamide as the single disclosed species of androgen receptor signaling inhibitor to be administered, and (iii) prostate cancer as the single disclosed species of solid tumor to be treated, as stated in the reply filed April 23, 2025, which is still in effect over the claims.
Therefore, for the reasons above and those made of record in the revised requirement for restriction/election set forth at p.3-7 of the previous Office Action dated May 28, 2025, the requirement remains proper and is hereby made FINAL.
In the claim listing filed August 27, 2025, Applicant amends claim 20 to now add the elected species of prostate cancer. As a result, Applicant’s claim 20 is rejoined with those claims under examination.
Also, in the claim listing filed August 27, 2025, Applicant seeks the addition of new claims 24-25, each directed to the solid tumor as metastatic castration-resistant prostate cancer. As a result, Applicant’s new claims 24-25 are also incorporated with those claims presently under examination.
Accordingly, claims 5-11 and 22-23 remain withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are, or remain, drawn to the elected species are claims 1-4, 12, 14-16, and 18-19, as well as newly added claims 24-25, and such claims are herein acted on the merits infra.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed August 29, 2025 (four pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08A, the Examiner has considered the cited references.
Status of Objections/Rejections in the May 28, 2025 Non-Final Action
In reply to the objection to claims 1, 3 and 12 as set forth at p.9-10 of the previous Office Action dated May 28, 2025, Applicant now amends each of claims 1, 3 and 12 to recite “selected from the group consisting of”. Accordingly, the objection is now hereby withdrawn.
In reply to the rejection of claims 1-4, 12, 14-16 and 18-19 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.10-11 of the previous Office Action dated May 28, 2025, Applicant now amends claim 1 to define the subject as one “in need of treatment” for a solid tumor and amends claim 19 to define the subject as one “in need of treatment” for an advanced relapsed solid tumor. Accordingly, the rejection is now hereby withdrawn.
Applicant’s cancellation of claim 24 in copending U.S. Patent Application No. 17/628,947 necessitates the withdrawal of the provisional rejection of claims 1-4, 12 and 14 on the ground of nonstatutory double patenting as being unpatentable over now cancelled claim 24 of the ‘947 application in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197), as set forth at p.16-18 of the previous Office Action dated May 28, 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(1) Claims 1-4, 12, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cote et al. (WO 2019/204490 A1; Published October 24, 2019, Filed April 17, 2019, cited by Applicant on the 06/27/22 Information Disclosure Statement) in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197), each already of record, for the reasons of record set forth at p.11-14 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 clarifies that the subject to be treated is one “in need of treatment” for a solid tumor.
As the grounds for rejection clearly address this embodiment of the claimed method in which the treated subject is one that is actually “in need of treatment” for a solid tumor, Applicant’s claim 1 remains properly included in the present rejection for the reasons already of record.
Applicant’s remaining amendments to claims 3 and 12 are editorial in nature only and do not alter the scope of subject matter presently under rejection.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “there is nothing in either of the cited references that suggests the combination of the claimed compound and enzalutamide would be expected to elicit synergistic effects” (Remarks, p.8). Applicant contends that “the synergistic results resulting from the combination of the claimed compound and enzalutamide negate the presently asserted obviousness rejection”, citing to “tumor reduction data described in [0064]-[0065] and shown in Figures 5-7 of the application as filed” (Remarks, p.8). Applicant argues that “not only is there no suggestion of synergism based on the cited references, there is also no evidence that the magnitude of Applicant’s synergistic results would have been foreseeable” (Remarks, p.9).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant cites to para.[0064]-[0065] of the as-filed specification as alleged evidence of synergy, but this is presumed to be in error as para.[0064]-[0065] are directed to a combination of the claimed compound with the DNA alkylating agent cisplatin – not the elected combination of the claimed compound with the androgen receptor signaling inhibitor enzalutamide that is presently under examination and subject to rejection. As a result, it is assumed for the purposes of this discussion that Applicant intends to refer to para.[0067]-[0068] and Fig.5-7 of the as-filed specification as alleged evidence of synergism.
