DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Benefit of Earlier Filing Date
The instant application was filed 7 November 2022; is a national stage application of PCT/US2021/031426, filed 7 May 2021, and claims the benefit of U.S. Prov. Pat. App. Serial Nos. 63/022,159, filed 8 May 2020; 63/036,244, filed 8 June 2020; 63/141,370, filed 25 January 2021; 63/167,523, filed 29 March 2021; 63/8170,776, filed 5 April 2021; 63/170,761, filed 5 April 2021; 63/170,708, filed 5 April 2021; 63/178,385, filed 22 April 2021; 63/185,257, filed 6 May 2021; 63/185,267, filed 6 May 2021; 63/185,274, filed 6 May 2021; 63/185,282, filed 6 May 2021; 63/185,286, filed 6 May 2021. Acknowledgment is made of Applicant’s claim.
Status of the Claims
The listing of claims filed 7 November 2022 has been examined.
Claims 1, 7, 11, 18, 24, 28, 34, 35, 38, 39, 45, 51, 58–61, 104, 106, 108, 110, 112, 114–116, 230, and 233 are pending. Claims 7, 11, 18, 24, 28, 34, 35, 38, 39, 45, 51, 58–61, 104, 106, 108, 110, 112, 114, 115, 230, and 233 are amended. Claims 2–6, 8–10, 12–17, 19–23, 25–27, 29–33, 36, 37, 40–44, 46–50, 52–57, 62–103, 105, 107, 109, 111, 113, 117–229, 231, 232, and 234 are canceled.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 March 2024 and 27 August 2025 are acknowledged and have been considered.
Reply to Restriction Requirement and Election of Species
Applicant’s election of species without traverse of
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is acknowledged. (Remarks, p.1–2).
Applicant states claims 1, 7, 24, 34, 35, 38, 58–61, 104, 115, 116, 230, and 233 read on the elected species. (Id).
Scope of Search and Examination
A prior art search and examination will begin with the elected species. (MPEP § 803.02). If no prior art is found that would anticipate or render obvious the elected species, then the search will be extended to other species of the elected group. If no prior art is found that would anticipate or render obvious the elected group, then the search will be extended to non-elected species in non-elected groups. If prior art is found that anticipates or renders obvious a non-elected species or group, then the search will stop and the Markush-type claim will be rejected. The prior art search will not be extended unnecessarily to cover all non-elected species.
Should Applicant overcome the rejection by amending the Markush-type claim, then the claim will be reexamined. The prior art search will be extended to the extent necessary to determine the patentability of the Markush-type claim. If prior art is found during reexamination that anticipates or renders obvious the amended Markush-type claim, then the claim will be rejected, any claims to the nonelected species will be held withdrawn from further consideration, and the Office action will be final.
In this case, the elected species was searched and is free of the prior art. Accordingly, the search was expanded until a species was found in the prior art that renders the Markush claim unpatentable. Any claim not rejected herein is provisionally withdrawn and eligible for rejoinder when the rejection to the Markush claim is overcome.
Claim Interpretation
Claim 1 recites “a NEK7 small molecule inhibitor compound.” The specification defines the term as “an organic molecule (i.e., comprising carbon) having a molecular weight ranging from about 300 g/mole to about 1500 g/mol.” (Spec., 5:4–6) (page:lines). Accordingly, any compound having a molecular weight ranging from about 300 g/mole to about 1500 g/mol will meet the definition.
Claim 1 recites “Hinge-binding element.” The specification defines the term as “a region of a NEK7 inhibitor that forms a terminal portion of the molecule that does not contain a direct covalent bond to a hydrophobic back pocket group.” (Id., 5:12–14). Accordingly, any terminal atom or functional group not bonded to the hydrophobic back pocket group will meet this definition.
Claim 1 recites “Flexible linker.” The specification defines the term as “a multi-valent (e.g., bivalent, trivalent, etc.) moiety connecting two or more portions of the NEK7 small molecule and comprising one or more rotatable bonds.” (Id., 5:15–19). Accordingly, any atom or functional group having a rotatable bond and connecting two portions of the compound will meet this definition.
Claim 1 recites “Urea-type linker.” The specification defines the term as “a multi-valent (e.g., bivalent, trivalent, etc.) moiety connecting two or more portions of the NEK7 small molecule and comprising at least one nitrogen and at least one oxo group as defined herein above.” (Id., 5:20–24). Accordingly, any functional group having a nitrogen and an oxo functional group that connects two portions of the compound will meet this definition.
Claim 1 recites “Hydrophobic back pocket group.” The specification defines the term as “a region of a NEK7 inhibitor that forms a terminal portion of the molecule that does not contain a direct covalent bond to a hinge-binding element.” (Id., 5:25–28). Accordingly, any terminal atom or functional group that is not bonded to the hinge-binding element will meet this definition.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7, 24, 34, 35, 39, 58–61, 104, 115, 116, 230, and 233 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by WO2019/192962 (“Jorand-Lebrun”) [IDS].
