DETAILED ACTION
The examiner of your application in the USPTO has changed. Michael Sveiven, Art Unit 1678, is now the examiner of record. The examiner’s contact information is set forth at the end of this office 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/23/2025 has been entered.
Priority
The instant application filed 10/15/2020, is a CIP of application 16/151,284 filed 10/03/2018 which is a CIP of 15/833,702 filed on 12/06/2017. As the instant application is a CIP containing matter not supported by the disclosure of the parent application, the instant examined claims are given priority to the filing date of 10/15/2020. Specifically, the parent applications’ disclosures do not support the affinity chromatography competition assay test of claim 1 from the instant application. Neither of the parent applications (15/833,702 and 16/151,284) disclose the affinity chromatography competition assay test of claim 1, therefore, the instant claims are given the priority filing date of 10/15/2020, the date the instant specification was filed.
Withdrawn Rejections/Objections
The rejection of claims 1-2 on the grounds of 35 U.S.C. 101 has been withdrawn, necessitated by amendments filed 06/23/2025. Claims 1-2 are not directed to a judicial exception without significantly more or without a practical application.
The rejection of claims 1-2 on the grounds of 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) has been withdrawn, due to absence of disclosure regarding the affinity chromatography competition assay test of claim 1 in the Maslar reference of record.
Status of Claims
Claims 1-2 are pending and examined herein.
Claim Objections
The claim objections have been modified, necessitated by amendments filed 06/23/2025.
Claim 1 is objected to because of the following informalities:
Claim 1 recites “by comparing [[a]] the first color intensity of the test visual indicator to [[a]] the second color intensity of the control visual indicator”. Due to the double-brackets used in the claims filed 2024-04-05, the claim should recite “by comparing the first color intensity of the test visual indicator to the second color intensity of the control visual indicator”.
Claim 1 recites “a competitive lateral flow assay test is contained within a test body”. The claim should recite “a competitive lateral flow assay test contained within a test body”.
Claim 1 recites “delivering the accepted saliva sample to both the testosterone reactive conjugate and a test visual indicator”. The claim should recite “delivering the accepted saliva sample to both the testosterone reactive conjugate and a test visual indicator”.
Claim 1 recites “a relative concentration of testosterone in the saliva sample is determined by comparing the first color intensity of the test visual indicator to the second color intensity of the control visual indicator without respect to the background of the test body deriving a testosterone quantity in the saliva sample by comparing the first color intensity of testosterone to the antibody or antigen with the second color intensity of testosterone bound to the antibody or antigen”. The passage is repetitive and lacking appropriate punctuation.
Claim 1 recites “proves visually” in line 16. However, the claim should recite “visually indicates”, as seen in line 22, as that language is clearer and more conventional.
Claim 2 recites “further characterized in that” in line 2. However, the claim should recite “further comprising” as that language is clearer and more conventional.
Appropriate correction is required.
Claim Interpretation
Claims 1 and 2 recite a test in the preamble of the claim, however the claims to not specify whether the test is a method or a product. The body of the claim recites the test is comprised of a lateral flow device integrated into a test body and further recites intermingling product features comprising steps that are interpreted as functional limitations of the test body as well as reciting new steps. See the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, below. For the purposes of applying prior art, the claims remain interpreted as being drawn to a test device.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The rejections of claims 1-2 on the grounds of 35 U.S.C. 112(b) have been modified, necessitated by amendments filed 06/23/2025.
Claim 1 recites both an apparatus and method steps i.e., “delivering the accepted saliva sample to both the the [sic] testosterone reactive conjugate and a test visual indicator”, “a relative concentration of testosterone in the saliva sample is determined by comparing the first color intensity of the test visual indicator to the second color intensity of the control visual indicator”, and “deriving a testosterone quantity in the saliva sample by comparing the first color intensity of testosterone to the antibody or antigen with the second color intensity of testosterone bound to the antibody or antigen”. A single claim which claims both an apparatus and method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. MPEP 2173.05(p)II.
Claim 1 recites the limitation “delivering the accepted saliva sample” in the body of the claim. There is insufficient antecedent basis for this limitation in the claim. “A saliva sample” has not been established in the preceding claim. Therefore, the metes and bounds of the claim cannot be ascertained.
Claim 1 recites “the first color intensity” in the body of the claim. There is insufficient antecedent basis for this limitation in the claim. “a first color intensity” has not been established in the preceding claim. Therefore, the metes and bounds of the claim cannot be ascertained.