At para.[0068], Applicant states that “[t]he antitumor effects of Compound 1 alone and in combination with the androgen receptor signaling inhibitor enzalutamide were evaluated in CTG 2428 PDX tumors in NOG mice”, further citing to Fig.5 as evidence that “the combination of Compound 1 and enzalutamide reduces absolute tumor volume better than Compound 1 or enzalutamide alone” and that “[s]imilar results were seen in CTG-2440 PDX” tumors (Fig.6) and “CTG-2441 PDX tumors in NOG mice” (Fig.7) (p.20, para.[0068]). Applicant states that “[t]his data establishes that Compound 1 can be combined with androgen receptor signaling inhibitors such as enzalutamide to treat solid tumors cancers such [as] prostate cancer” (p.20, para.[0068]).
Allegations of unexpected results must be supported by relying upon factual evidence establishing “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance”. MPEP §716.02(b)(I) (quoting Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)). To establish unexpected results, the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. MPEP §716.02(e) (see also In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)). To be of probative value, any objective evidence should be supported by actual proof. MPEP §716.01(c). Applicant is reminded that “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” MPEP §716.02(d). Also, it is Applicant, not the Office, that bears the burden of explaining any data provided as evidence of nonobviousness and unexpected results. MPEP §716.02(b). See Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
The proffered data pertaining to Compound 1 (Applicant’s compound of claim 1) in combination with enzalutamide fails to be probative of nonobviousness of the full scope of subject matter claimed as it is directed to the efficacy of this specific combination in prostate cancer, whereas the instant claims are broadly directed to the treatment of any solid tumor by administering the claimed compound with any one of the broad classes of second agents (topoisomerase inhibitors, DNA alkylating agents, or androgen receptor signaling inhibitors; claim 1). None of the claims presently rejected here are specifically directed to the combination of Applicant’s claimed compound with the specific androgen receptor signaling inhibitor enzalutamide for the treatment of prostate cancer. As a result, the evidence proffered in support of nonobviousness fails to be clearly commensurate in scope with the claims which the evidence is offered to support, as required by MPEP §716.02(d). In addition, Applicant fails to cite to any additional evidence that would be probative of a trend supportive of extrapolating this limited data discussed at p.20, para.[0068] to the broader scope of subject matter claimed.
Moreover, it is not plainly apparent that the data discussed at p.20, para.[0068] of the as-filed specification demonstrates a statistically and practically significant synergistic effect from the combination over each individual agent alone. Figs.5-7 report the data from (i) 75 mg/kg PO compound 1 (once daily), (ii) 10 mg/kg PO enzalutamide (once daily), and (iii) the combination of 75 mg/kg PO compound 1 (once daily) with 10 mg/kg PO enzalutamide (once daily). While it is noted that the greatest reduction in tumor volume resulted from the combination of compound 1 with enzalutamide, Applicant fails to report any statistical analysis of the data supporting his conclusion that the reduction in tumor volume achieved by such combination constitutes a greater than additive effect over each individual agent alone that would be indicative of synergism.
In summarizing this alleged evidence of synergism, Applicant provides only a conclusory statement that “the combination of Compound 1 and enzalutamide reduces absolute tumor volume better than Compound 1 or enzalutamide alone”. However, a “better” effect is not the standard for establishing unexpected results. MPEP §716.02(b)(I) makes clear that “the differences in results are in fact unexpected and unobvious and of both statistical and practical significance”. In other words, it is insufficient to demonstrate only that a greater effect results from the combination, as this would be expected by the ordinarily skilled artisan combining two therapies already known in the art for the same therapeutic use over each individual agent alone. Rather, the standard for nonobviousness is that the ultimate effect is greater than simply the additive effects of the two individual therapies and that it amounts to both a statistically and practically significant effect. Applicant fails to address this element necessary to establish nonobviousness as made clear by MPEP §716.02(b)(I) and, for this reason, the data cannot be accepted as establishing evidence of nonobviousness and secondary considerations probative of unexpected properties.
Accordingly, the data and remarks relied upon by Applicant to support his alleged position of nonobviousness have been fully and carefully considered, but are insufficient to outweigh the evidence provided in support of prima facie obviousness.
See MPEP §2144(II) (“The weight to be given any objective evidence is made on a case-by-case basis. The mere fact that an applicant has presented evidence does not mean that the evidence is dispositive of the issue of obviousness.”).
For these reasons supra, rejection of claims 1-4, 12, 14 and 18 is proper.
