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
2. Applicant’s election without traverse of claims 1-10 and 12 (Invention I) in the reply filed on May 7, 2026 is acknowledged.
Drawings
3. The drawings are objected to because FIGS. 9A, 9B, 9C, 9D, 10, and 13 are blurry which makes them unclear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
4. 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.
5. 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.
6. 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) is/are: analysis unit in claims 1, 5, 6, 8-10, and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 1-5, 7-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (2015/0140577)-cited by applicant in view of Ma et al. (CN 108169104 A)-cited by applicant-using machine translation and Abuljadayel (8,163,536).
As for claim 1, Li in an optical engine for flow cytometer, flow cytometer system and methods of use discloses/suggests the following: a flow cytometer (FIG. 1A: 5 and 10 with FIG. 1B) comprising: a flow cell (FIGS. 1B, 5, 6, 7, 11, and 12: 130); a sample supply part configured to supply, to the flow cell, a predetermined amount of a measurement sample prepared by mixing a specimen containing measurement- target substances and a labeled antibody which binds to the measurement-target substances (paragraphs 0018; 0041, 0042, 0048, noting FIG. 1B: 14 with 180; mixing: paragraph 0043; with presence of antibodies: paragraphs 0064 and 0073); a light source configured to apply light to the measurement sample passing through the flow cell (FIG. 1B: 100 with FIG. 5: 110 relative to 130; FIG. 6: 110v, 110b, 110r relative to 130); a detector configured to detect lights derived from the measurement-target substances contained in the measurement sample to which the light has been applied, and output signals (FIG. 1B: 100 with FIGS. 5 and 12: 160, FIG. 11: 160a-160f); and an analysis unit configured to count the measurement-target substances contained in the measurement sample on the basis of the signals (FIG. 11: 200 with paragraphs 0040, 0044, 0068 with paragraphs 0018 and 0048: demonstrating counting).
As for the analysis unit configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount, Li does not explicitly state this. Li apparently refers to the accuracy of the counting by the flow cytometer system by demonstrating a linear relationship between the counted vales and known particle concentrations (paragraphs 0018 and 0048). Nevertheless, Ma in a flow cytometry detecting device and method teaches that a predetermined amount, a predetermined volume, of a sample of particles injection pumped into the sample flow can have its concentration determined by measuring its particle number (paragraphs [0027] and [0064]). And Albuljadayel in a device for preparing an undifferentiated cell from a more committed cell teaches that any suitable cytometer can conduct cell counts with counting means thereby measuring the cell concentration of a cell population of a measured volume of a cell population (col. 5, line 65 to col. 6, line 10).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the analysis unit be configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount for in flow cytometry a predetermined volume of sample of particles supplied to the flow cell has its concentration determined by virtue of having the particles in the sample counted.
As for claims 2-3, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 1). In addition, Li discloses/suggests wherein the sample supply part includes a metering syringe and supplies the predetermined amount of the measurement sample by the metering syringe (claim 2); wherein the metering syringe has a syringe container and a piston, and supplies the predetermined amount of the measurement sample through movement, by a predetermined amount, of the piston (claim 3)(noting that the presence of a syringe at the minimum suggests the presence of a piston: paragraphs 0018, 0041, 0048).
As for claim 4, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 3). In addition, Li discloses/suggests wherein the sample supply part further includes a suction nozzle configured to suction the measurement sample and a flow path connecting the suction nozzle, the flow cell, and the metering syringe to each other, and the sample supply part pulls the piston of the metering syringe, to draw the measurement sample to the flow path and pushes the piston, to supply the measurement sample to the flow cell (FIG. 1B: interpreting 14 as having a nozzle and 19 as a flow path; again, noting that the presence of a syringe at the minimum suggests the presence of a piston: paragraphs 0018, 0041, 0048).
As for claim 5, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 3). In addition, Li in view of Mal and Albuljadayel discloses/suggests wherein the analysis unit obtains the concentration on the basis of the number of the measurement-target substances and an amount of the measurement sample used for counting the measurement-target substances, the amount of the measurement sample being based on the predetermined amount (see claim 1 above: ‘As for the analysis unit configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount, Li does not explicitly state this. Li apparently refers to the accuracy of the counting by the flow cytometer system by demonstrating a linear relationship between the counted vales and known particle concentrations (paragraphs 0018 and 0048). Nevertheless, Ma in a flow cytometry detecting device and method teaches that a predetermined amount, a predetermined volume, of a sample of particles injection pumped into the sample flow can have its concentration determined by measuring its particle number (paragraphs [0027] and [0064]). And Albuljadayel in a device for preparing an undifferentiated cell from a more committed cell teaches that any suitable cytometer can conduct cell counts with counting means thereby measuring the cell concentration of a cell population of a measured volume of a cell population (col. 5, line 65 to col. 6, line 10). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the analysis unit be configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount for in flow cytometry a predetermined volume of sample of particles supplied to the flow cell has its concentration determined by virtue of having the particles in the sample counted.’).
As for claim 7, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 1). In addition, Li discloses/suggests a display section configured to display the concentration (FIG. 1A: shows display to the right of 20; FIG. 14 and noting FIGS. 15-20; paragraphs 0069, 0077, 0079).
