R 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 .
Status of the Claims
Claims 2-5 have been cancelled by Applicant’s amendment. Claim 1 is pending and examined herein.
Priority
This application, filed on 09/21/2022, is a 371 of PCT/JP2021/012389, filed on 03/24/2021, which claims foreign benefit to application JAPAN 2020-055142, filed on 03/25/2020. This claim to foreign priority is acknowledged and the claims examined herein are treated as having an effective filing date of 03/25/2020.
Withdrawn Rejections
The rejection of claims 1-5 under 35 U.S.C. 112(a) has been withdrawn in response to applicant’s arguments.
The rejection of claims 1 and 3 under 35 U.S.C. 112(b) has been withdrawn in response to applicant’s arguments.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Amano et al., “Importance of Balance between Extracellular Matrix Synthesis and Degradation in Basement Membrane Formation” (published 12/10/2001, referred to herein as Amano) in view of Leeming et al., “Enzyme-linked immunosorbent serum assay specific for the 7S domain of Collagen Type IV (P4NP 7S): A marker related to the extracellular matrix remodeling during liver fibrosis” (IDS filed 11/14/2022, referred to herein as Lemming).
Amano’s general disclosure relates to a method of measuring type IV collagen using a sandwich ELISA immunoassay (p. 251, col. 1, para. 3, lines 1-3).
Regarding claim 1, Amano teaches a method of measuring human type IV collagen using a sandwich ELISA immunoassay (p. 251, col. 1, para. 3, lines 1-3). Amano teaches a first monoclonal antibody, JK-199, that recognizes type IV collagen (p. 251, col. 1, para. 3, lines 2-3) and is immobilized on a microtiter plate carrier (p. 251, col. 1, para. 3, lines 4-6). Amano teaches a second polyclonal antibody labelled with horseradish peroxidase that recognizes type IV collagen (p. 251, col. 1, para. 3, lines 10-13). Amano teaches a capturing step of contacting the sample with the first antibody (p. 251, col. 1, para. 3, lines 4-9) followed by a labeling step of contacting the labeled antibody with the captured collagen fragment/capture antibody complex (p. 251, col. 1, para. 3, lines 10-13). Amano teaches the use of phosphate buffered saline (PBS) as the reaction reagent for the first antibody (p. 251, col. 1, para. 3, lines 4-6) and the collagen samples (p. 251, col. 1, para. 3, lines 8-9) in blocking buffer (3% gelatin in PBS, p. 250, col. 2, para. 4, lines 7-9). While Amano teaches the use of salt in buffer, such as PBS, Amano fails to teach the claimed salt concentration. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed salt concentration was anything other than routine, that the properties of the 0.35 to 1.35 salt concentration range from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Fukunaga et al., “Improving the affinity of an antibody for its antigen via long-range electrostatic interactions” (published 11/07/2013, referred to herein as Fukunaga). Fukunaga teaches that altering the ionic strength, i.e. the salt concentration, from 0-1M NaCl in an immunoassay system can impact antibody binding and, thus, assay sensitivity (see for example Figure 7A). Therefore, an artisan would have a reasonable expectation of success in trying various salt concentrations within the claimed range to arrive at the claimed invention. In particular, an artisan would arrive at the claimed invention using the concentration range taught by Fukunaga which overlaps the claimed range due to the absence of a convincing showing of the criticality of the claimed concentrations outside of the range taught by Fukunaga.
Amano does not teach the use of a monoclonal secondary labeled antibody. Amano also does not teach the use of antibodies for the specific detection of the 7S domain of human type IV collagen.
However, Leeming’s general disclosure relates to a method of detection of the 7S domain of type IV collagen in a competitive immunoassay using monoclonal antibodies against the 7S domain of type IV collagen.
Regarding claim 1, Leeming teaches a labeled monoclonal antibody used in an ELISA immunoassay for the detection of the 7S domain of type IV collagen (NB102-1E6, p. 484, col. 1, para. 4, lines 7-10). Further, Leeming teaches the production of a “large number” of monoclonal antibodies against the 7S domain of type IV collagen (p. 486, col. 1, para. 2, lines 1-3). All of these antibodies were used in the immunodetection of the 7S domain of type IV collagen (p. 484, col. 1, para. 2, lines 1-4). Leeming teaches that the detection of 7S in serum can be used as a marker for liver fibrosis (p. 491, col. 2, para. 1, lines 3-5).
It would have been obvious to one of ordinary skill at the time of the effective filing date of the application to substitute the antibodies used in the immunoassay taught by Amaro with the monoclonal antibodies against the 7S domain of type IV collagen taught by Leeming because doing so would enable the specific detection of the 7S domain in serum. As taught in Leeming, the detection of the 7S domain of type IV collage in serum is useful because of its potential as a biomarker for liver fibrosis (p. 491, col. 2, para. 1, lines 3-5). One of ordinary skill in the art would have a reasonable expectation of success because the antibodies used in both embodiments are used in the detection of type IV collagen in immunoassays.
Response to Arguments
Applicant’s arguments, see page 3, filed 10/21/2025, with respect to the rejection of claims 1-5 under 35 U.S.C. 112(a) as failing to comply with the written description requirement have been fully considered and are persuasive. The rejection under 35 U.S.C. 112(a) of claims 1-5 has been withdrawn.
Applicant's arguments filed 10/21/2025 regarding the rejection of claims under 35 U.S.C. 103 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on page 6 para. 1-3, Applicant merely re-states the method of the claimed invention without presenting an argument.
Regarding the remarks on page 6 para. 4, Applicant argues that the claimed salt concentration results in the reduction of non-specific reactions in the specimen from a healthy person, which improves measuring accuracy. Applicant argues that this result shows that this is not merely routine optimization.
This argument is not persuasive. In response to applicant's argument that changing the salt concentration reduces non-specific reactions in samples from healthy specimens, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, as described above in the rejection under 35 U.S.C. 103, an artisan is motivated to optimize salt concentrations in immunoassays in order to maximize antibody binding and assay sensitivity.
Regarding the remarks on page 6 para. 5, Applicant argues that Amano is silent about the combination of monoclonal antibodies against the 7S domain and the claimed salt concentration range.
This argument is not persuasive. As described in the rejection under 35 U.S.C. 103 above, Amano alone is not relied upon for the obviousness of these claimed limitations.
Regarding the remarks on page 7 para. 1, Applicant argues that Leeming is silent about the use of two monoclonal antibodies specifically binding the 7S domain and the claimed salt concentration.
This argument is not persuasive. Regarding the claimed salt concentration, Leeming is not relied upon for the teaching of this limitation. In response to applicant's argument that Leeming is silent on the use of two monoclonal antibodies to bind to the 7S domain, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, the disclosure of many monoclonal antibodies that can bind to the 7S domain and the utility of detecting specifically the 7S domain together would suggest to those of ordinary skill in the art to use them as claimed.
Regarding the remarks on page 7 para. 2 about the rejection of claims 4-5 under 35 U.S.C. 103, these arguments are moot due to the cancellation of the claims by Applicant’s amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER EVANS whose telephone number is (571)272-4897. The examiner can normally be reached Mon - Fri 8:30am to 4:30pm EST.
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, Bao-Thuy Nguyen can be reached at (517) 272-0824. 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.
/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 October 28, 2025
Prosecution Insights