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 .
Applicant’s response filed on 06/30/2026 has been fully considered. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 16-33 are currently pending and under exam herein.
Claims 16-33 are rejected.
Priority
The instant application claims benefit to foreign application No. 202110400024.6 filed on April 14, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claim to foreign priority benefit is acknowledged. Thus, the effective filing date of claims 16-33 will be April 14, 2021 going forth.
Information Disclosure Statement
The information disclosure statement (IDS) was filed on 06/30/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 06/24/2026. These drawings are acceptable.
Specification
The Specification amendment filed on 06/24/2026 is accepted and has corrected the specification objection. Therefore, the objection to the Specification is withdrawn and the Specification filed on 06/24/2026 is accepted.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are: the term "portion" in claims 16 and 22.
In claims 16 and 22, the instant application recites “a blood sample supply portion configured to provide a blood sample”, which uses the generic placeholder “portion” coupled with the function language “configured to”. In addition, is not preceded or followed by sufficient structure, material, or acts for performing the claimed function. In looking at the specification paragraph [0109], the blood sample supply portion is described to include a sample needle that can perform 2D and 3D movements to aspirate a blood sample and move it to a mixing chamber. Hence, going forth, examiner will interpret the blood sample supply portion to be as such.
In claims 16 and 22, the instant application recites “a reagent supply portion configured to provide a reaction reagent”, which uses the generic placeholder “portion” coupled with the function language “configured to”. In addition, is not preceded or followed by sufficient structure, material, or acts for performing the claimed function. In looking at the specification paragraph [0109], the reagent supply portion is described to include a reagent tray and reagent needle. It further going on to detail how the combined tray and needle are able to hold multiple reagents and operate in 2D and 3D to move reagents to the mixing chamber. Hence, going forth, examiner will interpret the reagent supply portion to be as such.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16-33 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. The rejection of claims 16-33 are maintained and reiterated in view of the claim amendments and applicant arguments. Please see below for Response to Argument for more details.
The term “normal” in claims 16, 22, and 28 is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims 17-21, 23-27, and 29-33 are rejected as well, for they do not resolve the indefiniteness of the independent claims 16, 22 and 28.
The term “abnormal” in claims 16, 18-20, 22, 24-26, 28, 30-32 is a relative term which renders the claim indefinite. The term “abnormal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims 17, 21, 23, 27, 29, and 33 are rejected as well, for they do not resolve the indefiniteness of the independent claims 16, 22 and 28.
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendment to “whether any one or a combination of the number of reticulocytes, the number of immature platelets and the number of large volume platelets in the blood sample is abnormal” defines abnormal as any one of or a combination of the variables listed above. However, applicant fails to disclose what exact range of numbers would be considered abnormal in the context of the applicant’s blood analysis device. Abnormality and Normality of the variables above should include standards, threshold ranges, and parameters such that one of ordinary skilled in the art would be able to reasonably apprise the scope of the invention.
Therefore, the indefiniteness of “normal” in claims 16, 22, and 28 and the indefiniteness of “abnormal” in claims 16, 18-20, 22, 24-26, 28, 30-32 is not resolved. Thus, the 35 U.S.C. 112(b) indefiniteness rejection on the above claims along with their dependent claims is maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The previous rejections of claims 16-33 are withdrawn in view of the claim amendments.
Response to Arguments
Applicant’s arguments, see pages 16-21 under Claim Rejection under 35 U.S.C. 103, filed on 06/24/2026, with respect to claims 16-33 have been fully considered and are persuasive. The 103 rejection of claims 16-33 have been withdrawn due to amendments.
Claims Free from Prior Art
Claims 16-33 are currently free from the prior art.
The following is an examiner’s statement over the prior art:
Claims 16-33 pertain a blood analysis apparatus/method that has two measurement modes for detection of white blood cell, reticulocyte, immature platelet, and large volume platelet abnormalities. The apparatus contains a blood sample supply portion which consists of a needle that can aspirate and move the blood sample, a reagent supply portion which has a reagent tray and needle to aspirate and move different reagents into the mixing chamber, and a measuring portion which consists of an optical detection portion that utilizes flow cytometry principles to detect the cells passing through a flow chamber (claim 16, 22, 28). The apparatus starts by taking a first sample and running white blood cell count/classification in the first measurement mode. Then based on the measured optical signals of the first sample, the instant application is able to determine the white blood cell count/classification and detect any abnormalities in at least one of a reticulocyte parameter, an immature platelet parameter, and a large-volume platelet parameter (claim 16, 22, 28). If abnormalities are detected, the processor within the apparatus will enable the second measurement mode, which will allow the apparatus takes a second sample and runs a reticulocyte, immature platelet and large-volume platelet parameter test (claim 16, 22, 28).
The apparatus specifically utilizes a hemolytic agent and a first fluorescent agent on the first sample to collect forward scattering light signals and fluorescence signals from the first sample (claim 17, 23, 29). And with these signals, the processor in the apparatus is able to generate a scatter diagram corresponding to the first sample that contain a reticulocyte region, an immature platelet region, and a large volume platelet region for abnormality detection (claim 18, 24, 30). Then the processor is able to count the scatter points within the regions to determine if the number of reticulocytes, immature platelets, and large volume platelets are outside of a fist threshold range, a second threshold range, and a third threshold range respectively (claim 19, 25, 31). If the numbers are outside of the ranges, the apparatus generates a corresponding alarm prompt (claim 20, 26, 32). The apparatus then specifically utilizes a diluent and a second fluorescent agent on the second sample to collect forward scattering light signals and fluorescence signals from the second sample (claim 21, 27, 33).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENYU YANG whose telephone number is (571)272-0035. The examiner can normally be reached 8:30am - 5:00 pm.
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, Olivia Wise can be reached at (571) 272-2249. 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.
/W.Y./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
Prosecution Insights