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
Applicant’s election without traverse of Group II, claims 7-12, in the reply filed on 09/17/2025 is acknowledged.
Claims 1-6 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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’s election without traverse of (a) mRNA as the patient feature category; in the reply filed on 09/17/2025 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant elected MT1L as the specific feature listed for PRONTO-m in Table 6. However, the Examiner’s requirement for a species election for Group II of a specific feature selected from the features listed for PRONTO-m in Table 6 is withdrawn as the election of a specific feature is not encompassed by the scope of “substantially all of 94 patient features”.
Amendments to claim 12 is acknowledged.
Claims 1-15 are pending.
Claims 7 and 9-12 are under examination on the merits.
Priority
This application 17/714,778 filed on 04/06/2022 claims the benefit of provisional U.S. Patent Application No. 63/171,547, filed on 04/06/2021.
The priority date of claim 7 and its dependent claims 9-12 is determined to be 04/06/2021, the filing date of provisional U.S. Patent Application No. 63/171,547.
Specification
The use of the term Nanostring®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim 7 recites the limitation “patient features comprising the mRNA, CNA, methylation and clinical features listed for PRONTO-m in Table 6”. The claim recites mRNA and applicants have elected the patient feature category mRNA. However, Table 6 includes the category RNA. The RNA of Table 6 is interpreted to be the mRNA of the claim.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 9-12 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.
The claims are broadly drawn to methods for predicting disease progression risk in a subject with prostate cancer by obtaining a sample from any tumor cell from any source and encompass disease progression risk for a subject with prostate cancer.
The specification provides only one embodiment comprising obtaining punch cores from radical prostatectomy samples (i.e. prostate cancer tumor cells from patients with prostate cancer) at a single collection time (p. 12). However, the specification does not teach obtaining tumor cells from another cancer type much less any tumor cell from any source. No guidance or working examples are provided that show an analysis is performed on any tumor cell from any source.
Thus the claims encompass a broad genus of any tumor cell while the specification describes only a narrow single species (prostate tumor cell) with no evidence that the genus that includes any tumor cell is contemplated. See MPEP 2163.03(V).
The teachings of the specification are not representative of the whole species recited in the claims. The claims encompass a genus of any tumor cell from any cancer type in a subject with prostate cancer. For example, the patient with prostate cancer could also have bladder, colorectal, or skin cancer.
For claims drawn to a genus, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A “representative number of species” means that the species which are adequately described are representative of the entire genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. Further, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“ [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Thus considering the breadth of the tumor cells required by the claimed methods and the teachings of the instant specification, it is the conclusion that the specification does not provide an adequate written description of the broadly claimed subject matter.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 9-12 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.
The term “substantially all of” in claim 7 is a relative term which renders the claim indefinite. The term “substantially all of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation of "patient features" has been rendered indefinite by use of the term substantially all.
The term “some or all” in claim 7 is a relative term which renders the claim indefinite. The term “some or all” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation of "reference or control features" has been rendered indefinite by use of the term substantially all.
Claim 7 references the “patient features comprising the mRNA, CNA, methylation and clinical features listed for PRONTO-m in Table 6” and “reference or control features set forth in Table 6”. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP § 2173.05(s).
Claim 7 recites the limitation “reference or control features set forth in Table 6”. It is unclear what features in Table 6 are intended to be reference or control features. There is no column in Table 6 indicating reference or control features. For the purposes of examination it is assumed that features with zeros in both the PRONTO-e and PRONTO-m columns) are reference or control features.
Claim 7 recites the limitation “comparing said patient features to the reference or control features”. There appear to be no reference or control features in Table 6 for the feature category mRNA. It is unclear how “comparing” is intended to be performed across feature categories when reference or control features are not provided for all different types of patient features, e.g., mRNA, CNA, methylation, etc.
Claim 7 recites the limitation “a classifier that takes said patient feature values as input”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the patient feature “values” are derived from step (b) or step (c) of the claim.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claim recites the limitation “the classifier having been previously trained on samples from a population of early prostate cancer patients”. The omitted steps appear to be: a specific description of what the classifier was previously trained on. In particular the claim appears to be missing reference to data or the patient feature measured in the samples.
Claims 9-12 are similarly indefinite because they directly or indirectly depend from claim 7.
Claim 10 recites the limitations “the pathologic GG>2 class" and “the pathologic GG1 class”. There is insufficient antecedent basis for this limitation in the claim. Claim 7, which claim 10 depends upon does not have a limitation of a pathologic GG class. Amending claim 10 to depend from claim 9 would overcome this rejection.
