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 .
Response to Arguments/Amendments
Applicant appears to argue that due to the amendments, the claim terms should no longer be interpreted under 112f. The amended claims now include a non-structural term (“means” and “mechanism”) and functions (see the “Claim Interpretation” section for more details) as before; the claims have since been amended to include the language “structured to,” however this is not the same as adding specific structure that performs the claimed function, and therefore, the claims remain interpreted under 112f.
Applicant’s amendments overcome the previous prior art rejections; therefore, the previous prior art rejections have been withdrawn.
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.
Calculation means in claims 7-8, 10-11, 14 and 17-18, integration means in claims 10, 11, and determination means in claims 17-18 are interpreted under 112f;
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 limitations are: movement mechanism in claims 7-8, 10-11, 17-18.
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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 103 as obvious over Johansson (Time-Resolved NIR/Vis Spectroscopy for Analysis of Solids: Pharmaceutical Tablets) in view of Nagoya (JP2013205390A; cited by Applicant) and Ghetler (20160373663; cited by Applicant).
Regarding claim 1, Johansson teaches a tablet spectroscopic measurement method for measuring a spectral transmission spectrum of a tablet, the method comprising:
an irradiation step of irradiating the tablet with pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis (figure 1; pages 726-727 in “Materials and Methods” section; “the pulses were sent to a pulse stretcher consisting of two gratings yielding different path lengths for different wavelengths within the line profile, creating chirped pulses” in page 726, column 2); and
a calculation processing step of performing calculation processing on an output from a light receiver that receives transmission light from the tablet irradiated with the pulsed light in the irradiation step (figure 1), and obtaining the spectral transmission spectrum of the tablet (figures 3 and 6),
wherein a size of a beam of the pulsed light in the irradiation step on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet (spot size is 1mm and tablet diameter is 9mm as explained in page 726, right column, and page 727, right column).
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For the reasons given above, the examiner considers Johansson as anticipating the claim limitations. Alternatively, if one were to consider Johansson as not teaching “an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis,” then like Johansson (and like Applicant), Nagoya is also concerned with measuring the spectrum of light transmitted through a sample (paragraph 57) and teaches an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis (paragraph 54). Additionally, Nagoya teaches this provides the benefits of a “high-speed, highly accurate, high-resolution, and wide-band spectroscopic measurement” (paragraph 62). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis in order to achieve high-speed, highly accurate, high-resolution, and wide-band spectroscopic measurement.
Johansson doesn’t explicitly teach a moving step of moving the tablet so as to pass through an irradiation position without being stopped; a plurality of times, one tablet passing through the irradiation position, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet.
Like Johansson (and like Applicant), Ghetler is directed to a tablet measurement method and apparatus and teaches a moving step of moving the tablet so as to pass through an irradiation position a moving step of moving the tablet so as to pass through an irradiation position (paragraphs 17-18 and 25; figure 3); an irradiation step includes a step of irradiating one tablet with the pulsed light multiple times, and the irradiation is performed multiple times on locations different from each other on the light incident surface (paragraphs 17-18 and 25) and a tablet placement mechanism for placing the tablet at a position to which the pulsed light is radiated by the pulsed light irradiation system, wherein the tablet placement mechanism is a mechanism for placing the tablet such that one tablet is irradiated with the pulsed light multiple times, and the pulsed light is radiated to locations different from each other on the light incident surface multiple times (paragraphs 17-18 and 25; figure 3).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that it comprises a moving step of moving the tablet so as to pass through an irradiation position, and a plurality of times, one tablet passing through the irradiation position, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet -- – in order to determine the characteristics of the tablet at multiple areas to determine any variation in the tablet characteristics.
The above combination doesn’t explicitly teach the moving is without stopping.
Like Johansson (and like Applicant), Moriya is directed to the optical measurement of a sample and provides a general teaching that a moving step of moving the sample so as to pass through an irradiation position without being stopped provides the benefit of increasing the measurement speed (column 2, line 60 – column 3, line 5).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the moving is without stopping so as to enable faster measurements.
Regarding claim 2, Johansson teaches the beam of the pulsed light has such a size that two or more beams of the pulsed light can be incident to the light incident surface in a state of not overlapping each other (spot size is 1mm and tablet diameter is 9mm as explained in page 726, right column, and page 727, right column).
Regarding claim 7, Johansson teaches a tablet spectroscopic measurement apparatus that measures a spectral transmission spectrum of a tablet, the apparatus comprising:
a pulsed light irradiation system that includes a pulsed light source emitting pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis, and irradiates the tablet with the pulsed light (figure 1; pages 726-727 in “Materials and Methods” section; “the pulses were sent to a pulse stretcher consisting of two gratings yielding different path lengths for different wavelengths within the line profile, creating chirped pulses” in page 726, column 2);
a light receiver that is disposed at a position receiving transmission light from the tablet which is irradiated with the pulsed light by the pulsed light irradiation system (figure 1 and “Materials and Methods” section); and
a calculation means that performs calculation processing on an output from the light receiver, and obtains the spectral transmission spectrum of the tablet (figures 1, 3, and 5),
wherein a size of a beam of the pulsed light radiated by the pulsed light irradiation system on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet (spot size is 1mm and tablet diameter is 9mm as explained in page 726, right column, and page 727, right column).