As for claims 8-9, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 1). In addition, Li in view of Ma and Albuljadayel discloses/suggests wherein the analysis unit obtains a concentration of the measurement-target substances in the specimen (claim 8) and wherein the analysis unit obtains a concentration of the measurement-target substances in the measurement sample (claim 9)(Li: noting paragraphs 0069, 0077, 0079 and see claim 1 above: ‘As for the analysis unit configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount, Li does not explicitly state this. Li apparently refers to the accuracy of the counting by the flow cytometer system by demonstrating a linear relationship between the counted vales and known particle concentrations (paragraphs 0018 and 0048). Nevertheless, Ma in a flow cytometry detecting device and method teaches that a predetermined amount, a predetermined volume, of a sample of particles injection pumped into the sample flow can have its concentration determined by measuring its particle number (paragraphs [0027] and [0064]). And Albuljadayel in a device for preparing an undifferentiated cell from a more committed cell teaches that any suitable cytometer can conduct cell counts with counting means thereby measuring the cell concentration of a cell population of a measured volume of a cell population (col. 5, line 65 to col. 6, line 10). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the analysis unit be configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and the predetermined amount for in flow cytometry a predetermined volume of sample of particles supplied to the flow cell has its concentration determined by virtue of having the particles in the sample counted.’).
As for claim 10, Li in view of Ma and Albuljadayel discloses/suggests everything as above (see claim 1). In addition, Li discloses/suggests wherein the analysis unit is configured to be selectively operated in either a first mode in which the concentration is presented as a measurement result regarding the measurement- target substances or a second mode in which a count value of the measurement-target substances is presented as a measurement result regarding the measurement-target substances (FIG. 1A: shows display to the right of 20 and FIG. 14; wherein, the display suggests multiple modes of operation by virtue of displaying a plurality of windows and multiple columns of information and data; paragraphs 0013, 0069, 0070).
As for claim 12, Li in an optical engine for flow cytometer, flow cytometer system and methods of use discloses/suggests the following: a flow cytometer (FIG. 1A: 5 and 10 with FIG. 1B) comprising: a flow cell (FIGS. 1B, 5, 6, 7, 11, and 12: 130); a metering syringe configured to suction a measurement sample prepared by mixing a specimen containing measurement-target substances and a labeled antibody which binds to the measurement-target substances, and supply the suctioned measurement sample to the flow cell (paragraphs 0018; 0041, 0042, 0048, noting FIG. 1B: 14 with 180; mixing: paragraph 0043; with presence of antibodies: paragraphs 0064 and 0073); a light source configured to apply light to the measurement sample passing through the flow cell (FIG. 1B: 100 with FIG. 5: 110 relative to 130; FIG. 6: 110v, 110b, 110r relative to 130); a detector configured to detect lights derived from the measurement-target substances contained in the measurement sample to which the light has been applied, and output signals (FIG. 1B: 100 with FIGS. 5 and 12: 160, FIG. 11: 160a-160f); and an analysis unit configured to count the measurement-target substances contained in the measurement sample on the basis of the signals (FIG. 11: 200 with paragraphs 0040, 0044, 0068 with paragraphs 0018 and 0048: demonstrating counting).
As for the analysis unit configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and an amount of the measurement sample used for counting the measurement-target substances, Li does not explicitly state this. Li apparently refers to the accuracy of the counting by the flow cytometer system by demonstrating a linear relationship between the counted vales and known particle concentrations (paragraphs 0018 and 0048). Nevertheless, Ma in a flow cytometry detecting device and method teaches that a predetermined amount, a predetermined volume of a sample thereby being an amount of the measurement sample used for counting the measurement-target substances, of a sample of particles injection pumped into the sample flow can have its concentration determined by measuring its particle number (paragraphs [0027] and [0064]). And Albuljadayel in a device for preparing an undifferentiated cell from a more committed cell teaches that any suitable cytometer can conduct cell counts with counting means thereby measuring the cell concentration of a cell population of a measured volume of a cell population (col. 5, line 65 to col. 6, line 10).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the analysis unit be configured to obtain a concentration of the measurement-target substances on the basis of the number of the counted measurement-target substances and an amount of the measurement sample used for counting the measurement-target substances for in flow cytometry a predetermined volume of sample of particles supplied to the flow cell has its concentration determined by virtue of having the particles in the sample counted.
Allowable Subject Matter
13. Claim 6 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.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: please refer to the attached PTO-892. As well the examiner notes US 5,308,990 to Takahashi et al. (see col. 8, lines 17-21 and FIG. 1: 3 being a nozzle, 5 being a syringe pipettor, and a flow path from 3 to 4 and 6; and col. 16, lines 18-40: demonstrating that there is a relation between a concentration of the human AFP and a counted number of labeled microparticles).
Fax/Telephone Numbers
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gordon J. Stock, Jr. whose telephone number is (571) 272-2431.
The examiner can normally be reached on Monday-Friday, 10:00 a.m. - 6:30 p.m.
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, Kara Geisel, can be reached at 571-272-2416. 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.
/GORDON J STOCK JR/
Primary Examiner, Art Unit 2877
Prosecution Insights