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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of steps, each step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that it is not specified in the claims as to who and/what are required to perform the steps recited in the claims.
Furthermore, in claim 1 it is noted that the “information” is not specified, defined in the claim.
It is noted that a broad, unspecified, measurement sample is not defined in the claim as being any specific substance or material (nor any specific state of matter). The same is applicable to “particles”. There is no requirement for the measurement (does not further define the sample) sample to contain any specific “particles” (platelets, etc.). It is noted that the terms particles and platelets only require two.
There is no requirement for the sample (nor any unspecified contents (unspecified particles) of the sample) to scatter any light (in any specific directions relative to anything).
It is noted that providing for, exposing “a measurement sample” to light radiation from the Sun that emits a broad spectrum of light radiation, in the ultraviolet (100–400 nm), visible (400–700 nm), and infrared (700 nm–1 mm) ranges would read on claim 1. Furthermore, exposing the sample to light in a location lit, irradiated by conventionally known light bulbs such as incandescent light bulbs that are known to emit a continuous spectrum of light across the visible range, approximately 400–700 nanometers would also read on the claim. Neither of the prior scenarios, possibilities require any special knowledge and skill beyond that of one of ordinary skill in the art.
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 1-13 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.
As to claim 1, it is unclear who/what is required to perform the “acquiring” because the claim does not provide for such. It is noted that such steps can be performed mentally, via employing ones eyes and brain.
Furthermore, it is unclear what is required to be considered as “light scattered information” (not structure) because such is not defined in the claim as being any specific information.
It is unclear how the recited steps provides for “a method of detecting platelet aggregation” because there is no requirement for the unspecified measurement sample to be/comprise any specific matter, substance (platelets, nor any specific particles). There is no requirement for the measurement sample to comprise any platelets nor for any aggregation of any platelets to occur, and for any detecting (step) of such to be performed by anyone nor any structure(s).
Furthermore, it is unclear what is required of the broad, unspecified “information” to be considered as “indicative” of a presence or absence of platelet aggregation (of what, in what, where?) because the claim does clear recite such. As noted above, there is no requirement for the measurement sample to contain any platelets, no aggregation of such is required to occur; and what any information is interpreted as being indicative of is subjective. What such “information” (results, conclusions, data, etc.) gained, observed, inferred, etc. from the sample (unspecified and not required to contain any platelets) being irradiated by light is considered/interpreted as being “indicative” of to one person may not be considered as such to another and vice versa.
The claim as drafted does not clearly state how irradiating a measurement sample (not specified nor required to claim any platelets that required to be aggregated with anything) with light provides for any detecting of platelet aggregation and any “information” that would indicate a presence or absence of platelet aggregation. There is no step recited in the claim that requires any detecting of anything (including, but not limited to an absence or presence of “platelet aggregation”; of what; in what; by what; where?)
The last paragraph of claim 1 is confusing because the claim as drafted does not provide for any clear and definitive wavelength ranges. It is noted that “315 nm or longer” encompasses values greater that 600nm and “600nm or shorter” encompasses values less than 315 nm. If applicant intends for such first wavelength to be within a range of 315 nm to 600nm, then the claim should clearly recite such. The same is applicable to the further range values recited in the same paragraph directed to the second wavelength. The same is applicable to claim 13.
Dependent claims 2-13 are rejected via dependency upon a rejected claim.
As to claims 2-3, 6, and 13, it is unclear how such claims further limit the method of claim 1 because such claims do not provide for any additional step to that of claim 1 nor further limit and prior claimed step that defines the method of claim 1.
Claim 2 is directed to what the unspecified “first scattered light information” and “second scattered light information” is subjectively intended to be, can be considered as being “related to”. Any information can be subjectively considered as being “related to” to whatever one desires. Also applicable to the phrase “relate to” in claims 6, 9, and 11.
As to claims 2 and 6-12, it is unclear what is required to be considered as “side-scattered light” and “forward-scattered light” (wavelengths and intensity) because such have not been clearly defined in the claims. Nothing has been claimed as comprising any side and there is no relative basis provided for in the claim as to what is considered as “forward”. Therefore, it is unclear what is required by such phrases in the claims.
