DETAILED ACTION
This office action is in response to applicant’s filing dated September 24, 2025.
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 Claims
Claims 1-4 and 10-25 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed September 24, 2025. Acknowledgement is made of Applicant's amendment of claim 24. Claims 5-9 were previously canceled.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to method for treating an autoimmune disease, comprising administrating or applying the nicotinic acid derivative A with an immunosuppressive activity according to claim 1 to a subject in need, wherein the autoimmune disease comprises rheumatoid arthritis and psoriasis as the elected invention and 4-(3-carboxy-2-hydroxybutan-2-yl)nicotinic acid identified as nicotinic acid derivative A-2 in Figure 4 [0023], hereinafter referred to as Compound A-2:
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as the elected compound species and rheumatoid arthritis as the elected autoimmune disease species in the reply filed on September 24, 2025 is acknowledged.
Claims 1-4 and 10-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 24, 2025.
Claims 24 and 25 are presently under examination as they relate to the elected species:
Rheumatoid arthritis and Compound A-2:
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.
Priority
The present application is a 371 of PCT/CN2020/118818 filed on September 29, 2020.
Drawings
Acknowledgement is made of the drawings received on March 28, 2023. These drawings are accepted.
Claim Rejections - 35 USC § 112(b)
Indefinite
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.
Claims 24 and 25 are 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.
Claim 24 is directed to the administration of a nicotinic acid derivative A having the claimed formula which contains variables R1, R2, R1’, and R2’. Claim 24 recites R1 and R2 are different substitution sites of a main chain and R1’ and R2’ are different substitution sites of a side chain. However, claim 24 does not set forth the moieties that are encompassed by variables R1, R2, R1’, and R2’.
Claim 25 sets for definitions for R1 and R2. However, claim 25 does not set forth the moieties that are encompassed by variables R1’ and R2’. Thus, it is not clear what compounds are encompassed by the instant claims.
Claim Rejections - 35 USC § 112
Enablement
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.
Claims 24 and 25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 24 and 25 are directed to a method for treating an autoimmune disease, comprising administrating or applying a nicotinic acid derivative A with an immunosuppressive activity to a subject in need, wherein the autoimmune disease comprises rheumatoid arthritis and psoriasis; and the nicotinic acid derivative A has a general structural formula:
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2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
As illustrative of the state of the art regarding the development of therapeutic drugs for rheumatoid arthritis, the Examiner refers to Cassotta et al (ALTEX, 2019; 37(2):223-242) and Kim et al (Immune Netw, 2022; 22(1):e8 pp. 1-20), cited for evidentiary purposes.
Cassotta teaches rheumatoid arthritis (RA) is a chronic, systemic, autoimmune disease of unknown etiology that affects the connective tissue; RA is characterized by chronic synovitis, diarthrodial joint inflammation, and various degrees of bone and cartilage erosion; although joints are the primary target of RA, extra-articular manifestations, including sub-cutaneous nodules, vasculitis, pericarditis, and pulmonary fibrosis, can have a significant impact on other organ systems (page 223, left). Cassotta teaches conventional treatment choices for RA include corticosteroids and disease-modifying anti-rheumatic drugs (DMARDs); for patients who fail to respond adequately to these drugs, the additional use of biopharmaceuticals, in particular inhibitors of tumor necrosis factor α (TNFα), offers opportunities for disease management; however, despite the undoubted success of anti-TNFα treatment, about 40% of patients are non-responders; in addition, up to 50% of primary responders lose their response within 12 months of the start of therapy; and besides, these drugs do not specifically target the cause of the disease but interfere with generic steps of the immune response; thus they may be associated with systemic side effects, for example an increased risk of infection (page 223, right, last bridge paragraph). Cassotta teaches cack of knowledge of the disease-specific human pathophysiology and etiology of RA severely impedes the development of targeted drugs; this could partly be a consequence of the overuse of animal models that often cannot accurately recapitulate human RA etiopathogenesis and drug responses, and the inadequate consideration and/or use of in vitro research methods; animal models of arthritis have been used extensively to identify druggable targets for RA and test potential therapeutics; despite their having been extremely useful to test new approaches of intervention in many cases, concerns about low clinical development success rates for investigational drugs, coupled with increasing awareness of the ethical issues surrounding the use of animal models, have led many to question their utility in the study of complex human conditions and drug target identification; although traditional human cell cultures have been invaluable in the study of the pathogenesis of RA and for drug discovery research, simplistic cellular models, often utilizing cancer cell lines or nonhuman cells cultured under non-homeostatic and non-physiologic in vitro conditions are limited in their ability to fully reflect the pathogenetic mechanisms of RA; emerging sophisticated human cell culture systems and tools promise to increase our understanding of RA and improve our search for effective therapeutics, while reducing and replacing animals employed in biomedical research (page 224, left, 2nd paragraph). Cassotta teaches animal and simple cell culture models of RA have been useful to elucidate some of the mechanisms underlying the disease; however, simple cell culture models cannot mimic the complexity of the pathophysiological processes, biomechanical and hydrodynamic pressure conditions characterizing RA, and animal models may be misleading owing to interspecies differences regarding e.g., chondrocyte biology, articular cartilage and cartilage thickness (page 232, left, 4th paragraph).
