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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 SEPTEMBER 2025 has been entered.
Status of Claims
The claim set submitted with the RCE on 12 SEPTEMBER 2025 is acknowledged and considered. In the claim set, Claims 1-66, 69, 71-78, 82-87, 90-95 are ‘Canceled’; Claims 67 is ‘Currently Amended’; Claims 68, 70, 79-81, 88, 89, and 96-99 are ‘Previously Presented’.
Current pending claims are Claims 67, 68, 70, 79-81, 88, 89 and 96-99 are pending and are considered on the merits below.
Response to Amendment/Arguments
In the REMARKS filed on 12 SEPTEMBER 2025 with the RCE Applicant assets the pending claims should not be rejected under 101 for the reasons filed on May 9, 2025. Examiner has responded to Applicant’s assertions in the FINAL OFFICE Action on 13 JUNE 2025, pages 2-4.
In the responds on 12 SEPTEMBER 2025, Applicant has amended Claim 67 to include subject matter of Claim 90. The 101 rejection did in fact include all the dependent claims as stated in the previous Office Action:
“Dependent claims 68, 70, 79-81, 88-90 and 95-99 further limit the method by analysis technique or result, the type of procedure to be used in obtaining the tissue and the use of a solvent is well -understood routine and conventional and does not add any element that is significantly more than the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using “applying” and “transferring” to perform the method amounts to no more than mere instructions to apply the exception that is WURC for data gathering. Mere instructions to apply an exception cannot provide an inventive concept. The claim is not patent eligible.”
The 101 rejection and art rejections below has been amended to reflect the amendment to the claims submitted with the RCE.
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.
Claim 67 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recites steps in a method of : applying a fixed or discrete volume of solvent to a tissue site of a subject via a first channel of a sampling probe to an internal reservoir of the sampling probe, wherein the fixed or discrete volume of solvent is applied to the tissue site in vivo during a medical procedure, holding [[and]] the fixed or discrete volume of solvent in the internal reservoir in direct contact with the tissue site for a period of time such that the fixed or discrete volume of solvent interacts with the tissue site to form a liquid sample in the sampling probe; supplying gas to the internal reservoir of the sampling probe via a third channel of the sampling probe; transferring the liquid sample from the sampling probe via a second channel of the sampling probe by extracting the liquid sample from the internal reservoir via the second channel and transferring the liquid sample to a mass spectrometer; by operation of the mass spectrometer, subjecting the sample to
The limitation of “characterizing the liquid sample based on the mass spectrometry data profile; wherein characterizing the liquid sample comprises determining to identify whether the tissue site comprises healthy tissue or endometriosis tissue; and wherein, when the mass spectrometry profile comprises mass-to-charge (m/z) ratios of 281.2, 701.5, 750.5, 788.5, 861.5, and 885.5, then the tissue site is identified as endometriosis tissue,” as drafted, is a process that, under its broadest reasonable interpretation, cover performance of the limitation of the mind, i.e. a mental step. Nothing in the claim element precludes the step from practically being performed in the mind. Furthermore, the steps of ‘characterizing’ in art of mass spectrometry with mass-to-charge (m/z) ratios is well-understood, routine, conventional activities.
As seen in MPEP § 2106.05(d), Courts have found such steps to not be enough to qualify as “significantly more” as noted in “ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim
only recites the “characterizing” element/step in addition to the steps of applying a solvent to a tissue site via a first channel of a sampling probe, transferring the sample from the sampling probe via a second channel, and then subjecting the sample to mass spectrometry analysis and therefore produce mass spectrometry data. All three of these steps are done to gather data to be used in the analysis step. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g).
The steps of “applying a fixed or discrete volume of solvent to a tissue site of a subject via a first channel of a sampling probe, wherein the fixed or discrete volume of solvent is supplied to the tissue site in vivo during a medical procedure, and the fixed or discrete volume of solvent interacts with the tissue site to form a liquid sample in the sampling probe; and transferring the liquid sample from the sampling probe via a second channel of the sampling probe, wherein the liquid sample is transferred to a mass spectrometer” are well -understood, routine and conventional.
Dependent claims 68, 70, 79-81, 88-89 and 96-99 further limit the method by analysis technique or result, the type of procedure to be used in obtaining the tissue and the use of a solvent is well -understood routine and conventional and does not add any element that is significantly more than the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using “applying” and “transferring” to perform the method amounts to no more than mere instructions to apply the exception that is WURC for data gathering. Mere instructions to apply an exception cannot provide an inventive concept. The claim is not patent eligible.
