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 1-22 are pending in the instant application.
Claims 6 and 13 are cancelled.
Claims 1-5, 7-12, and 14-22 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63092958, filed on 16 October 2020 and PCT/US2021/071840, filed on 13 October 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 16 October 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 14 April 2023, 12 May 2023, and 16 October 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
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 1-5, 7-12, and 14 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 hematological cancer fails to provide the required enablement for the treatment of all diseases or conditions. 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 of treating a disease or condition. The specification fails to provide information that would allow the one skilled in the art to practice treating all diseases and conditions with a composition comprising a species of Compound A and Compound B.
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 of treating a disease or condition comprising administering an effective amount of a Compound A and an effective amount of one or more of Compound B.
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 the instant case, the prior arts recognize that therapeutic agents have potential to exhibit antagonistic property toward the BCL-2 protein, which can be used to treat blood cancers (Wei et al. Front. Hematol. 2023; 2: 1-8).
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 no explanation of the biological activity of BCL-2, but states in paragraph [0107] that the species of Compound (A) are BCL-2 inhibitors. There is no direction or guidance provided that supports a use of a BCL-2 inhibitor as a drug for treating all disease and conditions.
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 treating all 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 all diseases and conditions. The assays in the specification demonstrate that the instant compound 5A and azacitidine was tested for their ability to inhibit cell viability in vitro in three acute myeloid leukemia (AML) cell lines, and an acute lymphoblastic leukemia (ALL) cell line (Table 2). Table 3 demonstrates the ability for compound 5A in individual combination with azacitidine, bortezomib, bendamustine, and cytarabine to inhibit tumor growth in vivo.
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 species of Compounds A may treat all disease and conditions.
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 1-5, 7-12, and 14 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 disease and conditions.
Claims 1-5, 7-12, and 14 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.
Claim 1 recites the method of treating a disease or condition comprising administering an effective amount of Compound (A) and an effective amount of one or more of Compound (B). An “effective amount” is a functional limitation which requires both Compound (A) and Compound (B) to treat a disease or condition. The claims provide 56 species of Compound (A) and 21 species of Compound (B); however the Applicant’s disclosure does not provide sufficient written description to support the functional limitation of these compounds.
See MPEP 2163 II. A. 3. (a) (ii) with regards to the requirements for descriptive support and for functional limitations of generically described entities:
“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 (see i)(A) above), reduction to drawings (see i)(B) above), 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 (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”
“A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.”
There is no structure-function relationship provided in the specification. The assays demonstrate the tumor growth inhibition of a BCL-2 inhibitor with a hypomethylating agent, a proteasome inhibitor, an antimetabolite, and an alkylating agent. Additionally, the claims recite species of Compound (B) belonging to four more drug classes; platinum-based antineoplastics, topisomerase II inhbitors, anthracyclines, and vinca alkaloids. Proper support of the claimed functional limitation requires a presented correlation between the structure/function of Compound (A) and the structure/ function of Compound (B).
The specification does not provide an adequate representation of all the possible combinations of Compound (A) and Compound (B). The assays provide use of one of the possible fifty-six species of Compound (A) and four of Compound (B). Not considering that claim 1 recites the possibility of combining multiple Compound (B)s with Compound (A), there are at least five hundred and forty-six possible combinations. Showing four is 0.7% of the possibilities and is not representative of the claimed genus. Not all combination therapies work. Venetoclax, a BCL-2 inhibitor, known to be used in combination with the hypomethylating agents azacitidine and decitabine, was found not to show improved benefit when used in combination with the alkylating agent, bortezomib (Primeau. Hematology Advisor. Venetoclax Fails to Improve OS in Relapsed/Refractory Multiple Myeloma. https://www.hematologyadvisor.com/news/venetoclax-multiple-myeloma-fails-improve-survival-treatment-risk/). Failure to present a representative number of all the possible combinations of Compound (A) and Compound (B), which would provide an overall depiction of the claimed subject matter, suggests the applicant is not in possession of the claimed invention.
