nceDETAILED 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 .
Election/Restrictions
Applicant’s election of Group I, drawn to a compound represented by the structure of Formula IV12 or isomer thereof, and compound D12 having the structure of:
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as the elected species of compound represented by the structure of Formula IV12 or isomer thereof in the reply filed on March 31, 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)).
Claims 3-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 31, 2026.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 1, 2023, wherein claims 1-7 and 9-19 and 21-26 are unchanged; and claims 8 and 20 are amended.
Claims 1-26 are pending. Claims 3-26 are withdrawn.
Claims 1-2 are under examination in accordance with the elected species.
Priority
The instant application 18/039,815 filed on June 1, 2023 is a 371 of PCT/IL2021/051440 filed
on December 2, 2021, which claims priority to, and the benefits of Foreign Application No.
IL279168 filed on December 2, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Please note that foreign references without an English translation but have an English translation of the abstract will only have the abstract considered by the Examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not descriptive and appears to be lack of clarity. If the claimed invention is drawn to a chemical compound, its identify and use should be described; and if a process, the type of reaction, reagents and process condition should be described.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
the specification is repleted with the term “novel” (see e.g., [00301]) and “new” (see e.g., [004]). It is suggested that the term “novel” and “new” be deleted from the language of the disclosure. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “novel”. Thus, the incorporation of the term “novel” and “new” into the language of the specification is not appropriate.
The use of the term “Halaven”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
According to MPEP II-A-3-a-ii, “[t]he written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”; “[a] ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).”; and “’[a] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
The claim(s) promises a broad genus of compound represented by the structure of Formula IV12 or isomer thereof. In contrast, the specification only exemplifies a single compound D12, which has the structure of:
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, as the representative species, and does not describe any other species of compound represented by the structure of Formula IV12 or isomer thereof. While Applicant does not have to exemplify every possible species of compound represented by the structure of Formula IV12 or isomer thereof to satisfy the written description requirement, applicant needs to provide enough representative species from different corners of the range to represent the claimed genus fairly. In other words, applicant should give concrete examples that reflect the diversity of what they are claiming. Since the claims recite a large set of possible R14 and R16, applicant must provide a reasonable sampling of them —a representative number of compound species— so that a relevant artisan can see applicant truly envisioned the whole range.
Therefore, in view of the foregoing, applicant is not in the possession of the entire scope of compound represented by the structure of Formula IV12 or isomer thereof.
This is a written description rejection.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2015/066729 A1; cited in the IDS filed on July 22, 2024), in view of Vollhardt et al. (Organic Chemistry, 4th Edition: Structure and Function, 2002. W. H. Freeman: 286-293.)
Kim et al. teaches compound, 3-((2S,5S)-5-(2-((2S,4R,6R)-6-(((2S,3S,4R,5R)-5-((S)-2,3-dihydroxypropyl)-4-methoxy-3-((phenylsulfonyl)methyl)tetrahydrofuran-2-yl)methyl)-4-methyl-5-methylenetetrahydro-2H-pyran-2-yl)ethyl)-4-methylenetetrahydrofuran-2-yl)propyl pivalate, having the structure of:
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(referred to herein as “Compound 1”) in the preparation of a compound of Formula (ID) through a C.0-C.1 Macrocyclization shown below:
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(see e.g., p. 179, “Example 9”; p. 183-184); and it is an intermediate in the synthesis of eribulin (see e.g., claim 1). Kim et al. further teaches epimerization reactions can be used to invert a stereogenic center having an undesired stereochemical identity; for example, through epimerization, R stereogenic center can be converted to S stereogenic center and vice versa (see e.g., p. 88, line 14-16).
Kim et al. does not teach the elected species of compound of Formula IV12 (“D12”).
Vollhardt et al. teaches redox reactions allow chemist to connect alcohols to aldehydes and ketones shown below:
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(see e.g., p. 287, 1-2nd paragraph). Vollhardt et al. further teaches alcohol synthesis by reduction can be reversed: alcohols may be oxidized to produce aldehydes and ketones (see e.g., p. 291, 1st paragraph).
In the present case, the difference between the Compound 1 of Kim et al. and claimed compound is that the prior art compound contains a secondary alcohol rather than a ketone shown below (see shaded):
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.
The compound disclosed by Kim et al. contains a secondary alcohol. Vollhardt et al teach that secondary alcohols and ketones are related by routine oxidation transformations and that oxidation of a secondary alcohol affords the corresponding ketone. Because the secondary alcohol of Kim et al. is merely one oxidation state of the corresponding carbon center, one of ordinary skill in the art would have recognized that oxidation of that alcohol to the corresponding ketone would provide an alternate synthetic intermediate. Such ketones are routinely employed in organic synthesis because they may subsequently be reduced to regenerate the corresponding alcohol and permit stereochemical manipulation and further functional group transformations. Accordingly, one would have been motivated to oxidize the secondary alcohol of the compound of Kim et al to obtain the corresponding ketone with a reasonable expectation of success, since oxidation of secondary alcohols to ketone was a well-established and predictable transformation.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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