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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-4 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.
On line 2 of claim 1, the phrase “for hematological analyses of partially isotonic characteristic” is indefinite since it is not clear whether this phrase refers to the hematological analysis of erythrocytes and platelets in a sample. It is also not clear whether this phrase refers to measuring a partially isotonic characteristic of erythrocytes and platelets. Since this phrase appears to be part of the preamble of claim 1 and related to an unclear intended use of the formulation recited in claim 1 not needed for the patentability of the formulation, it is suggested to amend the preamble of claim 1 on lines 1-3 to read as follows: --A formulation for counting and morphological-based inferencing of erythrocytes and platelets that preserves the morphology of erythrocytes and platelets, comprising…--. The full meaning for the abbreviation “BSA” in the table included in both claim 1 and claim 2 should be recited.
On lines 3-4 of claim 3, the phrase “by weighing methylparaben and propylparaben” is indefinite since it is not clear how much of each of methylparaben and propylparaben should be “weighed” in the method. On line 4 of claim 3, the phrase “the homogenization” lacks antecedent basis. It is suggested to change the phrase “the homogenization of the formulation carried out on a thermal magnetic plate heated to100oC” on lines 4-5 of claim 3 to –homogenizing the preservative formulation on a thermal magnetic plate heated to 100oC --. On line 5 of claim 3, the phrase “or an equivalent procedure” is indefinite since it is not clear what constitutes being an “equivalent procedure” to homogenization on a thermal magnetic plate heated to 100oC. On lines 6-8 of claim 3, the phrase “the preservative formulation can be replaced by the addition of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one (3% by mass) dispersed in modified glycol (93-95% by mass) and alkyl carboxylate (2-3% by mass)” is indefinite since it is not clear whether this step is a definitive part of the claimed method or a definitive alternative for providing the preservative formulation in the method, or whether this step is merely optional in the method. If Applicant intends for the limitation recited on claims 6-8 of claim 3 to be a definitive alternative for providing the preservative formulation in the method, it is suggested to recite step 1) of the method as –preparing a preservative formation by either i) weighing methylparaben and propylparaben…. or ii) providing a preservative formulation comprising 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one (3% by mass) dispersed in modified glycol (93-95% by mass) and alkyl carboxylate (2-3% by mass);--. On lines 9-10 of claim 3, the phrase “by weighing sodium bicarbonate, …and K2EDTA” is indefinite since it is not clear how much of each of the recited components in step 2) should be “weighed” in the method. On line 14 of claim 3, the phrase “the range” lacks antecedent basis.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Allowable Subject Matter
Claims 1 and 3 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action since none of the prior art of record, including the references cited below and the references included in the Information Disclosure Statement filed on December 21, 2022, teach or fairly suggest a formulation or a composition for counting and morphological-based inferencing of erythrocytes and platelets in a sample that preserves the morphology of the erythrocytes and platelets, and a method of preparing the formulation or composition using the steps recited in claim 3, wherein the formulation or composition comprises deionized water in a range of 84.4701% to 93.4174% by mass, and each of the compounds listed in the table recited in claim 1 in the recited mass percentages.
Claims 2 and 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims for the same reasons as set forth above, and since none of the prior art of record teaches or fairly suggests a method of counting erythrocytes and platelets in an animal blood sample comprising diluting and homogenizing the blood sample with the formulation recited in claim 1 to obtain a mixture, and analyzing the mixture under an optical microscope of a hemocytometer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Wong (US 5,227,304) who teach of a multi-purpose blood diluent composition; Crews et al (US 4,405,719) who teach of a diluent composition for stabilizing platelets; Crews et al (US 2004/0241769) who teach of a multi-purpose isotonic diluent reagent; and Carter et al (US 4,528,274) who teach of a blood diluent for the differential determination of leukocyte populations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. 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 Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 October 28, 2025