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 .
Election/Restrictions
The Election filed 10/14/25 in response to the Office Action of 5/14/25 is acknowledged and has been entered. Applicant elected group I with traverse.
The traversal is on the ground(s) that elected group I and group III share a common technical feature that makes a contribution over the prior art and are related as product and process of using. Upon further consideration, the examiner rejoins group III with elected group I.
Claims 1-18 are pending.
Claims 3 and 15-18 are withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 2, and 4-14 are currently under consideration.
Claim Objections
Claim 7 is objected to for reciting methods of treating a cancer in a subject wherein the cancer comprises at least 10 cancers. It is suspected Applicant may not have intended the claim to recite treating a subject that has a cancer comprising 10 cancers. Applicant may wish to amend the claim recite the cancers in a Markush manner. See MPEP 2117. Proper correction is required.
Claim 11 is objected to for reciting methods of detecting a cancer in a subject wherein the cancer comprises at least 10 cancers. It is suspected Applicant may not have intended the claim to recite detecting a cancer comprising 10 cancers in a subject. Applicant may wish to amend the claim recite the cancers in a Markush manner. See MPEP 2117. Proper correction is required.
Claim 14 is objected to for reciting methods of assessing severity of a cancer in a subject wherein the cancer comprises at least 10 cancers. It is suspected Applicant may not have intended the claim to recite assessing severity of a cancer comprising 10 cancers in a subject. Applicant may wish to amend the claim recite the cancers in a Markush manner. See MPEP 2117. Proper correction is required.
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, 2, 4-7 and 12-14 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.
Claims 1, 2, and 4-7 are rejected because claim 1 recites “…or a protein encoded by circPCMTD1; wherein the circPCMTD1-encoded peptide to which the antibody binds….” There is insufficient antecedent basis for “the circPCMTD1-encoded peptide to which the antibody binds” in the claim. In an effort to expedite prosecution, the following amendment is suggested to obviate this rejection: “…or a peptide encoded by circPCMTD1; wherein the circPCMTD1-encoded peptide to which the antibody binds….”
Claims 12-14 are rejected because claim 12 recites “…indicates the cancer is more severe.” The metes-and-bounds of the claims are unclear because is unclear, as compared to what, the recited cancer is considered “more severe.”
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, 2, 4-7 and 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, the claims are inclusive of a genus of antibodies that specifically bind circPCMTD1 or a protein encoded by circPCMTD1. The specification does not disclose, and the art does not teach, the genus of antibodies as broadly encompassed in the claims.
The specification does not adequately describe any antibody that binds circPCMTD1 or a protein encoded by circPCMTD1. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
In regards to claims to a product defined by function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at1568 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of antibodies that encompass the genus nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number” of species. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352. The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.”Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112
Claims 4-7 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.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See also Ex parte Forman, 230 USPQ 546 (BPAI 1986).
The claims are broadly drawn to methods of treating cancer(s) in a subject comprising administering the subject an antibody that specifically binds circPCMTD1 or a protein encoded by circPCMTD1.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification discloses an antibody specific for circPCMTD1 has been generated (lines 14-15 on page 35, in particular). However, neither the specification nor the prior art describe an antibody that specifically binds circPCMTD1 or a protein encoded by circPCMTD1. The specification provides no working examples demonstrating the claimed method. Further, there is no indication that an antibody that specifically binds circPCMTD1 or a protein encoded by circPCMTD1 would provide therapeutic upon administration of the antibody to a subject with cancer(s).
In order to perform the method, as broadly claimed, it would require undue experimentation to (i) generate antibodies that specifically bind circPCMTD1 or a protein encoded by circPCMTD1 and (ii) determine which, if any, of those antibodies would provide therapeutic benefit to subjects with cancers encompassed by the claims.
