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 .
Status of the Claims
Claims 1, 6-16, and 23-24 are pending in this application. Claims 2-5 and 17-22 have been cancelled by applicant.
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 and 6-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 9,902,714 B2 (US ‘714) – From IDS; in view of Ma et al. (J. Med. Chem., 2001, 44, 4137-4256 – previously cited); further in view of Crawford et al. (J. Med. Chem., 2014, 57, 3484−3493 – previously cited).
Regarding instant claims 1 and 6-16, US ‘714 claims the compounds of Formula (I) below, which read on the instantly claimed general structure (US ‘714’s claim 1).
Further regarding claim 16, US ‘714 claims a pharmaceutical composition comprising their compounds and pharmaceutically acceptable carriers (US ‘714’s claim 22).
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US ‘714 does not specifically speak to the compounds with the instantly claimed 1,5-naphthyridine core (shown below for reference). The teachings of Ma and Crawford et al. are relied upon for these disclosures.
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Ma discloses a medicinal chemistry campaign to optimize an active agent, wherein a variety of nitrogen bearing heterocycles were utilized (see relevant examples below) (Chart 1, aryl group v, page 4140) and substituted for one another to assess the effects on potency of the modified structure. Ma’s study suggests a bioisosteric relation between the instantly claimed core and the core of US ‘714’s compounds.
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Crawford discloses a nitrogen-walking assay to increase the polarity of the core of their compounds (Table 3, page 3487, col. 1). Crawford discloses modification of their structure in order to optimize hydrogen bonding interactions with their desired target, thus optimizing inhibition (Figure 2A-B, page 34897, col. 1).
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘714’s disclosed formula I, in view of Ma, further in view of Crawford. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘714 in view of Ma’s suggestion of a bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above. Further, one of ordinary skill would have been motivated to prepare the instant compounds in view of Crawford’s teachings that a nitrogen walking approach around the bicyclic core of their compounds increased polarity of their compounds and optimized binding affinity to their desired target. One of ordinary skill would have had a reasonable expectation of success in view of US ‘714’s disclosure of their compounds; Ma’s teachings of the bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above; and Crawford’s disclosure of nitrogen-walking around a bicyclic core as a way to increase compound polarity and optimize binding affinity in their targets, thus suggesting that this “nitrogen walking” approach is an obvious technique in medicinal chemistry for lead compound and drug optimization.
A person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2143(E) KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Applicant is advised, the courts have stated that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Claims 1, 6-16, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of U.S. Patent No. 10,421,747 B2 (US ‘747) – From IDS; in view of Ma et al. (J. Med. Chem., 2001, 44, 4137-4256 – previously cited); further in view of Crawford et al. (J. Med. Chem., 2014, 57, 3484−3493 – previously cited).
Regarding instant claims 1, 6-16, and 23-24, US ‘747 claims a method of inhibiting FGFR kinase with the compounds of Formula (I) below (US ‘747’s claims 1-19).
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Further regarding claims 23-24, Applicant is advised, the courts have found similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
US ‘747 does not specifically speak to the compounds with the instantly claimed 1,5-naphthyridine core (shown below for reference). The teachings of Ma and Crawford et al. are relied upon for these disclosures.
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Ma discloses a medicinal chemistry campaign to optimize an active agent, wherein a variety of nitrogen bearing heterocycles were utilized (see relevant examples below) (Chart 1, aryl group v, page 4140) and substituted for one another to assess the effects on potency of the modified structure. Ma’s study suggests a bioisosteric relation between the instantly claimed core and the core of US ‘747’s compounds.
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Crawford discloses a nitrogen-walking assay to increase the polarity of the core of their compounds (Table 3, page 3487, col. 1). Crawford discloses modification of their structure in order to optimize hydrogen bonding interactions with their desired target, thus optimizing inhibition (Figure 2A-B, page 34897, col. 1).