The newly added portion of original Claim 90 is considered to be WURC and already taught in the prior art to EBERLIN, US Publication No. 2018/0158661 A1, submitted on the Information Disclosure Statement on 19 AUGUST 2022; US Patent Application Publications Cite No. A59.
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 67, 68, 70, 79-81, 88-89 and 96-99 are rejected under 35 U.S.C. 103 as being unpatentable over EBERLIN, US Publication No. 2018/0158661 A1, submitted on the Information Disclosure Statement on 19 AUGUST 2022; US Patent Application Publications Cite No. A59.
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant’s invention is drawn towards a method.
Regarding Claim 67, the EBERLIN reference discloses a method, abstract, method for assessing tissue samples, comprising:
applying a fixed or discrete volume of solvent to a tissue site of a subject via a first channel of a sampling probe to an internal reservoir of the sampling probe, Figure 1C and 1E-F, probe 110, solvent delivery in first conduit 111 from chamber 120 , [0011, 0051, 0052], wherein the fixed or discrete volume of solvent is applied supplied to the tissue site in vivo during a medical procedure, [0070, 0114, 0121-0122],
holding [[and]] the fixed or discrete volume of solvent in the internal reservoir in direct contact with the tissue site for a period of time such that the fixed or discrete volume of solvent interacts with the tissue site to form a liquid sample in the sampling probe, Figure 1E, [0052-0056];
supplying gas to the internal reservoir of the sampling probe via a third channel of the sampling probe;, Figure 1E, [0052, 0058];
transferring the liquid sample from the sampling probe via a second channel of the sampling probe by extracting the liquid sample from the internal reservoir via the second channel and transferring the liquid sample to a mass spectrometer, Figure 1E-F, third conduit 113 to mass spectrometer 140, [0011, 0052-0058];
by operation of the mass spectrometer, subjecting processing the liquid sample to produce mass spectrometry analysis, thereby obtaining a mass spectrometry profile comprising a plurality of mass-to-charge (m/z) ratios data, Figure 1G-1K, mass spectrometer 140, Figure 1L, profile of mass spectrometer , [0064], Figure 2A-8B; and
characterizing the liquid sample based on analyzing the mass spectrometry data profile, [0093], TABLES; wherein characterizing the liquid sample comprises determining to identify whether the tissue site comprises healthy tissue or endometriosis tissue, [0011, 0015, 0016, 0018, 0048, 0050, 0070, 0101]; and
wherein, when the mass spectrometry profile comprises mass-to-charge (m/z) ratios of 281.2, 701.5, 750.5, 788.5, 861.5, and 885.5, [0092], TABLES.
The EBERLIN discloses the claimed invention, but is silent in regards to wherein all the recited mass to charge ratios are then identified as endometriosis tissue.
EBERLIN discloses that all of the recited mass to charge ratios are detected and profiled, but they are all for different conditions, [0102], Figure 15B, Tables 1, 3, 4, [0091].
EBERLIN also discloses the system can be broadly used in a wide variety of oncological and other surgical interventions (such as endometriosis) for which real-time characterization and diagnosis of tissues are needed, [0014, 0101].
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to use the system already taught to be used in surgical interventions such as endometriosis, of EBERLIN and modify the profiles observed to be those of 281.2, 701.5, 750.5, 788.5, 861.5, and 885.5 to increase the accuracy, sensitivity and specificity of diagnosis and analysis of the method, [0102].
