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 .
Priority
This application 17/772,829 filed on 04/28/2022 is a 371 national phase of PCT/US2020/058406 filed on 10/30/2020, and claims the benefit of provisional U.S. Patent Application No. 62/929,579, filed on 11/01/2019; provisional U.S. Patent Application No. 62/930,465, filed on 11/04/2019; and provisional U.S. Patent Application No. 63/061,709, filed on 08/05/2020.
Applicant’s arguments filed 08/08/2025, with respect to priority of claims 113 and its dependent claims have been fully considered and are persuasive.
The priority date of claim 113 and its dependent claims is thus determined to be 11/01/2019, the filing date of provisional U.S. Patent Application No. 62/929,579.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
Status of Claims and Action Summary
This action is response to papers filed 03/03/2026.
Currently, claims 113, 117, 118, 123-128, 130, and 136 are amended. Claim 122 has been canceled.
Claims 113, 117-120, 123-128, 130-134, and 136-137 are pending and under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
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 113,117-120,123-128,130-134,136, and 137 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 113 recites the limitation “(e) comparing the RNA sequences of the cervicovaginal or menstrual fluid sample and the RNA sequences from the whole blood sample --- and (f) selecting a plurality of the menstrualome biomarkers to construct a sample menstrualome fingerprint. It is unclear what criteria would be used to determine the selection. The claim cites identifying clusters of RNA sequences (menstrualome biomarkers) that display any differential presence or level in cervicovaginal or menstrual fluid compared to whole blood. It is unclear what criteria would be used to select a subset of these menstrualome biomarkers as the menstrualome fingerprint.
Claim 113 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. Claim 1 steps (c) and d) recite limitations “obtaining RNA sequences” and further, in step (e), comparing the RNA sequences -- by performing a clustering analysis ---“. The omitted steps appear to be, at a minimum, active steps of sequencing RNA sequences obtained from the cervicovaginal or menstrual fluid and whole blood samples in order to be able cluster reads for identifying RNA sequences that display a differential presence or level in cervicovaginal or menstrual fluid as compared to whole blood.
Claims 117-120, 123-128, 130-134, and 136-137 are similarly indefinite because they directly or indirectly depend from claim 113.
Claim 123 recites the limitation “wherein the reference menstrualome fingerprint comprises a level or presence of the plurality of menstrualome biomarkers in a reference group of subjects”. It is unclear what criteria would define a reference group of subjects.
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 113,117-120,123-128,130-134,136, and 137 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 113 is directed to a method comprising “selecting a plurality of the menstrualome biomarkers to construct a sample menstrualome fingerprint”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the selecting step encompasses the mental step of looking at menstrualome biomarkers, making mental judgements, and choosing a subset.
Claims 117-120, 123-128, 130-134, and 136-137 depend from claim 113 , and require the same step of “selecting a plurality of the menstrualome biomarkers”.
Claims 1127-128, 130-134, and 136 depend from claim 113 , and require the same step of “selecting a plurality of the menstrualome biomarkers”.
Claim 130 is directed to a method comprising “wherein the plurality of menstrualome biomarkers is selected to comprise biomarkers that display differential presence or level in cervicovaginal or menstrual fluid between two or more health states of the subject”. This limitation is an abstract mental process (see MPEP 2106.04(a)(2)(III)). As written, the selecting step encompasses the mental step of looking at menstrualome biomarkers, making mental judgements, and choosing a subset.
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 1 additionally recites the active steps ” a) obtaining a cervicovaginal or menstrual fluid sample from a subject -- ; (b) eluting the cervicovaginal or menstrual fluid sample---; (c) obtaining RNA sequences from the cervicovaginal or menstrual fluid sample; (d) obtaining a whole blood sample from the subject and obtaining RNA sequences from the whole blood sample; (e) comparing the RNA sequences of the cervicovaginal or menstrual fluid sample and the RNA sequences from the whole blood sample by performing a clustering analysis — and construct[ing] a sample menstrualome fingerprint”, these are not integrations of the exception into a practical application. Instead, these elements are data gathering and data analysis required to perform the method.
Additional claims recite limitations on collection time points and sample sources (claims 117-120, 123-125 and 131-134) or repeat the data gathering and analysis steps of claim 113 (claim 126 and 130). These are not integrations of the exception into a practical application. Instead, claims 117-120, 123-125 present general parameters for performing the method while claims 126 and 130 repeat steps of claim 1 that are data gathering and data analysis required to perform the method.
