Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-10, 12-13, and 15-21 are pending in the instant application.
Claims 1-10, 12-13, and 15-21 are examined herein.
Priority
The instant application claims benefit of foreign priority to EP20206285.7, filed on 06 November 2020 and the benefit of priority to PCT/EP2021/080829, filed on 05 November 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 06 November 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 11 May 2023 and 21 August 2023, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
Claim 15 recites the method for selectively modulating the interaction of a serine/threonine kinase with a binding protein comprising contacting the kinase with a compound of claim 1. The specification only provides the example of one serine/threonine kinase, namely Aurora Kinase A (AURKA). A lack of written description on the grounds of an inadequate representation of species was considered but found unnecessary. The ATP binding sites of serine/threonine kinases are known in the art to be highly conserved across the group, meaning a compound that binds to one is likely to bind to another.
Claim Rejections - 35 USC § 112
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 12 and 13 are 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 the treatment of AURKA-mediated proliferative diseases fails to provide the required enablement for the treatment of prevention of all proliferative diseases. 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 instant claims are drawn to a method for the preventions and/or treatment of a proliferative disease comprising administering a compound of claim 1. The specification fails to provide information that would allow the one skilled in the art to practice treating or preventing all proliferative diseases.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
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 the 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).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
the nature of the invention
the state of the prior art
the predictability of the art
the amount of direction or guidance provided
the presence or absence of working examples
the breadth of the claims
the quantity of experimentation necessary
the relative skill of those in the art
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:
The nature of the invention - is a method for the preventions and/or treatment of a proliferative disease comprising administering a compound of claim
The state of the prior art - the pharmacological art requires the screening of potential drug candidates in vitro and in vivo to determine if the drug candidates exhibit the desired pharmacological activities.
In order to treat a disease: one would need to precisely identify what the disease is, identify what biological target is connected with the disease, demonstrate that the drug candidate in some way modulates the normal processes of the biological target, and demonstrate that a patient benefited from such modification without detrimental side effects. Typically, this process includes in vitro laboratory screening, preclinical in vivo screening, and three phases of clinical trials. Once this arduous process has been successfully completed by a drug candidate, subsequent drug candidates will benefit from the established proof of concept. The subsequent drug candidates must demonstrate a substantial correlation between their biological activity and that of the known drug candidate.
In order to prevent a disease: one would need to precisely identify those subjects likely to acquire such a disease, administer Applicant’s claimed invention, and demonstrate that the patient did not develop the disease as a result of the administration of the claim invention.
In the instant case, the prior arts recognize that therapeutic agents targeting AURKA have potential in the treatment of cancers where AURKA is overexpressed (Zheng et al. Acta Pharmaceutica Sinica B.2023;13(7):2826-2843). But the prior arts do not recognize serine/threonine kinase inhibitors can treat all proliferative diseases or prevent any.
The predictability or unpredictability of the art – the law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in
vivo animal model assays and a disclosed or a claimed method of use . . . 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.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for establishing the potential of new therapeutics.
Additionally, within pharmaceutics, the art of cancer therapeutics is well known to be unpredictable due to the differing etiologies and mechanisms of action for particular cancers. There are more than 200 known cancers; treatment applicable to one is unlikely to be applicable to another. Bianchi et al. (Current Opinion in Cell Biology. 2020; 63:135-143) attributes this unpredictability to tissue specificity, noting most cancer driver genes are mutated in a tissue-dependent manner, which affects therapeutic response (page 135). For example, BRAF inhibition is an effective therapy for BRAF-mutated melanomas, but not BRAF-mutated colon cancer (page 140); same mutation, different tumors, therefore different therapeutic outcomes. Therefore, from the well-established state of cancer arts, a skilled practitioner would not conclude all cancers could be treated, managed or improved with the same therapeutic agent.
