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
Claims 1-10, 17, 25, 33 and 41-42 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1-10; directed to compounds of formula I and pharmaceutical compositions thereof) and a species of Compound 1 without traverse in the reply filed April 21, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-10 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 17, 25, 33 and 41-42 do not read on the presently searched and examined subject matter. Therefore, claims 17, 25, 33 and 41-42 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Priority is granted to PCT/IB2022/000223, filed on April 14, 2019.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Switzerland on 04/14/2021. It is noted, however, that applicant has not filed a certified copy of the SWITZERLAND 00384/21 application as required by 37 CFR 1.55. Foreign priority is not granted for SWITZERLAND 00384/21, filed on April 14, 2021, as intervening prior art has been found. To perfect priority in the present application, an English translation of a certified copy of the foreign priority document is required.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 06/04/2024 and 01/16/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been being 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.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract exceeds 150 words, should include the nature and use of the compounds of the invention rather than a recitation of the definition of formula I, and the use of phrases which can be implied should be avoided. 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).
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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.
Regarding claim 7, the phrase "halogen, such as F, Cl, Br, e.g. F or Cl," in the definition for R1-R4 renders the claim indefinite because it is unclear whether the limitations following the phrase “such as” and “e.g.” are part of the claimed invention. See MPEP § 2173.05(d). Further regarding claim 7, the phrase "halogen, preferably F, or Cl, or more preferably F;" in the definition for R5-R6 renders the claim indefinite because it is unclear whether the limitations following the phrase preferably are part of the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2021126973 A1 (Kley et al.; Publication Date: June 24, 2021; International Filing Date: December 16, 2020).
WO 2021126973 A1 (Kley et al.; Publication Date: June 24, 2021; International Filing Date: December 16, 2020).
Kley discloses cereblon binders for the degradation of proteins by the ubiquitin proteasome pathway for therapeutic applications. See abstract and pages 2-16 and pages 50-51 for compounds of formula III of Kley.
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Kley discloses several compounds which are encompassed by formula I of present claim 1.
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Compound C84966 of Kley corresponds to a compound of present formula (I) where X1 is C1 alkyl, X2 is C6 aryl, L1 is -NH-, L2 is a covalent bond, and L3 is a covalent bond. See page 92 of Kley and present claims 1-4. Compound C84966 also corresponds to compound of formula II of claim 5 where X1 is C1 alkyl, X2 is C6 aryl, L1 is -NH-, L3 is a covalent bond and p is 0. Compound C84966 corresponds to compound of formula V where X1 is C1 alkyl, X2 is C6 aryl, L3 is a covalent bond and p is 0. See present claim 6. Compound C84966 corresponds to compound of formula VI where w1 is C, w2 is C, w3 is C, L1 is -NH-, L2 is a covalent bond, and m is 1. See present claim 7.
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Compound C84963 of Kley corresponds to a compound of present formula (I) where X1 is C3 cycloalkyl, X2 is hydrogen, L1 is -NH-, L2 is a covalent bond, and L3 is a covalent bond. See page 98 of Kley and present claims 1-4.
Compound C84963 also corresponds to compound of formula II of claim 5 where X1 is C3 cycloalkyl, X2 is hydrogen, L1 is -NH-, L3 is a covalent bond and p is 0. Compound C84963 corresponds to compound of formula V where X1 is C3 cycloalkyl, X2 is hydrogen, L3 is a covalent bond and p is 0. See present claim 6. Compound C84963 corresponds to compound of formula VIII where L1 is -NH-, L2 is a covalent bond, and Z is C3 cycloalkyl. See present claim 7.
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Compound C12693 corresponds to a compound of present formula (I) where X1 is 6-membered heterocycloalkyl, X2 is hydrogen, L1 is -NH-, L2 is a covalent bond, and L3 is a covalent bond. See page 115 of Kley and present claims 1-4.
Compound C12693 also corresponds to compound of formula II of claim 5 where X1 is 6-membered heterocycloalkyl, X2 is hydrogen, L1 is -NH-, L3 is a covalent bond and p is 0. Compound C12693 also corresponds to compound of formula V where X1 is 6-membered heterocycloalkyl, X2 is hydrogen, L3 is a covalent bond and p is 0. See present claim 6. Compound C12693 corresponds to compound of formula VIII where L1 is -NH-, L2 is a covalent bond, and Z is 6-membered heterocycloalkyl. See present claim 7.
Regarding claim 10 which is directed to a pharmaceutical composition comprising a compound of claim 1, Kley discloses the following in paragraph 331
The compounds of the present invention are administered to a patient in a therapeutically effective amount. The compounds can be administered alone or as part of a pharmaceutically acceptable composition or formulation. In addition, the compounds or compositions can be administered all at once, as for example, by a bolus injection, multiple times, such as by a series of tablets, or delivered substantially uniformly over a period of time, as for example, using transdermal delivery. It is also noted that the dose of the compound can be varied over time.
Allowable Subject Matter
Claims 8-9 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
Claims 1-7 and 10 are rejected.
Claims 8-9 are objected to.
Claims 17, 25, 33 and 41-42 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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 Murray 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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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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