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 1-9 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I,
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and the species of compound CPA-321, which is disclosed in paragraph [0259] on page 112 of the instant specification (reproduced below),
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in the reply filed on March 26, 2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 6-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 26, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on December 6, 2021 and October 19, 2023. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: there are Chemical Structures in the Specification filed August 26, 2022 which are not completely legible. See paragraph [0194] on page 74; paragraph [0250] on page 106; paragraph [0271] on page 118; paragraph [0273] on page 119; and paragraph [0316] on page 139
Appropriate correction is required.
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.
Claims 1-5 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 recites improper Markush language and is therefore, indefinite. See the open-ended term “comprising” on line 1 of claim 1. It is not permissible to use open-ended language to define the scope of compounds in the Markush claim of instant claim 1. See MPEP §2173.05(h).
Claim 1 is unclear because the substituents which define the reactive moiety (D) are listed as a “compound” instead of an expected radical or moiety (see the 3rd line from the bottom of page 2). Therefore, claim 1 is indefinite.
Claim 1 is unclear because the substituents which define the cleavable moiety (E) are listed as a “compound” instead of an expected radical or moiety (see the 1st line of page 3). Therefore, claim 1 is indefinite.
Claims which depend from claim 1 but do not resolve the problems discussed above in claim 1 are also found indefinite.
Claim 2 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 that variable n can represent zero as found in dependent claim 2. Therefore, claim 2 is indefinite.
Claim 2 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the cleavable moiety (E) representing formula (3),
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, as found in claim 2. Claim 1 states that the cleavable moiety (E) can represent specifically 1-(4,4-dimethyl-2,6-dioxocyclohex-1-ylidene)ethyl. Therefore, claim 2 is indefinite.
Claim 3 is unclear because there is a variable C listed in claim 3 but variable C is not found (or defined) in claim 1 or in either of the formulae in claim 3. See line 5 of claim 3. Therefore, the presence of variable C in claim 3 makes claim 3 indefinite.
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.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 fails to further limit claim 1 because claim 2 is broader in scope than claim 1 due to the definition of variable n. In claim 1, variable n is defined as representing 1 or 2 but claim 2 states that variable n can represent zero.
Claim 2 fails to further limit claim 1 because claim 2 is broader in scope than claim 1. The cleavable moiety (E) represents formula (3),
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, in claim 2. However, claim 1 states that the cleavable moiety (E) can represent specifically 1-(4,4-dimethyl-2,6-dioxocyclohex-1-ylidene)ethyl.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Improper Markush Rejection
Claims 1-5 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 a tetra-functional compound 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 species of the Markush group of tetra-functional compounds do not share a “single structural similarity” because, other than the biotin tag (B), there are no required structural features within each variable definition such that each member of the group would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds, in common. Claims 1-4 encompass a wide variety of chemical species which are in different recognized physical classes, and would embrace different chemical compounds that do not share any single structural similarity between the species. Such is evidenced by the fact there is no formula in instant claim 1.
Turning to the substituents which define the ligand-binding moiety (A), the reactive moiety (D), the cleavable moiety (E) and the spacer, one views a massive array of limitations which essentially appear to encompass anything. The ligand-binding moiety (A), the reactive moiety (D), the cleavable moiety (E) and the spacer can represent groups ranging from a simple alkylene to various functional groups, amine-reactive groups, diol-reactive groups, peptides, etc.
Clearly, one of ordinary skill in the art cannot envision the boundaries of these claims and the compounds claimed in claim 1 encompass, at the very least, millions of compounds. This is certainly not a grouping of patentable indistinct alternatively usable species. As a result of the wide range of compounds possible, each compound does not belong to the same recognized physical or chemical class or to the same art-recognized class and no credible evidence for a common use amongst all the claimed compounds exists. A person of ordinary skill in the art would understand that compounds with such greatly varied structure cannot be expected to have predictable properties.
Therefore, subject matter which has been searched and examined in the instant claims, inclusive of the elected species of the compound CPA-321, are tetra-functional compounds wherein:
the ligand-binding moiety (A) represents an N-hydroxysuccinimide ester group;
the biotin tag (B) represents formula (1),
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;
the reactive moiety (D) represents formula (2) or formula (2’),
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; and
the cleavable moiety (E) represents 1-(4,4-dimethyl-2,6-dioxocyclohex-1-ylidene)ethyl or formula (3),
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.
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.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Allowable Subject Matter
The elected species of CPA-321, which is disclosed in paragraph [0259] on page 112 of the instant specification, is allowable over the prior art of record.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
May 21, 2026
Book XXVIII, page 271
Prosecution Insights