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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because figures 1, 6A, 6B, 7A, 7B, 8A and 8B are all too blurry to read properly. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is two paragraphs and has too many words (161). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The specification is objected to because there are closed parenthesis in paragraphs [0010] and [0009], specifically “sample analyzer)”. Examiner requests clarification on where the open parenthesis is and appropriate amendments to these paragraphs.
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) is/are:
“a light irradiation unit that irradiates a biological particle contained in a biological sample with light” in claim 1, which is being interpreted as “two or more lasers” as disclosed in the second paragraph on pg. 4 of the specification and equivalents thereof;
“a detection unit that detects light generated by the light irradiation” in claim 1, which is being interpreted as “one or more photodiodes” as disclosed on pg. 4 of the specification and equivalents thereof; and
“an information processing unit that controls the light irradiation unit” in claim 1, which is being interpreted as “The information processing unit 6103 may be designed as a general-purpose computer, and may be designed as an information processing device that includes a CPU, a RAM, and a ROM, for example. The information processing unit 6103 may be included in the housing in which the light irradiation unit 6101 and the detection unit 6102 are included, or may be located outside the housing. Further, the various processes or functions to be executed by the information processing unit 6103 may be realized by a server computer or a cloud connected via a network.” as disclosed in paragraph [31] of the specification and equivalents thereof.
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 Objections
Claims 1-6, 8-10 and 13-17 are objected to because they contain limitations that do not properly recite additional structural elements of the claimed analyzer. Specifically, Claim 1 recites “the information processing unit determines… and adjusts an output of light irradiation by the light irradiation unit…”; Claims 2-6 and 15 recite “the information processing unit adjusts…”; Claim 8 recites “wherein, in the determination, the information processing unit determines…”; Claim 9 recites “the information processing unit refers to Height data…”; Claims 10 and 14 recites “…unit determines whether… unit has adjusted”; Claim 13 recites “…unit corrects the data”; Claim 16 recites “…unit does not perform the adjustment…”; Claim 17 recites “wherein the… unit executes the adjustment…”. None of these recitations properly introduce additional structural features of the analyzer because these “steps” require some kind of programming/algorithm to enable the analyzer to perform these steps. In the interest of compact prosecution, Examiner interprets each of these recitations to positively recite the inclusion of the necessary structural elements needed for the analyzer to perform these functions. Claim 1 is interpreted to read “the information processing unit is configured to determine… and is configured to adjust an output…”; claims 2-6, 8-10, and 13-17 are interpreted in the same manner. Appropriate correction is required for all of the noted sections of the claims.
Claims 1, 10, and 11 are objected to because the phrase “generated by the light irradiation” should be reworded to “generated by the light irradiation unit”.
Claim 9 is objected to because “in the determination” should be reworded to “in the determination step”.
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 1-17 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, in the last line “according to the determination result” is indefinite because the relationship between the adjustment, predetermined condition, and the determination result is unclear; does adjustment happen if fluorescence is too high or too low? Clarification should be added to the claim language. In the interest of compact prosecution, Examiner interprets “according to the determination result” to mean “after the determination step”.
Claim 10 recites the limitation "the laser light source" in line 4. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, Examiner interprets “the laser light source” as being “the light source”.
Claims 2-9 and 11-17 are rejected by virtue of their dependency on claim 1.
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.
Claim(s) 1-9, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tahara (EP3521807A1).
Regarding claim 1, Tahara teaches a biological sample analyzer (paragraph [44] and [25]) (the present technology provides a fine particle measuring device at least including and "fine particles" broadly include: bio-related fine particles such as cells) comprising:
a light irradiation unit that irradiates (interpreted as “two or more lasers” as discussed above) a biological particle contained in a biological sample with light (paragraph [12]-[13]) (at least two light sources having different wavelength regions… the light source may be a laser);
a detection unit that detects light (interpreted as “one or more photodiodes” as discussed above) generated by the light irradiation (paragraph [5]) (For the light receiving element array, there is used a PMT array or a photodiode array).
an information processing unit that controls the light irradiation unit (interpreted as a “generic purpose computer” as discussed above) (paragraph [77]) (device 1 according to the present technology can be stored as a program in a personal computer).
