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 Objections
Claim 10 is objected to because of the following informalities: there is insufficient antecedent basis for “the light detection unit” in the last 2 lines of the claim. Appropriate correction is required.
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 the sample in the sample accommodation space with light”; “a light detection unit that detects scattered light or fluorescent light generated from the sample irradiated with light”; and “an analysis unit that measures a particle size distribution of a particle group including the plurality of particles using a detection signal obtained by the light detection unit” in claim 1; and
“light detection unit” in claim 10; and
“a light irradiation unit that irradiates the sample in the sample accommodation space with light”; “a light detection unit that detects scattered light or fluorescent light generated from the sample irradiated with light”; and “an analysis unit that measures a particle size distribution of a particle group including the plurality of particles using a detection signal obtained by the light detection unit” in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3-6, 9-11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikeda (JP2003035650A), references to English machine translation, hereinafter “Ikeda”.
Regarding claim 1, Ikeda discloses a particle size distribution measuring device (abstract, Fig. 1) comprising:
a measurement cell (ref 1, paragraph [0011]) including a sample accommodation space that accommodates a sample (ref S, paragraph [0010]) obtained by dispersing a plurality of particles in a dispersion medium (paragraphs [0010]-[0011]);
a stirring means that stirs the sample by sucking and discharging the sample in the sample accommodation space (Fig. 2, ref 26, paragraphs [0031]-[0032]);
a light irradiation unit that irradiates the sample in the sample accommodation space with light (Fig. 1, ref 4, paragraph [0014]);
a light detection unit that detects scattered light or fluorescent light generated from the sample irradiated with light (refs 8, 9, paragraph [0015]); and
an analysis unit that measures a particle size distribution of a particle group including the plurality of particles using a detection signal obtained by the light detection unit (ref 24, paragraph [0024]).
Regarding claim 3, Ikeda discloses wherein stirring of the sample by the stirring means and measurement of the particle size distribution by the analysis unit are repeated a plurality of times (paragraph [0032]).
Regarding claim 4, Ikeda discloses wherein the stirring means is configured using a pipette (ref 27, paragraph [0033]).
Regarding claim 5, Ikeda discloses further comprising an attachment jig that attaches the pipette to the measurement cell, wherein the pipette is held by the attachment jig such that a distal end of a tip of the pipette is located in the sample accommodation space (Fig. 2, ref 28, paragraph [0032]).
Regarding claim 6, Ikeda discloses wherein the attachment jig includes a guide mechanism that guides a suction/discharge port of the pipette to suck and discharge the sample toward a predetermined position in the sample accommodation space when the pipette is attached (Fig. 2, ref 38, paragraph [0032]).
Regarding claim 9, Ikeda discloses wherein the sample is a biological sample (the sample does not change the structure of the device; the device of Ikeda functions with a biological sample).
Regarding claim 10, Ikeda discloses a method of measuring a particle size distribution of a particle group including a plurality of particles in a sample accommodated in a measurement cell (abstract, Fig. 1), the method comprising:
a stirring step of stirring the sample by sucking and discharging the sample in the measurement cell (Fig. 2, ref 26, paragraphs [0031]-[0032]);
a light irradiation step of irradiating the sample in the measurement cell with light (Fig. 1, ref 4, paragraph [0014]);
a light detection step of detecting scattered light or fluorescent light generated from the sample irradiated with light (refs 8, 9, paragraph [0015]); and
an analysis step of measuring a particle size distribution of the particle group using a detection signal obtained by the light detection unit (ref 24, paragraph [0024]).
Regarding claim 11, Ikeda discloses wherein the stirring step, the light detection step, and the analysis step are repeated a plurality of times for the same sample (paragraph [0032]).