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘747’s disclosed formula I, in view of Ma, further in view of Crawford. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘747 in view of Ma’s suggestion of a bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above. Further, one of ordinary skill would have been motivated to prepare the instant compounds in view of Crawford’s teachings that a nitrogen walking approach around the bicyclic core of their compounds increased polarity of their compounds and optimized binding affinity to their desired target. One of ordinary skill would have had a reasonable expectation of success in view of US ‘747’s disclosure of their compounds; Ma’s teachings of the bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above; and Crawford’s disclosure of nitrogen-walking around a bicyclic core as a way to increase compound polarity and optimize binding affinity in their targets, thus suggesting that this “nitrogen walking” approach is an obvious technique in medicinal chemistry for lead compound and drug optimization.
A person with ordinary skill has good reason to pursue known options within his or her technical grasp.
Applicant is reminded, the courts have stated that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Claims 1, 6-16, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25 of U.S. Patent No. 11,542,247 B2 (US ‘247) – From IDS; in view of Ma et al. (J. Med. Chem., 2001, 44, 4137-4256 – previously cited); further in view of Crawford et al. (J. Med. Chem., 2014, 57, 3484−3493 – previously cited).
Regarding instant claims 1, 6-16, and 23-24, US ‘247 claims the compounds of Formula I and Ia-b below (US ‘247’s claims 1-3). US ‘247 also claims a method of treating a disease or condition mediated by FGFR kinase comprising administration of their compounds (US ‘247’s claims 16-25).
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Further regarding instant claims 23-24, Applicant is reminded, the courts have found similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
US ‘247 does not specifically speak to the compounds with the instantly claimed 1,5-naphthyridine core (shown below for reference). The teachings of Ma and Crawford are relied upon for these disclosures.
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Ma discloses a medicinal chemistry campaign, wherein a variety of nitrogen bearing heterocycles were utilized (see relevant examples below) (Chart 1, aryl group v, page 4140) and substituted for one another to assess the effects on potency of the modified structure. Ma’s study suggests a bioisosteric relation between the instantly claimed core and the core of US ‘247’s compounds.
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Crawford discloses a nitrogen-walking assay to increase the polarity of the core of their compounds (Table 3, page 3487, col. 1). Crawford discloses modification of their structure in order to optimize hydrogen bonding interactions with their desired target, thus optimizing inhibition (Figure 2A-B, page 34897, col. 1).
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘247’s disclosed formula I, in view of Ma, further in view of Crawford. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘247 in view of Ma’s suggestion of a bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above. Further, one of ordinary skill would have been motivated to prepare the instant compounds in view of Crawford’s teachings that a nitrogen walking approach around the bicyclic core of their compounds increased polarity of their compounds and optimized binding affinity to their desired target. One of ordinary skill would have had a reasonable expectation of success in view of US ‘247’s disclosure of their compounds; Ma’s teachings of the bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above; and Crawford’s disclosure of nitrogen-walking around a bicyclic core as a way to increase compound polarity and optimize binding affinity in their targets, thus suggesting that this “nitrogen walking” approach is an obvious technique in medicinal chemistry for lead compound and drug optimization.
A person with ordinary skill has good reason to pursue known options within his or her technical grasp.
Applicant is reminded, the courts have stated that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Response to Arguments
Double Patenting
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Applicant requests reconsideration due to Examiner’s analysis being based on hindsight “provided by Applicant’s invention”. Applicant argues Examiner has failed to identify a reason why one of ordinary skill who was not already aware of the claimed subject matter would have applied the teachings of Ma and Crawford to the US ‘714 for obviousness-type non-statutory double patenting (NSDP) with a reasonable expectation that doing so would provide a “useful molecule”. Applicant mentions that Ma discloses erythromycins with a very different structure from the claimed invention; that Ma’s disclosure is so broad, diffuse, and structurally dissimilar … that it cannot credibly provide a reasonable expectation of success. Applicant argues that instant rings are bivalent, while Ma’s are monovalent. Applicant argues that Examiner’s application of Crawford is similarly flawed, and Examiner fails to identify a credible reason why a person of ordinary skill would have consulted Crawford. Once again, Applicant states, Crawford’s disclosure is so dissimilar it cannot credibly provide a reasonable expectation of success; that nothing in Crawford suggests the instantly claimed core, and that Crawford shows “vastly different biological activity”. Applicant states there is no evidence that one of ordinary skill who did not already have knowledge of “Applicant’s inventions” would have been motivated to modify US ‘714’s compounds, or had a reasonable expectation of success in doing so. Applicant further states “there is nothing predictable to be gleamed from Ma and Crawford about FGFR inhibition” because Ma and Crawford are directed toward different targets. Applicant concludes instant compounds are not obvious. Applicant reinstates the comments above for US ‘747 and US ‘247 NSDP rejections of record.