Regarding claim 2, Tahara teaches the analyzer of claim 1 as rejected above, wherein the detection unit includes one or more photodiodes (paragraph [5]) (For the light receiving element array, there is used… a photodiode array). Recall that “the information processing unit adjusts…” portion of claim 2 is interpreted as the intended use of the analyzer, and is not granted patentable weight (see Claim Interpretation section).
Regarding claim 3, Tahara teaches the analyzer of claim 1 as rejected above, wherein the information processing unit adjusts the output of light irradiation by the light irradiation unit on a basis of Height data in the detection result of the fluorescence (paragraph [16] and [44]) (unit may adjust an output of the another light source on the basis of a preset adjustment ratio of feature quantities of the output pulses of the reference light source and the another light source and A feature quantity of the output pulse is not particularly limited, but in the present technology, a height of an output pulse).
Regarding claim 4, Tahara teaches the analyzer of claim 1 as rejected above, wherein the information processing unit adjusts the output of light irradiation by the light irradiation unit using an adjustment coefficient set on a basis of Height data in the detection result of the fluorescence and a predetermined target value (paragraph [16] and [44]) (unit may adjust an output of the another light source on the basis of a preset adjustment ratio of feature quantities of the output pulses of the reference light source and the another light source and A feature quantity of the output pulse is… a height of an output pulse).
Regarding claim 5, Tahara teaches the analyzer of claim 1 as rejected above,
wherein the light irradiation unit includes two or more laser light sources for coaxial irradiation (paragraph [12]-[13]) (at least two light sources having different wavelength regions… the light source may be a laser), and
the information processing unit adjusts outputs of the two or more laser light sources for coaxial irradiation, using a same adjustment coefficient (paragraph [50]) (Both the LD_S and another light source (hereinafter also referred to as "LD_T") are lighted… LD_S and the LD_T are coaxially installed).
Regarding claim 6, Tahara teaches the analyzer of claim 1 as rejected above, wherein the light irradiation unit includes two or more laser light sources for irradiation with different axes (paragraph [12]-[13] and [50]) (at least two light sources having different wavelength regions… the light source may be a laser and In a case where the LD_S and the LD_T are installed with different axes), and the information processing unit adjusts outputs of the two or more laser light sources for irradiation with the different axes independently of each other (paragraph [59]) (In a case where there is another light source in addition to the LD_T, (b) and (c) are performed on the corresponding light source to perform output adjustment similarly to the LD_T).
Regarding claim 7, Tahara teaches the analyzer of claim 1 as rejected above, wherein the detection unit includes one or more photodiodes (paragraph [5]) (For the light receiving element array, there is used a PMT array or a photodiode array), and the predetermined condition is a condition set on a basis of a condition where saturation of a signal occurs in the detection unit (paragraph [54]) (it may be determined whether or not a current output value of the LD_T is within a range of an output upper limit standard value (Pmax)).
Regarding claim 8, Tahara teaches the analyzer of claim 1 as rejected above, wherein, in the determination, the information processing unit determines whether Height data in the detection result of the fluorescence satisfies the predetermined condition (paragraph [16] and [44]) (unit may adjust an output of the another light source on the basis of a preset adjustment ratio of feature quantities of the output pulses of the reference light source and the another light source and A feature quantity of the output pulse is … a height of an output pulse).
Regarding claim 9, Tahara teaches the analyzer of claim 8 as rejected above, wherein the detection unit includes a plurality of fluorescence channels (paragraph [50]) (the detection unit 12 has a plurality of channels), and the information processing unit refers to Height data of a fluorescence channel from which a maximum Height value is obtained from among the plurality of fluorescence channels, in the determination (paragraph [44]) (A feature quantity of the output pulse is … a height of an output pulse).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tahara (EP3521807A1) in view of Oshima (US 20080304055 A1).
Regarding claim 10, Tahara teaches the analyzer according to claim 1 as rejected above. Tahara teaches of adjusting the output of a laser light source (paragraph [16]) (unit may adjust an output of the another light source).
