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 .
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 and 7-11 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 claim 1, the claim recites that the processing circuity is able to “determine first pulse width values of the particles using a first technique” and “determine second pulse width values of the particles using a second technique”. However, these limitations are unclear, as, it is unclear what “a first technique” and “a second technique” refer to for determining the first and second pulse width values, respectively. Is the first technique and the second technique limited to only the first technique and the second technique found in the instant specification, where the first technique directly measures a pulse width and the second technique indirectly measures the pulse width values, with these techniques being further recited in claims 2 and 7? Or are the first and second technique any technique that is capable of determining the pulse width of particles, whether or not those techniques are known to the inventor or have yet to be invented? As the metes and bounds of the techniques set forth by the instant claim cannot be determined, the claim is rejected as indefinite.
In order to overcome this rejection, the examiner recommends amending the limitations of claims 2 and 7 (notwithstanding the additional issues discussed below regarding claim 7) into claim 1 in order to limit the first and second techniques to those found in the instant specification.
Claim 7 recites the limitation "a function of the maximum value of the waveform and an area of the waveform" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. First, what is the maximum value of the waveform? Is it the amplitude? Is it the width? The frequency? Some other aspect? Next, what waveform is being referred to here? Claim 1, the claim on which claim 7 depends, is silent with regards to a waveform. The examiner notes that the maximum value only finds antecedent basis in claim 4, while the waveform first finds antecedent basis in claim 3. Claim 7 does not depend on either of those claims.
Claims 8-11 are rejected by virtue of their dependency on claim 1, thereby containing all the limitations of the claim on which they depend.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,326,394 in view of Zilmer et al (“Flow Cytometric Analysis Using Digital Signal Processing”).
Regarding claim 1, claim 1 of the ‘394 patent claims a method for characterizing particles, the method comprising steps that are equivalent to the functions of the processing circuitry of the instant claim. These functions include determining first pulse width values of the particles using a first technique (see lines 3-4 of the ‘394 claim) ;determining second pulse width values of the particles using a second technique (see lines 5-6 of the ‘394 claim) ;comparing the first and second pulse width values (see line 7 of the ‘394 claim); and characterizing the particles as concatenated particles when a difference between the first and second pulse width values exceeds a threshold (see lines 8-10 of the ‘394 claim).
The ‘394 claim, however, fails to disclose the elements of a system for characterizing particles, these elements comprising a light emitting unit generating one or more excitation light beams; a fluidic system streaming the particles through the one or more excitation light beams at an interrogation zone; optical elements directing scattered light from the interrogation zone; one or more detectors measuring characteristics of the scattered light; and a processing circuitry having non-transitory computer readable storage media storing instructions to execute the functions set forth above.
Zilmer, in a device for flow cytometric analysis using digital signal processing, discloses a system for characterizing particles (see abstract) comprising a light emitting unit generating one or more excitation light beams (488 nm argon laser; see Col. 2 of page 103 in the flow cytometer section); a fluidic system streaming the particles through the one or more excitation light beams at an interrogation zone (inherent to the flow cytometer disclosed in Col. 2 of page 103 in the flow cytometer section); optical elements directing scattered light from the interrogation zone (narrow beam optics; see Col. 2 of page 103 in the flow cytometer section); one or more detectors measuring characteristics of the scattered light (PMTs in Col. 2 of page 103 in the flow cytometer section); and a processing circuitry having non-transitory computer readable storage media (see the processor board with RAM on a personal computer in Col. 2 of page 103 into Col. 1 of page 104 in the Processor Board section in the flow cytometer section).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the system of Zilmer to obtain the data that is then processed using the method of by claim 1 of the ‘394 patent, the motivation being that Zilmer discloses a classic flow cytometer while disclosing the benefits of digital processing such as the ability to discriminate between particle classes which produce feature values indistinguishable through analog pulse processing (see Zilmer abstract).
Further claim correspondence is as follows:
Claim 2 of the instant application with claim 2 of the ‘394 patent.
Claim 3 of the instant application with claim 3 of the ‘394 patent.
Claim 4 of the instant application with claim 4 of the ’394 patent.
Claim 5 of the instant application with claim 5 of the ’394 patent.
Claim 6 of the instant application with claim 6 of the ’394 patent.
Claim 7 of the instant application with claim 7 of the ’394 patent.
Claim 8 of the instant application with claim 8 of the ’394 patent.
Claim 9 of the instant application with claim 9 of the ’394 patent.
Claim 10 of the instant application with claim 10 of the ’394 patent.
Claim 11 of the instant application with claim 11 of the ’394 patent.
Allowable Subject Matter
Claims 1-11 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, along with the double patenting rejection set forth above.
Given the nature of the 35 USC 112(b) rejection set forth above, specific reasons for the allowability of the claimed invention are precluded until the rejection is properly overcome. However, the closest prior art, “Flow Cytometric Analysis Using Digital Signal Processing” by Zilmer et al, discloses a device for flow cytometric analysis using digital signal processing, discloses a system for characterizing particles (see abstract) comprising a light emitting unit generating one or more excitation light beams (488 nm argon laser; see Col. 2 of page 103 in the flow cytometer section); a fluidic system streaming the particles through the one or more excitation light beams at an interrogation zone (inherent to the flow cytometer disclosed in Col. 2 of page 103 in the flow cytometer section); optical elements directing scattered light from the interrogation zone (narrow beam optics; see Col. 2 of page 103 in the flow cytometer section); one or more detectors measuring characteristics of the scattered light (PMTs in Col. 2 of page 103 in the flow cytometer section); and a processing circuitry having non-transitory computer readable storage media (see the processor board with RAM on a personal computer in Col. 2 of page 103 into Col. 1 of page 104 in the Processor Board section in the flow cytometer section). Zilmer continues to determine whether or not a particle is concatenated by using pulse integral and pulse kurtosis (see the doublet discrimination section on page 110 along with Figs. 10 and 11). However, this process is different from the claimed invention that relies on characterizing particles as concatenated by comparing a difference between first and second pulse width values with a threshold, where the particles are considered concatenated when the difference exceeds that threshold.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. 4,263,508 to Leary et al. discloses pulse edge measurement for determining particle characteristics where the pulse edge width between two threshold values are measured using a flow cytometer as indications of particle dimensional attributes (see abstract); and US 2017/0191923 to Ling et al. discloses a detection and signal processing system for particle assays where particles are identified by the amplitudes of their waveforms (see claim 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
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/Michael A Lyons/Primary Examiner, Art Unit 2877 August 5, 2026
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