Kim teaches rheumatoid arthritis (RA) is a common autoimmune disease that causes persistent inflammation, resulting in irreversible joint destruction, which ultimately leads to disability and mortality; most evidence from immunological and bio-molecular studies points to an immune-mediated etiology associated with stromal tissue dysregulation, which together propagate chronic inflammation and joint damage in RA; thus, RA is characterized by the complex process of disordered innate and adaptive immune responses, dysregulated cytokine and signal transduction networks, and disease-progressing semi-autonomous features of joint stromal synovial fibroblasts (page 1, last paragraph). Kim teaches currently, two types of clinically successful targeted drugs for RA exist: i) injectable biologic disease-modifying anti-rheumatic drugs (bDMARDs), including TNF-α inhibitors, IL-6 blockers, B-cell depletion agents, and inhibitors of T-cell co-stimulation; (2) oral targeted synthetic DMARDs (tsDMARDs), including small molecules inhibiting the JAK pathway; current therapies have led to substantial progress toward achieving disease remission and preventing joint deformity in patients with RA (page 2, 1st paragraph). Kim teaches despite this, at best, these drugs induce significant clinical improvement in less than two-thirds of patients, most of whom will undergo a relapse of the disease after drug withdrawal; current RA drugs are not curative, nor do they reverse joint destruction; current targeted therapies can result in a considerable burden of adverse events, including serious infection and malignancy, which is a consequence of drug cessation; in contrast, biologic agents blocking IL-1β, IL-17A, and small molecule inhibitors of p38α have exhibited disappointing therapeutic results and severe adverse effects in clinical trials, even though these targets have meaningful roles in RA pathogenesis (page 2, 2nd paragraph). Kim teaches selection of the proper therapeutic target is crucial for the clinical success of targeted drugs in RA, such as cytokines with multipotent and pleiotropic activity and kinases in upstream immune synapse or upstream signal transduction pathways; the integration of proper targets based on lessons learned from clinically approved or failed drugs, as well as tandem targeting of pathologically relevant immune and stromal cell subsets, is critical to designing effective RA therapies (page 11, last bridge paragraph).
A search of the prior art revealed that the compounds of formula of claim 24 are novel and as such there is no known biological/pharmaceutical data associated with them.
Finally, it is also well known that the biological properties of organic small molecules highly depend on the core structure and the substituents of the core structure (also known as SAR: structure activity relationship). The more diverse are the substituents, the less likely is that they are going to show similar properties in a biological assay or similar effectiveness in treating a specific disease.
For example, it is known that “seemingly minor modifications of the molecule may result in a profound change in pharmacological response (increase, diminish, completely destroy, or alter the nature of the response). In pursuing analog design and synthesis, it must be recognized that the newly created analogs are different chemical entities from the lead compound. It is not possible to retain all and exactly the same solubility and solvent partition characteristics, chemical reactivity and stability, acid or base strength, and/or in vivo metabolism properties of the lead compound. Thus, although the new analog may demonstrate pharmacological similarity to the lead compound, it is not likely to be identical to, nor will its similarities and differences always be predictable.” (J. G. Cannon, Chapter Nineteen in Burger's Medicinal Chemistry and Drug Discovery, Fifth Edition, Volume I: Principles and Practice, Wiley-Interscience 1995, pp. 783-802). In the instant case, the variation of compounds are limitless with undefined substitution sites at R1, R2, R1’, and R2’ of the instant formula.
In summary, the art of determining the in vitro/in vivo activity of a compound or set of compounds based on structural similarity to the known in vitro/in vivo activity of a known set of compounds with little structural diversity is highly unpredictable.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure. The claims while narrow with regard to the autoimmune diseases, are extremely broad with regard to the compounds administered in the claimed method.
