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 . Claims 1-3, 5-19 and 28-29 are pending in this application.
Specification
The disclosure is objected to because of the following informalities: Several structures/synthetic processes at pages 114, and 117-128 are illegible or borederline illegible. Also see p 130 str XL5-VHL-5 appears to be missing a bond.
Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Group II and a single disclosed species in the reply filed on 02/20/2026 is acknowledged.
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The examiner searched the elected species and did not find any prior art. The search was expanded to cover full scope of the elected invention of Group II.
The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-3, 5, 7, 9-14, and 17 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of X-Y comprises carbon, oxygen, nitrogen, sulfur, a carbonyl group or a sulfonyl group is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the chemical structures of applicants elected species X-Y = -L-E wherein L comprises a linker and E comprises an E3 ubiquitin ligase targeting moiety, a bridging molecule, etc. are different from X-Y comprises carbon, oxygen, nitrogen, sulfur, a carbonyl group or a sulfonyl group.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-3, 5, 7, 9-14, and 17 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:
a. In claim 1 or elsewhere in the claims, the use of the phrase “comprise an aryl”, “comprise carbon”, “comprises an E3 ubiquitin”, etc. to define the parameters of the structure of the formulae renders the scope of the claims unclear and it is extremely broad. Note that the term “comprise” is an open-ended language. What does “comprise an aryl” mean? What is covered and what is not? In order to overcome this rejection, it is recommended that applicants delete “comprise” from the claims.
b. Claim 1 and claims dependent thereon are rejected because the phrase “linker moiety” is indefinite. What is covered and what is not? How can one tell if a given moiety is not a linker? It is recommended that applicants recite specific linkers from the specification (see paragraphs [0121]-[0124]).
c. Claim 1 and claims dependent thereon are rejected because the phrase “E comprises an E3 ubiquitin ligase targeting moiety, a bridging molecule to a ubiquitin E3 ligase complex…….or a proteasome subunit targeting molecule” is not clear.
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What is covered and what is not? How can one tell if a given moiety is not a an E3 ubiquitin ligase targeting moiety? It is recommended that applicants recite specific variable E as disclosed at page 35 of the specification (see below).
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Claim Objections
9. Claim 28 is objected to because of the following informalities: The three chemical structures shown below appears to be fuzzy and are different from the rest of the chemical structures that are drawn properly. The t-butyl and the some of the bonds are faded.
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It is recommended that applicants draw the compounds as shown on the last compound (see below).
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Appropriate correction is required.
Information Disclosure Statement
10. Applicant’s Information Disclosure Statement, filed on 09/02/2025, 08/10/2023 and 07/26/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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 on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
Prosecution Insights