Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Detailed Action Summary This is the Non-Final Office Action based on application 18/ 265547 filed 08/31/2023 , and was examined as part of the PBA program . Claims 1 - 1 6 are pendin g. 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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to FILLIN "Identify whether the claim(s) are directed to a law of nature; a natural phenomenon; or an abstract idea." \* MERGEFORMAT an abstract idea and law of nature (natural correlation) and abstract idea without significantly more. Step 1: Independent Claims 1-13 are directed towards methods. Claims 14-16 are directed to a kit, which as claimed seems to be a product (a composition and device). Step 2A, Prong One: Claims 1 recite s natural correlations. These claims follow a classic diagnostic analysis , measuring and amount of the claimed laminin biomarker in a specimen and providing information on breast cancer diagnosis associated with it. These claims are similar to those in Mayo Collaborative Services v. Prometheus Labs. Inc & also Example 29 of the USPTO subject matter eligibility examples. The e xaminer notes that as claimed, the claims are drawn towards more of a discovery of the natural correlation than a patent eligible invention. Examiner also notes that this discovery is not used in a practical application, such as administration of a particular treatment. Claims 1 also recites- “providing information,” which is an abstract idea/mental process. Independent Claim 14 is drawn towards a kit, but as claimed it only requires and antibody, which is a product of nature and also a judicial exception. It is not claimed in a way in which it is markedly different from what is found in nature. Claims 15-16 are analyzed below. Step 2A, Prong Two: These judicial exceptions in Claims 1 is not integrated into a practical application because upon comparison, nothing further is done that is not a judicial exception itself. For Claim 14, nothing is in the claim other than the natural compound/product of nature, so there is no practical application. Step 2B: Claims 1 does not recite anything in addition to the natural correlation so therefore does not add significantly more. Claim 14 also does not recite anything in addition to product of nature so therefore does not add significantly more. Analysis of the dependent claims. Claims 2- 13 and 15 -1 6 recite elements directed towards further limiting claim s 1 & 13 . Claims 2-4 indicate what the diagnosis/information is for and it is specifically the stage, subtype or presence or absence of breast cancer. This is still part of the judicial exception itself so does nothing to change the matters above. Claims 5-8 & 15 indicate the methods used for the claimed measuring including mass spectrometry, a specific kind of mass spectrometry ICP-MS, immunochromatography, labeling with metal particles or enzyme. However, all these methods are used just to gather data to perform the claimed judicial exceptions. Mere data gathering to perform the judicial exception is considered to be extra-solution activity which are incidental to the primary process and are mere data gathering but is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity .) Claims 9-10 & 13 recite that the amount of laminin is standardized with respect to exosomes or CD9 (other natural compounds), or that exosomes are “purified.” Therefore--- this is just claiming of another natural correlation, so does not change the matters above. Claims 11-12 recite what the biological sample is. The claimed biological compounds are still natural compounds and therefore this does not change matters above. Claims 16 recites that an immunochromatographic test strip is included in the kit. Test strips are WURC in the art however so this does not make the claim significantly more or change the natural compound to something that is markedly different. Claim Rejections - 35 USC § 10 2 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1- 6, 11 & 14 are rejected under 35 U.S.C. 10 2 (a) (1) and 102 (a) (2) as being anticipated by CARPENTER in Induction in Breast Carcinoma by Mammary Epithelial Laminin 332 (Laminin 5) . With respect to Claim 1, CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2). This reads on the instantly claimed, “method of assisting in breast cancer diagnosis ,” and “based on the amount of laminin 5,” “providing information for breast cancer diagnosis,” (Page 469, column 1, paragraph 2 , Page 471, column 1, paragraphs 2-3, also see Figure 11 ). With respect to Claim 2, CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2) and further it is used for detecting association with metastatic cancer (so shows information for presence of cancer) (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). With respect to Claim 3 , CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2) and further it is used for detecting association with metastatic cancer (so shows information for presence of cancer) (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). CARPENTER further teaches of examining sample of metaplastic carcinoma subtype of invasive breast carcinoma (Page 467, column 2, paragraph 2), so this reads on giving