For the reasons given above, the examiner considers Johansson as anticipating the above claim limitations. Alternatively, if one were to consider Johansson as not teaching “an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis,” then like Johansson (and like Applicant), Nagoya is also concerned with measuring the spectrum of light transmitted through a sample (paragraph 57) and teaches an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis (paragraph 54). Additionally, Nagoya teaches this provides the benefits of a “high-speed, highly accurate, high-resolution, and wide-band spectroscopic measurement” (paragraph 62). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis in order to achieve high-speed, highly accurate, high-resolution, and wide-band spectroscopic measurement.
Johansson doesn’t explicitly teach a moving step of moving the tablet so as to pass through an irradiation position without being stopped; a plurality of times, one tablet passing through the irradiation position, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet.
Like Johansson (and like Applicant), Ghetler is directed to a tablet measurement method and apparatus and teaches a moving step of moving the tablet so as to pass through an irradiation position a moving step of moving the tablet so as to pass through an irradiation position (paragraphs 17-18 and 25; figure 3); an irradiation step includes a step of irradiating one tablet with the pulsed light multiple times, and the irradiation is performed multiple times on locations different from each other on the light incident surface (paragraphs 17-18 and 25) and a tablet placement mechanism for placing the tablet at a position to which the pulsed light is radiated by the pulsed light irradiation system, wherein the tablet placement mechanism is a mechanism for placing the tablet such that one tablet is irradiated with the pulsed light multiple times, and the pulsed light is radiated to locations different from each other on the light incident surface multiple times (paragraphs 17-18 and 25; figure 3).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that it comprises a moving step of moving the tablet so as to pass through an irradiation position, and a plurality of times, one tablet passing through the irradiation position, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet -- – in order to determine the characteristics of the tablet at multiple areas to determine any variation in the tablet characteristics.
The above combination doesn’t explicitly teach the moving is without stopping.
Like Johansson (and like Applicant), Moriya is directed to the optical measurement of a sample and provides a general teaching that a moving step of moving the sample so as to pass through an irradiation position without being stopped provides the benefit of increasing the measurement speed (column 2, line 60 – column 3, line 5).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the moving is without stopping so as to enable faster measurements.
Regarding claim 8, Johansson teaches the beam of the pulsed light has such a size that two or more beams of the pulsed light can be incident to the light incident surface in a state of not overlapping each other (spot size is 1mm and tablet diameter is 9mm as explained in page 726, right column, and page 727, right column).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson and Nagoya as applied to claims 1 and 7 above, and further in view of Micheels (US 20130256534 A1).
Regarding claims 15-18, Johansson teaches a measurement step of performing the tablet spectroscopic measurement method according to claim 1 to obtain a spectral transmission spectrum of a tablet; and a determination step of determining characteristics of the tablet based on the spectral transmission spectrum obtained in the measurement step; a measurement step of performing the tablet spectroscopic measurement method according to claim 2 to obtain a spectral transmission spectrum of a tablet; and a determination step of determining characteristics of the tablet based on the spectral transmission spectrum obtained in the measurement step; the tablet spectroscopic measurement apparatus according to claim 7; and a determination means that determines characteristics of the tablet based on a spectral transmission spectrum that is a measurement result obtained by the tablet spectroscopic measurement apparatus; the tablet spectroscopic measurement apparatus according to claim 8; and a determination means that determines characteristics of the tablet based on a spectral transmission spectrum that is a measurement result obtained by the tablet spectroscopic measurement apparatus (abstract, page 729-730).
Johansson doesn’t explicitly teach the characteristics are quality.
Like Johansson (and like Applicant), Micheels is directed to a tablet spectroscopic measurement method and apparatus and teaches determining quality of the tablet based on the measured spectrum (abstract and paragraph 12).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above combination such that the method and apparatus is used to determine quality of the tablet based on the measured spectrum in order to determine if the tablet is the desired chemical composition and purity to achieve the desired medicinal purposes.
Allowable Subject Matter
Claims 4-5 and 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “a moving step of moving the tablet so as to pass through an irradiation position without being stopped; an irradiation step of irradiating, a plurality of times, one tablet passing through the irradiation position with pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis; and a calculation processing step of performing calculation processing on an output from a light receiver that receives transmission light from the tablet irradiated with the pulsed light in the irradiation step, and obtaining the spectral transmission spectrum of the tablet, wherein a size of a beam of the pulsed light in the irradiation step on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet… the calculation processing step includes a step of obtaining the average spectral transmission spectrum of the different portions according to respective integrated values for respective wavelengths,” in combination with the other claimed limitations.