Additional Disclosures Included are: Claim 68: wherein the method of claim 67, wherein the tissue site is identified as endometriosis tissue versus soft tissue, endometriosis tissue verses fallopian tube mucosa, or endometriosis tissue verses ovary tissue, [0018, 0101, 0120-0124].; Claim 70: wherein the method of claim 67, wherein the solvent is supplied to the tissue site in vivo during a laparoscopic procedure, and the fixed or discrete volume of solvent is applied through a cannula of a surgical instrument, wherein the surgical instrument sampling probe comprises at least one of a laparoscope, [0101], a trocar needle, or a biopsy guide, [0048].; Claim 79: wherein the method of claim 67, wherein the tissue site is on fallopian tube, or ovary, [0018, 0036, 0101, 0120-0124].; Claim 80: wherein the method of claim 67, wherein endometriosis tissue, is endometriosis on a cul-de-sac or ovarian endometriosis, [0015, 0016, 0048, 0070].; Claim 81: wherein the method of claim 67, wherein the fixed or discrete volume of solvent is not applied as a spray, Figure 1E, probe 110, solvent delivery in first conduit 111 from chamber 120 , [0011, 0051, 0052].; Claim 88: wherein the method of claim 67, further comprising resecting the tissue site based on a determination that the tissue site comprises endometriosis tissue, [0014].; Claim 89: wherein the method of claim 67, wherein the fixed or discrete volume of solvent is applied to the tissue site, [0007, 0048].; Claim 96: wherein the method of claim 67, wherein the liquid sample is collected in a substantially CO2 atmosphere, [0058]. ; Claim 97: wherein the method of claim 67, wherein the method comprises measuring the amount of lactate, gluconate, arachidonic acid, ascorbate, [0091], oleic acid, aspartate, glutathione, glycerophosphoethanolamine, [0084, 0085], glycerophosphoinisitol, triacylglycerol, or glycerophosphoserine, [0084, 0085], in the liquid sample.; Claim 98: wherein the method of claim 67, wherein the method comprises identifying a higher relative abundance of a fatty acid (FA) 18:1 (m/z = 281.2), phosphatidic acid (PA) 36:1 (m/z = 701.5), glycerophosphoethanolamine (PE) 0-38:4 (m/z = 750.5), glycerophosphoserine (PS) 36:1 (m/z = 788.5), glycophosphoinositols (PI) 36:2 (m/z = 861.5), and PI 38:4 (m/z = 885.5), [0094], Table 1.; and Claim 99: wherein the method of claim 67, wherein the method further comprises assessing the tissue site by histological analysis, [0111, 0112].
Claims 67, 68, 70, 79-81, 88, 89 and 97-99 are rejected under 35 U.S.C. 103 as being unpatentable over SANS, Clin Chem. 2019 May ; 65(5): 674–683. doi:10.1373/clinchem.2018.299289, as evidenced by Data Supplement for SANS, Clin Chem. 2019 May ; 65(5): 674–683. doi:10.1373/clinchem.2018.299289, herein referred ‘DATA SUPPLEMENT’, and further in view of VOUK, US Publication No. 2015/0185238 A1, submitted on the Information Disclosure Statement on 19 AUGUST 2022; US Patent Application Publications, Cite No. A41.
Applicant’s invention is drawn towards a method.
Regarding Claim 67, the SANS reference discloses a method, page 2, METHODS, for assessing tissue samples, comprising:
applying a fixed or discrete volume of solvent to a tissue site of a subject via a first channel of a sampling probe to an internal reservoir of the sampling probe, Figure 1A, page 13, MasSpec Pen, DATA SUPPLEMENT, MasSpec Pen Analysis, pen-sized probe to deliver 10 µL water droplet via a first conduit, wherein the fixed or discrete volume of solvent is supplied to the tissue site in vivo during a medical procedure, page 9, MasSpec Pen employed in operating room for in vivo use,
holding the fixed or discrete volume of solvent in the internal reservoir in direct contact with the tissue site for a period of time such that the fixed or discrete volume of solvent interacts with the tissue site to form a liquid sample in the sampling probe, Figure 1A, page 13, DATA SUPPLEMENT, MasSpec Pen Analysis water droplet contact with tissue sample, 3s of contact;
supplying gas to the internal reservoir of the sampling probe via a third channel of the sampling probe, , Figure 1A, page 13, at insert picture of MasSpec Pen t = 3sec;
transferring the liquid sample from the sampling probe via a second channel of the sampling probe by extracting the liquid sample from the internal reservoir via the second channel and transferring, the sample to a mass spectrometer, Figure 1A, page 13, DATA SUPPLEMENT, MasSpec Pen Analysis Concomitantly, the droplet containing extracted analytes was transported to third conduit to MS system inlet for analysis;
by operation of the mass spectrometer, subjecting processing the liquid sample to produce mass spectrometry analysis, thereby obtaining a mass spectrometry profile comprising a plurality of mass-to-charge (m/z) ratios data, DATA SUPPLEMENT, MasSpec Pen Analysis, Orbitrap analyses was performed, Ion trap analysis was performed, Figure 1A;
characterizing the liquid sample based on analyzing the mass spectrometry data profile, wherein characterizing the liquid sample comprises determining to identify whether the tissue site comprises healthy tissue or cancerous tissue, page 2, CONCLUSIONS, page 7, DISTINGUISHING OVARIA CANCER…., page 3, paragraph starting with Biocompatibility and the nondestructive nature…Nevertheless, testing of statistical classifiers using different samples …. validates its performance, page 5-6, STATISTICAL PREDICTION OF OVARIAN CANCER…
The SANS reference discloses the claimed invention, but is silent in regards to but is silent in regards to the characterizing step is to identify whether the tissue site comprises endometriosis tissue.