information for diagnosis of subtype. With respect to Claim 4 , CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2) and further it is used for detecting association with metastatic cancer (so shows information for presence of cancer) (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). Metastatic cancer is a stage of cancer. With respect to Claim 5, CARPENTER teaches of measuring the laminin 332 (laminin 5) by immunohistochemistry or mass spectrometry (Figure 4 description, Page 467, column 1, last paragraph and column 2 paragraphs 1-2 & Page 473, column 2). With respect to Claim 6, CARPENTER teaches of using chromatography for measurements (Page 465, column 1, paragraph 3). CARPTENTER further teaches of performing a Western Blot which is immunochromatography (Page 466, Figure 4 description). With respect to Claim 11, CARPENTER teaches of the specimens being breast cancer specimens (which are biological specimens) (abstract, page 473, column 2, line 2). With respect to Claim 14, CARPTENTER teaches of using an anti-laminin 332 (laminin 5) antibody (Page 466, column 1, paragraph 1 & Figures 4 & 5 descriptions). Since no other parts are claimed, this reads on the instantly claimed kit. Claim Rejections - 35 USC § 103 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 non-obviousness. 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. Claim s 7 , 9-10, 12 -13 & 15 -16 are rejected under 35 U.S.C. 103 as being obvious over CARPENTER in Induction in Breast Carcinoma by Mammary Epithelial Laminin 332 (Laminin 5) in view of LOBB in US 2020057068 . With respect to Claim 7 , CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2). This reads on the instantly claimed, “method of assisting in breast cancer diagnosis ,” and “based on the amount of laminin 5,” “providing information for breast cancer diagnosis,” (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). CARPTENTER teaches of using an anti-laminin 332 (laminin 5) antibody (Page 466, column 1, paragraph 1 & Figures 4 & 5 descriptions). CARPENTER does not teach of labeling the antibody with enzyme or metallic particles. LOBB is used to remedy this. LOBB more specifically teaches of methods for determining the aggressiveness of cancer by detecting markers in exosome samples (abstract, paragraph 0007). LOBB teaches of the detections being useful for breast cancer (paragraph 0004, 0052-0053) and of using enzymatic amplification and enzymatic substrates so things are labeled with enzymes (paragraph 0086, 0219-0221). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of labeling with enzyme as is done in LOBB in the method of CARPENTER due to the advantage enzymes offer for allowing for specificity of the desired compounds (LOBB, paragraph 0221). With respect to Claim 9, CARPENTER teaches of the above, but does not teach of standardization with respect to exosomes or amounts of exosomes . LOBB is used to remedy this and teaches of standardization with respect to exosomes (paragraph 0154) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of standardizing with respect to exosomes as is done in LOBB in the method of CARPENTER due to the advantage exosomes offer for allowing indication of cancer progression and aggressiveness (LOBB, para graph 0044 ). With respect to Claim 10, CARPENTER teaches of the above, but does not teach of standardization with respect t o CD9 . LOBB is used to remedy this and teaches of standardization with respect to CD9, and specifically that CD9 is used as a control (paragraph 0 037 ). Further LOBB teaches that the exosomes are characterized by the presence of markers including CD9 (paragraph 0073, 0075, 0213). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of standardizing with respect to exosomes (including their presence of CD9) as is done in LOBB in the method of CARPENTER due to the advantage exosomes offer for allowing indication of cancer progression and aggressiveness (LOBB, paragraph 0044). With respect to Claim 12, CARPENTER teaches of the above, but does not teach that the sample collected is blood . LOBB is used to remedy this and teaches of detection of exosomes in blood (paragraph 0 0 74 ). Further LOBB teaches that the exosomes are characterized by the presence of markers including CD9 (paragraph 0073, 0075, 0213). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of detecting exosomes in blood as is done in LOBB in the method of CARPENTER due to the advantag e blood detection offers for non-invasive detection of cancer (LOBB, paragraph 0 144 ). With respect to Claim 13, CARPENTER teaches of the above, but does not teach of detection in a purified exosom e sample . LOBB is used to remedy this and teaches of purification and detection of exosomes (paragraph 0 074 ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success to detect purified exosomes as is done in LOBB in the method of CARPENTER due to the advantage purification offers for facilitating removal of contaminants (LOBB, paragraph 00 7 4). With respect to Claim 15, CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2). This reads on the instantly claimed, “method of assisting in breast cancer diagnosis ,” and “based on the amount of laminin 5,” “providing information for breast cancer diagnosis,” (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). CARPTENTER teaches of using an anti-laminin 332 (laminin 5) antibody (Page 466, column 1, paragraph 1 & Figures 4 & 5 descriptions). Since no other parts are claimed, this reads on the instantly claimed kit. CARPENTER does not teach of labeling the antibody with enzyme or metallic particles. LOBB is used to remedy this. LOBB more specifically teaches of methods for determining the aggressiveness of cancer by detecting markers in exosome samples (abstract, paragraph 0007). LOBB teaches of the detections being useful for breast cancer (paragraph 0004, 0052-0053) and of using enzymatic amplification and enzymatic substrates so things are labeled with enzymes (paragraph 0086, 0219-0221). