DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
WITHDRAWN REJECTION
2. The office actions mailed on 10/01/2025 have been withdrawn by the examiner.
Amendment
3. The amendment filed on 09/04/2025 has been entered into this application.
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. Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
6. 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.
7. 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 limitations use 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 limitations are:
“a staining module configured to”, “a lighting module configured to”, “an imaging module configured to”, and “a collimator configured to” in claims 1, 10, and 16.
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.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 1-8 and 10-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Pub. No. 2020/0033249 A1 by Adams et al. (hereinafter Adams) in view of US Patent Pub. No. 2016/0231494 A1 by Feingold et al. (hereinafter Feingold).
Regarding Claim 1, Adams teaches a biological imaging analyzer (Fig. 1, Par. [0002]) comprising:
a staining module configured to stain cells of a biological sample so as to produce stained cells (Par. [0004]);
a lighting module (Fig. 1 @ 42, Par. [0117]) configured to illuminate the stained cells (Fig. 1 @ 32, Par. [0112]), the lighting module comprising a plurality of pulsed lights (Par. [0126]: strobe light, i.e. the plurality of pulsed lights, implicitly teaches); and
an imaging module (Fig. 1 @ 24, Par. [0112]) configured to capture images of the stained cells (Par. [0004, 0112]), the imaging module (Fig. 1 @ 24, Par. [0112]) defining an optical axis (Fig. 1 @ 57 to 46, defining an optical axis, Par. [0115]) but does not explicitly teach a plurality of pulsed lights having different wavelengths to produce a white light.
However, Feingold teaches a plurality of pulsed lights (Fig. 8 @ 150, 152, Par. [0048-0049, 0055, 0057]. Also see Fig. 9, Par. [0064-0065]) having different wavelengths to produce a white light (Fig. 3 @ 66a, 66b, 66c, Par. [00023, 0027], Fig. 4 @ 66a, 66b, 66c, Par. [00029, 0033-0034]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Adams by Feingold as taught above such that a plurality of pulsed lights having different wavelengths to produce a white light is accomplished in order to provide different emission wavelength distributions as a light source for measurement, and the measurement accuracy is improved.
Regarding Claim 2, Adams teaches a flowcell (Fig. 1 @ 22, Par. [0112]) configured to flow the stained cells therethrough, the flowcell further comprising an imaging region (Fig. 1 @ 23, Par. [0112-0113]) where the images are captured.
Regarding Claim 3, Adams teaches the imaging module comprises a camera (Par. [0006, 0060, 0181]).
Regarding Claim 4, Adams teaches the stained cells are white blood cells with a stained nuclear region (Par. [0002, 0004, 0056, 0065, 0175]).
Regarding Claim 5, Adams as modified by Feingold teaches the plurality of pulsed lights of the lighting module (See Claim 1 rejection) comprise three light emitting diodes (Feingold, (Fig. 3 @ 66a, 66b, 66c, Par. [00023, 0027], Fig. 4 @ 66a, 66b, 66c, Par. [00029, 0033-0034]). Note: 5-steps omitted due to same motivation.
Regarding Claim 6, Adams as modified by Feingold teaches the three light emitting diodes comprise a red light emitting diode, a blue light emitting diode, and a green light emitting diode (Feingold, Fig. 4 @ 66a-66c, Par. [0029]: red, green and blue LEDs 66a-66c, respectively).
Regarding Claim 7, Adams as modified by Feingold teaches dichroic filters (Feingold, Fig. 4 @ 90, 92, Par. [0030-0032]) but does not explicitly teach three dichroic filters.
However, it is considered obvious to try all known solutions when there is a recognized need in the art (three dichroic filters), there had been a finite number of identified (two, three, multiple dichroic filters), predictable solutions to the recognized need, and when one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. See MPEP § 2143, E. Furthermore, such an arrangement would imply to one of ordinary skill in the art before the effective filing date of the claimed invention to use three dichroic filters to achieve higher spectral precision, better signal-to-noise ratios, and to manage multiple wavelengths more effectively.