As to claim 3, it is unclear if it is intended for “the measurement sample” to comprise a mixture of whole blood and a (broad, unspecified dilution reagent) because the claim does not recite such. The claim is directed to what was previously done (prior to the method, currently being defined in the claims). How and/or what was previously done to “prepare” the measurement sample does not define the instant method being claimed. See also claim 5.
As to claims 3-5, it is unclear what is required to be considered as “a dilution reagent” and “hemolysis” reagent because such are not defined, specified in the claims. The dilution reagent and hemolysis reagent not mutually exclusive. The terms “dilution” and “hemolysis” are moreso directed to the intended use. However, it is noted that the claims do not provide for nor require and performance of “diluting” and “hemolyzing”. Nor is there any required for and fluorescing of anything to occur.
It is noted that claim 4 is directed to negative exclusions, what the “measurement sample” does not comprise, include, contain, etc. See also claim 5.
It is further noted that the measurement sample of claim 1 is not required to be whole blood. Therefore, it is unclear how the last paragraph of the claim further limits the method because no blood cells are previously stated as nor required to be present in the measurement sample.
As to claim 6-7, 9, and 12, it is unclear what is required to be done by who/what such that the anything is considered as “classified” and what is required to be done to be considered as “classifying” because the claims do not clearly recite such.
Therefore, in addition to prior applicable remarks/rejections above, as to claims 6-11, it is unclear what is required to be considered as defining the respective “populations” recited in the claims, and what is required of such populations to be related to any light nor anything else because the claims do clearly recite such. It is unclear what action(s) are required to be done by who or what such that the measurement sample is “classified” into a platelet containing population and a non-platelet blood cell-containing population because the claim does not clearly recite such. It is noted that “classifying” can be performed mentally. Furthermore, it has not been previously established that the measurement sample comprise any platelets and blood cells. The prior recited particles of the measurement sample are not required to be and/or include any platelets and blood cells. This is also applicable to the “classifying” in claims 7, 9, and 12.
Furthermore, as to claims 6 and 9, it is unclear what the pronoun “whose” references and it is noted that any value(s) can be considered as “threshold values”.
As to claims 8 and 10-12, it is presumed that it is intended for someone or something (not specified in the claims) to perform a step of creating a scattergram…. If so, the claims should be amended to clearly recite such. It is noted that the specification recites analysis unit 300 performs such a step. However, such is not recited in the claims.
As to claim 9, it is unclear what is “a while blood cell containing population”. The term “while” appears to be a misspelling.
As to claim 11, it is unclear what predetermined area of what is being referenced in the claim because the claim does not clearly recite such. Furthermore, it is unclear what is considered as a predetermined area because there is no step for determining of an area to be performed before (“pre”) any other step. Furthermore, such area is defined in the claims by any structural boundaries nor definitive dimensions so as to determine where such area begins and ends such the area can be distinguished from any other areas/locations.
As to claim 12, it is unclear how a scattergram can be created based of at least of white blood cell, platelet, and red blood cell because it is has not previously established, required for the measurement sample to contain any of such.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) steps of acquiring information, which can be performed mentally. Therefore, this is an abstract idea.
This judicial exception is not integrated into a practical application because once the information is “acquired” the claim does not require any further step that requires anything further to be done with such information. Therefore, there is no application, using the information to do anything, much less a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites irradiating the measurement sample. This does not add significantly more to the judicial exception because irradiating a sample with light via the sun or other means is well understood, routine and conventional in art for various purposes including providing for a stimulus for reactions and/or for detecting/analyzing the contents and properties of a sample.
The dependent claims 2-13 do not solve the issues of above because such do not provide for significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 13 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by KATSUMI; Hironori et al., US 20180267069.
Katsumi discloses a sample analyzer and method of use where , the first detectors 14b and the second detectors 15b output, to the second controller 26b, the detection signals obtained from the measurement specimens when emitting light having various wavelengths to the measurement specimens. The second controller 26b analyzes the samples based on the detection signals obtained for the respective wavelengths, by using the coagulation method (acquiring light scattering information). (Paragraph 0042).
