DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election of the species of Examples 2-5 in the reply filed on April 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species appeared to be novel and nonobvious over the prior art. Therefore, the search and examination was extended. Prior art was found that anticipates a nonelected species. Thus, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The claims were searched to the extent of the elected species and the nonelected species shown below.
4. Claim 4 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on April 21, 2026.
Priority
5. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
6. The information disclosure statements (dated May 15, 2024 and June 10, 2024 and July 5, 2024 and July 12, 2024 and July 31, 2024 and August 5, 2024 and August 16, 2024 and September 4, 2024 and September 30, 2024 and October 2, 2024 and October 16, 2024 and October 23, 2024 and November 8, 024 and November 20, 2024 and December 4, 2024 and December 13, 2024 and December 30, 2024 and January 14, 2025 and January 16, 2025 and January 28, 2025 and February 4, 2025 and February 7, 2025 and February 13, 2025 and February 24, 2025 and March 10, 2025 and March 21, 2025 and March 31, 2025 and April 3, 2025 and April 11, 2025 and April 16, 2025 and April 29, 2025 and May 2, 2025 and May 9, 2025 and May 28, 2025 and June 9, 2025 and July 11, 2025 and July 18, 2025 and July 22, 2025 and July 28, 2025 and July 30, 2025 and August 6, 2025 and August 12, 2025 and August 19, 2025 and September 4, 2025 and September 29, 2025 and November 7, 2025 and November 12, 2025 and November 13, 2025 and November 21, 2025 and December 4, 2025 and December 10, 2025 and December 12, 2025 and December 17, 2025 and December 19, 2025 and December 26, 2025 and January 12, 2026 and January 21, 2026 and February 4, 2026 and February 13, 2026 and February 20, 2026 and March 3, 2026 and March 5, 2026 and March 13, 2026 and March 17, 2026 and March 19, 2026 and March 20, 2026 and April 7, 2026 and April 10, 2026 and April 16, 2026) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Claim Objections
7. Claim 5 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.
Claim Rejections - 35 USC § 102
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.
8. Claim(s) 1, 2 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,951,047. The reference has a publication date of April 24, 2018 which antedates the present application having an effective filing date of August 29, 2022 and priority claim to foreign application dated Augst 31, 2021.
The reference teaches a process of making a compound of structure
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(Example 1, column 22, corresponding to claimed compound 3d succinate salt) comprising the reaction of a compound of structure
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(Example 1-6, column 15, corresponding to claimed compound 3a) with a compound of structure
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(Example 1-13, column 19, corresponding to claimed compound 2i), giving compound of structure
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(Example 1-14, column 20, corresponding to claimed compound 3c) wherein the protecting group of tert-butoxycarbonyl is removed (present claim 2). The compound is further reacted with a hydroxyethylating agent to produce
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(example 1-15, column 21, corresponding to claimed compound 3d). The compound is further reacted to produce the succinate salt (Example 1, column 22) – present claims 1, 2 and 6.
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.
9. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9,951,047 in view of US 2014023614.
Determining the scope and contents of the prior art
The reference teaches a process of making a compound of structure
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(Example 1, column 22, corresponding to claimed compound 3d succinate salt) comprising the reaction of a compound of structure
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(Example 1-6, column 15, corresponding to claimed compound 3a) with a compound of structure
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(Example 1-13, column 19, corresponding to claimed compound 2i), giving compound of structure
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(Example 1-14, column 20, corresponding to claimed compound 3c) wherein the protecting group of tert-butoxycarbonyl is removed (present claim 2). The compound is further reacted with a hydroxyethylating agent to produce
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(example 1-15, column 21, corresponding to claimed compound 3d). The compound is further reacted to produce the succinate salt (Example 1, column 22) – present claims 1, 2 and 6.
Ascertaining the differences between the prior art and the claims at issue
The reference does not teach a condensation agent that is 1-
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.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
MPEP 2143 B provides basic requirements of prima facie case of obviousness including examples of rationale of the simple substitution of one known element for another to obtain predictable results. To reject a claim based on this rationale the following is considered below and applied to the present claims:
A finding that the prior art method differs from claimed method by the substitution of some component with another component
US 9,951,047 does not teach a condensation agent that is 1-
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. The prior art differs from the claims by a substitution specific condensation agent.
A finding that the substituted components and their functions were known in the art
US 201402356 teaches a condensation agent with is 1-
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. See paragraph [0066]. This agent is used in the same reaction as taught by the primary reference.
a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable
One of ordinary skill has the knowledge that various condensation agents or reagents may be used in the prior art reaction. Thus, the substitution of one condensation agent with another leads to a predictable reaction in the preparation of the same product.
For these reasons, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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