(2) Claims 15-16 and 19, as well as newly added claims 24-25, are rejected under 35 U.S.C. 103 as being unpatentable over Cote et al. (WO 2019/204490 A1; Published October 24, 2019, Filed April 17, 2019, cited by Applicant on the 06/27/22 Information Disclosure Statement) in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197),
as applied above to claims 1-4, 12, 14 and 18,
further in view of Liu et al. (“Polycomb Group Proteins EZH2 and EED Directly Regulate Androgen Receptor in Advanced Prostate Cancer”, Int J Cancer, 2019 Feb 12; 145(2):415-426),
each already of record, for the reasons of record set forth at p.14-16 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly added claims 24-25 specify that the solid tumor is “metastatic castration-resistant prostate cancer”.
Cote et al. documents that downmodulation of EZH2 blocks prostate cancer metastasis in therapeutically relevant murine models (p.1-2, para.[0004]).
Scher et al. teaches that enzalutamide is effective for the treatment of prostate cancer, particularly progressive (metastatic) castration-resistant prostate cancer (abstract; col.1, para.2-3, p.1188).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in administering the proposed combination of Cote’s EZH2 inhibitor with Scher’s androgen receptor signaling inhibitor enzalutamide for the treatment of advanced and/or relapsed metastatic castration-resistant prostate cancer because each was known – or suggested – for the treatment of prostate cancer that has advanced and relapsed into castration-resistant prostate cancer. The skilled artisan would have found it prima facie obvious to use this proposed combination for the treatment of advanced, relapsed castration-resistant prostate cancer because Liu et al. demonstrates the efficacy of EZH2 inhibition (such as that achieved by Cote’s EZH2 inhibitor) and androgen receptor inhibitors (such as enzalutamide of Scher et al.) to repress progression of castration-resistant prostate cancer – thereby supporting the use of such combination of both therapies to provide an effective treatment for the same.
The skilled artisan would have also found it prima facie obvious to apply such combination specifically to the metastatic form of advanced, relapsed castration-resistant prostate cancer because Cote et al. clearly documents the function of EZH2 inhibition to block prostate cancer metastasis and Scher et al. teaches the function of enzalutamide to treat progressive (metastatic) castration-resistant prostate cancer.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “the pending claims are not obvious over Cote and Scher, and there is nothing in Liu that would suggest synergist[ic] effects, much less the magnitude of such obtained by the Applicant” (Remarks, p.10). Applicant contends that “the pending claims are not obvious over the combination of Cote, Scher and Liu” and “withdrawal of the present §103 rejection” is requested (Remarks, p.10).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant's remarks are predicated on a finding that the combination of Cote et al. in view of Scher et al. is deficient, which it is not for the reasons discussed above. Moreover, Liu et al. was relied upon for its teachings establishing the prima facie obviousness of employing the proposed combination of Cote’s EZH2 inhibitor with Scher’s androgen receptor inhibitor enzalutamide to advanced, relapsed metastatic castration-resistant prostate cancers. Piecemeal analysis of the references cannot establish nonobviousness because such analysis fails to consider the totality of the teachings and what they would have reasonably suggested to the ordinarily skilled artisan when combined.
Also, the allegedly synergistic effects urged by Applicant are insufficient to establish nonobviousness of the claimed subject matter over the cited prior art teachings for the reasons set forth above, which apply herein as well (but are not repeated in the interest of brevity).
For these reasons supra, rejection of claims 15-16, 19 and 24-25 is proper.
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.
(3) Claims 1-4, 12 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4 of U.S. Patent Application No. 18/037,120, already of record, for the reasons of record set forth at p.19 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 clarifies that the subject to be treated is one “in need of treatment” for a solid tumor.
As the grounds for rejection clearly address this embodiment of the claimed method in which the treated subject is one that is actually “in need of treatment” for a solid tumor, Applicant’s claim 1 remains properly included in the present rejection for the reasons already of record.
Applicant’s remaining amendments to claims 3 and 12 are editorial in nature only and do not alter the scope of subject matter presently under rejection.
(4) Claims 1-4, 12, 14-16 and 19, as well as newly added claims 24-25, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent Application No. 18/037,120 in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197), each already of record, for the reasons of record set forth at p.19-21 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 clarifies that the subject to be treated is one “in need of treatment” for a solid tumor.