The amount of direction or guidance presented – the instant specification provides an explanation of the biological activity of AURKA starting in paragraph [9], and discusses the implication of inhibiting the protein-protein interaction between N-MYC and MYC with AURKA. There is no direction or guidance provided that supports the use of a compound of claim 1 for the treatment of all proliferative diseases nor the prevention of any proliferative diseases.
The amount of guidance or direction to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. MPEP § 2164.03 (quoting In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970)). As identified supra, the pharmaceutical art is recognized as unpredictable.
Thus, in order to support a claim for preventing a [insert] disease a vast amount of evidence is required because such a claim is not supported by the prior art or the instant specification.
The presence or absence of working examples - there are no working or prophetic examples in the specification that demonstrate that the instant compounds or compositions thereof may treat or prevent a proliferative disease. The assays in the specification demonstrate that the instant compounds were tested for their ability to induce cell death in TP53 loss-of-function cells (paragraph [173]).
The breadth of the claims – is incommensurate in scope with the disclosure because a fair reading of the specification fails to support a finding that the compounds of instant formula [insert] may prevent a [insert] disease in a patient.
The quantity of experimentation necessary – generally speaking, the amount of experimentation to transform a molecule into medicine is vast and the success thereof is low. Recent statistics indicate that the attrition rates during drug development remain high. Schafer et al. Drug Discovery Today 2008, 13 (21/22), 913-916. The article makes clear that there are many steps necessary to promote a new molecular entity toward its clinical use, any one of which is cumbersome.
For instance, Schafer et al. discloses: "proof of concept trials have failed when the decision to enter clinical development was based on preclinical experiments using the wrong compound, the wrong experimental model, or the wrong endpoint.” It can be gleaned from this article that a plethora of experimentation is needed to identify the lead compound (i.e. one among many in a Markush-type claim), to establish which preclinical tests are predictive of clinical success, and to establish which diseases are the best to target for each lead compound.
There is generally a vast amount of experimentation to take a drug from bench to the clinic. See e.g., Horig et al. Journal of Translational Medicine 2004, 2(44) (“Successful drug development requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patent acceptance.") The Examiner finds that one of ordinary skill in the art would agree with the statements in these articles; that is, the amount of experimentation required to enable a pharmaceutical drug is extensive.
The level of skill in the art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) 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 those 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 typical education level of the active workers in the field of pharmaceuticals and/or medicine, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in a field related to medicine and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
Therefore, claims 12 and 13 are rejected because the Examiner finds that the Wands factors suggest a conclusion that the skilled artisan would not be able to make and use the instant invention without undue experimentation, although the level of skill for an ordinary person in the art is high. That is, due to the breadth of the claims, the unpredictability of the art, the lack of guidance or direction from the disclosure, the lack of any working examples, and the amount of experimentation needed illustrate that a person having ordinary skill in the art would not be able to treat all proliferative disease nor prevent any proliferative diseases.
Claim Rejections - 35 USC § 112
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 1, 3, 7-10, 12-13, 15-16, and 20-21 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 1 recites the limitation of X and Y in b) for the R6 substituent of Formula (I). There is insufficient antecedent basis for this limitation in the claim as X and Y are undefined.