The general formula:
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encompasses a very diverse and large number of substituents (R1, R2, R1’, and R2’) as these variables are not defined in claim 24 and R1’ and R2’ are not defined in claim 25. For this reason, one of ordinary skill in the art may envision thousands of possible compounds according to the above general formulas. However, the specification only discloses 3 compounds with a very narrow set of substituents (see specification, paragraphs [0010-0015]). For example, R1 and R2 are always H; R1’ is -OH or H; and R2’ is -OH or H, despite Applicant claiming that R1, R2, R1’, and R2’ are substitution sites with no limitations as to what the substitutions can encompass.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification discloses the effect of the disclosed compounds in vitro in macrophages on inflammatory factors (IL-6, IL-8, MCP-1, and TNF-α and transcription regulator (PPARγ) (Example 3 and Fig 7); inhibitory activity of the disclosed compounds on adenosine diphosphate (ADP)-induced platelet aggregation in rabbits (Example 4 and Fig. 8); the effect of the disclosed compounds in vitro in HepG2 cells high glucose model on inflammatory factors (IL-6, IL-8, MCP-1, and TNF-α and transcription regulator (PPARγ)(Example 5 and Fig 9); and the effect of the disclosed compounds in vitro in HepG2 cells hepatoma cell model on inflammatory factors (IL-6, IL-8, MCP-1, and TNF-α and transcription regulator (PPARγ)(Example 6 and Fig 10).
As noted above, the role of inflammatory factors, including IL-6, IL-8, MCP-1, and TNF-α, in rheumatoid arthritis is highly unpredictable. The specification and the prior art appears to be silent on a clear nexus between the inflammatory factors (IL-6, IL-8, MCP-1, and TNF-α and transcription regulator (PPARγ) inhibitory activity of these compounds and their efficacy for treating rheumatoid arthritis in vivo.
That is, where physiological activity is concerned (i.e., the claimed method of treatment), one skilled in the art reasonably would not and properly should not accept in vitro results as support for in vivo activity. Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1216-1217, 18 USPQ2d 1016, 1030 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991) (“we hold that the district court erred in accepting the in vitro data as support for claims containing what has been found to be an in vivo limitation”). Therefore, to enable one skilled in the art to use a method of treatment in vivo based solely on in vitro testing some evidence correlating in vivo results to in vitro testing at the pertinent time is required. See In re Brana, 51 F.3d 1560, 1565 USPQ2d 1437, 1442 (Fed. Cir. 1995) (to enable one skilled in the art to use a clinical method based on preclinical testing, the preclinical testing must be shown to be statistically significant) and Cross v. Iizuka, 753 F.2d 1040, 1050-1051, 224 USPQ 739, 747-748 (Fed. Cir. 1985) (preclinical testing activity must at least reasonably correlate to clinical activity to establish utility).
As such, if there is no correlation, then the in vitro inflammatory factors (IL-6, IL-8, MCP-1, and TNF-α and transcription regulator (PPARγ) activity examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of any rheumatoid arthritis, and in particular with novel untested compounds, is required for practice of the claimed invention.
6. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is a high unpredictability in the art of treating rheumatoid arthritis; the instantly claimed compounds are novel, as such no biological/pharmacological data is known to be associated with these structures. Based on this and in the absence of experimental evidence commensurate in scope with the claims (see: 5. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that any compound of the claimed formula, will be effective in treating rheumatoid arthritis as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single compound of the claimed formula that correlates with the treatment of rheumatoid arthritis.
So, determining which compound of the claimed compound, if any, will be effective in treating rheumatoid arthritis, will require first require testing new synthetic pathways for the thousands of compounds that were not specifically disclosed in the specification, assaying these compounds in an assay that correlates with the treatment of arthritis, and then further determine their efficacy in a validated animal model.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
7. Conclusion
Accordingly, the inventions of claims 24 and 25 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
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 24 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 10-25 of copending Application No. 18/029,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for treating an autoimmune disease, comprising administrating or applying a nicotinic acid derivative A with an immunosuppressive activity to a subject in need, wherein the autoimmune disease comprises rheumatoid arthritis and psoriasis; and the nicotinic acid derivative A has a general structural formula as follows:
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The copending claims are directed to a method for treating rheumatoid arthritis, psoriasis, and other autoimmune diseases, comprising administering or applying the nicotinic acid derivative B having immunosuppressive activity to a subject; wherein the nicotinic acid derivative B is represented by the following general molecular formula:
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The method of the copending claims differs in that the side chain contains an additional carbon in the chain. MPEP 2144.09 states:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, the R1’ and R2’ encompass H+ as evidenced by instant specification [0009]. The R11’, R12’, R21’, R22’, R31’, and R32’ encompass H+ and CH3-. Thus, the compounds of the copending claims differ in the successive addition of the same chemical group, a carbon, substituted with the same moieties. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive produce a homolog differing in side chain length to arrive at the compounds of the instant claims to treat rheumatoid arthritis from the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 24 and 25 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628