Rather SANS analyzes tissue to determine if the tissue site is present for ovarian cancer, page 2.
Since it is known in the art the comprises endometriosis tissue can be found in the ovaries, it would be obvious to one having ordinary skill in the art before the effective filing date to modify SANS to identify whether the tissue site comprises endometriosis tissue in ovary tissue or in the determination of ovarian cancer, because this would aid in the accurate diagnosis of endometriosis.
The VOUK reference discloses a method, abstract, method of diagnosing endometriosis, comprising: processing mass spectrometry data generated by a mass spectrometer processing a sample collected from a tissue site in vivo during a medical procedure, [0027, 0064, 0066, 0087]; and analyzing the mass spectrometry data to identify whether the tissue site comprises endometriosis tissue, [0011, 0032, 0039, 0040].
Since VOUK teaches it is well known in the art to use biomarkers and ratios of certain biomarker to determine endometriosis from mass spectrometry data, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the analyzing step of SANS reference to determine whether the tissue site comprises endometriosis tissue as taught by VOUK to accurately determine endometriosis which has over 100 biomarkers and as a matter of experimental design choice and modify the profiles observed to be those of 281.2, 701.5, 750.5, 788.5, 861.5, and 885.5 to increase the accuracy, sensitivity and specificity of diagnosis and analysis of the method.
Additional Disclosures Included by the combination are: Claim 68: wherein the method of claim 67, wherein the tissue site is identified as endometriosis tissue versus soft tissue, endometriosis tissue verses fallopian tube mucosa, or endometriosis tissue verses ovary tissue, SANS, page 2, METHODS, page 3, We tested the MasSpec Pen for molecular evaluation and diagnosis of 253 human tissue samples (normal and cancer ovarian, lung, thyroid, and breast), page 4, HUMAN TISSUE SAMPLES, VOUK, Claim 8, [0087].; Claim 70: wherein the method of claim 67, wherein the solvent is supplied to the tissue site in vivo during a laparoscopic procedure, and the fixed or discrete volume of solvent is applied through a cannula of a surgical instrument, wherein the surgical instrument comprises at least one of a laparoscope, a trocar needle, or a biopsy guide, SANS, page 3, in vivo nondestructive molecular analysis, page 4, HUMAN TISSUE SAMPLE, fresh specimens obtained during endometriosis surgery, VOUK [0030].; Claim 79: wherein the method of claim 67 , wherein the tissue site is on a fallopian tube, or ovary, SANS, page 2, METHODS, PAGE 3, We tested the MasSpec Pen for molecular evaluation and diagnosis of 253 human tissue samples (normal and cancer ovarian, lung, thyroid, and breast), page 4, HUMAN TISSUE SAMPLES, VOUK, Claim 8, [0087].; Claim 80: wherein the method of claim 67, wherein endometriosis tissue is endometriosis on a cul-de-sac or ovarian endometriosis, SANS, page 6-7, STATISTICAL PREDICTION OF OVARIAN CANCER… AND DISTINGUISHING OVARIAN CANCER…, VOUK [0011, 0031-0036, 0039-0041].; Claim 81: wherein the method of claim 67 , wherein the fixed or discrete volume of solvent is not applied as a spray, page 4, HUMAN TISSUE SAMPLE, fresh specimens obtained during endometriosis surgery, VOUK [0030, 0128].; Claim 88: wherein the method of claim 67, further comprising resecting the tissue site based on a determination that the tissue site comprises endometriosis tissue, SANS, page 2, patients likely under complete resection….; Claim 89: wherein the method of claim 67, wherein the fixed or discrete volume of solvent is applied to the tissue site as a single droplet of the solvent to the tissue site, DATA SUPPLEMENT, MasSpec Pen Analysis, 10 µL water droplet.; Claim 97: wherein the method of claim 67, wherein the method comprises measuring the amount of lactate, gluconate, arachidonic acid, ascorbate, oleic acid, aspartate, glutathione, glycerophosphoethanolamine, glycerophosphoinisitol, triacylglycerol, or glycerophosphoserine, in the liquid sample, [0064, 0164].; Claim 98: wherein the method of claim 67, wherein the method comprises identifying a higher relative abundance of a fatty acid (FA) 18:1 (m/z = 281.2), phosphatidic acid (PA) 36:1 (m/z = 701.5), glycerophosphoethanolamine (PE) 0-38:4 (m/z = 750.5), glycerophosphoserine (PS) 36:1 (m/z = 788.5), glycophosphoinositols (PI) 36:2 (m/z = 861.5), and PI 38:4 (m/z = 885.5), [0064, 0164]; and Claim 99: wherein the method further comprises assessing the tissue site by histological analysis, [0131].