Claims 1 and 3 recites parenthetical language that renders the claim indefinite. The substituents for R1 contain the term “(hetero)aryl”. As placing hetero in parenthesis is not standard in the art it is unclear whether the claim intends for the parenthesis to be optional i.e. the substituent could be heteroaryl or aryl, or if the intended interpretation is for the option to be heteroaryl. For the purpose of examination the term is taken to be either heteroaryl or aryl as some of the preferred embodiments have an aryl substituent as R1, such as N-(5-(((4-(1H-Pyrrolo[2,3-b]pyridin-2-yl)pyridin-2-yl)methyl)amino)-2-fluorophenyl )-2-cyclohexylacetamide.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “halogen”, and the claim also recites “preferably F or Cl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 7-10, 12-13, 15-16, and 20-21 do not resolve this issue and are therefore subject to the rejection as well.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “liver cancer, hepatocellular carcinoma (HCC), lung cancer, small cell lung cancer (SCLC), bladder cancer, ovarian cancer, uterine cancer, endometrial cancer, breast cancer, gastric cancer, urinary bladder cancer, renal cancer, pancreatic cancer, stomach cancer, cervical cancer, cephalic cancer, thyroid cancer, esophageal cancer, medulloblastoma, head and neck cancer, lymphoma, leukemia, acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, chronic myeloid cancer, prostate cancer, salivary gland, cancer, bone cancer, brain cancer, glioma, colon cancer, rectal cancer, colorectal cancer, kidney cancer, skin cancer, melanoma, glioblastoma, squamous cell carcinoma, pleomorphic adenoma, endometrioma, nasopharynx cancer, small intestine cancer, testicular cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, cancer of the anus, cancer of the anal canal, cancer of the anorectum, cancer of the oropharynx, vaginal carcinoma, vulval carcinoma, enteric cancer, endocrine gland cancer, adrenal cancer, urethral cancer, lymphocytoma, cystic cancer, nephritic cancer, hydrouretic cancer, renal cell carcinoma, renal pelvic carcinoma, hypophyseal adenomatosis, adenocarcinoma, and/or a MYC-dependent tumor” and the claim also recites “preferably wherein the cancer is liver cancer…or lung cancer” which is the narrower statement of the range/limitation, and the claim further recites “in particular hepatocellular carcinoma (HCC)” which is the narrowest statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10, 12-13, 16-17, and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. (WO2006000420A1) in view of Ciapetti et al. (The Practice of Medicinal Chemistry. Chapter 8. Molecular Variations Based on Isosteric Replacements. 2008;4:181-241).
Regarding claim 1, Ding teaches compounds of Formula (I) (pictured below) for the treatment of protein kinase-mediated diseases. The reference Formula (I) (claim 1) overlaps with the instant Formula (I) when:
X is C-R5; wherein R5 is H
Y is C-R5; wherein R5 is H, halo or methyl (corresponds to instant R4)
Z is N (corresponds to instant W)
R1 is X5NR7R8 or X5OR7; wherein X5 is a bond; wherein R7 is C6-10aryl-C0-4alkyl, C5-10heteroaryl-C0-4alkyl, C3-10cycloalkyl-C0-4alkyl, or C3-10heterocycloalkyl-C0-4alkyl; and R8 is H or alkyl (corresponds to instant Z)
R2 is H
R3 is H or methyl (corresponds to instant R2)
R4 is substituted hydroxy
n is 0 or 1
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474
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386
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Ding teaches that two of the substituents of X, Y, and Z, have to be N, forming a pyrimidine core, not a pyridine as seen in the instant genus if the instant W is N.
Ciapetti teaches that pyrimidine and pyridines are bioisosteric replacements (page 193).
It would be prima facie obvious to one of ordinary skill in the art to replace the pyrimidine core, as taught by Ding for a pyridine, as these two nitrogen containing heterocycles are bioisostere and would be expected to exhibit similar properties.
Regarding claim 2, Ding teaches compounds of Formula (I) (pictured below) for the treatment of protein kinase-mediated diseases. The reference Formula (I) overlaps with the instant Formula (I) when
X is C-R5; wherein R5 is H
Y is C-R5; wherein R5 is H, halo or methyl (corresponds to instant R4)
Z is N or C-R5; wherein R5 is H, halo, or methyl (corresponds to instant W)
R1 is substituted amino
R2 is H
R3 is H or methyl (corresponds to instant R2)
R4 is substituted hydroxy
n is 0 or 1
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168
474
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168
494
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Ding teaches that two of the substituents of X, Y, and Z, have to be N, forming a pyrimidine core, not a pyridine as seen in the instant genus if the instant W is N.
Ciapetti teaches that pyrimidine and pyridines are bioisosteric replacements (page 193).
