CTNF 19/078,491 CTNF 100099 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites “an illuminator that illuminates a bottom surface of the transparent container; a multispectral light receiver that obtains an image of a lateral surface of the transparent container; and a hardware processor that calculates an absorption spectrum at multiple wavelengths, based on a light reception result by the multispectral light receiver, and that detects an inspection target component contained in the inspection target sample, based on the calculated absorption spectrum”, which falls in the category of Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2); calculating which falls within the category of “mathematical concepts” ( See MPEP 2106.04(a)(2)). The “mathematical concepts” abstract idea grouping is defined as mathematical relationships, mathematical formulas or equations, mathematical calculations. The claim limitations are considered mathematical concepts because they correspond to a mathematical relationship and performing a mathematical calculation. This judicial exception is not integrated into a practical application because the claims only recite the additional elements of “an illuminator that illuminates a bottom surface of the transparent container, a multispectral light receiver that obtains an image of a lateral surface of the transparent container.” These limitations appear to only add insignificant extra-solution activity, such as data gathering, for use in the judicial exception. In particular, the illuminator and multispectral light receiver are used to obtain measurement data that is subsequently processed by the recited steps of calculating an absorption spectrum at multiple wavelengths and detecting an inspection target component based on the calculated absorption spectrum, only generally links the use of the judicial exception to the particular technological environment of pharmaceutical quality inspection using an optical inspection system. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these are well-understood, conventional activities previously known to the industry, recited at a high level of generality. The use of the computer components that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook , 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions , 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). As a result, claim 1 is rejected under 3 5 USC 101 as being directed to an abstract idea without significantly more. As for claims 2-9, these claims are rejected for the same reasons as set forth above regarding claim 1 as they are only drawn to details of the abstract idea, and therefore do not integrate the abstract idea into a practical application or provide limitations that are significantly more than the abstract idea. In claim 2, the claim only provides a further limitation of compare an absorption spectrum to a reference spectrum. In claim 3, the claim only provides the mathematical relationship. In claim 4, the claim only further defines a field-of-use. In claim 5, the claim only provides mathematical evaluation and classification of data based on a threshold comparison. In claim 6, the claim only provides a further limitation of data gathering and data processing. In claim 7, the claim only provides a further limitation of data gathering used in calculating the absorption spectrum. In claim 8, the claim only provides a further limitation of a generic adjustment. In claim 9, the claim only provides a further limitation of a generic imaging component. Claims 10-11 recites “calculating an absorption spectrum at multiple wavelengths, based on a light reception result by the multispectral light receiver; and detecting an inspection target component contained in the inspection target sample, based on the calculated absorption spectrum.” The limitations in the claim are directed to mathematical steps for calculating the absorption spectrum. The claim recites the judicial exception of an abstract idea of “detecting an inspection target component contained in the inspection target sample, based on the calculated absorption spectrum”, which falls in the category of Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2); calculating which falls within the category of “mathematical concepts” ( See MPEP 2106.04(a)(2)). The “mathematical concepts” abstract idea grouping is defined as mathematical relationships, mathematical formulas or equations, mathematical calculations. The claim limitations are considered mathematical concepts because they correspond to a mathematical relationship and performing a mathematical calculation. This judicial exception is not integrated into a practical application because the claims only recite the additional elements of “an illuminator that illuminates a bottom surface of the transparent container, a multispectral light receiver that obtains an image of a lateral surface of the transparent container.” These limitations appear to only add insignificant extra-solution activity, such as data gathering, for use in the judicial exception. In particular, the illuminator and multispectral light receiver are used to obtain measurement data that is subsequently processed by the recited steps of calculating an absorption spectrum at multiple wavelengths and detecting an inspection target component based on the calculated absorption spectrum, only generally links the use of the judicial exception to the particular technological environment of pharmaceutical quality inspection using an optical inspection system. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these are well-understood, conventional activities previously known to the industry, recited at a high level of generality. The use of the computer components that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook , 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions , 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). As a result, claims 10-11 are rejected under 3 5 USC 101 as being directed to an abstract idea without significantly more. To overcome the above rejections, the examiner suggests amending claims 1, 10 and 11 to add the structure of the device to the optical arrangement, illumination configuration, or spectral measurement mechanism that performs the recited functions and improves the operation of the quality inspection apparatus. