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 .
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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1 and 15-18, in the reply filed on 8/18/2026 is acknowledged. The traversal is on the ground(s) that "claims 2-14...recited dependency to independent claim 1" (bridge paragraph pages 7-8). This is not found persuasive because although claim 2 recites "selecting fifteen (15) cell markers for biological cells of interest as recited in claim 1. Therefore, claim 2 is independent from claim 1. Although the groups are related as process of making and product made, the groups are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In this case, tclaim 1, thereby making another and materially different product. Therefore, the groups of inventions are independent and distinct from each other.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-14 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/18/2026.
Priority
The present application was filed on 12/13/2023.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraph 145. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 and 15-18 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 contains the trademark/trade name CFLUOR. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a fluorochrome and, accordingly, the identification/description is indefinite.
Furthermore, claim 1 recites “L423” (see Violet Antibody/Clone, second row, second column). It is not clear what antibody clone “L423” refers to because antibody “L423” does not appear to be a known antibody clone specific for HLA-DR. Does Applicant refer to antibody clone “L243”. See for example, Cytek (retrieved online https://cytekbio.com/products/cfluor-b515-anti-human-hla-dr-l243?variant=39964658925604 on 9/17/2026) teaches that the L243 antibody clone targets HLA-DR, not the L423. Because of this apparent discrepancy, a person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claims 15-18 are included in this rejection because the claims depend from rejected claim 1 but fail to clarify the scope of patent protection sought.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The closest prior art found is considered to be Cytek “Cytek cFluor® Reagents” N9-20060 Rev. C May 2022 (retrieved online https://imaflow.com/wp-content/uploads/2023/10/Cytek-cFluor-Reagents-Flyer.pdf 9/17/2026).
Cytek teaches “dyes and antibody conjugates optimized for full spectrum analysis on Cytek flow cytometers” (page 1 para. 2). Cytek further teaches “cFluor® V547 Anti-Human CD45 HI30… cFluor® V610 Anti-Human CD4…SK3” (page 1, see reagents Table column 1 rows 15-16). Therefore, Cytek teaches 2 of the 15 conjugates (fluorochrome-antibody pairs) claimed. Cytek further teaches the fluorochromes cFluor V450, cFluor V547, cFluor V610, cFluor B515, cFluor BYG575, cFluor BYG610, cFluor BYG667, cFluor BYG710, cFluor BYG750, cFluor BYG781, cFluor 659, cFluor R685, cFluor R720 and cFluor R780; which are 14 of the 15 fluorochromes claimed. Cytek further teaches 10 of the 15 antibodies claimed; namely, SK1, L243, HI30, SK3, 3G8, 6H6, HIB19, CD7-6B7, 2H7 and SK7.
Cytek fails to teach cFluor V505 and the antibodies 4H11, 5E8, LT56, MEM-15 and G10F5. Furthermore, there is not enough motivation in Cytek or the prior art to change the antibody-fluorochrome combinations made by Cytek because Cytek suggests that the conjugates were optimized for Cytek flow cytometers (“Cytek’s experience in designing highly multiparametric panels has led to a deeper understanding of how fluorochromes react together in increasingly complex fluorescent experiments. We are now applying this expertise and understanding to identify and evaluate dyes and antibody conjugates optimized for full spectrum analysis on Cytek flow cytometers” page 1 para. 2, “Look for more cFluor® dyes coming soon, validated to work in pre-optimized panels” page 1 col. 2 para. 1).
See also Chang et al. (US 20240159757 Al) (“Chang”). Note that Chang has a common Applicant (Cytek) and two joint inventors (Mark Edinger and Jun Deng) with the instant application.
Chang teaches “a method of building an optimized color flow high parameter reagent 20-color panel for detection of aberrant cells in acute myeloid leukemia (AML)” (Abstract). Chang further teaches “the following combination of fluorochromes and clones specific to the listed cell markers… cFluor V505…HLA-DR…L243…cFluor…BYG585…CD34…4H11” (claim 6). Therefore, Chang teaches another 2 of the 15 conjugates (fluorochrome-antibody pairs) claimed. Chang further teaches all of the fluorochromes claimed (claim 1). Chang teaches antibodies L243, HI30. 3G8, 4H11, 6H6, 5E8, LT56 and CD7-6B7, which are 8 of the 15 antibodies claimed.
Chang fails to teach antibodies SK1, SK3, HIB19, MIM-15, 2H7, G10F5 and SK7. Furthermore, there appears to be not enough motivation in Chang or the prior art to change the antibody-fluorochrome combinations made by Chang because Chang appears to be interested in their “unique conjugated antibodies and fluorescent dyes for the detection of target antigens or cells” (para. 134).
There were no references found that teach or suggest the other 11 fluorochrome-antibodies claimed, i.e. cFluor V450-SK1, cFluor B515-3G8, cFluor BYG610-6H6, cFluor BYG667-5E8, cFluor BYG710-LT56, cFluor BYG750-HIB19, cFluor BYG781-MEM-15, cFluor R659-CD7-6B7, cFluor R685-2H7, cFluor R720-G10F5 and cFluor R780-SK7. Therefore, the claims appear to be free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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, Gregory S. Emch can be reached at (571) 272-8149. 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.
/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