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 7 and 9-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Step 1
The claimed invention is directed to the statutory category of a process.
Step 2A, Prong One
The claim is (claims are) taken to be directed to an abstract idea, a judicial exception.
Claim 7 is directed to a method comprising “determining… substantially all of 94 patient features comprising the mRNA, CNA, methylation and clinical features listed for PRONTO-m in Table 6,and some or all reference or control features set forth in Table 6 ”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the “determining” step encompasses the mental step of encompasses the mental step of looking at data and making a mental judgement.
Claim 7 is directed to a method comprising “comparing said patient features to the reference or control features”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the comparing step encompasses the mental step of encompasses the mental step of looking at patient features and making a mental judgment.
Claim 7 is directed to a method comprising “computing a prediction score using a classifier that takes said patient feature values as input, the classifier having been previously trained on samples from a population of early prostate cancer patients”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the computing step encompasses mathematical concepts such as mathematical calculations.
Claims 9-12 depend from claim7, and require the same steps of determining, comparing and computing.
Claim 9 is directed to a method comprising “classifying the patient tumour into a pathological Gleason Grade Group (GG) class”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the classifying step encompasses the mental step of looking at data and making a mental judgement to categorize the data.
Step 2A, Prong Two
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception.
While claim 7 recites “providing a sample containing RNA and DNA material from tumour cells”, and “measuring substantially all of 94 patient features…” , these are not integrations of the exception into a practical application. Instead, these elements are data gathering required to perform the method.
Furthermore, while claim 11 recites “managing the patient with active surveillance” and claim 12 recites “treating the patient with surgery, endocrine therapy, chemotherapy, radiotherapy, hormone therapy, gene therapy, thermal therapy, or ultrasound therapy”. These are not integrations of the exception into a practical application, but are rather generalized instructions to treat which are well understood, routine and conventional. Simply appending them is not enough to qualify as significantly more when recited in a claim with a judicial exception.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not add a specific limitation other than what is well-understood, routine, and conventional in the field. Steps directed to “providing a sample”, “measuring” and “treating” are techniques that are routine, conventional, and well-known in the art as demonstrated in the 102 and 103 rejections documented below.
For these reasons, the claims are rejected under section 101 as being directed to non-statutory subject matter.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. (Personalized risk stratification for patients with early prostate cancer (PRONTO): A Canadian team biomarker project. 2018. Journal of Clinical Oncology. 36(6): 1).
Regarding claim 7, Berman teaches a method of risk stratification (predicting disease progression risk) in patients with prostate cancer (Background). The method comprises measuring transcripts (mRNA) from biopsy samples. The samples contain RNA and DNA as indicated by the use of assays directed to RNA (measuring transcripts) and DNA (copy number variations (CNV), DNA hypermethylation) (Methods).
Berman teaches the method comprises PRONTO (Personalized risk stratification for patients with early prostate cancer), which comprises taking data from multiple diagnostic assays (Methods) and identifying a classifier (Results).
Regarding the patient feature category mRNA, Berman teaches measuring 393 transcripts) (Methods), which are relevant to the mRNA features of PRONTO-m and reference or control features of the claim.
Berman teaches computing a ‘score’ that distinguishes low grade from intermediate grade prostate cancer (Conclusions) using a classifier that had been trained on samples from the cases of radical prostatectomy (Results). While Berman does not explicitly teach the instantly claimed mRNA features of PRONTO-m and reference or control features, the transcripts of Berman are functionally equivalent in that both Berman and the instant application obtained prostate cancer samples, and measured transcripts to develop a classifier and compute a score in method comprising PRONTO. Because these elements are functionally equivalent, they are considered obvious variants and for this reason the claim is rendered obvious.
Claims 9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. (Personalized risk stratification for patients with early prostate cancer (PRONTO): A Canadian team biomarker project. 2018. Journal of Clinical Oncology. 36(6): 1) as applied to claim 7 above, and further in view of Williams et al. (US PGPub 2020/0116728).
Regarding claims 9, 11, and 12, the teachings of Berman regarding claim 7 as required by claims 9, 11 and 12 are discussed above.
Berman does not teach determining the prediction score comprises classifying the patient tumour into a pathological Gleason Grade Group (GG) class (claim 9), managing the patient with active surveillance if the patient is classified into the pathologic GG1 class (claim 11) or treating the patient classified into the pathologic GG>2 class with one of the limitations of claim 12.
Regarding claim 9, Williams teaches a method for determining high-risk cancer, the method comprising grouping patients by GGS (Gleason group Score, i.e. Gleason Grade Group (GG) class) (para 88).
