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
Claims 59-78 are pending in the present application.
AMENDMENTS
The amendment filed 09/23/2025 has been acknowledged and entered in the present application file.
Previous Claim Rejections - 35 USC § 103
Claims 1-3, 6, 8, 12, 21-22, 32, 35, 37, 40-41, 43-44 and 54-58 were previously rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/085825 (Pietras et al.), in view of in view of US 2019/0216923 A1 (Lee et al.).
Applicant has amended the claims, provided a declaration and traversed the previous rejection on several grounds. Applicant provides results from the specification where a compound of formula (I), or representative compound SERD128, combined with anti-PD-L1 antibody increases inhibition of tumor growth and a statistically significant impact on the immune system in response to cancer cells when compared to the inhibition/impact of a compound of formula (I) alone or an anti-PD-L1 antibody alone. Applicant points to the data provided in the present specification in Figures 4A and 23C as well as data summarized in paragraphs [0605]-[0612] of the specification.
Applicant further argues the Chou-Talalay method is not the established standard or sole method for determining superior results and dose-effect curves are not required to establish synergy. Applicant alleges synergy can be defined as combinations of drugs that lead to a statistically significant increase over the effect of either agent alone as well as drug combinations which lead to the greatest difference between desired effects and undesirable side effects. See Applicant Remarks filed 03/26/2025 pages 8-9 and Pietras Declaration paragraphs 15-16.
The Examiner has considered the amendment and traversal fully but must disagree for the following reasons.
The instant claims encompass a method of inhibiting or treating any type/subtype of breast cancer tumor growth comprising administration of a combination of a first amount of an anti-PD-L1 inhibitor, and a second amount of SERD128, in any ratio or administration schedule, provided the first and second amount are a combined synergistic amount. The results provided cannot be considered unexpected for the scope of the subject matter embraced by the instantly claimed method. The results provided do not occur over the entire claimed range (a combination of a first amount of any anti-PD-L1 inhibitor, and a second amount of SERD128, in any ratio or administration schedule, provided the first and second amount are a combined synergistic amount, for the treatment of all types of breast cancer tumors) of claims 59 and 69.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Also see MPEP 716.02 (d) and MPEP 716.02 (e). Applicant refers to alleged unexpected results; however, even if the results were considered unexpected, the results would not be commensurate in scope with the instant claims. Applicant has allegedly provided evidence demonstrating synergy for singular dosages of SERD128 and anti-PD-L1 inhibitor and a singular combination ratio. However, Applicant has not provided evidence for synergy in a combination comprising any first amount of an anti-PD-L1 inhibitor and any second amount of SERD128.
At minimum, an additive effect is expected between two antitumor agents, however Applicant has not provided evidence of statistically significant inhibition of tumor growth. The data provided in paragraphs [0605]-[0606] and paragraph [0651] and Fig. 4A, Fig. 4B, Fig. 5A and Fig. 23C appear to only test administration of 50 mg/kg of SERD128 combined with 100 µg and 100 mg of anti-PD-L1 antibody. Although the Chou-Talalay method is not the sole method for establishing unexpected, superior results, the data cannot be established as statistically significant based greater than additive effects for the scope of the subject matter encompassed. It is difficult for one of ordinary skill in the art to assess whether actual statistically significant inhibition/impact is occurring between the claimed composition components. As applicant argues synergy is simply an additive effect and seen as combinations which yield the greatest differences between desired and undesired properties, one of ordinary skill in the art would expect the prior art combinations to have some degree of the presently defined synergy and the equivalent presently claimed properties as they have the same structure as the claimed combination.
As both Pietras and Lee teach a composition suitable for the treatment of breast cancer comprising the instantly claimed combination of SERD128 and an anti-PD-L1 inhibitor, it would have been prima facie obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising an anti PD-L1 inhibitor and SERD128 suitable for the same utility.
Therefore, the previous rejection is maintained.
Applicant can provide a showing of difference in anticancer activity or efficacy for the prior art recommended dosage for the claimed combination compared to the presently claimed recommended dosage, or a showing of a critical, unexpected result for a claimed dosage range compared to the prior art to overcome this rejection.
Previous Double Patenting Rejection
Claims 59-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11-19 of U.S. Patent No. 10,918,648 in view of US 2019/0216923 A1 (Lee et al.).
Applicant has amended the claims and traversed the previous rejection on grounds that claims 7 and 11-19 of US Patent No. 10,918,648 do not disclose or suggest the use of an anti-PD-L1 antibody and incorporate the arguments from the traversal of the previous 103 rejection regarding unexpected, superior results.
