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 Final Office Action based on application 18/265547 response filed 04/21/2026.
Claims 1, 5-8, 11-16 are pending.
Claims 2-4 & 9-10 are cancelled.
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 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is drawn to a product of nature without being markedly different or signfiicnatly more.
Step 1: Claims 14-16 are directed to a kit, which as claimed seems to be a product (a composition and device).
Step 2A, Prong One: Independent Claim 14 is drawn towards a kit, but as claimed it only requires two antibodies and that the antibodies are labeled with “a substance suitable for detection.” Antibodies are 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. As broadly claimed, “substance suitable for detection,” could be almost anything and therefore does not make the claim markedly different from what is found in nature.
Step 2A, Prong Two:
For Claim 14, nothing is in the claim other than the natural compound/product of nature, and the “substance suitable for detection,” so there is no practical application.
Step 2B: Claims 14 does not recite anything in addition to the product of nature that is significantly more, since “substance suitable for detection,” could be almost anything, so therefore does not add significantly more.
Analysis of the dependent claims.
Claims15-16 recite elements directed towards further limiting claim 14.
Claim15 indicates the antibodies are labeled with metal particles or enzymes. Enzymes are natural compounds that naturally bind to antibodies. Therefore there is nothing that makes the compound markedly different from what is found in nature, nor is there anything adding here which practically applies. Using metal particles also does nothing to practically apply. Further both the enzyme and metal particles are well understood routine and conventional in the art for labeling and therefore do not add significantly more to the judicial exception.
Claims 16 recites that an immunochromatographic test strip is included in the kit. This is not used in a method for the claimed kit, so there is not practical application. Also- the strip does not make the claimed compounds markedly different from what is found in nature. Further, 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 § 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.
Claims 1, 5-7, 11-16 are rejected under 35 U.S.C. 103 as being obvious by LOBB in US 20200057068 in view of CARPENTER in Induction in Breast Carcinoma by Mammary Epithelial Laminin 332 (Laminin 5)( as cited in last action).
With respect to Claim 1, LOBB teaches of a method of detecting and determining cancer based on measuring (abstract, paragraph 0082, 0084-0085, 0091-0092).
LOBB teaches that one step include measuring upregulated proteins which include Laminin subunit alpha 5, which reads on the claimed laminin 5, through broadest reasonable interpretation (Table 1, paragraph 0031-0033 and Figures 2-6).
LOBB further teaches of another measurement step including measuring exosomes and characterizing them/normalizing them by the presence of marker proteins including CD9 (paragraph 0073, 0075).
Specifically, LOBB teaches of measuring and isolating exosomes using any means known in the art, such as, but not limited to, ultracentrifugation, size-exclusion chromatography, exosome precipitation (e.g., ExoQuick from System Biosciences), affinity-based capture of exosomes (e.g., affinity purification with antibodies to CD63, CD81, CD82, CD9 Alix, annexin, EpCAM, and Rab5) and any combination thereof (paragraph 0075).
LOBB also specifically teaches of normalizing all of the protein bands to a loading control (paragraph 0217) and that the loading control is CD9 (0037).
Therefore, LOBB teaches of detection of laminin 5, normalizing proteins with respect to a loading control, which can be CD9, and detecting exosomes by detection CD9. Therefore all together--- this teaches of all the claimed relationships and implicitly teaches of the proteins including laminin, being standardized or normalized with respect to exosomes. This is largely the case due to broadest reasonable interpretation and since nothing more specific is claimed with respect to how exactly any of the claimed measurements occur, nor is anything claimed with respect how the claimed normalization or standardization occurs.
Though LOBB teaches of measurement of Laminin subunit alpha 5, which reads on the claimed laminin 5, through broadest reasonable interpretation (Table 1, paragraph 0031-0033 and Figures 2-6), if this is not what is meant by the claimed Laminin 5, CARPENTER is used to remedy this.
CARPENTER teaches of method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract, Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11).
It would have been obvious to one of ordinary skill in the art to detection laminin 332 (laminin 5) as is done in CARPENTER in the method of LOBB due to the advantage it has for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2).
With respect to Claim 5, LOBB teaches of measurement of the proetins including laminin by mass spectrometry (paragraph 0031). CARPENTER also 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, LOBB teaches of using immunochemistry methods for analysis including ELISA (paragraph 0091). CARPENTER also 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 7, LOBB teaches of using antibodies for the detection of the proteins including laminin taught above (paragraph 0091). 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(paragraph 0221, 0219, 0086). CARPENTER also 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. See claim 1 for reason for combination.
With respect to Claim 11, LOBB teaches of detection of exosomes and the proteins in blood (paragraph 0074). Further LOBB teaches that the exosomes are characterized by the presence of markers including CD9 (paragraph 0073, 0075, 0213).
With respect to Claim 12, LOBB teaches of detection of exosomes and the proteins in blood (paragraph 0074). Further LOBB teaches that the exosomes are characterized by the presence of markers including CD9 (paragraph 0073, 0075, 0213).
With respect to Claim 13, LOBB teaches of purification and detection of exosomes (paragraph 0074).