Claims 67, 68, 70, 79-81, 88-89 and 96-99 are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG, Nondestructive tissue analysis for ex vivo and in vivo cancer diagnosis using a handheld mass spectrometry system, Sci. Transl. Med. 9, eaan3968 (2017), submitted on the Information Disclosure Statement on 19 AUGUST 2022; Non-Patent Literature Documents Cite NO. A70, and further in view of VOUK, US Publication No. 2015/0185238 A1, submitted on the Information Disclosure Statement on 19 AUGUST 2022; US Patent Application Publications, Cite No. A41.
Examiner’s Note: Parts of the pdf of ZHANG reference submitted appear blurry to the Examiner. The Examiner has obtain a copy from Google Scholar and the rejection below has been based off the copy obtained from Google Scholar. This reference has also been cited on the PTO-892 and has been attached with this Office Action.
Regarding Claim 67, the reference ZHANG discloses a method, abstract, Introduction, pages 1-2 of 11, comprising:
applying a fixed or discrete volume of solvent to a tissue site via the first channel of the sampling probe to an internal reservoir of the sampling probe, Figure 1, where t= 0 s, page 2 of 11, Optimization of the MasSpec Pen design…;
holding the fixed or discrete volume of the solvent in the internal reservoir in direct contact with the tissue site for a period of time to form the liquid sample in the sampling probe, page 2 of 11, Optimization of the MasSpec Pen design…, a single water droplet is retained and exposed to the tissue sample for a controlled amount of time (3s), allowing efficient analyte extraction; and
supplying gas to the internal reservoir of the sampling probe via a third channel of the sampling probe, page 2 of 11, Optimization of the MasSpec Pen design…, positive pressure from a low-pressure gas delivery (<10 psi) is provided through conduit 2 (Fig. 1C), where t = 3 s,
transferring the liquid sample from the sampling probe via the second channel of the sampling probe comprises extracting the sample from the internal reservoir via the second channel, page 2 of 11, Optimization of the MasSpec Pen design…, Concomitantly, conduit 3 is opened, allowing vacuum extraction of the droplet to the mass spectrometer, Figure 1C, where t = 3 s; by operation of the mass spectrometer, processing the sample to produce mass spectrometry data, page 2 of 11, Optimization of the MasSpec Pen design… transport from the tissue to the mass spectrometer, Figure 1A.; and
analyzing the mass spectrometry data to identify whether the tissue site comprises cancer tissue, page 2-4 of 11 , Molecular analysis of thin tissue… and Nondestructive molecular analysis….and Molecular diagnosis and statistical prediction.
The ZHANG reference discloses the claimed invention, but is silent in regards to but is silent in regards to the analyzing step is to identify whether the tissue site comprises endometriosis tissue.
Rather ZHANG analyzes tissue to determine if the tissue site is present for cancer in mouse brain, human breast, thyroid, lung and ovary tissue, page 2 of 11, Nondestructive molecular analysis of tissue sample.
Since it is known in the art the comprises endometriosis tissue can be found in the ovaries, it would be obvious to one having ordinary skill in the art before the effective filing date to modify ZHANG to identify whether the tissue site comprises endometriosis tissue in ovary tissue, because this would aid in the accurate diagnosis of endometriosis.
