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 .
Claim Status
Claims 1-10 are pending and under examination.
Objections to the Claims
Claims 1 and 5-10 are objected to for being directed to a method to obtain monoclonal antibodies and not reciting active method steps.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4, 6, and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 discloses “the immunogenic material” which does not refer back to a limitation disclosed in claim 1.
Claims 2-4, 6, and 7 disclose “the target protein” which does not refer back to a limitation disclosed in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
WRITTEN DESCRIPTION
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
The teachings of the specification and the claimed invention
The claims are directed to a method for obtaining monoclonal antibodies, or fragments or conjugates thereof, which bind with high affinity processed proteins that are specifically expressed in local and metastatic tumors.
The specification discloses production and screening procedures for obtaining monoclonal antibodies that recognized cleaved, tumor-specific Trop-2.
The specification does not provide examples of the method for “processed proteins” other than Trop-2 cleaved by ADAM10. The specification does not provide examples of the use of the antibodies distilled to practice for use in treating or diagnosing tumors.
Claim Analysis
In view of the claims and teachings of the specification, the claims have the following written description issues:
Claim 1 states the antibodies of the method bind with high affinity to processed proteins that are specifically expressed in local and metastatic tumors. The specification provides a single example of a “processed protein”, specifically Trop-2 cleaved at amino acids T88 and R87. The examples are not representative of all of the potential processing methods of proteins, both endogenous and external.
Claim 2 claims immunization procedures comprising immunogenic material consisting of target protein, fragments and conjugates. The claims do not provide a host for the immunization procedures. The claims do not provide what target proteins or fragments can be used in the methods.
Claim 5 claims the processing of the proteins is posttranslational and comprises at least one of the modifications selected from the group consisting of peptide bond cleavage, amino acid modifications, including deamidation, addition of chemical groups, including phosphorylation, acetylation, hydroxylation, methylation, addition of complex organic molecules, including lipidation, AMPylation, ubiquitination, and SUMOylation. The specification provides evidence the applicant’s method only included a single post-translation modification, specifically, cleavage of Trop-2.
One of skill in the art would neither expect nor predict the appropriate functioning of the method as claimed. As the disclosure does not provide sufficient written description to support the functionality for each of these claimed elements, the disclosure does not allow those of skill in the art to recognize other members of the claimed genus.
Therefore, the skilled artisan would not reasonably conclude that the inventors, at the time the application was filed, had full possession of method as broadly claimed.
SCOPE OF ENABLEMENT
Claims 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of a tumor in a subject, does not reasonably provide enablement for prevention of occurrence of a tumor. 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 these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
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.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and the nature of the invention
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. As such, the broadest reasonable interpretation of the claimed method is that the monoclonal antibodies obtained by the claimed method can be used for both the treatment and prevention of cancer. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
The state of the relevant art and level of predictability in the art
The art does not provide compensatory teachings regarding the prevention of cancer. Cancer has a wide variety of causes, from environmental and/or developmental exposure to ionizing radiation and/or chemical exposure in addition to some types viral and bacterial exposure (Lichtman MA et al. The Oncologist 2017; 22(5); 542–548). Even though cancer is characterized by the infinite cell proliferation, its pathogenesis is extremely complex and related to many mechanisms. In general, the hallmarks of cancer consist of ten biological capabilities during the development of cancers, namely sustaining proliferative signaling, evading growth suppressors, resisting cell death, enabling replicative immortality, inducing angiogenesis, activating invasion and metastasis, tumor-promoting inflammation, genome instability and mutation, evading immune destruction and reprogramming energy metabolism (Hanahan D et al. Cell 2011 144(5) p646-674, Figures 1 and 3). More than 100 types of cancer have been identified which are typically termed for the organs or tissues where they occur. Hanahan taught over the past decade, tumors have increasingly been recognized as organs whose complexity approaches and may even exceed that of normal healthy tissues (page 661, right column second to last paragraph). Hanahan taught many human tumors are histopathologically diverse, containing regions demarcated by various degrees of differentiation, proliferation, vascularity, inflammation, and/or invasiveness (page 662, left column, first paragraph).
The art pertaining to the prevention of cancer focuses mostly on health promoting primary prevention methods that mitigate known risk factors through behavior modification such as reducing of tobacco usage, reducing exposure to occupational carcinogens and managing obesity (Vineis, P. Lancet. 2014 Feb 8;383(9916):549-57)
There is no evidence of the use of immunotherapy comprising monoclonal antibodies as described in the instant claims in undiagnosed individuals for the prevention of cancer. Clinical trials aimed at proving preventative cancer activity attributable to a specific intervention are largely infeasible, due to the impossibly large number of subjects and an equally impossible long timeframe. Although cancer is a common disease, specific types of cancer are still relatively infrequent events in an otherwise healthy population. Therefore, trials with cancer incidence as endpoints would necessarily involve several thousands of subjects followed for several decades. Such logistic difficulties have precluded trials with cancer incidence prevention as an endpoint.
