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 .
DETAILED ACTION
Priority and Status of the Claims
1. This application claims benefit of the provisional application: 63436515 12/31/2022.
2. Claims 1-45 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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.
Claims 1-27 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 pre-AIA the applicant regards as the invention.
Claim 1 recites a limitation “pre-set specifications” which is indefinite and ambiguous. It is unclear what the scope of pre-set specifications is. Clarification is required.
4. 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 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.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 34-35 and 45 are rejected under 35 U.S.C. 103(a) as being obvious
over Kirkland’s US 2018/0354940 A1 and Cayman’s product 2-bromo LS, 1989.
Applicants claim a batch of pharmaceutical grade 2-Br-LSD, or a pharmaceutically acceptable salt thereof, prepared according to the method of claim 1, see claim 34. It is noted that claim 34 is drawn a composition comprising 2-Br-LSD per se.
Applicants claim batch of 2-bromolysergic acid, or a pharmaceutically acceptable salt thereof, prepared according to the method of claim 28, see claim 35. It is noted that claim 35 is drawn a composition comprising 2-bromolysergic acid per se.
Determination of the scope and content of the prior art (MPEP §2141.01)
Kirkland’s ‘940 discloses a composition comprising 2-bromolysergic acid, see section [0031] in column 2.
Cayman’s product discloses a solution comprising 2-bromo-LSD.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Kirkland’s ‘940 and Cayman’s product is that the instant claims are embraced within the scope of Kirkland’s ‘940 and Cayman’s product. Kirkland’s ‘940 and Cayman’s product read on the instant claims 34-35 and 45 respectively.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 34-35 and 45 prima facie obvious because one would be motivated to employ compositions of Kirkland’s ‘940 and Cayman’s product to obtain instant invention.
The motivation to make the claimed compositions derived from the known compositions of Kirkland’s ‘940 and Cayman’s product would possess similar activity to that which is claimed in the reference.
6. Claims 28-33 and 36-44 are neither anticipated nor rendered obvious over the record, and therefore are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
March 09, 2026