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
Status of the Claims
Claims 20-27 and 29-36 currently pending. Claims 20-27 and 29-36 are rejected.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/JP2021/042502, filed 11/18/2021, which claims priority under 35 U.S.C. 119(a-d) to JAPAN 2020-193073, filed 11/20/2020. Acknowledgement is made of Applicant’s claim for foreign priority, however, it is noted that Applicant has not filed an English translation of the certified copy of the JAPAN 2020-193073 application as required by 37 CFR 1.55. Therefore, the effective filing date is 11/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/10/2024 and 04/30/2026 have been considered by the examiner. Please note that the IDSs dated 01/10/2024 and 01/18/2024 are identical. NPL Documents filed 01/10/2024 do not have an accompanying IDS submitted: (1) Watanabe et al. “Effects of long-chain fatty alcohol on peripheral nerve conduction and bladder function in diabetic rats” Life Sciences, 70 (2002) 2215-2224. (2) China National Intellectual Property Administration, Notification of First Office Action, Application No. 202180046082.1, Mailing Date: December 13, 2023. (3) Saito et al. “Effect of cyclohexenonic long-chain fatty alcohol on rat overactive bladder induced by bladder neck obstruction” European Journal of Pharmacology, 501 (2004) 143-149.
Response to Amendment/Arguments
The amendment filed 01/30/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
Objection to the Claims
The objections of the claims for informalities have been overcome by the amendment correcting said informalities. The objections have been withdrawn.
35 USC § 102 Rejection
Applicant's arguments and amendments with respect to the rejection of claims 20-37 under 35 USC 102 for being anticipated by Miyazaki et al. in US Patent 10,155,768 have been fully considered and are persuasive.
Applicant has amended claims 20 and 29 to incorporate the “primary or metastatic brain” tumor subject matter from now-cancelled claims 28 and 37. Since the Miyazaki ‘768 reference does not include examples wherein relevant compounds have been used for treatment of a brain tumor, the rejection is withdrawn.
35 USC § 103 Rejection
Applicant’s arguments with respect to the rejection of claims 20-37 under 35 USC 103 for being obvious over Miyazaki et al. in US Patent 10,155,768 have been fully considered but are not persuasive.
Applicant argues that Miyazaki does not teach brain penetration by any compounds and does not provide any specific Examples relevant to the treatment of brain tumors. The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II). In the instant case, it would have been obvious for a person having ordinary skill in the art to use the known compounds as a treatment for a brain tumor since Miyazaki et al. demonstrated their use toward treating a thyroid tumor and included treatment of a brain tumor as a preferred embodiment. The fact that Applicant is now aware that the prior art compounds have a brain penetration property does not give the claimed invention patentable weight as brain penetration and/or blood-brain barrier permeability flows naturally from treating brain tumors.
Applicant also argues that comparative compounds of Table 4 in the present application with similar structures do not have brain penetrable properties and therefore it would not be expected that the compounds of the instant claims would have the same property. This argument is not relevant to the situation since the compounds of the prior art are either identical to compounds of the present claims or are embraced by instant formula (I). As identified in the Office Action mailed 09/30/2025, cited compounds 88 and 127 are identical to compounds (12) and (9) in instant claims 26 and 35. Further, the Office Action discusses numerous prior art examples that are embraced by the instant formula. See pages 11-12.
Applicant’s arguments with respect to the rejection of claims 20-37 under 35 USC 103 for being obvious over Hayashi et al. in US 2020/0190154 in view of Miyazaki et al. in US Patent 10,155,768 have been fully considered but are not persuasive.
Applicant argues that Hayashi does not describe or suggest the application of compound (I) to brain tumors. Applicant appears to be arguing against references individually instead of in combination. See MPEP 2145(IV): “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).”
Applicant also argues that there was no explanation of a reasonable expectation of success nor motivation that a person of ordinary skill in the art must have had in order to pursue the combination of references. See Remarks, page 20. However the Office Action dated 09/30/2025 on page 20-21 states: “Upon finding compounds 6-9 from Hayashi et al. reported for their usefulness as therapeutic agents for cancer, a skilled artisan would be motivated to pursue using the compounds in methods wherein cancer is treated. The Miyazaki et al. reference provides an expectation of success using said compounds since the compounds from Hayashi et al. are identical to compounds 85, 87, 89 and 90 of Miyazaki et al. also cited in the rejection under 35 U.S.C. 102 section of this Office Action” (emphasis added). Though the now-amended claims include “primary or metastatic brain” tumor subject matter, since Miyazaki et al. include treating a brain tumor as a preferred embodiment, the case for obviousness stands and the rejection is maintained.
Double Patenting Rejection
Applicant’s arguments in response to the rejection of claims 20-37 for nonstatutory obvious double patenting over claims 1-7 of US Patent 10,155,768 have been fully considered but are not persuasive. Applicant reiterates the arguments made in regards to the 102 and 103 rejections, however, the instant claims remain obvious in view of the patented claims. The rejection is maintained.