Further, similar to claims at issue in Amgen Inc. v Sanofi, the instant specification does not enable the full scope of the claims. In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Claim Rejections - 35 USC § 112
Claims 8-11 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 methods of detecting the presence of circPCMTD1 RNA in a sample from a subject, does not reasonably provide enablement for methods of detecting the presence of circPCMTD1 RNA in a subject wherein the presence or increased expression of circPCMTD1 relative to a control indicates the presence of a p53 mutation or BCR/ABL fusion. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
The instant claims are drawn to methods of detecting the presence of circPCMTD1 RNA in a subject wherein the presence or increased expression of circPCMTD1 relative to a control indicates the presence of a p53 mutation or BCR/ABL fusion. This includes methods of detecting circPCMTD1 RNA with oligonucleotides known in the prior art to bind circPCMTD1 RNA (see probe used in Figure 5F of Zheng et al (Frontiers in Oncology, 2019, 398: 1-13; 5/6/22 IDS), for example) or antibodies that are not adequately described.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The specification discloses detecting circPCMTD1 RNA (Fig. 12, in particular). The specification further discloses leukemic cell lines used in disclosed experiments have a BCR/ABL fusion protein and p53 mutations (sentence spanning pages 35-36) and goes on to state “When experiments were repeated in leukemic cell lines without the p53 mutations the same effects were not observed.” However, neither the specification nor the prior art demonstrates the presence or increased expression of circPCMTD1 relative to a control predictably indicates the presence of a p53 mutation or BCR/ABL fusion. It has not been shown presence or increased expression of circPCMTD1 relative to a control is more likely to be found in cells with a p53 mutation or BCR/ABL fusion, as compared to cells lacking a p53 mutation or lacking BCR/ABL. Undue, and inventive, experimentation would be required to determine whether such an association exists.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Claim Rejections - 35 USC § 112
Claims 12-14 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 methods of measuring the expression level of circPCMTD1 in a cancerous cell comprising p53 mutation or BCR/ABL fusion from a subject, does not reasonably provide enablement for methods of measuring the expression level of circPCMTD1 in a cancerous cell comprising p53 mutation or BCR/ABL fusion from a subject wherein increased expression of circPCMTD1 relative to a cancerous nondividing control indicates the cancer is more severe. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
The instant claims are drawn to methods of measuring the expression level of circPCMTD1 in a cancerous cell comprising p53 mutation or BCR/ABL fusion from a subject wherein increased expression of circPCMTD1 relative to a cancerous nondividing control indicates the cancer is more severe. This includes methods of measuring circPCMTD1 with oligonucleotides known in the prior art to bind circPCMTD1 RNA (see probe used in Figure 5F of Zheng et al (Frontiers in Oncology, 2019, 398: 1-13; 5/6/22 IDS), for example) or antibodies that are not adequately described.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The level of unpredictability for using a particular expression pattern of a particular molecule to detect any disease state (such as severity) is quite high. The state of the prior art dictates that one of skill in the art would not predict that a particular expression pattern of a particular molecule is indicative of a particular diseased state without a demonstration that said particular diseased stated correlates with said particular expression pattern of said particular molecule. For example, Tockman et al (Cancer Res., 1992, 52:2711s-2718s) teach considerations necessary in bringing a cancer biomarker (intermediate end point marker) to successful application. Absent evidence demonstrating a particular expression pattern of a particular molecule correlating with a particular diseased state, one of skill in the art would not predict said particular expression pattern of said particular molecule correlates with said particular diseased state without undue experimentation. Experimentation to identify such a correlation would in itself be inventive.
The specification discloses detecting circPCMTD1 (Fig. 12, in particular). The specification further discloses leukemic cell lines used in disclosed experiments have a BCR/ABL fusion protein and p53 mutations (sentence spanning pages 35-36). However, neither the specification nor the prior art demonstrates increased expression of circPCMTD1 in just any type of cancer cell relative to a cancerous nondividing control indicates the cancer is more severe. Undue, and inventive, experimentation would be required to determine whether such an association exists.
It is acknowledged Figure 1A of the instant specification is described as showing prognostic significance of circPCMTD1 in AML where “High” levels indicate better survival than “Low” levels. However, it is unclear whether the illustrated levels of Fig. 1A are in cells with BCR/ABL fusion protein and p53 mutations. Further, it is unclear whether the results of Fig. 1A are indicative of any cancer types other than AML.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, it would require undue experimentation by one of skill in the art to determine with any predictability, that the method would function as claimed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. The rationale for this determination is explained below:
Claims 8-14 are directed to natural phenomenon because the claims recite natural phenomenon (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: expression of circPCMTD1 RNA correlates with presence of p53 mutation, BCR/ABL fusion, and cancer severity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of measuring/detecting circular RNA, using reagents such as oligonucleotides known in the prior art to bind circular RNA (see probe used in Figure 5F of Zheng et al (Frontiers in Oncology, 2019, 398: 1-13; 5/6/22 IDS), for example), in cells from subjects (“Step 2B”). Zheng et al and Okholm et al (npj Genomic Medicine, 2017, 36: 1-14) both teach measuring/detecting circPCMTD1 RNA in cancer cells (Fig. 5F of Zheng et al, Fig. 4E of Okholm et al, in particular). Further, the prior art teachings of Zeng et al (PLOS, 2017, e1005420, 1-21) is a review article focused on detecting circular RNA. Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
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vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
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viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
Here, the claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the broad instant claims, encompassing correlations between the presence/levels of circPCMTD1 RNA and natural phenomenon that have yet to be demonstrated, do not relate the judicial exception(s) in a significant way and appear to be a drafting effort designed to monopolize laws of nature in a manner that is antithetical to patent laws. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression) are routinely performed in the art to obtain data regarding expression. Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…." Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642