Regarding claim 10, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “a movement mechanism structured to move the tablet so as to pass through an irradiation position without being stopped; a pulsed light irradiation system that includes a pulsed light source emitting pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis, and the pulsed light irradiation system being structured to irradiate one tablet passing through the irradiation position a plurality of times with the pulsed light; a light receiver that is disposed at a position receiving transmission light from the tablet which is irradiated with the pulsed light by the pulsed light irradiation system; and a calculation means that performs calculation processing on an output from the light receiver, and obtains the spectral transmission spectrum of the tablet, wherein a size of a beam of the pulsed light radiated by the pulsed light irradiation system on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet, and wherein the pulsed light is irradiated onto different portions within the light incident surface of the one tablet.… the calculation processing step includes a step of obtaining the average spectral transmission spectrum of the different portions according to respective integrated values for respective wavelengths,” in combination with the other claimed limitations.
Regarding claim 5, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “a moving step of moving the tablet so as to pass through an irradiation position without being stopped; an irradiation step of irradiating, a plurality of times, one tablet passing through the irradiation position with pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis; and a calculation processing step of performing calculation processing on an output from a light receiver that receives transmission light from the tablet irradiated with the pulsed light in the irradiation step, and obtaining the spectral transmission spectrum of the tablet, wherein a size of a beam of the pulsed light in the irradiation step on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet, wherein in the irradiation step, the pulsed light is irradiated onto different portions within the light incident surface of the one tablet… multiple irradiations of the pulsed light onto one tablet are divided into a plurality of groups onto a plurality of regions in the light incident surface of the tablet, the integration step includes: a step of integrating, for irradiations of each of the plurality of groups, values at respective times that are regarded as being of the same wavelength, wherein the calculation processing step includes a step of obtaining, for each of the plurality of groups, a spectral transmission spectrum of the region corresponding to the group according to values integrated for respective wavelengths; and a step of determining the quality of the tablet based on the spectral transmission spectra of the plurality of regions,” in combination with the other claimed limitations.
Regarding claim 11, the prior art of record (taken alone or in combination) fails to anticipate or render obvious, “a movement mechanism structured to move the tablet so as to pass through an irradiation position without being stopped; a pulsed light irradiation system that includes a pulsed light source emitting pulsed light in which an elapsed time in each pulse and a wavelength correspond to each other on a one-to-one basis, and the pulsed light irradiation system being structured to irradiate one tablet passing through the irradiation position a plurality of times with the pulsed light; a light receiver that is disposed at a position receiving transmission light from the tablet which is irradiated with the pulsed light by the pulsed light irradiation system; and a calculation means that performs calculation processing on an output from the light receiver, and obtains the spectral transmission spectrum of the tablet, wherein a size of a beam of the pulsed light radiated by the pulsed light irradiation system on a light incident surface of the tablet is smaller than the size of the light incident surface of the tablet, and wherein the pulsed light is irradiated onto different portions within the light incident surface of the one tablet.… multiple irradiations of the pulsed light onto one tablet are divided into a plurality of groups onto a plurality of regions in the light incident surface of the tablet, the integration step includes: a step of integrating, for irradiations of each of the plurality of groups, values at respective times that are regarded as being of the same wavelength, wherein the calculation processing step includes a step of obtaining, for each of the plurality of groups, a spectral transmission spectrum of the region corresponding to the group according to values integrated for respective wavelengths; and a step of determining the quality of the tablet based on the spectral transmission spectra of the plurality of regions,” in combination with the other claimed limitations.
Additional Prior Art
Hitachi (JP2011191129A; cited by Applicant)is directed to a tablet inspection device that uses transmission spectroscopy
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CN 1543567 A reads, “In the device shown, sample 24 can be with, for example, a 9 mm diameter solid tablet. an excitation beam 20 can be focused to point of about 1 mm.”
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Myrick (US 20100302539 A1) reads, “ While the detector integrates or co-adds measurements at these important wavelengths, the signal increases linearly while the noise increases as a square root of the signal” (paragraph 25).
WO 2020075375 A1 reads, “the tablet pixel Qb is extracted by calculating an integrated value of spectrum data (luminance value of each wavelength component) for each pixel Qa and determining whether or not the value is equal to or more than a predetermined threshold value.”
US 20160131523 A1 reads, “[0009] According to an aspect of an exemplary embodiment, a spectroscopy system includes: a plurality of detectors that obtain detection spectrums of a plurality of detection areas that are located at different positions of an object; and an information processor that obtains a target spectrum of a desired target area by using position information of the plurality of detection areas and the detection spectrums obtained by the plurality of detectors.” (paragraph 9)
Lewis (US 2011/0238327) directed to optical spectroscopic measurements, including measurements of tablets (paragraph 21) reads, “This method includes acquiring a plurality of separate spectral measurements at different locations on a sample and evaluating results of the measurements based on one or more predetermined test criteria” (abstract)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUFUS L PHILLIPS whose telephone number is (571)270-7021. The examiner can normally be reached M-Th, 2 -10 pm.
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/RUFUS L PHILLIPS/ Examiner, Art Unit 2877