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
Election of Species and Status of the Claims
Applicant’s election of HY-1 as the “single specific compound,” in the response filed on December 15th 2025 is acknowledged. Applicant’s elected species is not found in the art. As recognized by MEPEP § 803.02(III)(C)(2):
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art- recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
Claims 1-22 are pending. Claims 5 and 7-18 are withdrawn from further consideration as being directed to nonelected species until a generic claim has been found allowable. Claims 1-4, 6, and 19-22 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on September 6th 2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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 1-3 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 1 and its dependent claims 2 and 3 are indefinite for the phrase “comprising a hybrid molecule having both a ferroptotic pharmacophore and a histone deacetylase inhibitor pharmacophore,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim. Specifically, the functional descriptive language of the claim does not direct towards any particular chemical moieties. While later claims do recite such moieties, the full scope of claim 1 and its dependent claims 2 and 3 could not be determined by one of ordinary skill in the art.
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 19-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a method of killing cancer cells via contact with a compound of Formula A, B, or C. This judicial exception is not integrated into a practical application because only the contact of cancer cells with the compound (i.e. a natural phenomenon) and the results of the contact (the death of the cancer cells) is recited. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the method does not recite a patient population or an administration step but merely the contact of cells with the compound and results of said contact.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fan (Fan et al., A Dual PI3K/HDAC Inhibitor Induces Immunogenic Ferroptosis to Potentiate Cancer Immune Checkpoint Therapy. Cancer Res 15 December 2021; 81 (24): 6233–6245).
Claim 1 is directed towards a composition comprising a hybrid molecule having both a ferroptotic pharmacophore and a histone deacetylase inhibitor pharmacophore. Claim 3 further limits the described molecule to comprise a hydroxamic acid metal-binding group.
Fan teaches the compound,
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(Fan, pg. 6236),
which includes a hydroxamic acid moiety.
Fan’s describes both the compound’s activity as an HDAC inhibitor (Fan, pg. 6236), and in inducing ferroptosis (Fan, pg. 6238). Fan therefore anticipates claims 1 and 3.
Allowable Subject Matter
Claims 4, 6, and 21-22 are free of the prior art.
Claims 21-22 are allowed.
Applicant has developed a series of bifunctional molecules that comprise both a ferroptotic pharmacophore and a histone deacetylase (HDAC) inhibitor pharmacophore. Applicant’s compounds are useful in the treatment of various cancers.
While compounds with the general activity of “compounds with both ferroptotic and HDAC inhibiting activity” are found in the art, including with applicant’s particular HDAC-inhibiting moiety of ‘hydroxamic acid,’ (see the above 102 rejection of claims 1 and 3 over Fan), applicant’s particular compounds, as well as the compound genus of claim 4, are not found in the art, and would not be predictable from the art. As claims 21-22 do not depend on the rejected claim 1, they are allowed.
Claims 4, and 6 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET 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, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629