The specification as filed does not provide enabling guidance that overcomes this unpredictability within the art.
The amount of direction provided by the inventor and the existence of working examples
What is enabled by the working examples is narrow in comparison to the breadth of the claims. The specification discloses two examples of the claimed method distilled to practice.
The specification discloses production and screening procedures for obtaining monoclonal antibodies that recognized cleaved, tumor-specific Trop-2. There are no examples distilled to practice for the use of the obtained antibodies for either treatment or prevention of tumor occurrence. The methods provided in the specification do not provide enablement for prevention of cancer in an undiagnosed population.
The quantity of experimentation needed to make or use the invention
The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution. Given that the nature of the invention is in vivo prevention and treatment of disease, a person having ordinary skill in the art would have to perform multiple further in vivo experiments, in human clinical trials, or in animal models that are predictive of cancer prevention of the broadly recited diseases with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating and preventing the disclosed diseases and conditions.
In view of the lack of predictability of the art to which the invention pertains, the lack of guidance and direction provided by applicant, and the absence of appropriate working examples commensurate with the scope of the claims, undue experimentation would be required to use the claimed invention.
Removal of the term “preventing” would obviate this scope of enablement rejection.
Claim Rejections - 35 USC § 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 1-5 and 8-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yoo (US2018/0118830A1, published 05/03/2018, effectively filed 03/30/2015).
The disclosure of Yoo is directed to antibodies that bind specifically to glycosylated PD-L1 relative to un-glycosylated PD-L1 as well as methods for making and using such antibodies for the treatment of cancer (see Abstract). The inventors discovered glycosylation of PD-L1 expressed on tumor cells promotes enhanced binding to PD-1 expressed on immune effector cells, increasing suppression of T cell activity against the tumor cells ([0005], Lines 1-6).
Regarding claim 1, pertaining to a method to obtain monoclonal antibodies, or fragments or conjugates thereof, which bind with high affinity processed proteins that are specifically expressed in local and metastatic tumors, Yoo discloses the production and screening of glycosylated PD-L1 binding monoclonal antibodies (see Example 5, Pg. 42).
Regarding claim 2, comprising immunization procedures wherein immunogenic material consists of the target protein produced in different organisms that have been transfected with vectors that express the target proteins, Yoo discloses immunization of BALB/c mice with human PD-L1 ([0226], Lines 1-6).
Regarding claims 3 and 4, wherein the monoclonal antibodies are selected using the disclosed screening procedures (claim 3) and wherein binding is measured by flow cytometry (claim 4), Yoon teaches the antibody preferentially binds to cells expressing glycosylated PD-L1 with an MFI that is 2-fold to 10-fold higher than the MFI of the antibody binding to cells expressing un-glycosylated PD-L1 as measured by flow cytometry (Pg. 68, claim 7).
Regarding claim 5, wherein processing is posttranslational and comprises at least one modification from a list that includes additional of chemical groups, the processing of Yoon’s disclosure if glycosylation of PD-L1, which was found to enhance tumorigenicity through increased immune effector cell suppression ([0005], Lines 1-6).
Regarding claim 8, wherein tumors include cancers of the disclosed list, Yoo discloses the antibody is specific for cancers that express the tumor antigen of disclosure, including breast cancer, head and neck cancer, skin cancer, colon cancer, rectal cancer, lung cancer, and prostate cancer (Pg. 69, claim 42).
Regarding claims 9 and 10, pertaining to the method of claim 1 to obtain monoclonal antibodies or fragments or conjugates thereof for use as a medicament (claim 9), and to obtain monoclonal antibodies or fragments or conjugates thereof for use in diagnosing (claim 10), these claims pertain to the intended use of the product of the method of claim 1 and are not required to be taught in the prior art reference. However, to this end, Yoo teaches the use of the antibodies for treating and diagnosing tumor antigen-associated cancers (see for example, [0147] and [0186])
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US2018/0118830A1, published 05/03/2018) as applied to claims 1-5 and 8-10 above, and further in view of Stoyanova (Genes Dev. 2012 Oct 15;26(20):2271-85.).
The disclosure of Yoo teaches the generation and selection of antibodies specific for glycosylated PD-L1 protein. In Yoo’s disclosure, the post translation modification is glycosylation of PD-L1. The inventors discovered glycosylation of PD-L1 expressed on tumor cells promotes enhanced binding to PD-1 expressed on immune effector cells, increasing suppression of T cell activity against the tumor cells ([0005], Lines 1-6).
The disclosure of Yoo does not teach that (1) the processing consists of the cleavage of at least one peptide bond of the target protein or (2) the target protein is Trop-2.
These deficiencies are taught by Stoyanova.
