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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the inclusion of legal phraseology such as “comprises”. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 9 and 19-20 are objected to because of the following informalities: On line 3 of claim 9, the phrase “is one or more second fluorophores and” should be deleted since claim 1 no longer recites “one or more fluorophores”. On lines 3-4 of claim 19, the phrase “UV light source capable of exciting the fluorescein” should be changed to –or a UV light source capable of exciting the fluorescein—since a UV light source is the last positively recited type of fluorescence detection recited in claim 19. Claim 20 is objected to for the same reason as claim 19 since claim 20 depends from claim 19. Appropriate correction is required.
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 2-4 are 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.
On line 2 of claim 2, the phrase “other substances” is indefinite since it is not clear what constitutes being “other substances”. It is not clear what other substances are included in the possible substances that the urine sample is screened for. Also, on line 2 of claim 2, the phrase “urine parameters” is indefinite since it is not clear what specific parameters constitute these “urine parameters”. Claims 3-4 are rejected for the same reasons due to their dependency on claim 2.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,871,492 (submitted in the IDS filed on February 6, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of labeling urine in a subject comprising the steps of orally administering an amount of fluorescein to the subject 20 minutes prior to miction (see instant claim 1, and claims and 13-141 in U.S. 10,871,492), obtaining a urine sample from the subject (see instant claim 1 and claim 1 in U.S. 10,871,492), and detecting fluorescence of the fluorescein in the urine sample (see instant claim 1, and claim 1 of U.S. 10,871,492), wherein the one or more fluorophores comprise non-toxic fluorescein sodium (see instant claims 8 and 10-11, and claims 1, 4 and 6-7 of U.S. 10,871,492). Both sets of claims also recite the same further limitations in the dependent claims such as screening the urine sample for one or more drugs, illicit substances and/or urine parameters (see instant claims 2-6 and claim 2 in U.S. 10,871,492), preliminarily inspecting the subject for one or more signs of substance abuse (see instant claim 7 and claim 3 in U.S. 10,871,492), analyzing the fluorescein which is excreted unchanged in the urine or which is metabolized into one or more second compounds and excreted in the urine (see instant claim 9 and claim 5 in U.S. 10,871,492), administering the same amounts of the one or more fluorophores to the subject (see instant claims 12-15 and claims 8-12 in U.S. 10,871,492), administering the one or more fluorophores to the subject at the same times prior to miction (see instant claims 17-18 and claims 13-14 in U.S. 10,871,492), and detecting fluorescein in the urine using an ophthalmoscope equipped with a cobalt blue or equivalent filter (see instant claims 19-20 and claim 1 in U.S. 10,871,492).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strauss, H. (abstract from Berliner Klinische Wochenschrift, vol. 50, 1914, pages 2226-2227, submitted in the IDS filed on February 6, 2025).
With regards to claim 1, Strauss (abstract) teaches of a method for testing kidney function in a subject by labeling urine in the subject. The method comprises sequentially: orally administering fluorescein sodium to a patient by having the patient consume a cup of tea or cocoa that contains fluorescein sodium, wherein the fluorescein sodium is orally administered to the patient 20 minutes prior to miction. The method then comprises collecting a urine sample from the subject at different time intervals, and detecting fluorescence of the fluorescein sodium in the urine samples. In particular, Strauss teaches of orally administering the fluorescein sodium to the subject about 20 minutes prior to miction because Strauss teaches that fluorescence from the fluorescein sodium appears in the urine of the subject about 10 to 20 minutes after orally ingesting the fluorescein sodium, and also teaches that urine from the subject is examined at intervals until the fluorescence appears (i.e. fluorescence appears at 10 and 20 minutes after the fluorescein sodium is administered to the subject). See the entire abstract to Strauss.
With regards to claims 8 and 10-11, Strauss teaches that non-toxic fluorescein sodium is administered to the subject in the method.
With regards to claim 9, since the fluorescein sodium which is administered to the subject in the method taught by Strauss is the same as the fluorescein sodium administered to the subject in the method recited in the instant claims, the fluorescein is excreted either unchanged or metabolized into one or more second compounds that is excreted in the urine sample.
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 nonobviousness.
Claim(s) 2-4, 7, 12-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (abstract from Berliner Klinische Wochenschrift, vol. 50, 1914, pages 2226-2227, submitted in the IDS filed on February 6, 2025) in view of Rosen et al (US 4,953,562, submitted in the IDS filed on February 6, 2025). For a teaching of Strauss, see previous paragraphs in this Office action.
With regards to claims 2-4, 7, 12-15 and 19, Strauss fails to teach that the urine labeling method can be used to detect drugs and other illicit substances in a urine sample, that an administrator preliminarily inspects the subject analyzed in the method for signs of substance abuse, that the amount of fluorescein sodium administered to the subject in the method is within the ranges recited in claims 12-15, and that the fluorescence from the fluorescein sodium is detected with one of the instruments recited in claim 19.