Tahara does not explicitly describe wherein the information processing unit determines whether the information processing unit has adjusted the output of the laser light source included in the light irradiation unit, and corrects data related to scattered light generated by the light irradiation according to the determination result.
In the analogous art of using a fluorescence-analyzer to analyze a sample, Oshima teaches of correcting fluorescence data after adjusting a laser light source’s intensity (paragraph [0136]) (sensor sensitivity is corrected by changing the voltage applied to the image intensifier and the multi-anode PMT, changing the sensor storage time, performing the illumination at the changed illumination intensity and the like). Oshima teaches that this allows for optimization of each of the fluorescence channels to, for example, account for different wavelengths (paragraph [136]) (This makes it possible to change the detection sensitivity for each of the light receiving sections so as to perform the sensor sensitivity correction).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the adjustment of the light source as disclosed by Tahara by correcting fluorescence data after adjusting the light source as disclosed by Oshima because doing so would lead to the predictable outcome of optimizing each of the plurality of fluorescence channels with a reasonable expectation of success (see [16] of Tahara and [136] of Oshima). See MPEP 2143(I)(G).
Regarding claim 11, modified Tahara teaches the analyzer of claim 10 as rejected above. Tahara further teaches wherein the data related to the scattered light includes Area data, Height data, or both the Area data and Height data of the scattered light generated by the light irradiation (paragraph [44]) (A feature quantity of the output pulse is not particularly limited, but in the present technology, a height of an output pulse or an area of an output pulse is preferable). Claim 11 is rejected under 35 USC 103 by virtue of its dependency on claim 10.
Regarding claim 12, modified Tahara teaches the analyzer of claim 10 as rejected above. Tahara further teaches an apparatus that performs the analysis of biological particles (paragraph [44] and [25]) (the present technology provides a fine particle measuring device and "fine particles" broadly include: bio-related fine particles such as cells). Tahara teaches an analyzer that collects data related to scattered light (paragraph [12]) (the present technology provides… a detection unit configured to detect light from a fluorescent reference particle).
Tahara is silent to wherein the data related to the scattered light includes threshold data for specifying a biological particle as an analysis target.
In the analogous art of using a fluorescence-analyzer to analyze a sample, Oshima teaches an analyzer that is programmed with a threshold value to determine the presence or absence of an analysis target (paragraph [10]) (elements are allowed to set the threshold value). Oshima teaches that the threshold value can allow for differentiation between noise and the presence of an analysis target (paragraph [10]) (threshold value capable of distinguishing… noise from the defect signal based on the level of the shot noise).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the detection of a biological particle as disclosed by Tahara by setting a threshold value as disclosed by Oshima because doing so would lead to the predictable outcome of differentiating between background noise and an analyte signal with a reasonable expectation of success (see paragraph [44] and [25] of Tahara and paragraph [10] of Oshima). See MPEP 2143(I)(G).
Regarding claim 13, modified Tahara teaches the analyzer of claim 10 as rejected above. Tahara further teaches wherein the information processing unit corrects the data related to the scattered light using a correction coefficient set on a basis of laser power before output adjustment and laser power after output adjustment of any laser light source included in the light irradiation unit (paragraph [16] and [62]) (unit may adjust an output of the another light source and In the separation unit 14, separation of fine particles is performed on the basis of spectrum data generated by correcting, with the information processing unit 13, a value detected by the detection unit 12). Claim 13 is rejected under 35 USC 103 by virtue of its dependency on claim 10.
Regarding claim 14, Tahara teaches the analyzer of claim 1 as rejected above. Tahara further teaches of adjusting the output of a laser light source (paragraph [16]) (unit may adjust an output of the another light source).
Tahara does not clearly describe wherein the information processing unit determines whether the information processing unit has adjusted the output of the light irradiation by the light irradiation unit, and adjusts a compensation matrix used in fluorescence correction according to the determination result.