The disclosure of Stoyanova is teaches that Trop2 is a regulator of self-renewal, proliferation, and transformation. Trop2 controls these processes through a mechanism of regulated intramembrane proteolysis that leads to cleavage of Trop2, creating two products: the extracellular domain and the intracellular domain. The intracellular domain of Trop2 is released from the membrane and accumulates in the nucleus. Heightened expression of the Trop2 intracellular domain promotes stem/progenitor self-renewal through signaling via b-catenin and is sufficient to initiate precursor lesions to prostate cancer in vivo (see Abstract).
Regarding claims 6 and 7, wherein the processing consists of the cleavage of at least one peptide bond of the target protein and wherein the protein is Trop-2, Stoyanova teaches the role for Trop2 cleavage in tumorigenesis, demonstrated by the fact that g-secretase cleavage within the transmembrane domain, resulting in shedding of the extracellular domain (ECD) and accumulation of the intracellular domain (ICD) to the nucleus. Nuclear ICD is found in human prostate cancer but not in the cancer adjacent benign tissue (Pg. 2272, Left column, Full paragraph 4, Lines 8-16).
It would have been obvious to one having ordinary skill in the art to apply the antibody generation and selection method of Yoo to generate antibodies for cleaved Trop2 as taught by Stoyanova. One would have been motivated to do so because Yoo teaches the method and rationale for generating antibodies specific for tumorigenic post-translationally modified proteins and Stoyanova teaches post-translational cleavage of Trop2 is associated with driving tumorigenesis. There would be an expectation of success in generating antibodies for cleaved Trop-2 because Yoo provides a well-known method of generating antibodies specific for a tumor antigen and means of selecting for antibodies that bind the post-translationally modified product with higher affinity than the non-modified variation.
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 1-2 and 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/259,000 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a more specific method that anticipates the more broadly claimed methods of the instant application.
Regarding instant claims 1 and 2, ‘000 claim 1 discloses A method to obtain monoclonal antibodies, or fragments or conjugates thereof, which bind with high affinity to a target protein which is a protein specifically expressed in local and metastatic tumors, wherein said method comprises: - making available an immunogenic material, wherein the immunogenic material is selected in the group comprising the target protein, fragments and conjugates thereof produced in different organisms.
Regarding instant claims 5-7, ‘000 claim 6 discloses an antibody specific for Trop-2 wherein binding epitope of the Trop-2 protein is cleaved between R87 and T88.
Regarding instant claim 8, ‘000 claim 3 discloses the tumors of the method include cancers of the breast, head and neck, skin, colon-rectum, stomach, lung, ovary, thyroid, prostate, pancreas, endometrium, cervix, gallbladder, bile ducts, kidney, urinary bladder and choriocarcinomas and their metastases.
Regarding instant claims 9 and 10, ‘000 claim 5 discloses the method to obtain monoclonal antibodies or fragments or conjugates thereof for use in diagnosing and/or assessing the risk of developing and/or prognosing and/or for monitoring the progression and/or for monitoring the efficacy of a therapeutic treatment and/or for the screening of a therapeutic treatment of a tumor or metastasis in a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/259,000 as applied to claims 1-2 and 5-10 above and further in view of Yoo (US2018/0118830A1, published 05/03/2018, effectively filed 03/30/2015).
Application No. ‘000 does not teach (1) the screening procedures of instant claim 3 or (2) wherein binding is measured by flow cytometry.
These deficiencies are taught by Yoo.
The disclosure of Yoo is directed to antibodies that bind specifically to glycosylated PD-L1 relative to un-glycosylated PD-L1 as well as methods for making and using such antibodies for the treatment of cancer (see Abstract). The inventors discovered glycosylation of PD-L1 expressed on tumor cells promotes enhanced binding to PD-1 expressed on immune effector cells, increasing suppression of T cell activity against the tumor cells ([0005], Lines 1-6).
Regarding claims 3 and 4, wherein the monoclonal antibodies are selected using the disclosed screening procedures (claim 3) and wherein binding is measured by flow cytometry (claim 4), Yoon teaches the antibody preferentially binds to cells expressing glycosylated PD-L1 with an MFI that is 2-fold to 10-fold higher than the MFI of the antibody binding to cells expressing un-glycosylated PD-L1 as measured by flow cytometry (Pg. 68, claim 7).
It would have been obvious to one having ordinary skill in the art to modify the method of ‘000 with the teachings of Yoo to (1) use the screening procedures of instant claim 3 and (2) to measure binding by flow cytometry. One would have been motivated to do so because Yoo teaches standard antibody generation methods and methods for screening for specificity using flow cytometry. There would be an expectation of success because Yoo demonstrates a method of generating and screening antibodies specific for post-translationally modified PD-L1 and these methods could readily be applied to Trop-2
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Epps-Smith can be reached at 571-272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAROL ANN CHASE/Examiner, Art Unit 1646 /JANET L EPPS -SMITH/Supervisory Patent Examiner, Art Unit 1646