To summarize, there is a lack of descriptive support since the claims recite a functional limitation and: (i) the provided species are not sufficiently representative of the genus of compounds having such function, (ii) multiple other species with the function are known in the art with completely different structural and variable mechanistic features and (iii) there is no general art-recognized structure-function relationship for compounds with the required functional activity.
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.
Claims 1-5, 7-10, 15-19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchman et al. (WO2019139899A1; cited by applicant on 1449 IDS) in view of Li et al. (Front Pharmacol. 2019;10:697).
Regarding claim 1, Pinchman discloses the method of treating cancer (claim 85) comprising administering a pharmaceutical composition of a compound of Formula (I) (pictured below), a BCL-2 inhibitor, in combination with additional active pharmaceutical ingredients (paragraph [0245]). Formula (I) overlaps with the instant genus of Compound (A) when R1 is -CH2F, -CHF2, or -CF3; m is 0, 1, 2 or 3; R2 is independently halogen, C1-6 alkyl, C1-6 haloalkyl, C3-6 cycloalkyl, or two R2 groups are taken together to form a C3-6 cycloalkyl, or 3 to 6 membered heterocycle; R3 is X-R3A; X is O; R3A is 5 to 10 membered heterocycle; R4 is NO2, S(O)R6, SO2R6, halogen, cyano, or C1-6 haloalkyl; R6 is C1-6 alkyl, C1-6 haloalkyl, or C3-6 cycloalkyl; R5 is -X1-(Alk1)n-R7; X1 is -NH-; Alk1 is C1-4- alkylene; R7 is C1-6 alkoxy, C3-10 cycloalkyl, 3 to 10 membered heterocycle, hydroxy, amino, mono substituted amine, di-substituted amine, N-carbamyl, C-amido, or N-amido; and n is 0 or 1.
PNG
media_image1.png
418
282
media_image1.png
Greyscale
PNG
media_image2.png
300
288
media_image2.png
Greyscale
Pinchman does not teach the additional therapeutic agent to be azacitidine, bendamustine, bortezomib, carfilzomib, ixazomib, busulfan, carboplatin, cytarabine, cyclophosphamide, cladribine, cisplatin, capecitabine, decitabine, etoposide, fludarabine, gemcitabine, daunorubicin, doxorubicin, ifosfamide, methotrexate or vincristine.
Li teaches venetoclax, a BCL-2 inhibitor, in combination with bortezomib, decitabine, azacitidine, bendamustine, and cytarabine in the treatment of hematological malignancies (Table 4).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. It would be prima facie obvious to one of ordinary skill in the art to replace one BCL-2 inhibitor with another, as they share the same mechanism of action. Pinchman discloses a genus of BCL-2 inhibitors that can be used in combination therapy for the treatment of cancer. Li discloses the BCL-2 inhibitor venetoclax in combination with additional therapeutic agents in the treatment of hematological cancers. The skilled artisan would possess a reasonable expectation of success in substitution of one BCL-2 inhibitor for another.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 2, Pinchman discloses Examples 1-5, 9-15, 17-21, 23-25, 27, 39, 40, 43, 72, 83-86, 88, 93-95, 6-8, 26, 31, 36, 96, 97, 28-30, 32-35, 37, 38, 41, 42, 44, and 73 (Figure 4A; partially pictured below) which are the compounds recited in the instant claim.
PNG
media_image3.png
828
294
media_image3.png
Greyscale
PNG
media_image4.png
842
298
media_image4.png
Greyscale
PNG
media_image5.png
832
298
media_image5.png
Greyscale
Regarding claim 3, Pinchman discloses Examples 20 and 34 (Table 4A).
PNG
media_image6.png
180
296
media_image6.png
Greyscale
PNG
media_image7.png
180
296
media_image7.png
Greyscale
Regarding claim 4, Pinchman discloses Examples 89, 35, and 30 (Table 4A).
PNG
media_image8.png
202
298
media_image8.png
Greyscale
PNG
media_image9.png
166
300
media_image9.png
Greyscale
PNG
media_image10.png
170
298
media_image10.png
Greyscale
Regarding claim 5, Pinchman discloses Examples 24, 38, and 29 (Table 4A).