Regarding claim 14, Ikeda discloses a kit for a particle size distribution measuring device that measures a particle size distribution of a particle group including a plurality of particles dispersed in a dispersion medium (abstract, Fig. 1), the kit comprising:
a measurement cell (ref 1, paragraph [0011]) including a sample accommodation space that accommodates a sample (ref S, paragraph [0010]) obtained by dispersing the particle group in a dispersion medium (paragraphs [0010]-[0011]); and
an attachment jig that attaches a pipette to the measurement cell such that a distal end of a tip of the pipette is located in the sample accommodation space (Fig. 2, ref 28, paragraph [0032]).
Claim Rejections - 35 USC § 103
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 2, 7, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeda as applied to claim 1 above.
Regarding claim 2, Ikeda is silent regarding further comprising an operation control unit that controls a suction operation and a discharge operation by the stirring means.
However, it has been held that providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). Furthermore, the Examiner takes Official Notice that using an operation control unit to perform the above method is well-known in the art. One would include an operation control unit that controls a suction operation and a discharge operation by the stirring means in order to rapidly perform analysis on samples without user input.
Regarding claim 7, Ikeda is silent regarding wherein the measurement cell includes a cuvette member including an internal space, and a block body accommodated in the internal space of the cuvette member, and the sample accommodation space is formed in the block body.
However, it has been held that a change is shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). One would select a block in order to have a flat surface for light to transmit, rather than a curved surface which would cause reflections.
Regarding claim 8, Ikeda is silent regarding wherein a volume of the sample accommodation space is less than or equal to 10 μL.
However, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). One would choose the claimed dimensions in order to have smaller samples, and not waste any sample. Having a smaller cell allows a smaller sample volume to mix and be analyzed.
Regarding claim 12, Ikeda discloses further comprising: a sample injection step of injecting the sample into the measurement cell using a pipette (paragraph [0031]); and wherein in the stirring step, the sample is stirred by pipetting using the pipette (paragraph [0031]), but is silent regarding an installation step of installing the pipette and the measurement cell at a predetermined measurement position.
However, the Examiner takes Official Notice that an installation step of installing the pipette and the measurement cell at a predetermined measurement position is well-known in the art in order to perform the optical analysis.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ikeda.
Regarding claim 13, Ikeda teaches a particle size distribution measuring device (abstract, Fig. 1) comprising: a measurement cell (ref 1, paragraph [0011]) including a sample accommodation space that accommodates a sample (ref S, paragraph [0010]) obtained by dispersing a plurality of particles in a dispersion medium (paragraphs [0010]-[0011]); a stirring means that stirs the sample by sucking and discharging the sample in the sample accommodation space (Fig. 2, ref 26, paragraphs [0031]-[0032]); a light irradiation unit that irradiates the sample in the sample accommodation space with light (Fig. 1, ref 4, paragraph [0014]); a light detection unit that detects scattered light or fluorescent light generated from the sample irradiated with light (refs 8, 9, paragraph [0015]); and an analysis unit that measures a particle size distribution of a particle group including the plurality of particles using a detection signal obtained by the light detection unit (ref 24, paragraph [0024]), an operation of suction and discharge of the sample by the stirring means (Fig. 2, ref 26, paragraphs [0031]-[0032]).
Ikeda is silent regarding a non-transitory computer readable medium storing a program; the program causing a computer to exhibit a function as a stirring operation control unit that controls an operation of suction and discharge.
However, it has been held that providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). Furthermore, the Examiner takes Official Notice that using a computer program to perform the above method is well-known in the art. One would include a non-transitory computer readable medium storing a program; the program causing a computer to exhibit a function as a stirring operation control unit that controls an operation of suction and discharge in order to rapidly perform analysis on samples without user input.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ikeda (US 2004/0075833) teaches a particle measuring device that includes a pump that circulates and stirs the sample.
Misawa (US 2022/0244161) teaches a conventional particle measuring device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC J BOLOGNA whose telephone number is (571)272-9282. The examiner can normally be reached Monday - Friday 7:30am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara E Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC J BOLOGNA/Primary Examiner, Art Unit 2877
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