The Examiner has considered the amendment and traversal fully but must disagree for the following reasons. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is based on the claims of the ‘648 patent in further view of US 2019/0216923 A1 (Lee et al.). Lee (reference publication ‘923) discloses a method for treating cancer that consists essentially of administering an anti-PD-L1 inhibitor, such as nivolumab or pembrolizumab. See para [0010], [0017]-[0020] and [0092], also see Table 2 of Lee. Also see paragraph [0093] where Lee discloses the anti-PD-L1 inhibitors of instant claims 60-64 and 70-74.
The response to the arguments regarding unexpected, superior results provided by Applicant and in the filed Declaration stated above are incorporated herein by reference.
As both the claims of the ‘648 patent, in further view of Lee, teach a composition suitable for the treatment of breast cancer, or triple-negative breast cancer, it would have been obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising SERD128 and an anti PD-L1 inhibitor suitable for the same utility with a reasonable expectation of success of arriving at the present invention.
Until a showing of unexpected, superior results commensurate in scope with the subject matter of the present claims is established, the double patenting rejection is maintained.
Claims 59-78 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-11, 13-14, 16, 18-19 and 21 of U.S. Patent No. 10,400,006 in view of US 2019/0216923 A1 (Lee et al.).
Similarly as stated in the above response to the traversal of the previous 103 rejection, Applicant has amended the claims and traversed the rejection on the grounds do not disclose or suggest the use of an anti-PD-L1 inhibitor and incorporate the arguments from the traversal of the previous 103 rejection regarding unexpected, superior results.
The Examiner has considered the amendment and traversal fully but must disagree for the following reasons. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is based on the claims of the ‘648 patent in further view of US 2019/0216923 A1 (Lee et al.). Lee (reference publication ‘923) discloses a method for treating cancer that consists essentially of administering an anti-PD-L1 inhibitor, such as nivolumab or pembrolizumab. See para [0010], [0017]-[0020] and [0092], also see Table 2 of Lee. Also see paragraph [0093] where Lee discloses the anti-PD-L1 inhibitors of instant claims 60-64 and 70-74.
The response to the arguments regarding unexpected, superior results provided by Applicant and in the filed Declaration stated above are incorporated herein by reference.
As both the claims of the ‘648 patent, in further view of Lee, teach a composition suitable for the treatment of a hyperproliferative disease, such as cancer or triple-negative breast cancer, it would have been obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising SERD128 (a compound of present claims 59 and 69) and an anti PD-L1 inhibitor suitable for the same utility with a reasonable expectation of success of arriving at the present invention.
Until a showing of unexpected, superior results commensurate in scope with the subject matter of the present claims is established, the double patenting rejection is maintained an in amended form necessitated by Applicant amendment.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 59-78 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/085825 (Pietras et al.), in view of in view of US 2019/0216923 A1 (Lee et al.).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Pietras teaches a method for treating breast cancer in a subject including administering the compound of formula I and a further agent. See pages 88-90, paragraphs [0244]-[0248]. Pietras further discloses in some embodiments where the cancer is ER positive breast cancer, ER negative breast cancer, or triple negative breast cancer. See paragraph [0247]. See present claims 65-67 and 75-77.
Pietras teaches a compound of formula (I):
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See page 41, paragraph [0122] to page 45, paragraph [0137].
Pietras discloses the compound of (ii) of present claims 59 and 69. See compound JD128 on page 151, paragraph [0433].
Further agents for administration provided by Pietras also include HER2 inhibitors and aromatase inhibitors.
Pietras teaches anticancer activity of compounds of the disclosure. See page 135, paragraph [0379] to page 141, paragraph [0392].
Ascertainment of the differences between the prior art and the claims.
(See MPEP § 2141.02)
Pietras does not teach a method of inhibiting breast cancer tumor growth or treating breast cancer in a patient, comprising administering an anti-PD-L1 inhibitor.
Pietras does not disclose where the first amount and second amount are a combined synergistic amount.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Lee teaches a method for treating cancer that consists essentially of administering a PD-1 binding antagonist and a MEK inhibitor, such as binimetinib. See para [0010] of Lee.
Lee teaches where the cancer is breast cancer or triple negative breast cancer. See para. [0147] of Lee.
Lee teaches in one embodiment, the PD-1 binding antagonist is an anti PD-1 inhibitor selected from nivolumab, pembrolizumab, a biosimilar of nivolumab, and a biosimilar of pembrolizumab. See para [0017]-[0020] and [0092], also see Table 2.