Regarding claim 11, Williams teaches that patients who have a Gleason group score of 1 at initial diagnosis are unlikely to progress (para 75), i.e. are low-risk. Williams further teaches that low-risk cancer is cancer that is unlikely to progress and can undergo active surveillance (para 77).
Regarding claim 12, Williams teaches that patients who have a Gleason group score of 3 (GG>2) have a higher chance of progressing to advanced disease (para 75). Williams further teaches that high-risk cancer is cancer that has an increased likelihood of a negative outcome (e.g., progression) and a diagnosis of high-risk cancer indicates the need for treatment such as surgery, radiation therapy or chemotherapy (para 76).
Williams states that there is consistent and longstanding evidence that the Gleason score system is a powerful prognosticator for survival, failure, and/or progression for patients with histologically proven prostate cancer (para 118).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Berman and Williams to arrive at the instantly claimed invention. The modification would have entailed using the Gleason group score as a predictor in the method of Berman. One would have been motivated by the historical success of Gleason scoring in predicting progression for patients with prostate cancer. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. (Personalized risk stratification for patients with early prostate cancer (PRONTO): A Canadian team biomarker project. 2018. Journal of Clinical Oncology. 36(6): 1) as applied to claim 7 above, and further in view of Shipitsin et al. (US PGPub 20160266126).
Regarding claim 10, the teachings of Berman regarding claim 7 as required by claim 10 are discussed above.
Berman teaches low grade (GG1) and intermediate grade (GG2 and 3) cancers (Background). However, Berman does not teach the patient tumour is classified in the pathologic GG>2 class if the risk score is > 0.5 or the pathologic GG1 class if the risk score is < 0.5.
Shipitsin teaches methods for evaluating a cancer sample, including predicting risk of progression (para 366). Shipitsin teaches calculating a risk score that allows discrimination between ‘favorable’ cases, e.g., surgical Gleason 3+3 (i.e. Gleason grade 1, GG1) and ‘non-favorable’ cases, e.g. a dominant Gleason 4 pattern or higher (i.e. Gleason grade 3 or higher, GG>2) (para 147).
Shipitsin teaches determining a risk score threshold for sensitivity to non-favorable (Fig. 40A) or favorable (Fig. 40B) disease states.
Shipitsin does not teach the risk score threshold is >0.5 for nonfavorable (GG>2) and <0.5 for favorable (GG1) cases.
However, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Berman and Shipitsin to arrive at the instantly claimed invention sing the method of Shipitsin to set a score threshold value relative to the low grade and intermediate grade cancers of Berman using the classifier of Berman. Determining an appropriate threshold would have been merely a matter of routine optimization which is considered conventional, and within the skill of the ordinary artisan. One would have been motivated by the desire to set an accurate threshold value and correlate a risk score derived from the classifier with known Gleason grade categories. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
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.
(i). Claims 7, 9,11 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/612,695 (reference application) in view of Williams et al. (US PGPub 2020/0116728).
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a method for diagnosing cancer cells.
Regarding instant claim 7, copending claim 1 requires providing a sample containing genetic material from patient cells suspected of being cancerous; b) determining or measuring expression levels in the patient cells of at least 3 of the 1919 genes by measuring their corresponding RNA levels; and c) computing a score using a classifier that takes said expression level values as input, the classifier having been previously trained on known cancerous and non-cancerous samples. The 1919 genes listed in Table B of copending claim 1 includes substantially all of the mRNAs listed for PRONTO-m in Table 6 of instant claim 1, including, but not limited to, LRRN1, MEIS2, MT1L, and MYLK.
Regarding instant claim 9, copending claims do not require classifying the patient tumour into a pathological Gleason Grade Group (GG) class (instant claim 9).
The teachings of Williams as they relate to this claim are given previously in this office action and are fully incorporated here.
Regarding instant claim 11, copending claim 19 requires if there is a low likelihood of cancer (pathologic Gleason Grade 1), further comprising managing the patient with active surveillance
Regarding instant claim 12, copending claim 20 requires if there is a high likelihood of cancer (pathologic Gleason Grade>2), further comprising treating the patient with the claimed limitations of instant claim 12.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii). Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/612,695 (reference application) in view of Shipitsin et al. (US PGPub 20160266126).
Regarding instant claim 10, the copending claims do not require the patient tumour is classified in the pathologic GG>2 class if the score is > 0.5 or the pathologic GG1 class if the score is < 0.5.
The teachings of Shipitsin as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JESSICA GRAY/Examiner, Art Unit 1682 /JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682