It would be prima facie obvious to one of ordinary skill in the art to replace the pyrimidine core, as taught by Ding for a pyridine, as these two nitrogen containing heterocycles are bioisostere and would be expected to exhibit similar properties.
Regarding claim 3, Ding teaches compounds of Formula (I) (pictured below) for the treatment of protein kinase-mediated diseases. The reference Formula (I) (claim 1) overlaps with the instant Formula (I) when:
X is C-R5; wherein R5 is H
Y is C-R5; wherein R5 is H, halo or methyl (corresponds to instant R4)
Z is N (corresponds to instant W)
R1 is X5NR7R8; wherein X5 is a bond; wherein R7 is C6-aryl-C0-4alkyl or C6heteroaryl-C0-4alkyl, substituted with -X5R11; wherein R11 is C5heterocycloalkyl; and R8 is H or alkyl (corresponds to instant Z)
R2 is H
R3 is H or methyl (corresponds to instant R2)
R4 is substituted hydroxy
n is 0 or 1
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168
474
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Ding teaches that two of the substituents of X, Y, and Z, have to be N, forming a pyrimidine core, not a pyridine as seen in the instant genus if the instant W is N.
Ciapetti teaches that pyrimidine and pyridines are bioisosteric replacements (page 193).
It would be prima facie obvious to one of ordinary skill in the art to replace the pyrimidine core, as taught by Ding for a pyridine, as these two nitrogen containing heterocycles are bioisostere and would be expected to exhibit similar properties.
Regarding claim 5, Ding teaches R3 can be H, which corresponds to the instant R2; Y can be C-R5 wherein R5 is H, which corresponds to the instant R4; and Z can be C-R5 wherein R5 is F, which corresponds to the instant R3.
Regarding claim 7, Ding teaches the compounds as inhibitors of serine/threonine kinases (page 130).
Regarding claim 8, Ding teaches a genus of compounds as inhibitors of serine/threonine kinases of which the instant Formula (I) is a species. As Ding teaches the claimed genus as inhibitors of the claimed kinases it would appear that the claimed limitation of modulating, mimicking, stabilizing and/or destabilizing an interaction of the serine/threonine kinase does necessarily occurs. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claim 9, Ding teaches a genus of compounds as inhibitors of serine/threonine kinases of which the instant Formula (I) is a species. As Ding teaches the claimed genus as inhibitors of the claimed kinases it would appear that the claimed limitation of destabilizing and/or decreasing the level and/or the activity of MYC in a cell, and/or wherein the compound induces and/or enhances an abnormal and/or defect mitosis of a cell, and wherein the compound induces and/or enhances the formation of at least one abnormal and/or defect spindle in the cell does necessarily occurs. See MPEP 2112.01:I.
Regarding claims 10, Ding teaches the pharmaceutical composition of Formula (I) (page 134) and a pharmaceutically acceptable carrier (page 134), stabilizers (page 136), and/or excipients (page 136).
Regarding claim 12, Ding teaches the method of treating proliferative diseases (page 108).
Regarding claim 13, Ding teaches the method of treating a proliferative disease wherein the proliferative disease is cancer (page 110).
Regarding claims 16 and 17, Ding teaches that R7 can be substituted with 2 halo groups, which corresponds to the instant R8 (claim 1).
Regarding claim 19, Ding teaches R1, which corresponds to the instant ZR5R6, can be X5NR7R8; wherein X5 is a bond and R8 is H (claim 1).
Regarding claim 20, Ding teaches a genus of compounds as inhibitors of serine/threonine kinases of which the instant Formula (I) is a species. As Ding teaches the claimed genus as inhibitors of the claimed kinases it would appear that the claimed limitation of modulating, stabilizing, and/or destabilizing the conformation of the serine/threonine kinase does necessarily occurs. See MPEP 2112.01:I.
Regarding claim 21, Ding teaches the proliferative disease to be small cell lung cancer (page 111).
Claim Objections
Claims 15 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-10, 12-13, 16-17, and 19-21 are rejected.
Claims 15 and 18 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621