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 .
The applicant's election of Group I, claims 1-9, 11, 15, 17, and 19-20, without traverse in their reply dated 4/27/2026 is acknowledged. Claims 10, 13, 16, 18, and 24 are cancelled. Claims 12, 14, 21-23, and 25 have been withdrawn. Claims 1-9, 11, 15, 17, and 19-20 are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 5/12/2023, 4/18/2024, 3/25/2025, and 6/15/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered. An initialed copy of the Form 1449 is enclosed herewith.
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 3, 4, 5, 8, 9, 17, and 19 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.
Regarding claims 3, 4, 5, 8, 9, 17, and 19, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are a required part of the claimed invention. For examination purposes the examiner interprets that the limitations following “preferably” are not required.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-9, 11, 15, 17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Volkova et al. (Bioorganic & Medicinal Chemistry 16 (2008) 1452–1459).
Regarding claims 1, 2, 3, 4, 5, 6, 7, Volkova describes a leukocyte classification reagent, comprising a fluorescent dye represented by general formula F, wherein the fluorescent dye is represented by chemical formula II:
PNG
media_image1.png
190
208
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Greyscale
(Table 1: PO
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92
186
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Greyscale
and abstract “a-synuclein (ASN)” is found in leukocyte cells. )
Regarding claim 8, Volkova describes the leukocyte classification reagent of claim 1, further comprising an erythrolysis agent, preferably wherein the erythrolysis agent comprises a cationic surfactant, a non-ionic surfactant, an anionic surfactant, or any combination thereof (page 1457 “monomeric and fibrillar ASN” can function as a non-ionic surfactant); and
a buffer that maintains pH of a tested system in a range of 5-11 (page 1458 “Hepes buffer (pH 7.4).”).
Regarding claim 9, Volkova describes the leukocyte classification reagent of claim 1, wherein a concentration of the fluorescent dye is in a range of 0.1-1000 mg/L, preferably 20-500 mg/L, more preferably 50-200 mg/L (page 1456-1457 “the dye concentration (Fig. 4)” figure for shows concentration of the fluorescent dye is in a range of 0.1-1000 mg/L).
Regarding claim 11, Volkova describes a leukocyte analysis kit, comprising the leukocyte classification reagent of claim 1 (page 1457-1458 “Experimental” section provide the kit components including the reagent of claim 1).
Regarding claim 15, Volkova describes an erythrocyte classification reagent, comprising a fluorescent dye as defined in claim 1 (page 1457-1458 “Experimental” section provide the kit components including the reagent of claim 1, and abstract “a-synuclein (ASN)” is found in erythrocyte cells.).
Regarding claim 17, Volkova describes further comprising a spheroidizing reagent, preferably wherein the spheroidizing reagent comprises an amphoteric surfactant, an osmotic pressure regulator and a buffer 11 (page 1458 “Hepes buffer (pH 7.4).”).
Regarding claim 19, Volkova describes the erythrocyte classification reagent of claim 15, wherein a concentration of the fluorescent dye is in a range of 0.1-1000 mg/L, preferably 20-500 mg/L, more preferably 50-200 mg/L (page 1456-1457 “the dye concentration (Fig. 4)” figure for shows concentration of the fluorescent dye is in a range of 0.1-1000 mg/L).
Regarding claim 20, Volkova describes An erythrocyte analysis kit, comprising an erythrocyte classification reagent of claim 15 (page 1457-1458 “Experimental” section provide the kit components including the reagent of claim 1, and abstract “a-synuclein (ASN)” is found in erythrocyte cells.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796
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