With respect to Claim 14, LOBB teaches of the invention as shown above for Claim 1 and further teaches of an ELISA kit (paragraph 0159), which would include the detection antibodies for detection of the compounds shown in claim a rejection (paragraph 0075, 0091) and further teach that the antibodies may be fluorescently labeled (paragraph 0091). In case it is not clear that LOBB teaches of the claimed specific laminin antibody, CARPENTER is sued to remedy this and more specifically, 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. It would have been obvious to one of ordinary skill in the art to detection laminin 332 (laminin 5) as is done in CARPENTER in the method of LOBB due to the advantage it has for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2).
With respect to Claim 15, LOBB teaches of using antibodies for the detection of the proteins including laminin taught above (paragraph 0091). 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. CARPENTER also 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. See claim 1 for reason for combination.
With respect to Claim 16, LOBB teaches of using immunochemistry methods for analysis including ELISA (paragraph 0091). CARPENTER aslo 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).
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over LOBB in US 20200057068 in view of CARPENTER in Induction in Breast Carcinoma by Mammary Epithelial Laminin 332 (Laminin 5)( as cited in last action)and further in view of ALEXANDER in US 20200049599.
With respect to Claim 8, LOBB teaches of a method of detecting and determining cancer based on measuring (abstract, paragraph 0082, 0084-0085, 0091-0092).
LOBB teaches that one step include measuring upregulated proteins which include Laminin subunit alpha 5, which reads on the claimed laminin 5, through broadest reasonable interpretation (Table 1, paragraph 0031-0033 and Figures 2-6).
LOBB further teaches of another measurement step including measuring exosomes and characterizing them/normalizing them by the presence of marker proteins including CD9 (paragraph 0073).
Specifically, LOBB teaches of measuring and isolating exosomes using any means known in the art, such as, but not limited to, ultracentrifugation, size-exclusion chromatography, exosome precipitation (e.g., ExoQuick from System Biosciences), affinity-based capture of exosomes (e.g., affinity purification with antibodies to CD63, CD81, CD82, CD9 Alix, annexin, EpCAM, and Rab5) and any combination thereof (paragraph 0075).
LOBB also specifically teaches of normalizing all of the protein bands to a loading control (paragraph 0217) and that the loading control is CD9 (0037).
Therefore, LOBB teaches of detection of laminin 5, normalizing proteins with respect to a loading control, which can be CD9, and detecting exosomes by detection CD9. Therefore all together--- this teaches of all the claimed relationships and implicitly teaches of the proteins including laminin, being standardized or normalized with respect to exosomes. This is largely the case due to broadest reasonable interpretation and since nothing more specific is claimed with respect to how exactly any of the claimed measurements occur, nor is anything claimed with respect how the claimed normalization or standardization occurs.
Though LOBB teaches of measurement of Laminin subunit alpha 5, which reads on the claimed laminin 5, through broadest reasonable interpretation (Table 1, paragraph 0031-0033 and Figures 2-6), if this is not what is meant by the claimed Laminin 5, CARPENTER is used to remedy this.
CARPENTER teaches of method which detects that tumor motility in breast cancer specimen is caused by laminin 332 (laminin 5) in breast cancer (abstract, Page 469, column 1, paragraph 2, Page 471, column 1, paragraphs 2-3, also see Figure 11).
It would have been obvious to one of ordinary skill in the art to detection laminin 332 (laminin 5) as is done in CARPENTER in the method of LOBB due to the advantage it has for diagnostic purposes to assist in detecting tumor motility in a specimen (Page 473, column 2, lines 1-3 & paragraph 2).
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 0686).
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive.
The examiner notes that further search and consideration was performed post interview dated 03/16/2026. Though what is found in this office action does maintain some of the thoughts by the examiner during that interview (for example the 101 rejection Claim 1 and those dependent therefrom was dropped) , after further search and consideration the same prior art is used though in a different order, and the 101 rejection for Claim 14 is maintained. The examiner notes that they are not given time to fully consider these matters pre and during interviews--- though it is still the examiners thought that interviews can often help expedite prosecution and is happy to hold another interview if applicant decides to file further if they think this might help.
The prior 101 rejection was overcome for Claim 1 and those dependent therefrom due to amendments dated 04/21/2026 which make the claims now a detection method versus a diagnostic method encompassing a judicial exception. The 101 rejection for Claim 14 and those dependent from is maintained.
All claims also remain rejected under 103. The same references used in the prior office action are still used, however their order is reversed due to amendments made 04/21/2026 which significantly change the scope of the claims. As the reliance of these references is drastically different from how used before, the examiner has not responded to applicants comments on the references and they should see the rejection made above.
The same applies to the 101 rejection for Claims 14-16. Since the claims were drastically amended, the rejection is very different, so the applicant should see the examiners comments in the rejection above.
With respect to the instant claims--- the examiner notes that the instant claims are very very general and broad in scope with respect to the claimed “measurement step/s,” normalization, standardizing steps and determining amount steps, and also for the claimed kit. For example, as claimed, it is claimed “determining an amount of exosomes,” which can just read broadly of determining any level of exosome in a sample through any mechanism, which the instant prior art reads on. If applicant can add more specifics to the claims with respect to measuring or processing steps or kit components which are not taught by the instantly used prior art, then they might have an easier time overcoming the prior art.
All claims remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 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, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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