Jorand-Lebrun discloses numerous compounds meeting the definition of “a NEK7 small molecule inhibitor compound,” including compounds 2 and 3 shown below. (Jorand-Lebrun, ¶¶1, 49, 88, 108–115; claims 1–14).
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Jorand-Lebrun discloses pharmaceutical compositions comprising the compounds. (Id., ¶¶93, 139, 142–156, 243–251; claim 15).
Jorand-Lebrun discloses administering the compound for the treatment of inflammatory disorders, autoimmune disorders, and cancer. (Id., ¶¶1, 139, 154; claims 16–20).
Jorand-Lebrun discloses a method of administering one of the disclosed compounds with other active ingredients in a combination therapy. (Id., ¶¶127–137).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 7, 24, 34, 35, 38, 39, 58–61, 104, and 115 are rejected under 35 U.S.C. § 112(a) because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claims.
MPEP § 2164.01(a) explains how enablement for the claimed invention can be analyzed:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” . . . These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Wands factors are analyzed with respect to the claimed invention in turn below.
The breadth of the claim is broad in scope, as it extends to treating or preventing an unknown number of diseases or disorders for an unidentified patient population. Dependent claims 59 and 60 include a list of diseases and disorders, including, for example, auto-immune disorders, bacterial and viral infections, cancer, etc. The claim therefore encompasses a method of preventing auto-immune disorders, bacterial and viral infections, and cancer.
The nature of the invention generally relates to the pharmaceutical art and more specifically to a “NEK7 small molecule inhibitor compound,” pharmaceutical compositions thereof, methods of making the compound, and methods of administering the compound to a subject. The claim encompasses a method of preventing auto-immune disorders, bacterial and viral infections, and cancer. Thus, the nature of the invention is sophisticated.
The state of the prior art is discussed in the instant specification, which states: “the exact mechanism of the NLRP3-NEK7 interaction is not well understood. Accordingly, there is a need to develop inhibitors that will directly target NEK7 to affect the inflammatory response modulated by the NLRP3 inflammasome in several pathological diseases . . ..” (Id., 1:27–2:6). Accordingly, the state of the art is not very advanced.
Generally, in order to treat a disease, one of skill in the art must identify a biological target for affecting the disease, demonstrate a first drug candidate some way modulates the normal processes of the biological target, and demonstrate that a subject would benefit from such modulation without detrimental side effects. Typically, the process includes in vitro laboratory screening, in vivo testing, and clinical testing. Once that process has been successfully completed by the first drug candidate, subsequent drug candidates can benefit from the established proof of concept if a substantial correlation can be established between the first drug candidate and the subsequent drug candidates. In order to prevent a disease, one of skill in the art would need to identify the subjects likely to acquire such as disease, carry out the claimed invention (e.g., administer the claimed compound/composition), and demonstrate the subject did not have any cells infected by the pathogen and/or demonstrate the subject did not develop the disease as a result of the administration of the compound/composition.
Examiner is unaware of evidence from the specification or prior art that supports a claim for preventing any diseases with a NEK7 small molecule inhibitor compound. Thus, the state of the prior art is in its infancy for preventing diseases with the claimed compounds.
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
The level of predictability in the art is generally unpredictable. The relevant art requires each potential drug candidate to be assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18, 24 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. MPEP § 2164.02(II) explains that a correlation between the claimed invention and the evidence provided in an application, along with a correlation between the evidence and the models recognized in the art, are required:
“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” In this regard, the issue of “correlation” is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications).
Further, treatments may be effective for some subjects and ineffective for other subjects. Thus, each candidate for pharmaceutical or veterinary medicine must be evaluated on its own even when a nexus to an existing drug or class of drugs has been established.
The amount of direction provided by the inventor is limited to in vitro assays of representative compounds to assess activity against NEK7 and IL-1b. (Spec., 213:4–213:7; 484:1–500:12).
The existence of working examples relate to in vitro assays of representative compounds to assess activity against NEK7 and IL-1b. There are no examples demonstrating in vivo activity against a specific disease with such compounds.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure is extensive, as it includes in vitro and in vivo screening for each specific disease or disorder encompassed by the claims. As claimed, the indefinite scope of such diseases is essentially unbound.
Scope of Enablement Conclusion
In view of the Wands factors discussed above, the disclosure of the instant application does not reasonably enable a person having ordinary skill in the art to use the full scope of the claimed invention. The breadth of the claims is broad in scope; the nature of the invention is sophisticated; the state of the prior art is in its infancy for treating or preventing a disease or disorder; the level of skill in the art is high; the pharmaceutical art is unpredictable; the direction provided by the inventor is limited to in vitro assays of representative compounds to assess activity against NEK7 and IL-1b; there are no working examples demonstrating in vivo activity against a specific disease with such compounds; and the quantify of experimentation needed to practice the claimed invention is extensive. Thus, when the evidence is considered as a whole, undue experimentation would be required to practice the full scope of the claimed invention.