Rosen et al teach of a method of labeling and identifying a source of a urine specimen to be collected from a subject for biochemical analysis. The method comprises administering to a subject one or more fluorophores by having the subject orally consume a formulation such as a tablet, capsule or liquid containing the one or more fluorophores at a time prior to miction, obtaining a urine sample from the subject after about 30-120 minutes, and detecting a presence of the one or more fluorophores in the urine sample using an established fluorometric method such as with a fluorometer (claim 19). Rosen et al teach that the one or more fluorophores administered to the subject are non-toxic and harmless to the subject, are administered to the subject in an amount ranging from 25 to 100 mgs (claims 12-13), and are either excreted unchanged in the urine sample or metabolites of the one or more fluorophores in the urine sample are detected. Rosen et al teach that the one or more fluorophores that are administered to the subject in the method comprise riboflavin, thiamine, niacinamide and pyridoxine. Rosen et al teach that the method is used to determine a source of a urine sample provided by a subject undergoing drug testing so as to ensure that the urine sample has not been substituted. In one embodiment taught by Rosen et al, an administrator or manager of a sports team determines that the players/athletes on the team require drug testing. The players/athletes are then directed to orally consume a formulation containing the one or more fluorophores at a time prior to miction. The players/athletes are then requested to collect a urine sample after about 30-120 minutes, and the sample is then analyzed using a common fluorometric method for detection of the one or more fluorophores. This step ensures that the urine sample originated from the players/athletes who consumed the one or more fluorophores, and that the urine sample has not been substituted for another sample. The method further comprises testing the collected urine sample from the players/athletes for one or more drugs such as cocaine, marijuana, and other drugs (claims 2-3). See the abstract, lines 7-18 and 63-68 in column 1, all of columns 2 and 3, and lines 1-49 in column 4 of Rosen et al.
With regards to claims 2-3, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the urine labeling method taught by Strauss for detecting drugs and other illicit substances in a urine sample because Rosen et al teach that the presence of drugs and other illicit substances in a subject can be detected by orally administering a non-toxic fluorophore to the subject thus labeling urine of the subject with the fluorophore, and then measuring fluorescence of a collected urine sample, which are the same steps taught in the urine labeling method taught by Strauss.
With regards to claim 4, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the urine labeling method taught by Strauss for detecting illicit substances in a urine sample such as androgens including testosterone and other anabolic steroids, for the same reasons as set forth above, and since Rosen et al teach that a urine labeling method can be used to screen for drug use in athletes on a sports team and such athletes often also use androgens including testosterone and other anabolic steroids which are illegal in sports, thus motivating one of ordinary skill in the art to also screen the urine sample obtained in the method taught by the combination of Strauss and Rosen et al for these substances in addition to illegal drugs.
With regards to claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the urine labeling method taught by Strauss for detecting drugs and other illicit substances in a urine sample, for the reasons set forth above, and to have the administrator or manager of the sports team taught by Rosen et al preliminarily inspect a player/athlete on their team for one or more signs of drug use prior to labeling the urine of the player/athlete since Rosen et al teach that an administrator or manager of a sports team is often the person who initiates the urine labeling test in order to determine whether players on the team have used illicit drugs, and a visual inspection of the players for outward signs of drug use would confirm the applicability of performing the method taught by the combination of Strauss and Rosen et al.
With regards to claims 12-13, Rosen et al teach that the one or more fluorophores are administered to the subject in an amount ranging from 25 to 100 mgs, which overlaps with the range of 50-100 mg or about 100 mg recited in claims 12-13. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the range disclosed by Rosen et al because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP 2144.05.l.
With regards to claims 14-15, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the amount of the one or more fluorophores administered to the subject in the method taught by the combination of Strauss and Rosen et al to the amounts recited in claims 14-15 since where the general conditions of a claim are disclosed in the prior at, it is not inventive to discover an optimum or workable range for a result effective parameter such as an amount of a substance to administer to a subject using routine experimentation, and the amount of the one or more fluorophores administered to a subject in the method taught by the combination of Strauss and Rosen et al would depend on the size and weight of the subject, as well as how much the fluorophores are excreted into the urine over time.
With regards to claim 19, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure the fluorescence from the fluorescein sodium in the urine sample collected from the subject in the method taught by Strauss using one of the instruments recited in claim 19 because Rosen et al teach that an instrument such as a fluorometer is commonly used to measure fluorescence in a urine sample of a subject produced by one or more fluorophores orally consumed by the subject.
Claim(s) 2 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (abstract from Berliner Klinische Wochenschrift, vol. 50, 1914, pages 2226-2227, submitted in the IDS filed on February 6, 2025) in view of Huppertz et al (article from Clinical Chemical Laboratory Medicine, vol. 42(6), 2004, pages 621-626, submitted in the IDS filed on March 29, 2024, submitted in the IDS filed on February 6, 2025). For a teaching of Strauss, see previous paragraphs in this Office action.
With regards to claims 2 and 5-6, Strauss fails to teach that the urine labeling method can be used to detect substances such as growth hormones, growth factors or creatine, and evaluated for parameters such as temperature, specific gravity, pH, etc. in a urine sample.
Huppertz et al teach of a method for labeling urine which comprises orally administering marker substances comprising low molecular weight polyethylene glycols to a subject prior to miction, collecting a urine sample from the subject at a time after the administration of the marker substances to the subject, and detecting a presence of the marker substances in the urine sample. Huppertz et al teach that the urine sample is further screened for the presence of drugs such as amphetamines, barbiturates, cocaine, methadone, opiates and THC metabolites, as well as other substances such as creatine. The urine sample is also further screened for parameters such as pH, glucose, protein, hemoglobin, nitrate, etc. See pages 621-622 in Huppertz et al.
With regards to claims 2 and 5-6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the urine labeling method taught by Strauss for detecting substances such as growth hormones, growth factors or creatine in a urine sample, and for evaluating parameters such as temperature, specific gravity, pH, etc. in a urine sample since Huppertz et al teach that these types of further substances and parameters can be detected in a subject by orally administering a non-toxic marker substance to the subject thus labeling urine of the subject with the marker substance, and then measuring the marker substance in a collected urine sample, which are the same steps taught in the urine labeling method taught by Strauss.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 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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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 3, 2026
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