Lastly, claim 137 recites the limitation “wherein the clustering analysis comprises a k means clustering, a heat map, a tSNE dimensionality analysis, or a principal component analysis”. This is not an integration of the exception into a practical application. Instead, these elements are routine and conventional data analysis steps required to perform the method.
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 obtaining samples, eluting material, obtaining RNA sequences, and performing cluster analysis are techniques that are routine, conventional, and well-known in the art as demonstrated in the 103 rejection documented below.
Furthermore, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activities in the life science arts when they are claimed in a merely generic manner or as insignificant extra-solution activity:
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);
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.
Claims 113,117-120,123-128,130-134,136, and 137 are rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (WO 2017/180909, on IDS dated 07/15/2022) in view of Hanson et al. (Messenger RNA biomarker signatures for forensic body fluid identification revealed by targeted RNA sequencing. 2018 Forensic Science International: Genetics 34:206-221, on IDS dated 12/13/2023).
Regarding claim 113, Tariyal teaches devices and methods for analysis of vaginal biological samples (abstract).
Regarding step (a), Tariyal teaches use of a device for detecting markers (e.g. biomarkers) associated with cervicovaginal fluids or menstrual blood (menstrual fluid) (para 487 and paras 22, 29, 39, 54). Tariyal teaches that the sample collector comprises an absorbent-diffuse material that can absorb cervicovaginal or other vaginal fluids, encompassed by menstrual fluids (paras 54, 254).
Regarding step (b), Tariyal teaches eluting the biological material and receiving the biological sample with buffer from the sample collector (para 416, step 12).
Regarding step (c), Tariyal teaches extracting RNA (para 151 and claim 60) and sequencing the RNA (para 487).
Regarding step (d), teaches whole blood as a biological sample (paras 232 and 418) and extracting (para 151 and claim 60) and sequencing RNA (para 487) from a biological sample, as encompassed by step (d).
Regarding step (e), Tariyal teaches detecting a presence or level of biomarkers in a sample (para 25) and comparing biomarker expression level of the biomarker to a sample from the subject that is in a different region of the body (e.g. a whole blood sample which is taught as a biological sample) (para 425).
Regarding step (f), Tariyal teaches determining a set of biomarkers (para 425) such as those listed in Tables 2-10 that determine the presence, absence and/or severity of endometriosis based on changes in expression level (para 425).
Tariyal does not teach for step (e) comparing the RNA sequences -- by performing a clustering analysis to identify one or more clusters of RNA sequences or (ii) identifying one or more clusters of RNA sequences as the menstrualome biomarkers.
Hanson teaches a method identifying RNA biomarker signatures in body fluid, the method comprising obtaining RNA sequences using an absorbent collector from multiple sources including vaginal secretions, menstrual blood and blood (methods, p. 207, col. 2), and performing clustering analysis (p. 209 col. 1-2 and Fig. 1) to identify groups (i.e. clusters) of RNA sequences displaying different levels in vaginal samples compared to blood (Fig. 1, Table 2).
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 Tariyal and Hanson to arrive at the instantly claimed invention. The modification would have entailed using the analysis of Hanson with the method of Tariyal to construct a menstrualome fingerprint. One would have been motivated by the ability to resolve differences in level or expression of RNA biomarkers in vaginal samples (cervicovaginal or menstrual) compared to a control sample of whole blood. 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.
Regarding claim 117, Tariyal teaches assaying at different times (para 466) and using the method for monitoring effectiveness of a medical or therapeutic regimen (para 270), as encompassed by the claimed prior time point before a medical treatment and the first sample time point after the medical treatment.
Regarding claim 118, Tariyal teaches assaying a condition at different times (para 466) and using the method for monitoring effectiveness of a medical or therapeutic regimen (para 270).Tariyal further teaches surgical procedures are a medical treatment (para 485). Thus, the teachings of Tariyal are encompassed by a prior time point before a surgery and a sample collected at a time point after the surgery.
Regarding claim 119, Tariyal teaches a change of expression level of the biomarker indicates a pathological condition associated with endometriosis (para 25), a menstrual disorder.
Regarding claim 120, Tariyal teaches a change of expression level of the biomarker indicates a pathological condition associated with endometriosis (para 25).