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 1-4 and 6-11 are rejected under 35 U.S.C. 102( a)(1) and 35 U.S.C. 102(a)(2 ) as being anticipated by Milne et al. (US Pub 2023/0038654 A1)(hereinafter, “Milne”) . Regarding claim 1, Milne teaches a quality inspection apparatus (100) configured to inspect quality of an inspection target sample filled in a transparent container (10), the inspection target sample being a lyophilized product or a powdery pharmaceutical product (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, implies powder pharmaceutical products as one class of particles, [0069] and [0207-0208]), the quality inspection (100) apparatus comprising: an illuminator (122e) that illuminates a bottom surface of the transparent container (10, discloses bottom illumination geometry, backlight illumination through container base, [0196-0198]); a multispectral light receiver (110 and 4500) that obtains an image of a lateral surface of the transparent container(discloses imaging arms 110 capture sidewall images and sensor 4500 wavelength separation via grating spectrometer, [0231-0233] and [0247-0250]); and a hardware processor (memory 90, computer software instructions 92 and data 94, sensor system) that calculates an absorption spectrum (discloses wavelength separation, intensity measurement per wavelength band, reconstruction of spectral profile, [0202] and [0250]) at multiple wavelengths (multi-wavelength decomposition is inherent in grating spectrometer system, [0248]), based on a light reception result by the multispectral light receiver(discloses sensor 4500 receives light, [0248]), and that detects an inspection target component contained in the inspection target sample (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, [0069]) based on the calculated absorption spectrum (discloses spectral based decision input, figure 45, [0250] ). Regarding claim 2, Milne teaches wherein the hardware processor (memory 90, computer software instructions 92 and data 94, sensor system) detects the inspection target component by comparing the absorption spectrum of the inspection target sample with an absorption spectrum of a reference sample (discloses LENS calibration curves a shown in figures 34-36, measures spectral signature to known particle types and known material responses, [0217-0221]). Regarding claim 3, Milne teaches wherein the hardware processor (memory 90, computer software instructions 92 and data 94, sensor system) calculates an amount of the inspection target component by applying the absorption spectrum to a calibration model built in advance (discloses LENS calibration curves for size distribution estimation, particle tracking for concentration estimation and spectral intensity normalization implies calibration layer, figures 35-36, [0217-0221]). Regarding claim 4, Milne teaches wherein the inspection target component is at least one of an active pharmaceutical ingredient, an excipient, and moisture (discloses refractive index measurements, chemical classification layer of spectral sensor 4500, [0253-0256]). Regarding claim 6, Milne teaches the multispectral light receiver (4500) is a camera or a multichannel spectrometer (discloses sensor 4500 grating based spectral imaging system and spatially resolved spectral detector, [0248]) and obtains images at multiple points in a vertical direction of the transparent container(discloses imaging arms 110 capture sidewall images and sensor 4500 wavelength separation via grating spectrometer, [0231-0233] and [0247-0250]), and based on a relative light reception amount with respect to another light reception amount as a reference among light reception results at the multiple points (discloses intensity comparisons across spatial locations, wavelengths, normalization of spectral data, calibration curves, [0217-0221]), the hardware processor calculates the absorption spectrum(discloses spectral based decision input, figure 45, [0250] ). Regarding claim 7, Milne teaches further comprising a reference light receiver (4500) that measures an amount of light emitted by a light source of the illuminator (122e), wherein based on the amount of emitted light measured by the reference light receiver ([0196-0198]), the hardware processor calculates the absorption spectrum(discloses wavelength separation, intensity measurement per wavelength band, reconstruction of spectral profile, [0202] and [0250]). Regarding claim 8, Milne teaches wherein an illumination region on the bottom surface of the transparent container illuminated by the illuminator is adjustable(discloses multiple light sources 122a, 122b, 122e, 122f, angle variation of illumination, allows dynamic illumination geometry control, [0196-0198]). Regarding claim 9, Milne teaches wherein the multispectral light receiver is a hyperspectral camera (4500). Regarding claim 10, Milne teaches a quality inspection method to be executed by a quality control apparatus (100) configured to inspect quality of an inspection target sample filled in a transparent container(10), the inspection target sample being a lyophilized product or a powdery pharmaceutical product (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, implies powder pharmaceutical products as one class of particles, [0069] and [0207-0208]), the quality inspection apparatus (100) including: an illuminator (122e) that illuminates a bottom surface of the transparent container (10, discloses bottom illumination geometry, backlight illumination through container base, [0196-0198]); and a multispectral light receiver (110 and 4500) that obtains an