Lee discloses the term “PD-1 binding antagonist” as used refers to a molecule that binds specifically to PD-1 and decreases the interaction of PD-1 with one or more of its binding partners, such as PD-L1 and/or PD-L2. See para. [0087].
Lee teaches further examples of an anti-PD-1 inhibitor include CT-011 (pidilizumab), IBI-308, atezolizumab (MPDL3280A), MED14736 (durvalumab), avelumab, BMS 936559, ANB011 (TSR-042), mDX-400, BGB-108, MEDI-0680, SHR-1210, PF-06801591, PDR-001, GB-226, STI-1110, MEDI-0680 (AMP-514), PDR001, REGN2810, BGB-108, and BGB-A317. See present claims 60-64 and 70-74. See para. [0093] of Lee.
Lee discloses working examples of combinatorial treatment for cancer comprising an anti-PD-1 inhibitor RMP1-14. See Example 2 in para. [0215]-[0222] and Table 4 as well as Example 4 in para. [0226]-[0228] and Tables 6-8.
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 their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
At minimum, an additive effect is expected between two antitumor agents, however Applicant has not provided evidence of statistically significant inhibition of tumor growth. The data provided in paragraphs [0605]-[0606] and paragraph [0651] and Fig. 4A, Fig. 4B, Fig. 5A and Fig. 23C appear to only test administration of 50 mg/kg of SERD128 combined with 100 µg and 100 mg of anti-PD-L1 antibody. Although the Chou-Talalay method is not the sole method for establishing unexpected, superior results, the data cannot be established as statistically significant based greater than additive effects for the scope of the subject matter encompassed. It is difficult for one of ordinary skill in the art to assess whether actual statistically significant inhibition/impact is occurring between the claimed composition components.
The present claims are drawn to a method of inhibiting a breast cancer tumor or treating breast cancer in a patient comprising administration of an anti-PD-L1 and SERD128 in any ratio or dosage which is effective.
As both Pietras and Lee teach a composition suitable for the treatment of breast cancer, it would have been prima facie obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising an anti PD-L1 antibody and SERD128 (or a compound of instant claims 59 and 69) suitable for the same utility.
Applicant can provide a showing of difference in anticancer activity or efficacy for the prior art recommended dosage for the claimed combination compared to the presently claimed recommended dosage, or a showing of a critical, unexpected result for a claimed dosage range compared to the prior art to overcome this rejection.
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 59-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11-19 of U.S. Patent No. 10,918,648 in view of US 2019/0216923 A1 (Lee et al.).
Claim 7 of the ‘648 patent teaches a method of treating cancer associated with ER activity comprising administration of a compound of formula IIa.
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Figure 1. Formula (IIa) of claim 7 the '648 patent.
Claim 12 of the ‘648 patent teach the compounds (ii) of present claims 59 and 69.
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Figure 5. Compound of claim 12 of the '648 patent.
Claims 17 and 18 of the ‘648 patent teach where the cancer is non-small cell lung cancer and breast cancer, respectively. Claim 19 of the ‘648 patent teaches where the breast cancer to be treated includes ER-positive breast cancer, ER-negative breast cancer or triple negative breast cancer. See present claims 65-67 and 75-77.
Claim 20 of the ‘648 patent discloses wherein (i) and (ii) are in the form of a single pharmaceutical composition further comprising a pharmaceutically acceptable excipient. See present claims 68 and 78.
The ‘648 patent does not teach a method of inhibiting a breast cancer tumor or treating breast cancer in a patient comprising administering an anti-PD-L1 inhibitor.
Lee teaches a method for treating cancer that consists essentially of administering a PD-1 binding antagonist and a MEK inhibitor, such as binimetinib. See para [0010] of Lee.
Lee teaches where the cancer is breast cancer or triple negative breast cancer. See para. [0147] of Lee.
Lee teaches in one embodiment, the PD-1 binding antagonist is an anti PD-1 inhibitor selected from nivolumab, pembrolizumab, a biosimilar of nivolumab, and a biosimilar of pembrolizumab. See para [0017]-[0020] and [0092], also see Table 2.
Lee discloses the term “PD-1 binding antagonist” as used refers to a molecule that binds specifically to PD-1 and decreases the interaction of PD-1 with one or more of its binding partners, such as PD-L1 and/or PD-L2. See para. [0087].