For example, in the coagulation (aggregation) time method, each of the first detectors 14b and the second detectors 15b emits light with a wavelength of 660 nm (second wavelength) to the corresponding measurement specimen and detects the transmitted or scattered light from the measurement specimen with a photodetector to analyze the time it takes for the fibrinogen to convert to fibrin. Measurement items of the coagulation time method include PT (prothrombin time), APTT (activated partial thromboplastin time), Fbg (fibrinogen amount), and the like. Moreover, in the chromogenic substrate method, each of the first detectors 14b and the second detectors 15b emits light with a wavelength of 405 nm (first wavelength) to the corresponding measurement specimen and detects the transmitted or scattered light from the measurement specimen with the photodetector. Measurement items of the chromogenic substrate method include ATIII, α2-PI (α2-plasmin inhibitor), PLG (plasminogen), and the like. Furthermore, in the immunonephelometry, each of the first detectors 14b and the second detectors 15b emits light with a wavelength of 800 nm to the corresponding measurement specimen and detects the transmitted and scattered light from the measurement specimen with the photodetector. Measurement items of the immunonephelometry include D dimer, FDP, and the like. Moreover, in the platelet aggregation method, each of the first detectors 14b and the second detectors 15b emits light with a wavelength of 575 nm to the corresponding measurement specimen and detects transmitted or scattered light from the measurement specimen with the photodetector. (paragraph 0043).
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1),(a),(2) as being anticipated by TOUGAN; Takahiro et al., US 20210318240.
Tougan discloses a blood analyzer and a method of use where the light source unit 62 applies, to the flow cell 61, light in a band of wavelength that is not less than 400 nm and not greater than 435 nm (acquiring information at the first wavelength). Specifically, the light source unit 62 is a semiconductor laser light source, and applies, to the flow cell 61, blue-violet laser light having a wavelength of 405 nm. (paragraph 0059).
The intrinsic fluorescence is red light having a wavelength of not less than 600 nm and not greater than 700 nm (acquiring information at the second wavelength), and the intrinsic fluorescence generated from each of the red blood cells is individually detected by the detector 63. (paragraph 0090).
Each time light is applied to the red blood cell, scattered light is generated from the red blood cell. The scattered light (forward scattered light) generated from the red blood cell has a wavelength of 405 nm and is detected by the detector 64. (paragraph 0091).
When the first measurement data analysis process starts, the CPU 301 firstly sorts the detected blood cells into white blood cells, aggregate platelets, normal red blood cells, and malaria-infected red blood cells based on the fluorescence intensity and the forward scattered light intensity included in the first measurement data, and counts each of the white blood cells, the aggregate platelets, the normal red blood cells, and the malaria-infected red blood cells (step S401). (paragraph 0096).
An operation of sorting the detected blood cells into white blood cells, aggregate platelets, normal red blood cells, and malaria-infected red blood cells will be described with reference to FIG. 8. In the scattergram illustrated in FIG. 8, the vertical axis represents forward scattered light intensities, and the horizontal axis represents fluorescence intensities.
The white blood cells substantially appear in a region 401 (hereinafter, a particle group in the region 401 is referred to as a first particle group) in which the forward scattered light intensity is higher than that of an aggregation of normal red blood cells and malaria-infected red blood cells, and the fluorescence intensity is higher than that of an aggregation of the normal red blood cells and aggregate platelets. The aggregate platelets substantially appear in a region 402 in which the forward scattered light intensity is almost the same as that in the region 401, and the fluorescence intensity is lower than that in the region 401. (classifying of particles, paragraphs 0097-98).
As to claims 2 and 6-7, the detector 64 detects forward scattered light generated from a measurement sample. (paragraph 0061). A detector may be disposed at an appropriate position relative to the flow cell 61 and detect other scattered light such as side scattered light or backward scattered light instead of forward scattered light. (paragraph 0062).
