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 .1
Status of Claims
Claims 1, 311 and 337-339. Claim 1 is directed to a multibiotic agent of the following structure
PNG
media_image1.png
214
398
media_image1.png
Greyscale
. 2
Claims 311 recites the functional descriptive limitation where the agent is substantially active by a human microbiota; and claims 337-339 is directed to a formulation comprising the claim 1 compound comprising a pharmaceutically acceptable diluent, carrier or excipient; an oral formulation; such as a tablet.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dec 20 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Allowable Subject Matter
Claims 1, 311 and 338-339. allowed. Note the compound of claim 1, aka CAS RN # 2254711-12-9, is only disclosed in one patent family of references, this application’s patent family as detailed below.
PNG
media_image2.png
592
782
media_image2.png
Greyscale
PNG
media_image3.png
864
1060
media_image3.png
Greyscale
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.
Claim 337 is 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 337 recites the functional language limitation where the multi-biotic agent is “substantially activated’ by a human microbiota, i.e. a function or result achieved by the invention to be substantially be activated by a human microbiota.
This functional description of the claimed compound recited in claim 1, is therefore determined to be indefinite, as it fails “to provide a clear-cut indication of the scope of the subject matter embraced by the claim.” See MPEP 2173.05, citing to In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). “For example, when claims merely recite a . . . . a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008). Id. at MPEP 2173.05.
As a quick aside, while the claim recites the relative term of “substantially activated”, such relative term is defined in the specification, and therefore not indefinite as follows:
"substantially activated" means that a multibiotic agent preparation described herein is at least 50% cleaved into at least two constituent parts at a target site in a subject's body (e.g., at least 50% hydrolyzed by an enzymatic action present at the target site, e.g., by an enzyme produced by the microbiota at the target site). A substantially activated multibiotic agent may be at least 50%, 60%, 70%, 80%, 90%, 95%, 100% cleaved into at least two constituent parts at a target site in a subject's body. See page 31, lines 14-19.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached 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, Adam C. Milligan can be reached at (571) 270-7674. 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.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 16/701,705 12/03/2019 ABN
16/701,705 is a CON of PCT/US2018/036113 06/05/2018
PCT/US2018/036113 has PRO 62/632,531 02/20/2018
PCT/US2018/036113 has PRO 62/613,359 01/03/2018
PCT/US2018/036113 has PRO 62/515,409 06/05/2017
2 CAS Registry Number 2254711-12-9
2-Propenoic acid, 3-(1H-indol-3-yl)-, 1,1′-[(1R)-1-[[[3-[[(2E)-3-(1H-indol-3-yl)-1-oxo-2-propen-1-yl]oxy]propyl]amino]carbonyl]-2,2-dimethyl-1,3-propanediyl] ester, (2E,2′E)- (ACI)
Prosecution Insights