Of particular note is the lack of information correlating the in vitro activity against NEK7 and IL-1b to existing technologies. As such, the disclosure does not indicate which, if any, specific diseases may be treated using the claimed compounds. Furthermore, there is no evidence that the disclosed compounds can prevent any disease according the claimed method.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 116, 230, and 233 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.” (Id.). “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011).
What is required to meet the written description requirement “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). In Ariad, the Federal Circuit explained what is required to meet the written description requirement:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v. Eshhar, 418 F.3d 1349, 1357–58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.” Id. at 1359.
(Ariad, at 1351).
The written description of a genus, such as a chemical genus, “requires a precise structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit commented on that case in the Ariad decision:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
(Ariad, at 1350).
The factors outlined in the above Federal Circuit cases are analyzed with respect to the claimed invention in turn below.
(A) The nature and scope of the claim invention in view of the specification: the claimed invention relates generally to the pharmaceutical art and more specifically to a composition comprising a NEK7 small molecule inhibitor compound and at least one NEK7 protein.
The claimed NEK7 small molecule inhibitor compound is defined in the specification as “an organic molecule (i.e., comprising carbon) having a molecular weight ranging from about 300 g/mole to about 1500 g/mol.” (Spec., 5:4–6). The scope of such compounds in unbound.
The claimed at least one NEK7 protein is not defined in the specification. The chemical structures of such proteins are not disclosed. And there are no examples in the specification showing how to make or use a composition comprising at least one NEK7 protein. The scope of such proteins is not known.
The specification does not provide any details related to the relative concentrations or the ratio for each of the active ingredients in a combination composition. The specification does not provide any details related to the preparation such a combination composition. The specification does not provide any details related to testing such a combination composition for efficacy.
The scope of the claimed composition comprising two active ingredients is broad, as it encompasses a large and unknown number of compositions.
The nature of the claimed invention is sophisticated, as it encompasses active agents in the pharmaceutical art.
(B) The extent and content of the prior art: embodiments of the claimed NEK7 small molecule inhibitor compound are disclosed in, e.g., WO2019/192962 (“Jorand-Lebrun”). A method of administering one of the disclosed compounds with an additional active ingredient in a combination therapy is also described in Jorand-Lebrun. (Id., ¶¶127–137). But a composition comprising the claimed NEK7 small molecule inhibitor compound and at least one NEK7 protein is not described in Jorand-Lebrun or other prior art that has been reviewed.
(C) The maturity of the science or technology: while combination drug therapies exist, the claims are directed to a relatively specific composition comprising NEK7 small molecule inhibitor compound and at least one NEK7 protein, and there does not appear to be any pre-clinical or clinical trials that provide a proof of concept for the claimed invention. As such, the science relevant to the claimed invention is in its infancy.
(D) The predictability of the aspect at issue: the pharmaceutical art is generally recognized as unpredictable. In re Fisher, 427 F.2d 833, 839 (CCPA 1970). The art requires each potential drug candidate to be assessed for physiological activity. Id. The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. In this case, there is no evidence suggesting the claimed invention is any more predictable than the pharmaceutical art is generally.
The question of written description
When the above factors and evidence discussed therein are considered as a whole, the specification (in view of the prior art) does not adequately describe a representative number of species to support the claimed invention to composition comprising the combination of a NEK7 small molecule inhibitor compound and at least one NEK7 protein. The scope of the claimed invention is broad and the nature of the claimed invention is sophisticated. The science relevant to the claimed invention is in its infancy. The prior art that has been reviewed does not disclose a composition comprising a NEK7 small molecule inhibitor compound and at least one NEK7 protein. As such, it is the instant specification that must adequately describe the claimed composition, and the specification does not disclose any examples of the claimed composition. In view of the record as a whole, the Specification would not reasonably convey to those skilled in the art the inventor had possession of the claimed subject matter as of the filing date.
Examiner recommends canceling the rejected claims.
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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 116, 230, and 233 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–3, 7, 9, 11, 12, 20, 21, 25, 27, 28, 33, 34, 43, 45, 47, 51–59, 63, and 64 of copending App. No. 18/001,064 (reference claims).
The instant claims are directed to compositions comprising a NEK7 small molecule inhibitor compound. The reference claims are directed to compounds and compositions comprising the compounds. Although the claims at issue are not identical, each claim reads on the elected species. Accordingly, an infringer of a patent granted based on the claims of one of the instant application or the reference application may also be an infringer of the other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Claims 11, 18, 28, 45, 51, 106, 108, 110, 112, and 114 are withdrawn.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623