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of labeling with enzyme as is done in LOBB in the method of CARPENTER due to the advantage enzymes offer for allowing for specificity of the desired compounds (LOBB, paragraph 0221). With respect to Claim 16, CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2). This reads on the instantly claimed, “method of assisting in breast cancer diagnosis ,” and “based on the amount of laminin 5,” “providing information for breast cancer diagnosis,” (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). CARPTENTER teaches of using an anti-laminin 332 (laminin 5) antibody (Page 466, column 1, paragraph 1 & Figures 4 & 5 descriptions). Since no other parts are claimed, this reads on the instantly claimed kit. CARPENTER further teaches of using wells (which can be interpreted as a strip through BRI) (Figure 2 description). If it is unclear that CARPENTER teaches of strips, LOBB is used to remedy this . LOBB more specifically teaches of methods for determining the aggressiveness of cancer by detecting markers in exosome samples (abstract, paragraph 0007). LOBB teaches of the detections being useful for breast cancer (paragraph 0004, 0052-0053) and of using enzymatic amplification and enzymatic substrates (paragraph 0086, 0219-0221). LOBB further teaches of using Western blotting and ELISA which are performed on test strips of wells (paragraph 0031, 0035, 0037, 0091, 0136, 0157-0159). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of using strips as is done in LOBB in the method of CARPENTER due to the advantage that ELISA well strips/kits offer for eases of use as you follow manufacturers instructions (LOBB, paragraph 0159 ). Claim 8 is rejected under 35 U.S.C. 103 as being obvious over CARPENTER in Induction in Breast Carcinoma by Mammary Epithelial Laminin 332 (Laminin 5) in view of LOBB in US 202005 5 7068 and further in view of ALEXANDER in US 20200049599 . With respect to Claim 8, CARPENTER teaches of a method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract). CARPENTER teaches of doing this for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2). This reads on the instantly claimed, “method of assisting in breast cancer diagnosis ,” and “based on the amount of laminin 5,” “providing information for breast cancer diagnosis,” (Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11). CARPTENTER teaches of using an anti-laminin 332 (laminin 5) antibody (Page 466, column 1, paragraph 1 & Figures 4 & 5 descriptions). CARPENTER does not teach of labeling the antibody with enzyme or metallic particles. LOBB is used to remedy this. LOBB more specifically teaches of methods for determining the aggressiveness of cancer by detecting markers in exosome samples (abstract, paragraph 0007). LOBB teaches of the detections being useful for breast cancer (paragraph 0004, 0052-0053) and of using enzymatic amplification and enzymatic substrates so things are labeled with enzymes (paragraph 0086, 0219-0221). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of labeling with enzyme as is done in LOBB in the method of CARPENTER due to the advantage enzymes offer for allowing for specificity of the desired compounds (LOBB, paragraph 0221). CARPENTER and LOBB do not teach of using inductively coupled plasmas mass spectrometry to detect metallic particles. ALEXANDER is used to remedy this. ALEXANDER further teaches of methods of measuring samples (abstract) for cancers such as breast cancers (paragraph 0040, 0053) and further that the biological sample which can be exosomes (paragraph 0076) is analyzed is conjugated to a metallic nanoparticle (paragraph 0058), which can then be detected by inductively coupled plasma mass spectrometry (paragraph 0686 ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of using inductively coupled plasma mass spectrometry as is done in ALEXANDER in the method of CARPENTER and LOBB due to the advantage it has for multiplexing analyses for complex molecules ( ALEXANDER, paragraph 0 686 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT REBECCA M FRITCHMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (303)297-4344 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT 9:30-4:30 MT Monday-Friday . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Maris Kessel can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7698 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /REBECCA M FRITCHMAN/ Primary Examiner, Art Unit 1758