In the analogous art of using a fluorescence-analyzer to analyze a sample, Oshima teaches of adjusting fluorescence data by manipulating a compensation matrix ([0136]) (The sensor sensitivity is corrected by changing the voltage applied to the image intensifier and the multi-anode PMT, changing the sensor storage time, performing the illumination at the changed illumination intensity and the like). Oshima teaches that this makes it possible to expand the dynamic range of the detection target (paragraph [122]) (This makes it possible to expand the dynamic range of the detectable defect).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the adjustment of laser power as disclosed by Tahara by adjusting a compensation matrix used in fluorescence correction as taught/disclosed by Oshima because doing so would lead to the predictable outcome of expanding the dynamic range of the detection target with a reasonable expectation of success (see [16] of Tahara and [122] of Oshima). See MPEP 2143(I)(G).
Regarding claim 15, modified Tahara teaches the analyzer of claim 14 as rejected above. Tahara teaches of adjusting the output of a laser light source (paragraph [16]) (unit may adjust an output of the another light source).
Tahara does not clearly describe wherein the information processing unit adjusts one or more compensation values in the compensation matrix by using a change coefficient set on a basis of laser power before output adjustment and laser power after output adjustment of any laser light source included in the light irradiation unit.
In the analogous art of using a fluorescence-analyzer to analyze a sample, Oshima teaches of adjusting correction coefficient set variables on a basis of the laser power before and after adjustment (paragraph [59] and [122]) (The laser beam from the laser light source 2 has its light intensity adjusted to the required value by the attenuator 3 and Illumination intensity of the beam spots 2-20c and 2-20d divided by the Wallaston prism 2-43 may be arbitrarily adjusted by controlling the ellipticity/azimuth of elliptic long axis). Oshima teaches that this makes it possible to expand the dynamic range of the detection target (paragraph [122]) (This makes it possible to expand the dynamic range of the detectable defect).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the adjustment as disclosed by Tahara by using a correction coefficient set on a basis of laser power before and after adjustment as disclosed by Oshima because doing so would lead to the predictable outcome of expanding the dynamic range of the detection target with a reasonable expectation of success (see [16] of Tahara and [122] of Oshima). See MPEP 2143(I)(G).
Regarding claim 16, modified Tahara teaches the analyzer of claim 15 as rejected above. Tahara teaches of optionally re-adjusting the light source depending on the output of data after the first adjustment (paragraph [23]) (Furthermore, in the information processing step, it is also possible to adjust an output of the another light source again in a case where the output value after output adjustment is not valid). Tahara teaches of using reference fluorescent particles as part of the analyzer (paragraph [47]) (A condition for being allowed to be used as the fluorescent reference particle includes being capable of providing a sufficient fluorescence intensity in a wavelength region of the light source to be corrected)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the analyzer of Tahara to not perform an additional adjustment step for a compensation value related to a pair of fluorescent dyes using a laser light source on which output adjustment has been performed as an excitation light because it would not generate new information/results and would lead to the predictable outcome of maintaining the same corrected laser light power and compensation matrix with a reasonable chance of success.
Regarding claim 17, modified Tahara teaches the analyzer of claim 15 as rejected above. Tahara further teaches wherein the information processing unit executes the adjustment on a compensation value related to a pair of one fluorescent dye using a laser light source on which the output adjustment has been performed as excitation light and one fluorescent dye using a laser light source on which the output adjustment has not been performed as excitation light (paragraph [16] and [47]) (unit may adjust an output of the another light source on the basis of a preset adjustment ratio of feature quantities of the output pulses of the reference light source and the another light source and A condition for being allowed to be used as the fluorescent reference particle includes being capable of providing a sufficient fluorescence intensity in a wavelength region of the light source to be corrected). Claim 17 is rejected under 35 USC 103 by virtue of its dependency on claim 15.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/730001 (published as US20250180461A1) in view of Tahara (EP 3521807 A1).
Instant Application 18/570,391
Reference Application 18/730001
Note: Additional elements of Instant Application are bolded
Claim 1: A biological sample analyzer comprising:
a light irradiation unit that irradiates a biological particle contained in a biological sample with light;
a detection unit that detects light generated by the light irradiation; and
an information processing unit that controls the light irradiation unit,
wherein the information processing unit determines whether a detection result of fluorescence by the detection unit satisfies a predetermined condition, and adjusts an output of light irradiation by the light irradiation unit according to the determination result.