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).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, for the NSDP over US ‘714 specifically, US ‘714 claims the compounds of Formula (I) below, which read on the instantly claimed general structure (US ‘714’s claim 1).
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While US ‘714 does not specifically speak to the compounds with the instantly claimed 1,5-naphthyridine core (shown below for reference). The teachings of Ma and Crawford are relied upon for these disclosures.
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Ma discloses a medicinal chemistry campaign to optimize an active agent, wherein a variety of nitrogen bearing heterocycles were utilized (see relevant examples below) (Chart 1, aryl group v, page 4140) and substituted for one another to assess the effects on potency of the modified structure. Ma’s study suggests a bioisosteric relation between the instantly claimed core and the core of US ‘714’s compounds.
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Crawford discloses a nitrogen-walking assay to increase the polarity of the core of their compounds (Table 3, page 3487, col. 1). Crawford discloses modification of their structure in order to optimize hydrogen bonding interactions with their desired target, thus optimizing inhibition (Figure 2A-B, page 34897, col. 1).
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by US ‘714’s disclosed formula I, in view of Ma, further in view of Crawford. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by US ‘714 in view of Ma’s suggestion of a bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above. Further, one of ordinary skill would have been motivated to prepare the instant compounds in view of Crawford’s teachings that a nitrogen walking approach around the bicyclic core of their compounds increased polarity of their compounds and optimized binding affinity to their desired target. One of ordinary skill would have had a reasonable expectation of success in view of US ‘714’s disclosure of their compounds; Ma’s teachings of the bioisosteric relationship between the two-nitrogen containing bicyclic systems shown above; and Crawford’s disclosure of nitrogen-walking around a bicyclic core as a way to increase compound polarity and optimize binding affinity, suggesting this “nitrogen walking” approach as an obvious technique in medicinal chemistry for lead compound and drug optimization.
Applicant is reminded that a person with ordinary skill has good reason to pursue known options within his or her technical grasp.
Applicant is reminded, the courts have stated that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Regarding Applicant arguments that Ma discloses erythromycins with a very different structure from the claimed invention; that Ma’s disclosure is so broad, diffuse, and structurally dissimilar … that it cannot credibly provide a reasonable expectation of success; Ma specifically suggests the bioisosteric relationship between the aza-bicyclic cores below. Regarding Applicant’s comment that Crawford’s disclosure is so dissimilar it cannot credibly provide a reasonable expectation of success; Crawford specifically teaches “nitrogen walking” as a known approach in medicinal chemistry for optimizing polarity, H-bonding, and binding affinity of lead compounds and drugs. Thus, per MPEP 2123 (I): “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).”
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Regarding Applicant’s arguments that there is no evidence that one of ordinary skill who did not already have knowledge of “Applicant’s inventions” would have been motivated to modify US ‘714’s compounds, etc. Applicant is directed to the comment above, regarding “hindsight reasoning”.
Regarding Applicant’s comment that “there is nothing predictable to be gleamed from Ma and Crawford about FGFR inhibition” because Ma and Crawford are directed toward different targets; Applicant is advised that the courts have found that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)). While US ‘714 does not claim their compounds for FGFR inhibition (which is why instant claims 23-24 were not rejected under NSDP over US ‘714); US ‘747 and US ‘247 claim their compounds as FGFR inhibitors – see rejections herein).
The comments above are applicable to Applicant’s statement regarding NSDP rejections of record over US ‘747 and US ‘247.
This action is made final.
Conclusion
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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627