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 .
Election/Restrictions
Applicant's election with traverse of group I comprising claims 1 – 6, 12 and 13 in the reply filed on 5/13/2026 is acknowledged. Claims 7 – 11 and 14 have been rejoined.
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 7 – 11 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim 7 provides for the use of the indole carboxylic acid in an analytical method, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. Claim 7 merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 7 – 11 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.
Claim 7 provides for the use of the indole carboxylic acid in an analytical method, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4 – 7 and 12 – 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huijser et al. (Cite No. 2 in IDS (page 2) filed 6/27/2024 submitted by Applicant; hereinafter “Huijser”).
Regarding claims 1, 2, 4 – 7 and 12 – 14, Huijser teaches in figure 1 molecule B, which is perdeuterated indole carboxylic acid (page 2424). Huijser further teaches the compound 4,7-dideutero-indole carboxylic acid (DHICA-d2) from 2,5,6-d3-L-DOPA (Experimental Section; page 2429).
PNG
media_image1.png
155
325
media_image1.png
Greyscale
Claim(s) 1 – 5 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sato et al. al. (Cite No. 1 in IDS (page 1: Foreign Patent Documents section) filed 6/27/2024 submitted by Applicant; hereinafter “Sato”).
Regarding claims 1 – 5, Sato teaches in paragraph 21 the compounds DHICA (5, 6-dihydroxy-indole-2-carboxylic acid), 6H5MICA(6-hydroxy-5-methoxy-indole-2-carboxylic acid) and 5H6MICA (5-hydroxy-6-methoxy-indole-2-carboxylic acid).
Claim(s) 1 – 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brochez et al. (Cite No. 3 in IDS (page 2) filed 6/27/2024 submitted by Applicant; hereinafter “Brochez”).
Regarding claims 1 – 7, Brochez teaches the compound 6-hydroxy-5-methoxy-indole-2-carboxylic acid as a serological marker for melanoma (See Abstract).
Allowable Subject Matter
Claims 8 – 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the cited prior art neither teaches nor fairly suggests the analytical method according to claim 7, further comprising carrying out mass spectrometry.
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.
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, 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.
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.
BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
Prosecution Insights