Claim 1: A biological sample analysis system comprising:
a light irradiation unit designed to irradiate each particle flowing through a flow channel with light at a plurality of irradiation points;
a detection unit that detects light generated when each of the particles passes through each of the plurality of irradiation points; and
an information processing unit that processes data related to light detected by the detection unit,
wherein the information processing unit is designed to perform processing of setting a section that defines a time for acquiring data related to light generated by light irradiation at an irradiation point different from a reference irradiation point, and
the information processing unit executes the section setting processing on a basis of a change in data related to light accompanying a change in the section.
Regarding claim 1 of the instant application: As mapped above, claim 1 of Copending Application No. 18/730,001 (hereinafter called “reference application”) teaches the limitations of claim 1 of the instant application exception for “wherein the information processing unit determines whether a detection result of fluorescence by the detection unit satisfies a predetermined condition, and adjusts an output of light irradiation by the light irradiation unit according to the determination result”. Claim 1 of the reference application instead recites “setting a section that defines a time for acquiring data”.
Tahara teaches all of the limitations of claim 1 as rejected above under 35 USC 102 above. Tahara teaches that the adjustment enables high accuracy while using a plurality of light sources (paragraph [45]) (This configuration enables adjustment of an output difference of the plurality of light sources 11 with higher accuracy).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the instant application to modify the “setting a section that defines a time” step of the reference application with the adjustment of Tahara to lead to the predictable outcome of accurately adjusting the outputs of a plurality of light sources with a reasonable chance of success (see [45] Tahara). This is a provisional nonstatutory double patenting rejection.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12578259 in view of Tahara (EP 3521807 A1).
Instant Application 18/570,391
US Patent No. 12578259
Note: Bold text indicates where the reference patent does not teach the instant application
Claim 1: A biological sample analyzer comprising:
a light irradiation unit that irradiates a biological particle contained in a biological sample with light;
a detection unit that detects light generated by the light irradiation; and
an information processing unit that controls the light irradiation unit,
wherein the information processing unit determines whether a detection result of fluorescence by the detection unit satisfies a predetermined condition, and adjusts an output of light irradiation by the light irradiation unit according to the determination result.
Claim 1: A biological sample analyzer comprising:
a light irradiation unit that irradiates a particle with light;
a detection unit that detects light generated by the light irradiation; and
an information processing unit that controls the light irradiation unit and the detection unit,
wherein the information processing unit corrects a signal intensity measurement value of the light detected by the detection unit on a basis of a relationship between a light irradiation output value of the light irradiation unit and a signal intensity measurement value of the light detected by the detection unit;
wherein the information processing unit is configured to execute the correction using an n-th order approximation formula indicating the relationship, and n in the n-th order approximation formula is an odd number equal to or greater than 3; and
wherein the information processing unit creates a first-order approximation formula indicating a relationship between a light irradiation output value equal to or less than a predetermined value and a signal intensity measurement value acquired in a case of the light irradiation output value, and acquires a data group for generating the n-th order approximation formula using the first-order approximation formula.
Regarding claim 1 of the instant application: As mapped above, claim 1 of US Patent No. 12578259 (hereinafter called “reference patent”) teaches the limitations of claim 1 of the instant application exception for “wherein the information processing unit determines whether a detection result of fluorescence by the detection unit satisfies a predetermined condition, and adjusts an output of light irradiation by the light irradiation unit according to the determination result”. Claim 1 of the reference application instead recites correction steps as bolded in the table above.
Tahara teaches all of the limitations of claim 1 as rejected above under 35 USC 102 above. Tahara teaches that this adjustment enables high accuracy while using a plurality of light sources (paragraph [45]) (This configuration enables adjustment of an output difference of the plurality of light sources 11 with higher accuracy).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the instant application to modify the correction steps of the reference patent with the adjustment of Tahara to lead to the predictable outcome of accurately adjusting the outputs of a plurality of light sources with a reasonable chance of success (see [45] Tahara).
Conclusion
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/H.D.C./Examiner, Art Unit 1758
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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