Claim 1 recites “An affinity chromatography competition assay test” in the preamble. However, the claim continues by reciting, “delivering the accepted saliva sample to both the the [sic] testosterone reactive conjugate and a test visual indicator without chromatographic separation of the saliva being required” (see lines 7-10). The metes and bounds of the claim are indefinite because the claim is directed at an affinity chromatography competition assay test, but the claim’s only disclosure of chromatography is a negative limitation that attempts to disclaim chromatographic separation. Further, affinity chromatography does not encompass lateral flow assays in the art and the specification has not defined lateral flow assays as encompassed by affinity chromatography. Therefore, the metes and bounds of the claim cannot be ascertained.
Claim 2 depends on claim 1, therefore, it is also indefinite.
However, for the purpose of compact prosecution, the phrase “delivering the accepted saliva sample” will be interpreted as “delivering an accepted saliva sample”. Also, the phrase “the first color intensity” will be interpreted as “a first color intensity”.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, et al. ("Preparation of a monoclonal antibody against testosterone and its use in development of an immunochromatographic assay", published 2016-01-29) in view of Trieu (US 20140349862 A1, published 2014-11-27) and Clifton, et al. (“Salivary Testosterone Levels and Health Status in Men and Women in the British General Population: Findings from the Third National Survey of Sexual Attitudes and Lifestyles (Natsal-3)”, published 2016-08-23).
Wang teaches a competitive lateral flow assay for testosterone comprising: a testosterone reactive conjugate adhered to a test area; a control visual indicator that proves visually that the testosterone reactive conjugate is reacting effectively with the testosterone in the sample; a test visual indicator that when reacted with the sample visually indicates the concentration of testosterone by changing color; a control visual indicator that when reacted with the sample proves visually that the testosterone reactive conjugate is reacting effectively with the testosterone in the sample, as in claim 1 (see, e.g., a competitive lateral flow assay for testosterone comprising: a testosterone reactive conjugate adhered to a test area - p. 550, under “Scheme 1.”, and p. 551, under “2.6. Immunochromatography for the detection of testosterone”: “On the NC [(nitrocellulose)] membrane, the immobilized antigen and the free antigen compete with the GNP-antibody”; testosterone analyte – p.550, under “2.5. Preparation of the immunochromatographic assay”: “The nitrocellulose (NC) membrane was loaded with [methyltestosterone-3-CMO-OVA (MT-3-CMO-OVA)] or [Testosterone-3-CMO (T-3-CMO)] as the test line and goat anti-mouse IgG as the control line”; a test visual indicator and a control visual indicator that when reacted with the sample visually indicates the concentration of testosterone by changing color - p. 555, under “Figure 5.”). It is understood that the control visual indicator is the “C line” and the test visual indicator is the “T line”, as seen in “Scheme 1.” of Wang.
Wang teaches the competition assay for testosterone is paired with an electronic sensor for determining the intensity of the test visual indicator, as in claim 2 (see, e.g., p. 551, under “2.6. Immunochromatography for the detection of testosterone”: “For quantitative measurement, the intensity of each strip was recorded using a strip reader and the LOD was judged”).
Wang fails to teach the concentration of testosterone in the sample is determined by comparing the color intensity of the test visual indicator to the color intensity of the control visual indicator, as in claims 1-2.
However, in a patent application publication on methods and kits of employing point-of-care pharmacokinetic profiling, Trieu rectifies this deficiency. Trieu teaches using an electronic sensor to quantitate the analyte concentration by comparing the test line versus the control line, as in claims 1-2 (see, e.g., para. [0081]).
Wang and Trieu teach as set forth above, but fail to teach the sample is a saliva sample, as in claims 1-2.
However, in a journal article on salivary testosterone measurements, Clifton rectifies this deficiency. Clifton teaches using saliva to measure testosterone, as in claims 1-2 (see, e.g., p. 3940, col. 1, para. 2: “Salivary testosterone (Sal-T) is believed to represent tissue hormone levels, which are unaffected by variations in circulating binding proteins (15), thereby providing an alternative to serum free testosterone (free-T) in the assessment of androgen status”).
Wang, Trieu, and Clifton are analogous to the field of the claimed invention because they are all in the field of bioassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the quantitation technique of Trieu into the testosterone assay of Wang. An artisan would have been motivated to do so because Trieu discloses, “the Intensity ratio of test over control was used to plot intensity vs. concentration showing good quantitative trend” (see para. [0081]). Furthermore, one of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the saliva samples of Clifton into the testosterone assay of Wang and Trieu. An artisan would have been motivated to do so because Clifton teaches, “In contrast to the collection of serum, which is invasive and expensive, collection of saliva is relatively straightforward and requires minimal training” (see p. 3940, col. 1, para. 2). An artisan would have a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678