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/Restrictions and Status of the Claims
Applicant’s election of Group I, encompassing claims 1-6 and 8-15 in the response filed on November 2nd 2025 is acknowledged. Applicant’s further election of ‘formula 21’ as the ‘single compound, ‘example 13,’ as the ‘single method,’ and ‘melanoma’ as the ‘single condition,’ in the response filed on November 2nd 2025 is acknowledged. Claims 1-15 are pending. Claim 7 is withdrawn being directed towards a nonelected group. Claim 5 is withdrawn from further consideration as being directed towards a compound other than formula 21 until a generic claim has been found allowable. Claims 1-4, 6, and 8-15 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on August 2nd 2022 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 10-13 and 15 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.
Claims 10-13 are indefinite for the phrase “The compound according to claim 1 for use…” because the use of a compound is not patently distinct from the compound itself. Therefore, it is unclear how any of claims 10-13 further limit the compound of claim 1.
Claim 15 is directed towards the method according to claim 10 comprising a step of transforming the resulting compound in acidic form into a salt thereof. However, claim 10 is directed towards a compound, not a method. For the purpose of examination, claim 15 will be interpreted as “the method according to claim 9, comprising a step…”
Claim Rejections - 35 USC § 103
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 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.
Claims 1-4, 6, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Li (Li et al., Eur J Med Chem. 2018 Mar 25;148:279-290) in view of Mehrpour (U.S. Patent No. 10,287,298 issued on May 14th 2019).
Claims 1-4 are directed towards applicant’s salinomycin derivative of
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Li teaches the compound,
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(Li, pg. 281, Compound 10)
The compound is a stereoisomer of applicant’s compound, differing only in the orientation around the C20 location:
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One of ordinary skill in the art would have a reasonable expectation of success in developing applicant’s stereoisomer of Li’s compound, because such stereoisomers of salinomycin derivatives are already known in the art. For example, Mehrpour teaches many salinomycin derivatives that differ only in the orientation around the C20 carbon:
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As salinomycin derivatives varying only in their C20 orientation are known in the art one of ordinary skill in the art would have a reasonable expectation of success in developing stereoisomers of known salinomycin derivatives, such as Li’s compound, and changing the orientation around the C20 carbon, thus coming upon applicant’s elected species. Applicant’s compound and claims 1-4 are thereby prima facie obvious.
Claim 6 is directed towards a pharmaceutical composition of the compound of claim 1. As the compound would necessarily be administered in a pharmaceutical composition, claim 6 is prima facie obvious.
Claim 8 is directed towards a method of synthesis of the compound of claim 1 comprising reacting C20 aminosalinomycin with an acid comprising the C20 R group. Li describes (Li, pg. 280, Results and Discussion, 1st Paragraph) and illustrates (Li, pg. 281) an analogous synthesis method, rendering claim 8 prima facie obvious.
Claim 9 limits claim 8 to require that first a compound of formula (1) is converted to a compound of formula (3), followed by a conversion to a compound of formula (2):
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This method is analogous to that taught by Li:
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with the exception that Li does not maintain the stereochemistry in the first step. However, as the stereoisomers described in claim 1 are prima facie obvious, maintaining the stereochemistry would likewise be prima facie obvious.
Claims 10-13 are directed towards the compound according to claim 1 for use as a medicament for the treatment of cancers such as colon cancer. As a preliminary matter, a “compound for use” is patently indistinct from the compound itself (see the above 112(b) rejection for claims 10-13). Regarding the use of the compound for the treatment of colon cancer, Li teaches the anticancer activity of the compound against colon adenocarcinoma cells (Li, pg. 280), rendering claims 10-13 prima facie obvious.
Claim 14 is directed towards the method of claim 8 comprising a step of transforming the resulting compound into a salt form. Li teaches salt forms of the compounds (Li, pg. 281, Figure 2) and claim 14 is prima facie obvious.
Claim 15 is interpreted as being directed towards the method of claim 9 comprising the step of transforming the resulting compound into a salt form. Li teaches salt forms of the compounds (Li, pg. 281, Figure 2) and claim 15 is prima facie obvious.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, and 12-19 of copending Application No. 18/686,403 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the instant application,
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are a subset of those of the reference application,
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, and 12-19 of copending Application No. 18/686,402 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the instant application,
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are a subset of those of the reference application,
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/681,141 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the instant application,
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share significant overlap with those of the reference application,
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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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