Regarding claim 123, Tariyal teaches that the biomarker expression level of a subject diagnosed with endometriosis can be compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed (para 425), which is encompassed by comparing the sample menstrualome fingerprint to a reference menstrualome fingerprint comprising a level or presence of the plurality of menstrualome biomarkers from a reference group of subjects .
Regarding claim 124, Tariyal teaches that the biomarker expression level of a subject diagnosed with endometriosis can be compared to the expression level of the biomarker in a sample from a second subject that is not diagnosed, or to a sample from the subject that is in a different region of the body (i.e. a reference fingerprint) (para 425).Tariyal teaches the method further comprises monitoring the health condition regularly, including monitoring the health condition about every 10 to 90 days, as encompassed by the claimed limitation of comparing a sample to a prior time point (para 33).
Regarding claim 125, Tariyal teaches that the biomarker expression level of a subject diagnosed with endometriosis can be evaluated by associating the expression level of at least one biomarker or at least one set of biomarkers from a list of biomarkers associated with the disease (para 426) or determining the presence or absence of a biomarker (para 425).
Regarding claim 126, regarding step (a) Tariyal teaches monitoring a health condition about every 10 to 90 days (para 33) and also self-monitoring on a regular basis (para 270), i.e. obtaining a second sample from a subject. Tariyal teaches use of a device for detecting markers (e.g. biomarkers) associated with cervicovaginal fluids or menstrual blood (menstrual fluid) (para 487 and paras 22, 29, 39, 54). Tariyal teaches that the sample collector can absorb cervicovaginal fluids (paras 54, 254).
Regarding step (b), Tariyal teaches eluting biological material and receiving the biological sample with buffer from the sample collector (para 416, step 12).
Regarding step (c), Tariyal teaches extracting RNA (para 151 and claim 60) and sequencing the RNA (para 487).
Regarding step (d), Tariyal teaches detecting a presence or level of biomarkers in the sample, i.e. cervicovaginal fluids or menstrual blood (menstrual fluid) (para 25).
Regarding claim 127, Tariyal teaches using the method for self-monitoring on a regular basis including about every month, or about every 28-40 days, and that the self-monitoring period can be synchronized with a woman's menstrual cycle (para 270), i.e. samples from the same subject. Thus, Tariyal teaches elements encompassed by samples collected from separate menstrual cycles.
Regarding claim 128, Tariyal teaches using the method to detect changes of biomarker expression levels to indicate a pathological condition (paras 25 and 272) or monitor a subject’s health status (para 12). Tariyal further teaches monitoring a health condition regularly (para 33). This monitoring of changes in biomarkers from samples collected regularly satisfies the requirement of the claimed third menstrualome fingerprint obtained by comparing biomarkers between a first and second sample from the subject.
Regarding claim 130, Tariyal teaches biomarkers indicative of a pathological condition determined by changes in expression level of biomarkers in samples collected at different times in the menstrual cycle (para 25).
Regarding claim 131, Tariyal teaches using the method for monitoring effectiveness of a medical or therapeutic regimen (para 269), encompassing the before and after medical treatment of claim 117.
Regarding claim 132, Tariyal teaches using the method for self-monitoring of effectiveness of a medical regimen (para 270), as encompassed by the claimed before and after surgery.
Regarding claim 133, Tariyal teaches a change of expression level of the biomarker indicates a pathological condition associated with endometriosis (para 25), a menstrual disorder.
Regarding claim 134, Tariyal teaches a change of expression level of the biomarker indicates a pathological condition associated with endometriosis (para 25).
Regarding claim 136, Tariyal teaches monitoring the health condition regularly, including monitoring the health condition about every 10 to 90 days (para 33) including during menstrual phase (MP), proliferative phase (PE), early secretory phase (ESE), mid-secretory phase (MSE) (para 425), i.e. different days in the menstrual cycle.
Regarding claim 137, Tariyal does not teach any of the the claimed methods of clustering analysis.
Hanson teaches clustering analysis with a heat map (Fig. 1).
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 Tariyal and Hanson to arrive at the instantly claimed invention. The modification would have entailed using the analysis of Hanson with the method of Tariyal to construct a menstrualome fingerprint. One would have been motivated by the ability to resolve differences in level or expression of RNA biomarkers in vaginal samples (cervicovaginal or menstrual) compared to a control sample of whole blood. 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.