PNG
media_image11.png
162
294
media_image11.png
Greyscale
PNG
media_image12.png
170
292
media_image12.png
Greyscale
PNG
media_image13.png
168
298
media_image13.png
Greyscale
Regarding claim 7, Li teaches azacitidine (Table 4).
Regarding claim 8, Li teaches bendamustine (Table 4).
Regarding claim 9, Li teaches bortezomib (Table 4).
Regarding claim 10, Li teaches cytarabine (Table 4).
Regarding claims 15 and 16, Pinchman teaches the method of treating lymphoblastic leukemias, follicular lymphomas, lymphoid malignancies of T-cell or B-cell origin, melanomas, myelogenous leukemias, Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, chronic lymphocytic leukemias, and myelomas (including multiple myelomas) (paragraph [0253]); all of which are hematological cancers. Additionally Li teaches the method of treating hematological malignancies.
Regarding claim 17, Pinchman teaches the method of treating myelogenous leukemias, which includes acute myeloid leukemia (AML). Additionally, Li teaches the method of treating AML (Introduction).
Regarding claims 18, Pinchman teaches the method of treating non-Hodgkin’s lymphoma (paragraph [0253]).
Regarding claim 19, Pinchman teaches the method of treating lymphoblastic leukemias, which includes acute lymphoblastic leukemia (ALL) (paragraph [0253]).
Regarding claim 21, Pinchman discloses Example 17 (Table 4A).
PNG
media_image14.png
166
298
media_image14.png
Greyscale
Regarding claim 22, Pinchman discloses Example 34 (Table 4A), or 2-(( 1H-pyrrolo[2,3-b]pyridin-5-yl)oxy)-4-(4-((2-(3-(difluoromethyl)bicyclo[1.1.1]pentan-1-yl)-4,4-dimethylcyclohex-1-en-1-yl)methyl) piperazin-1-yl)-N-((4-((((1r,4r)-4-hydroxy-4-methylcyclohexyl)methyl)amino)-3-nitrophenyl)sulfonyl) benzamide, and Li teaches the additional therapeutic agents bortezomib, , azacitidine, bendamustine, and cytarabine (Table 4).
PNG
media_image15.png
182
684
media_image15.png
Greyscale
Claims 1-5, 7-12, and 14-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pinchman et al. (cited above) in view of Li et al. (cited above) in further view of Fisher et al. (N Engl J Med. 1993;328(14):1002-6).
The teachings of Pinchman and Li are disclosed above and incorporated by reference herein.
Regarding claim 1, the combination of Pinchman and Li does not teach administering doxorubicin, cyclophosphamide, vincristine, or etoposide as additional chemotherapeutic agent.
Fisher discloses four combination therapies for the treatment of non-Hodgkin’s lymphoma, a hematological cancer, that include doxorubicin, cyclophosphamide, vincristine, or etoposide.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong A of KSR applies – combining known compounds for the same purpose of treating a hematological cancer. The combination of Pinchman and Li teach combining a BCL-2 inhibitor and an additional therapeutic agent for the treatment of hematological cancers. Fisher demonstrates additional therapeutic agents that also treat a hematological cancer. As all the art is teaching treatment of blood cancers it would be prima facie obvious to one of ordinary skill in the art to combine the BCL-2 inhibitors, taught by Pinchman, with additional therapeutic agents known to treat blood cancers, as taught by Fisher, to produce a combination therapy, which is taught by all three references.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 11, Fisher teaches doxorubicin administered intravenously (page 1003 states chemotherapy administered as originally reported, reference 11 reports IV administration). When administered by IV doxorubicin is administered as the salt doxorubicin HCl, as it is water soluble.
Regarding claim 12, Fisher teaches cyclophosphamide and vincristine.
Regarding claim 14, Fisher teaches etoposide.
Regarding claim 20, Fisher teaches administering prednisone.
Conclusion
Claims 1-5, 7-12, and 14-22 are rejected.
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.
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, 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.
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.
/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621