Applicant’s arguments in response to the rejection of claims 20-27 and 29-36 for nonstatutory obvious double patenting over claim 83 of co-pending application 18/253,229 have been fully considered. In light of Applicant’s amendments to claims 20 and 29 to incorporate subject matter from now-cancelled claims 28 and 37, the rejection has been withdrawn.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(1 of 2) Claims 20-27 and 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Miyazaki et al. in US Patent 10,155,768 B2 published December 18, 2018.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Miyazaki et al. teach compounds that are “useful for the prevention and/or treatment of RET-related diseases, particularly cancer, based on RET inhibitory activity” (see abstract). Further, Miyazaki et al. describes specific types of cancer to be treated, including brain tumors as a preferred embodiment:
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. See col. 90, lines 32-36.
As an example of the prior art genus, Miyazaki et al. teach Example 88 in col. 195:
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. The compound is embraced by the instant Formula (I) wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is pyrrolidinyl substituted C3 alkynyl (see instant claims 23, 25, 32, 34).
Regarding instant dependent claims 26-27 and 35-36 which recite the methods wherein the compound of Formula (I) is
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, Example 88 is identical to said compound recited in the claims.
As another example of the prior art genus, Miyazaki et al. teach Example 127 in col. 213:
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. The compound is embraced by the instant Formula (I) wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is methyl substituted C1 alkoxy (see instant claims 24, 25, 33, 34).
Regarding instant dependent claims 26-27 and 35-36 which recite the methods wherein the compound of Formula (I) is
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, Example 127 is identical to said compound recited in the claims.
Applicant is advised that numerous compounds are embraced by Formula (I) of the instant claims noted above including, for instance, compound Examples 25 (col. 163), 36 (col. 167), 39 (col. 169), 44-47 (col. 171-173), 49 (col. 175), 57 (col. 179), 66 (col. 183), 85-87 (col. 193), 89-105 (col. 195-201), 108 (col. 203), 110-114 (col. 205-207), 118-126 (col. 209-213), 128-132 (col. 213-215), 134-144 (col. 215-221), 151-152 (col. 225), 155-163 (col. 227-231), 165-166 (col. 233), 168-170 (col. 233-235), 172-178 (col. 235-239), 180-189 (col. 239-245), 191-193 (col. 245-247), 195-200 (col. 247-249) and 204 (col. 251).
Additionally, Example 62 in col. 181,
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, is nearly embraced by the instant formula wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 20 and 29); and
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22 and 30-31).
Example 62 differs from instant Formula (I) of claims 20 and 29 wherein R3 is methyl instead of hydrogen.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
The prior art does not teach explicit embodiments wherein the compounds cited above are administered to a subject having a tumor as recited in instant claim 20 or a subject having a tumor with enhanced activation of RET as recited in instant claim 29.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Regarding instant independent claims 20 and 29 directed to a method for treating a subject having a primary or metastatic brain tumor with (per claim 29) or without (per claim 20) enhanced activation of RET, comprising administering a compound of Formula (I).
Miyazaki et al. teach a method of using related compounds 85, 87, 89 and 90 for the treatment of thyroid cancer in a mouse model. See Test Example 10 in col. 280 and results of the test in Tables 54 and 55 in col. 281 and cited in the Office Action dated 09/30/2025 in the rejection under 35 U.S.C. 102.
Miyazaki et al. also identified in an in vitro assay that compounds 85, 87, 89 and 90 inhibited RET kinase activity with IC50 values in the range of 0.2-0.4 nM. See Table 35 in col. 257 for results. The prior art also finds that compounds 85, 87, 89 and 90 are able to inhibit RET V804L and V804M mutations in vitro with IC50 values in the range of 0.6-3.2 nM. See Table 46 in col. 271 for results. In comparison, compound 88 cited above inhibits RET, RET V804L and RET V804M in vitro at IC50 values of 0.2, 0.4, and 0.9 nM, respectively. See Table 35 in col. 257 and Table 46 in col. 271. Likewise, compound 127 cited above inhibits RET, RET V804L and RET V804M in vitro at IC50 values of 0.5, 1.3, and 7.5 nM, respectively. See Table 36 in col. 258 and Table 47 in col. 271. In fact, the compounds cited in this rejection under 35 U.S.C. 103 section inhibit RET activity with IC50 values in the range of 0.2-9.0 nM. By that measure alone, each of the cited compounds has improved activity over known RET inhibitor Vandetanib cited by Miyazaki et al. as having an IC50 value of 9.2 nM.
Thus, a skilled artisan would have a reasonable expectation of success in using any of the compounds cited herein in a method for treating cancer in a subject having a tumor, including those tumors with RET kinase present. Further, Miyazaki et al. teach methods wherein the cited prior art compounds read on the instant claims with respect to treating a tumor, and preferably a brain tumor per col. 90, lines 32-36 of the Miyazaki disclosure. Thus, claims 20-27 and 29-36 are obvious wherein the tumor is a primary brain tumor.