image of a lateral surface of the transparent container (discloses imaging arms 110 capture sidewall images and sensor 4500 wavelength separation via grating spectrometer, [0231-0233] and [0247-0250]), the method comprising: calculating an absorption spectrum (discloses wavelength separation, intensity measurement per wavelength band, reconstruction of spectral profile, [0202] and [0250]) at multiple wavelengths (multi-wavelength decomposition is inherent in grating spectrometer system, [0248]), based on a light reception result by the multispectral light receiver (discloses sensor 4500 receives light, [0248]); and detecting an inspection target component contained in the inspection target sample (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, [0069]), based on the calculated absorption spectrum (discloses spectral based decision input, figure 45, [0250] ). Regarding claim 11, Milne teaches a non-transitory computer-readable storage medium storing a program for a computer (memory 90, computer software instructions 92 and data 94, sensor system) of a quality control apparatus (100) configured to inspect quality of an inspection target sample filled in a transparent container (10), the inspection target sample being a lyophilized product or a powdery pharmaceutical product (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, implies powder pharmaceutical products as one class of particles, [0069] and [0207-0208]), the quality inspection apparatus(100) including: an illuminator (122e) that illuminates a bottom surface of the transparent container (10, discloses bottom illumination geometry, backlight illumination through container base, [0196-0198]); and a multispectral light receiver (110 and 4500) that obtains an image of a lateral surface of the transparent container (discloses imaging arms 110 capture sidewall images and sensor 4500 wavelength separation via grating spectrometer, [0231-0233] and [0247-0250]), the program causing the computer to: calculate an absorption spectrum (discloses wavelength separation, intensity measurement per wavelength band, reconstruction of spectral profile, [0202] and [0250]) at multiple wavelengths (multi- wavelength decomposition is inherent in grating spectrometer system, [0248]), based on a light reception result by the multispectral light receiver (discloses sensor 4500 receives light, [0248]); and detect an inspection target component contained in the inspection target sample (discloses a protein-containing pharmaceutical composition, drugs, biotechnology products, [0069]), based on the calculated absorption spectrum (discloses spectral based decision input, figure 45, [0250] ) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Milne et al. (US Pub 2023/0038654 A1)(hereinafter, “Milne”) in view of Carneiro et al. (“ A Quantitative Method using Near Infrared Imaging Spectroscopy for Determination of Surface Composition of Tablet Dosage Forms: an Example of Spirolactone Tablets”, 2012) (hereinafter, “Carneiro”) . Regarding claim 5, Milne teaches the hardware processor (memory 90, computer software instructions 92 and data 94, sensor system), the hardware processor determines that the specific inspection target sample is abnormal(discloses excludes unwanted particles, [0273-0277]). However, Milne fails to disclose compares shapes of absorption spectra of multiple inspection target samples each of which is the inspection target sample, and when a degree to which a shape of an absorption spectrum of a specific inspection target sample matches with shapes of other absorption spectra of other inspection target samples is less than a predetermined threshold. Carneiro teaches compares shapes of absorption spectra of multiple inspection target samples each of which is the inspection target sample (discloses spectral average of each tablet, spectra used in cross-validation, and pixel wise spectra used to build concentration models, abstract), and when a degree to which a shape of an absorption spectrum of a specific inspection target sample matches with shapes of other absorption spectra of other inspection target samples (discloses calibration model fitting, cross-validation error metrics, prediction accuracy per pixel/tablet, inherently comparing predicted vs. actual spectral behavior, evaluating spectral consistency, abstract) is less than a predetermined threshold (cross-validation error ranges 0.49-1.26% and prediction error ranges 0.05-1.06%, abstract). It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate calibration and multi-sample spectral comparison of Carneiro to Milne to improve classification accuracy . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shimizu et al. (U.S. Patent 5,719,679) teaches a method and an apparatus for inspecting vials, particularly filled with freeze-dried medicine, and it appears to render obvious at least the independent claims . Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA XING whose telephone number is (571)270-7743. The examiner can normally be reached Monday - Friday 9AM - 5 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.X./ Examiner, Art Unit 2877 /Kara E. Geisel/ Supervisory Patent Examiner, Art Unit 2877 Application/Control Number: 19/078,491 Page 2 Art Unit: 2877 Application/Control Number: 19/078,491 Page 3 Art Unit: 2877 Application/Control Number: 19/078,491 Page 4 Art Unit: 2877 Application/Control Number: 19/078,491 Page 5 Art Unit: 2877 Application/Control Number: 19/078,491 Page 6 Art Unit: 2877 Application/Control Number: 19/078,491 Page 7 Art Unit: 2877 Application/Control Number: 19/078,491 Page 8 Art Unit: 2877 Application/Control Number: 19/078,491 Page 9 Art Unit: 2877 Application/Control Number: 19/078,491 Page 10 Art Unit: 2877 Application/Control Number: 19/078,491 Page 11 Art Unit: 2877 Application/Control Number: 19/078,491 Page 12 Art Unit: 2877 Application/Control Number: 19/078,491 Page 13 Art Unit: 2877
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