Claims 113,117-120,123-128,130-134 and 136-137 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,446,011 in view of Tariyal et al. (WO2017/180909, on IDS dated 07/15/2022) and Hanson et al. (Messenger RNA biomarker signatures for forensic body fluid identification revealed by targeted RNA sequencing. 2018 Forensic Science International: Genetics 34:206-221, on IDS dated 12/13/2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are species claims that anticipate the genus claims of instant application.
Regarding claim 113, claims 1, 6-10, 19, and 20 of the ‘011 patent require collecting a vaginal sample comprising cervicovaginal fluid with a sample collector that is absorbent, removing the sample from the collector and extracting DNA, RNA, or protein (biological material) to detect the presence, absence or change in expression level of a biomarker, and monitoring over 10-90 days (longitudinal menstrual samples). Claims 1 and 9 further requires detecting a presence, absence of change in biomarkers.
Claims of the ‘011 patent do not require obtaining a whole blood sample from the subject, obtaining RNA sequences from the whole blood sample or identifying genes with differential presence or level in cervicovaginal or menstrual fluid as compared to whole blood by performing a clustering analysis.
The teachings of Tariyal and Hanson as they relate to this claim are given previously in this office action and are fully incorporated here.
Regarding claims 117 and 118, the claims of the ‘011 patent require monitoring a health condition (patent claim 1) and collecting samples at different time points (patent claims 9 and 10) but do not require the prior time point comprises before a medical treatment and the first sample comprises a time point after the medical treatment (instant claim 117) or the prior time point comprises before a surgery and the first sample comprises a time point after the surgery (instant claim 118).
The teachings of Tariyal as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding claim 119, claims 6 and 12 of the ‘011 patent require detecting a presence or absence of a biomarker to test a presence or absence of a health condition, including endometriosis, as encompassed by the claimed menstrual disorder of instant claim 119.
Regarding claim 120, claims 6 and 12 of the ‘011 patent require detecting a presence or absence of a biomarker to test a presence or absence of a health condition, including endometriosis.
Regarding claim 123, claims of the ‘011 do not require a reference menstrualome fingerprint wherein the reference menstrualome fingerprint comprises the level and/or presence of the plurality of menstrualome biomarkers in a reference group of subjects.
The teachings of Tariyal as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claims 124- 125, claims 12- 15 require a change of expression level of said biomarker is indicative of a disorder or disease, which reads on a level or presence of the plurality of menstrualome biomarkers in the subject at a prior time point to the collection of the cervicovaginal or menstrual fluid sample. (instant claim 124) and a level or presence of the plurality of menstrualome biomarkers that are associated with a health state (instant claim 125).
Regarding claim 126, claim 9 of the ‘011 patent requires collecting a second vaginal biological sample and detecting a presence, an absence, or a change in expression level of a biomarker.
Regarding claim 127, claim 10 of the ‘011 patent requires monitoring the biomarker about every 10 days to about every 90 days, as encompassed by the claimed separate menstrual cycles of instant claim 127.
Regarding claim 128, claims 9 and 10 of the ‘011 patent require collecting a second vaginal biological sample and monitoring biomarkers over time, as encompassed by the claimed third menstrualome fingerprint of instant claim 128.
Regarding claim 130, claims 7 and 8 of the ‘011 patent require a biological sample comprised of cervicovaginal fluid.
Regarding claims 131 and 132, claims of the ‘011 patent do not require wherein the two or more health states comprise before and after a medical treatment (instant claim 131); or wherein the two or more health states comprise before and after a surgery (instant claim 132).
The teachings of Tariyal as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding claim 133, claims 6 and 12 of the ‘011 patent require detecting a presence or absence of a biomarker to test a presence or absence of a health condition, including endometriosis, as encompassed by the claimed menstrual disorder of instant claim 133.
Regarding claim 134, claims 6 and 12 of the ‘011 patent require detecting a presence or absence of a biomarker to test a presence or absence of a health condition, including endometriosis.
Regarding claim 136, claims of the ‘011 patent do not require the second menstrualome fingerprint comprises a time point from a different day within a menstrual cycle of the subject.
The teachings of Tariyal as they relate to this claim is given previously in this office action and are fully incorporated here.
Regarding claim 137, claims of the ‘011 patent do not require a clustering analysis selected from the listed limitations.
The teachings of Tariyal and Hanson as they relate to this claim is given previously in this office action and are fully incorporated here.
Conclusion
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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