(2 of 2) Claims 20-27 and 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al. in US 2020/0190154 A1, published June 18, 2020, which in view of Miyazaki et al. in US Patent 10,155,768 B2, published December 18, 2018.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Hayashi et al. teach pharmaceutical compositions containing a compound that inhibits RET as an active ingredient (see abstract). Hayashi et al. also teach that RET inhibition is useful in the treatment of cancer patients. See page 1, para. [0014]:
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. Hayashi et al. also describes compounds 6-9 as RET inhibitors that are able to inhibit the growth of DCTN1-RET fusion gene-expressing NIH/3T3 cells. See Table 7 and paragraphs [0154]-[0155] on page 20, also reproduced here:
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.
Compound 6,
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(see Table 6, page 19), reads on instant formula (I)
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of claims 20 and 29 wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is morpholinyl substituted C3 alkynyl (see instant claims 23, 25, 32, 34).
Regarding instant dependent claims 26-27 and 35-36 which recite the methods wherein the compound of Formula (I) is
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, Compound 6 is identical to said compound recited in the claims.
Compound 7,
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(see Table 6, page 19), reads on instant formula (I)
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of claims 20 and 29 wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is tetrahydropyranyl substituted C2 alkynyl (see instant claims 23, 25, 32, 34).
Regarding instant dependent claims 26-27 and 35-36 which recite the methods wherein the compound of Formula (I) is
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, Compound 7 is identical to said compound recited in the claims.
Compound 8,
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(see Table 6, page 19) reads on instant formula (I)
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of claims 20 and 29 wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is tetrahydrofuranyl substituted C1 alkoxy (see instant claims 24, 25, 33, 34).
Regarding instant dependent claims 26 and 35 which recite the methods wherein the compound of Formula (I) is
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, Compound 8 is identical to said compound recited in the claims.
Compound 9,
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(see Table 6, page 20), reads on instant formula (I)
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of claims 20 and 29 wherein:
R1 is the C1 alkoxy C1 alkyl methoxymethyl (see instant claims 25, 34);
R2 is methyl substituted C3 cycloalkyl (see instant claims 21-22, 25, 30-31, 34); and
R3 is methylpyrazolyl substituted C2 alkynyl (see instant claims 23, 25, 32, 34).
Regarding instant dependent claims 26-27 and 35-36 which recite the methods wherein the compound of Formula (I) is
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, Compound 9 is identical to said compound recited in the claims.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Neither Hayashi et al. nor Miyazaki et al. teach explicit embodiments wherein the compounds cited above are administered to a subject having a tumor as recited in instant claim 20 or a subject having a tumor with enhanced activation of RET as recited in instant claim 29. Moreover, Hayashi et al. do not teach the use of RET inhibitors for treatment of brain tumors.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Hayashi et al. rely on the teachings of Miyazaki et al. for evidence that compounds 6-9 are able to inhibit cancerous cell growth and inhibit the RET protein. See the beginning of paragraph [0114] reproduced here:
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. Please note that WO 2017/146116 is related to Miyazaki et al. in US Patent 10,155,768 B2 already cited in this Office Action. Further, compounds 6-9 of Hayashi et al. are identical to compounds 85, 87, 89 and 90 of Miyazaki et al. also cited in the rejection under 35 U.S.C. 102 section of the Office Action dated 09/30/2025.
Upon finding compounds 6-9 from Hayashi et al. reported for their usefulness as therapeutic agents for cancer, a skilled artisan would be motivated to pursue using the compounds in methods wherein cancer is treated. The Miyazaki et al. reference provides an expectation of success using said compounds since the compounds from Hayashi et al. are identical to compounds 85, 87, 89 and 90 of Miyazaki et al. Further, Miyazaki et al. teach methods wherein the cited prior art compounds read on the instant claims with respect to treating a tumor, and preferably a brain tumor per col. 90, lines 32-36 of the Miyazaki disclosure. Thus, claims 20-27 and 29-36 are obvious wherein the tumor is a primary brain tumor.
Maintained Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20-27 and 29-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,155,768. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘768 claims a compound of Formula (I’):
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and claim 7 in US ‘768 specifically claims the compounds, for example,
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and
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. Compounds (8) and (20) of US ‘768 are identical to compounds (2) and (9), respectively, of instant claims 26-27 and 35-36.
With respect to the instant claims, the claims in US ‘768 do not explicitly claim the method of using/ administering the compound of Formula (I’) to treat a tumor in a subject.
With respect to the conflicting claims in US ‘768 being directed to a different statutory class of invention (instantly claimed methods of using compounds rather than the compounds themselves), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘768 identifies the utility of the compounds for treating RET-related diseases, such as malignant tumors (see col. 3, lines 36-41). Please note that compounds (8) and (20) of the claims are the same as example compounds 85 and 127, respectively. See Table 20, col. 193 and Table 25, col. 213.
The specification also defines a preferred embodiment wherein the compounds of the patent are used to treat brain tumors:
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. See col. 90.
Since said utility of the compound as claimed in US ‘768 is identical to the utility of the compounds claimed in the instant claims, the claims in US ‘768 render the instant claims 20-37 unpatentable for anticipatory-type double patenting.
Conclusion
Claims 20-27 and 29-36 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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