As the grounds for rejection clearly address this embodiment of the claimed method in which the treated subject is one that is actually “in need of treatment” for a solid tumor, Applicant’s claim 1 remains properly included in the present rejection for the reasons already of record.
Applicant’s remaining amendments to claims 3 and 12 are editorial in nature only and do not alter the scope of subject matter presently under rejection.
Newly added claims 24-25 specify that the solid tumor is metastatic castration-resistant prostate cancer.
Claim 5 of the ‘120 application specifies that the prostate cancer is metastatic castration-resistant prostate cancer.
(5) Claims 1-4, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 28-29 of U.S. Patent No. 10,689,371 B2 in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197), each already of record, for the reasons of record set forth at p.21-23 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 clarifies that the subject to be treated is one “in need of treatment” for a solid tumor.
As the grounds for rejection clearly address this embodiment of the claimed method in which the treated subject is one that is actually “in need of treatment” for a solid tumor, Applicant’s claim 1 remains properly included in the present rejection for the reasons already of record.
Applicant’s remaining amendments to claims 3 and 12 are editorial in nature only and do not alter the scope of subject matter presently under rejection.
(6) Claims 1-4, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 28-29 of U.S. Patent No. 11,274,095 B2 in view of Scher et al. (“Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy”, N Engl J Med, 2012; 367:1187-1197), each already of record, for the reasons of record set forth at p.24-25 of the previous Office Action dated May 28, 2025, of which said reasons are herein incorporated by reference.
Newly amended claim 1 clarifies that the subject to be treated is one “in need of treatment” for a solid tumor.
As the grounds for rejection clearly address this embodiment of the claimed method in which the treated subject is one that is actually “in need of treatment” for a solid tumor, Applicant’s claim 1 remains properly included in the present rejection for the reasons already of record.
Applicant’s remaining amendments to claims 3 and 12 are editorial in nature only and do not alter the scope of subject matter presently under rejection.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejections collectively, stating that “[o]bvious-type double patenting analysis is based on the claims, not the teachings within a prior art disclosure” (Remarks, p.10). Applicant contends that “the Examiner is not using the disclosure of Scher as a dictionary or to establish an inherent fact”, but rather “to support an ‘obvious to combine’ argument” (Remarks, p.11). Applicant alleges that this “is not the proper standard for establishing a double patenting rejection, and Applicant is not aware of any authority that supports it” (Remarks, p.11).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s arguments are not understood. MPEP §804 makes clear that “[a] nonstatutory double patenting rejection, if not based on an anticipation rationale or an ‘unjustified timewise extension’ rationale, is ‘analogous to [a failure to meet] the nonobviousness requirement of 35 U.S.C. 103’ except that the patent disclosure principally underlying the double patenting rejection is not considered prior art”. Here, the provisional and nonprovisional rejections set forth above rely upon the claims of the cited copending application or patent and, where necessary, cite to the teachings of a secondary reference to Scher et al. (which is prior art to the instant claims) to resolve the differences between the copending or patented claims and the instant claims as being prima facie obvious variations to one of ordinary skill in the art before the effective filing date of the claimed invention.
MPEP §804 goes on to state that “[a]ny secondary reference used to support an obviousness analysis for a nonstatutory double patenting rejection must be prior art under 35 U.S.C. 102 or pre-AIA 35 U.S.C. 102”. This guidance explicitly rebuts Applicant’s unfounded statement that he “is not aware of any authority that supports” the use of a secondary reference to support obviousness rationale set forth in a nonstatutory double patenting rejection because this authority is expressly provided for in the MPEP. Again, see MPEP §804.
Finally, Applicant opines that “the examined subject matter comprises synergistic activity in terms of tumor reduction”, citing again to para.[0068] and Fig.5-7 of the as-filed specification in support thereof (Remarks, p.11).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s evidence of alleged synergism as set forth at para.[0068] and Fig.5-7 of the as-filed specification was fully and carefully considered in response to the obviousness rejection above, but was not found probative of nonobviousness for the reasons set forth therein. Such reasons apply equally herein, but are not repeated in the interest of brevity in the record.
For these reasons supra, rejection of claims 1-4, 12, 14-16 and 19 is proper.
Conclusion
Rejection of claims 1-4, 12, 14-16, 18-19 and 24-25 is proper.
Claims 5-11 and 22-23 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
October 8, 2025