Regarding Claim 8, Adams as modified by Feingold teaches a collimator configured to combine the plurality of pulsed lights into a white light (Feingold, Fig. 3 @ 68, Par. [0023]. Also see Fig. 4 @ 96, Par. [0038]).
Regarding Claim 10, Adams as modified by Feingold teaches a biological imaging analyzer (See Claim 1 rejection) comprising:
a lighting module configured to illuminate stained cells, the lighting module comprising a plurality of pulsed lights having different wavelengths to produce a white light (See Claim 1 rejection);
a flowcell configured to flow the stained cells therethrough, the flowcell including an imaging region (See Claim 2 rejection); and
an imaging module configured to capture images of the stained cells at the imaging region of the flowcell (See Claim 2 rejection), the imaging module defining an optical axis (See Claim 1 rejection).
Regarding Claim 11, Adams as modified by Feingold teaches the imaging module comprises a camera (See Claim 3 rejection).
Regarding Claim 12, Adams as modified by Feingold teaches the stained cells are white blood cells with a stained nuclear region (See Claim 4 rejection).
Regarding Claim 13, Adams as modified by Feingold teaches the plurality of pulsed lights of the lighting module comprise three light emitting diodes (See Claim 5 rejection).
Regarding Claim 14, Adams as modified by Feingold teaches the three light emitting diodes comprise a red light emitting diode, a blue light emitting diode, and a green light emitting diode (See Claim 6 rejection).
Regarding Claim 15, Adams as modified by Feingold teaches three dichroic filters (See Claim 7 rejection).
Regarding Claim 16, Adams as modified by Feingold teaches a collimator configured to combine the plurality of pulsed lights into a white light (See Claim 8 rejection).
Regarding Claim 18, Adams as modified by Feingold teaches a method of flow imaging a biological sample (See Claim 1 rejection. Note: an apparatus claim can be used to implement a method claim) comprising:
flowing the biological sample including a plurality of stained cells through an image capture region of a flowcell (See Claim 2 rejection: stained cells thus teaches a plurality of stained cells);
utilizing a lighting module to illuminate the image capture region with a plurality of pulsed lights having different wavelengths to produce a white light (See Claim 1 rejection) as the biological sample flows through the image capture region of the flowcell (See Claims 1, 2 rejection); and
capturing images of the plurality of stained cells at the image capture region with a camera (See Claims 1-3 rejection), the camera defining an optical axis (See Claim 1 rejection).
Regarding Claim 19, Adams as modified by Feingold teaches combining the plurality of pulsed lights into a white light (See Claim 8 rejection).
10. Claims 9, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Feingold and further in view of US Patent No. 5544140 by Seagrave et al. (hereinafter Seagrave).
Regarding Claim 9, Adams as modified by Feingold teaches the lighting module (See Claim 1 rejection) but does not explicitly teach further comprises a lightpipe configured to randomize the white light.
However, Seagrave teaches a lightpipe (Fig. 7 @ 24, Col. 11, line 48-50) configured to randomize the white light (Fig. 7 @ 20, Col. 11, line 48-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Adams as modified by Feingold by Seagrave as taught above such that a lightpipe configured to randomize the white light is accomplished in order to provide more balanced, consistent output across the entire fiber face.
Regarding Claim 17, Adams as modified by Feingold as modified by Seagrave teaches the lighting module further comprises a lightpipe configured to randomize the white light (See Claim 9 rejection).
Regarding Claim 20, Adams as modified by Feingold teaches randomizing the white light (See Claim 9 rejection).
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The reference listed teaches of other prior art method/system of producing white light.
JPH11295219A by WATABE SHIGEO et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMIL AHMED whose telephone number is (571)272-1950. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM.
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/JAMIL AHMED/Primary Examiner, Art Unit 2877