The VOUK reference discloses a method, abstract, method of diagnosing endometriosis, comprising: processing mass spectrometry data generated by a mass spectrometer processing a sample collected from a tissue site in vivo during a medical procedure, [0027, 0064, 0066, 0087]; and analyzing the mass spectrometry data to identify whether the tissue site comprises endometriosis tissue, [0011, 0032, 0039, 0040].
Since VOUK teaches it is well known in the art to use biomarkers and ratios of certain biomarker to determine endometriosis from mass spectrometry data, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the analyzing step of SANS reference to determine whether the tissue site comprises endometriosis tissue as taught by VOUK to accurately determine endometriosis which has over 100 biomarkers and as a matter of experimental design choice, and modify the profiles observed to be those of 281.2, 701.5, 750.5, 788.5, 861.5, and 885.5 to increase the accuracy, sensitivity and specificity of diagnosis and analysis of the method.
Additional Disclosures Included are: Claim 68: wherein the method of claim 67, wherein the tissue site is identified as endometriosis tissue versus soft tissue, endometriosis tissue verses fallopian tube mucosa, or endometriosis tissue verses ovary tissue, page 2 of 11, Nondestructive molecular analysis of tissue sample.; Claim 70: wherein the method of claim 67, wherein the solvent is supplied to the tissue site in vivo during a laparoscopic procedure, and the fixed or discrete volume of solvent is applied through a cannula of a surgical instrument, wherein the surgical instrument comprises at least one of a laparoscope, a trocar needle, or a biopsy guide, page 8 of 11, laparoscopic system for minimally invasive procedures, MasSpec Pen could be suitable for biopsies.; Claim 79: wherein the method of claim 67, wherein the tissue site is one a fallopian tube, or ovary tissue, page 2 of 11, Nondestructive molecular analysis of tissue sample.; Claim 80: wherein the method of claim 67, wherein endometriosis tissue is endometriosis on cul-de-sac or ovarian endometriosis, page 3-4 of 11, normal tissue was compared to cancer tissue, Figure 2, Table 1. The ZHANG reference discloses the claimed invention, but is silent in regards to but is silent in regards to the analyzing step is to identify whether the tissue site comprises endometriosis tissue. Rather ZHANG analyzes tissue to determine if the tissue site is present for cancer in mouse brain, human breast, thyroid, lung and ovary tissue, page 2 of 11, Nondestructive molecular analysis of tissue sample. Since it is known in the art the comprises endometriosis tissue can be found in the ovaries, it would be obvious to one having ordinary skill in the art before the effective filing date to modify ZHANG to identify whether the tissue site comprises endometriosis tissue in ovary tissue, because this would aid in the accurate diagnosis of endometriosis.; Claim 81: wherein the method of claim 67, wherein the fixed or discrete volume of solvent is not applied as spray, page 2 of 11, Nondestructive molecular analysis of tissue sample.; Claim 88: wherein the method of claim 67, further comprising resecting the tissue site based on a determination that the tissue site comprises endometriosis tissue, page 6 of 11, In vivo analysis of a murine model…, page 10 of 11, In vivo mouse experiments.; Claim 89: wherein the method of claim 67, wherein the fixed or discrete volume of solvent to the tissue site, page 2 of 11, Optimization of the MasSpec Pen design…a single water droplet to the probe tip.; Claim 96: wherein the method of claim 67, wherein the liquid sample is collected in a substantially CO2 atmosphere, ZHANG probe conduit 2 has carbon dioxide and so when liquid sample is collected in conduit 3, it has carbon dioxide.; Claim 97: wherein the method of claim 67, wherein the method comprises measuring the amount of lactate, gluconate, arachidonic acid, ascorbate, oleic acid, aspartate, glutathione, glycerophosphoethanolamine, glycerophosphoinisitol, triacylglycerol, or glycerophosphoserine, in the liquid sample [0064, 0164].; Claim 98: wherein the method of claim 67, wherein the method comprises identifying a higher relative abundance of a fatty acid (FA) 18:1 (m/z = 281.2), phosphatidic acid (PA) 36:1 (m/z = 701.5), glycerophosphoethanolamine (PE) 0-38:4 (m/z = 750.5), glycerophosphoserine (PS) 36:1 (m/z = 788.5), glycophosphoinositols (PI) 36:2 (m/z = 861.5), and PI 38:4 (m/z = 885.5), [0064, 0164]; and Claim 99: wherein the method further comprises assessing the tissue site by histological analysis, [0131].
Conclusion
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797