As to claim 3, the diluent is sent from the reagent container 53 into the first reaction chamber 54A, and a reaction solution of the blood sample, the hemolyzing agent, and the nucleic acid staining reagent is diluted by the diluent, to prepare the first measurement sample. (paragraph 0040).
As to claims 4-5, the reagent container 53 stores a diluent that does not contain a hemolyzing agent and a staining dye. (paragraph 0039).
As to claims 8-12, an operation of sorting the detected blood cells into white blood cells, aggregate platelets, normal red blood cells, and malaria-infected red blood cells will be described with reference to FIG. 8. In the scattergram illustrated in FIG. 8, the vertical axis represents forward scattered light intensities, and the horizontal axis represents fluorescence intensities. (paragraphs 0097, 106, 118, 123, 138).
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 1-2, 6-7, 9-10, and 13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 21-22, and 30 of copending Application No. 18/766,805 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application fully encompass the scope of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the copending applicant are:
1. A method for analyzing blood cells, the method comprising: acquiring first scattered light information, second scattered light information, and fluorescence information generated by irradiating a measurement sample that contains a particle stained with a fluorescent dye with a light of a first wavelength and a light of a second wavelength; identifying blood cells other than white blood cell from the particles in the measurement sample, with reference to the first scattered light information and the second scattered light information, and/or, with reference to the first scattered light information and the fluorescence information; and classifying the blood cells other than white blood cell into reticulocyte and platelet, with reference to the fluorescence information and the second scattered light information, the first wavelength being 315 nm or longer and 600 nm or shorter, and the second wavelength being 610 nm or longer and 750 nm or shorter.
2. The method according to claim 1, wherein the first scattered light information is information related to side-scattered light generated from the particle upon irradiation of the measurement sample with the light of the first wavelength, the second scattered light information is information related to forward-scattered light generated from the particle upon irradiation of the measurement sample with the light having the second wavelength, and the fluorescence information is information related to fluorescence generated from the fluorescent dye on the particle upon irradiation of the measurement sample with the light of the first wavelength.
21. The method according to claim 20, wherein the first scattered light information is the intensity of the side-scattered light from the particle irradiated with the light of the first wavelength, the second scattered light information is the intensity of the forward-scattered light from the particle irradiated with the light of the second wavelength; and in the step of identifying, the blood cells other than white blood cell are identified, with reference to the forward-scattered light intensity and the side-scattered light intensity, the blood cells other than white blood cell are classified into a red blood cell-containing population and a platelet-containing population with reference to the forward-scattered light intensity, and, information that indicates presence of the platelet aggregation is acquired, if the platelet-containing population contains a particle that exhibits a forward-scattered light intensity equal to or above a threshold value.
22. The method according to claim 21, wherein in the step of identifying, a scattergram is created with reference to the forward-scattered light intensity and the side-scattered light intensity; the particles in the measurement sample are identified as a red blood cell-containing population, a platelet-containing population, and white blood cell on the scattergram; and information that indicates presence of the platelet aggregation is acquired, if the platelet-containing population contains a particle that exhibits a forward-scattered light intensity equal to or above a threshold value.
30. The method according to claim 1, wherein the first wavelength is 315 nm or longer and 490 nm or shorter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matsuba; Hiroaki et al.; HAYDEN; Oliver et al.; MIZUKAMI; Toshihiro et al.; TOYA; Yuji; Mizukami; Toshihiro et al.; MIZUKAMI; Toshihiro et al.; BULL; Brian S. et al., ZHENG; Wenbo et al.; YASUDA; Kenji; Tougan; Takahiro et al.; SUZUKI; Yuhgi et al.; Suzuki; Yuhgi et al.; YAMADA; Kazuhiro; KURONO; Hiroshi et al.; Tsuji; Tomohiro et al.; Tsuji; Tomohiro et al.; Tsuji; Tomohiro et al.; Dertinger, Stephen D.; Roche, John W. et al. and Shirasawa; Yoshiaki disclose devices and methods for irradiating a sample.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
Prosecution Insights