Lee teaches further examples of an anti-PD-1 inhibitor include CT-011 (pidilizumab), IBI-308, atezolizumab (MPDL3280A), MED14736 (durvalumab), avelumab, BMS 936559, ANB011 (TSR-042), mDX-400, BGB-108, MEDI-0680, SHR-1210, PF-06801591, PDR-001, GB-226, STI-1110, MEDI-0680 (AMP-514), PDR001, REGN2810, BGB-108, and BGB-A317. See present claims 60-64 and 70-74. See para. [0093] of Lee.
Lee discloses working examples of combinatorial treatment for cancer comprising an anti-PD-1 inhibitor RMP1-14. See Example 2 in para. [0215]-[0222] and Table 4 as well as Example 4 in para. [0226]-[0228] and Tables 6-8.
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 their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As both the ‘648 patent, in further view of Lee, teach a composition suitable for the treatment of breast cancer, or triple-negative breast cancer, it would have been obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising a compound of present claims 59 and 69 and an anti PD-L1 antibody suitable for the same utility with a reasonable expectation of success of arriving at the present invention.
Claims 1-3, 6, 8, 12, 21-22, 32, 35, 37, 40-41, 43-44 and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-11, 13-14, 16, 18-19 and 21 of U.S. Patent No. 10,400,006 in view of US 2019/0216923 A1 (Lee et al.).
Claim 18 of the ‘006 patent teaches a method of treating a hyperproliferative disorder comprising administering compounds of formula I of claim 1 of the ‘006 patent. Claim 18 also discloses wherein the hyperproliferative disorder is sensitive to inhibition of estrogen receptor activity. Claim 19 of the ‘006 patent discloses the method of claim 18 of the ‘006 patent wherein the hyperproliferative is cancer. Claim 21 of the ‘006 patent teaches where the cancer includes breast cancer. See present claims 66-67 and 76-77.
Claim 1 of the ‘006 patent teaches a compound of formula (I).
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Claim 16 of the ‘006 patent teaches wherein the compound of formula (I) of the ‘006 patent corresponds to compound (ii) of present claims 59 and 69.
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Figure 5. Compound of claim 16 of the '006 patent.
The claims of the‘006 patent do not teach a method of inhibiting a breast cancer tumor or treating breast cancer in a patient comprising administering an anti-PD-L1 inhibitor.
Lee teaches a method for treating cancer that consists essentially of administering a PD-1 binding antagonist and a MEK inhibitor, such as binimetinib. See para [0010] of Lee.
Lee teaches where the cancer is breast cancer or triple negative breast cancer. See para. [0147] of Lee. See present claims 65 and 75.
Lee teaches in one embodiment, the PD-1 binding antagonist is an anti PD-1 inhibitor selected from nivolumab, pembrolizumab, a biosimilar of nivolumab, and a biosimilar of pembrolizumab. See para [0017]-[0020] and [0092], also see Table 2.
Lee discloses the term “PD-1 binding antagonist” as used refers to a molecule that binds specifically to PD-1 and decreases the interaction of PD-1 with one or more of its binding partners, such as PD-L1 and/or PD-L2. See para. [0087].
Lee teaches further examples of an anti-PD-1 inhibitor include CT-011 (pidilizumab), IBI-308, atezolizumab (MPDL3280A), MED14736 (durvalumab), avelumab, BMS 936559, ANB011 (TSR-042), mDX-400, BGB-108, MEDI-0680, SHR-1210, PF-06801591, PDR-001, GB-226, STI-1110, MEDI-0680 (AMP-514), PDR001, REGN2810, BGB-108, and BGB-A317. See present claims 60-64 and 70-74. See para. [0093] of Lee.
Lee discloses working examples of combinatorial treatment for cancer comprising an anti-PD-1 inhibitor RMP1-14. See Example 2 in para. [0215]-[0222] and Table 4 as well as Example 4 in para. [0226]-[0228] and Tables 6-8.
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 their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The present claims are drawn to a method of inhibiting a breast cancer tumor or treating breast cancer in a patient comprising administration of an anti-PD-L1 and SERD128 in any ratio or dosage which is effective.
As both the ‘006 patent, in further view of Lee, teach a composition suitable for the treatment of breast cancer, or triple-negative breast cancer, it would have been obvious to one of ordinary skill in the art to combine these compositions to form a third composition comprising a compound of present claims 59 and 69 and an anti PD-L1 antibody suitable for the same utility with a reasonable expectation of success of arriving at the present invention.
Conclusion
Claims 59-78 are rejected.
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 QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626