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 .
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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.
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (Cite No. 18 in the IDS filed 7/1/2024 by Applicant; hereinafter “Yu”) in view of Fleischman et al. (US 2019/0064165 A1; hereinafter “Fleischman”).
Regarding claim 40, Yu teaches a method of testing a sample, the method comprising a step of determining the level of the biomarker neutrophil collagenase (MMP8) in a urine sample specimens taken from a subject suffering from urinary tract infection (UTI) (Abstract; Methods section; and page 5, right column, first paragraph).
Yu does not teach the determination of the level of an additional biomarker comprising HNE.
However, Fleischman teaches that an assay for human neutrophil elastase (HNE) has also been reported to have great sensitivity for the diagnosis of urethral infections in men (paragraph 3). Consequently, as evidenced by Fleischman, the determination of HNE in the specimen samples for diagnosing UTI in patients would have been considered to be suitable and predictable to a person of ordinary skill in the art. The additional determination of the level of HNE in the samples could assist in confirming the presence of the UTI in the patient sample. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the additional step of determining the level of an additional biomarker comprising HNE. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 41, Yu teaches the method of claim 40, wherein the method further comprises determining levels of the biomarkers myeloperoxidase (MPO), gelatinase (MMP9) (page 5; left column, bottom paragraph and the left column, top paragraph).
Claim(s) 42 – 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu and Fleischman, as applied to claims 40 and 41 above, and further in view of Parekh et al. (WO 2015/128681 A1; hereinafter “Parekh”).
Regarding claim 42, modified Yu does not specifically teach the method of claim 40, comprising determining the levels of:
(i) MMP8, HNE and fibrinogen;
(ii) MMP8, HNE and Cystatin C; or
(iii) MMP8, HNE and CRP,
in a urine sample from a subject suffering from urinary tract infection.
However, Parekh teaches the detection of a plurality of markers in a urine sample in which the additional markers can include fibrinogen, Cystatin C and CRP (page 4, line 21 – page 5, line 27; page 8, lines 4 – 23; and the Table on page 41; page 49, lines 11 – 18). Consequently, as evidenced by Parekh, the determination of these additional markers in the specimen samples for diagnosing UTI in patients would have been considered to be suitable and predictable to a person of ordinary skill in the art. The additional determination of the level of each of these markers in the samples could assist in confirming the presence of the UTI in the patient sample. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the additional step of determining the level of each the recited markers including fibrinogen, Cystatin C and/or CRP for use in determining the presence of a UTI in the patient samples.Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 43, Parekh further teaches wherein at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 or 14 or more urine samples (page 46, lines 20 – 33) are taken from the subject at different times (page 46, lines 20 – 33; page 53, lines 23 – 29) and the levels of the at least two biomarkers are determined (page 4, line 21 – page 5, line 27; page 8, lines 4 – 23; and the Table on page 41; page 46, lines 20 – 33).
Regarding claim 44, Parekh further teaches wherein the samples are taken every 6 to 24 hours (page 49, lines 5 – 9), or every 3, 4, 5, 6, 7 or 14 days (page 46, lines 20 – 33; page 47, lines 32 – 35).
Regarding claim 45, Parekh teaches wherein the method further comprises a step of comparing each determined level with a threshold level (page 46, line 20 – page 47, line 30; page 49, lines 11 – 18).
Regarding claim 46, Parekh further teaches wherein the levels of at least two biomarkers are determined using a lateral flow strip or device (page 11, lines 26 and 27; page 36, line 29 – page 37, line 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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