DETAILED 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 without traverse of Group I (Claims 1-14 and 17) and the species
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in the reply filed on 27 March 2026 is acknowledged. A search was performed for the claimed compound, with no prior art retrieved. The search was then expanded to all compounds of Formula IV, with no prior art retrieved (See STN Search, Search Notes).
Claim 12 is directed to an allowable product. There is no prior art which teaches, suggests, or provides motivation for the compounds of Formula (I) (See STN Search, Search Notes). Pursuant to the procedures set forth in MPEP § 821.04(B), claims 15, 16, and 18, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 3 February 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 12-22, submitted on 27 March 2026, represent all claims currently under consideration.
Priority
This application is a 371 of PCT/US2022/031587, filed 31 May 2022, which claims priority to US 63/195,231, filed 1 June 2021. The effective filing date is 1 June 2021.
Information Disclosure Statement
Two Information Disclosure Statements (IDSs), both submitted on 6 March 2024, are acknowledged and have been considered.
Claim Objections
Claim 12 is objected to because of the following informalities: There is a superfluous “the” in the limitation (the the structure of Formula IV). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: There is a missing “compound” or similar in “selenium containing of Formula IV” in line 6. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 15 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. Factors to be considered
in making the determination as to whether one skilled in the art would recognize that
applicant was in possession of the claimed invention as a whole at the time of filing
include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural
chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional
characteristics when coupled with a known or disclosed correlation between function
and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
Claim 15 is directed to a method of preparing the compound of Claim 12, comprising contacting a selenium containing compound with a base, a molecule comprising a functional group, and a coupling reagent. The specification states that a “functional group” is a group of atoms or a single atom that will react with another group of atoms or a single atom to form a chemical interaction between the two groups or atoms (Paragraph 0068). “Selenium containing compound” is understood to include the compounds as described in Paragraphs 0073 through 0076, and more specifically, those of Formula IV (Paragraph 0083). From the provided synthesis (Example 1, Paragraph 00114) demonstrating the synthesis of compound 2, it is apparent that applicant is in possession of the selenium containing compound
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and 1-(2-aminothethyl)maleimide as the molecule which comprises a functional group. The specification does not provide any other examples of selenium compounds which can be used to synthesize compounds of the invention, nor does the specification provide any other examples of compounds comprising functional groups which can be used to synthesize the compounds claimed. The artisan would generally understand what a selenium containing compound is (a compound which has selenium), and what a functional group is. However, the specification does not provide any other examples of selenium containing compounds or compounds which have a functional group which can be used to practice this invention. The artisan would have no predictability in practicing this invention as the specification does not provide examples demonstrating the breadth of “selenium containing compounds” or “compounds with functional groups” in the preparation of the compounds of the invention. Thus, there is no support in the specification that Applicant was in possession of the whole invention as claimed at the time of filing.
Claim 18 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. Factors to be considered
in making the determination as to whether one skilled in the art would recognize that
applicant was in possession of the claimed invention as a whole at the time of filing
include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural
chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional
characteristics when coupled with a known or disclosed correlation between function
and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
The claims are directed to a method for quantifying an analyte or target of interest using a compound of the invention. The compounds of the invention react with cellular sulfhydryl groups via maleimide-functionalized selenophores which can be detected using single cell resolution by a mass cytometer (Paragraph 0025). The specification states that labeling with a single selenium isotope or combination of isotopes, samples may be pooled, stained with antibodies, and analyzed as a single sample (Paragraph 0105), and the compounds can be used in cytometry assays that might use fluorescent markers (Paragraph 00106). These compounds can be coupled to affinity reagents such as antibodies, oligonucleotides, lectin, aptamers, and the like and used for detecting a target analyte, optionally in or on a cell (Paragraph 00106). The specification does not describe what analytes or targets are bound by the selenium compounds of the invention. The figures provided demonstrate that the SeMal compounds of the invention are capable of labeling PBMCs, but does not describe what specific analytes or targets these compounds bind to. The specification does not provide description of what specific targets or analytes can be barcoded using this method, with the data that is provided demonstrating that compounds are capable of binding to cells and being detected using flow cytometry techniques. The artisan would understand how barcoding technology generally works with respect to its use in flow cytometry and cellular biology. However, without description from the specification as to what specific analytes or targets can be detected using the compounds and methods of the invention, the artisan would have no expectation of predictability in practicing this invention. Therefore, there is no support in the specification that Applicant was in possession of the whole invention as claimed at the time of filing.
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.
Claim 18 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 18 is indefinite due to the limitation “wherein the compound of Formula (IV) may bind the target analyte” (emphasis added). It is unclear how this method can be performed without the compound of Formula (IV) binding the target analyte; the use of “may” introduces indefiniteness to this method, causing it to be unclear how the compounds of Formula (IV) are used within this method if they are not binding the target analyte.
Allowable Subject Matter
Claims 12-14, 17, and 19-22 are allowed.
Claim 16 is 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.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches, suggests, or provides motivation for the compounds claimed in examined Claim 12 (See STN Search, Search Notes). The closest prior art comes from Lee (KR-20200102325; Publication Date: 31 August 2020). Lee discloses selenium ring compounds and methods of their manufacture (Paragraph 0001). Compounds of the invention include
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and
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(Paragraph 0052). Lee discloses variants which contain heterocycles bound to selenium ring, such as
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(Paragraph 0052). However, Lee does not disclose, nor does Lee provide any teaching, suggestion, or motivation to arrive at compounds which contain a maleimide moiety conjugated to this selenium heterocycle. The methods of synthesis Lee discloses are also distinct from those claimed in the examined application (Claim 3, Equation 5
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).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 15 and 18 are rejected.
Claims 12-14, 17, and 19-22 are allowed.
Claim 16 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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