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 .
Election/Restrictions
Applicant's election with traverse of claims 1, 5, 11-14, and 16 in the reply filed on 30 June 2026 is acknowledged. The traversal is on the ground(s) that independent claims 1 and 16 have been amended to include ultrafast light source and pulse limitations which are generic to all the other claims. This is not found persuasive because while the dependent claims necessarily share the technical features of claims 1 and 16, these technical features are not special, as previously described. Applicant has not argued how the further limitations in the cited groups would be directed to a single inventive concept. For example, group I, claim 2, drawn to producing a spectrum of infrared absorption of the sample, is an entirely different inventive concept than Applicant’s elected group, Group VI, claims 11-14, drawn to classifying individual particles within a pharmaceutical mixture, and Applicant has not made any specific arguments to the contrary.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because Figure(s) 4A, 4G-H, 5D, 8A-C is/are not in compliance with 37 CFR 1.84(p)(3), which requires numbers, letters, and reference characters to measure at least .32 cm (1/8 inch) in height. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 8, “polymophs” is recited where --polymorphs-- would be expected.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Regarding claim 1, “autofluoresence” is recited where --autofluorescence-- would be expected.
Regarding claim 13, “polymophs” is recited where --polymorphs-- would be expected.
Appropriate correction is required.
Claim Rejections — 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102–103 (or as subject to pre-AIA 35 U.S.C. § 102–103) is incorrect, any correction of the statutory basis 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.
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 C.F.R. § 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), that are applied 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 1 and 16
Claims 1 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Prater (US 2022/0018773 A1) in view of Cheng (US 2022/0074861 A1).
Claim 1
Regarding claim 1, Prater discloses a method for analyzing a sample (110), the method comprising: illuminating a region (illuminated by IR spot 108) of the sample (110) with an infrared radiation beam (102); illuminating at least a sub-region (illuminated by probe beam spot 116, with spot 116 being smaller and within spot 108) of the region of the sample (110) with a pulsed excitation beam (113) having a shorter wavelength (UV/visible) than the infrared radiation beam (102), wherein the excitation beam is generated by a light source (112), wherein the excitation beam (113) is configured to excite multi-photon autofluorescence in the sample (110); collecting an autofluorescent emission (within 115) from the sample (110) in response to absorption of the pulsed excitation beam (113) by the sample (110); detecting a change in the autofluorescent emission from the sample (110) in response to absorption of infrared radiation (102) by the sample (110); and generating measurements indicative of infrared absorption of the sub-region of the sample (110) from the change in autofluorescent emission from the sample (110; ¶¶ 7-11, 54-74, 85; Figs. 1A-B; note ¶ 55 erroneously refers to the probe beam as element 102 when it should be element 113, as seen in ¶¶ 75-76 and Figs. 1A and 2).
Prater does not expressly disclose the light source is ultrafast.
Cheng discloses a photothermal infrared spectroscopy system comprising an infrared source (110) and an ultrafast light source (520 nm femtosecond pulse laser 150, with a femtosecond pulse generally considered ultrafast; ¶¶ 2, 40-43; Figs. 3A).
It would have been obvious to one of ordinary skill in the art in view of the teachings of Cheng to have modified the invention of Prater to use an ultrafast light source.
One would have been motivated to do so provide more precise illumination of the sample as compared to when using slower light sources.
Claim 16
Regarding claim 16, Prater discloses a photothermal infrared spectroscopy system comprising: an infrared source (100) configured to illuminate a region (illuminated by IR spot 108) of a sample (110) with a beam of infrared radiation (102); a light source (112) configured to illuminate a second region (illuminated by probe beam spot 116, with spot 116 being smaller and within spot 108) of the sample (110) at least partially overlapping the infrared illuminated region (108), wherein the light source (112) is configured to generate a pulsed excitation beam, wherein the light source (112) is configured to excite multi-photon autofluorescence in the sample (110); at least one detector (124) configured to detect autofluorescent emission from the sample (110); and a demodulator (128) to detect a change in autofluorescent emission from the second region (116) of the sample (110) in response to absorption of infrared radiation by the second region (116) of the sample (110; ¶¶ 7-11, 54-74, 85; Figs. 1A-B; note ¶ 55 erroneously refers to the probe beam as element 102 when it should be element 113, as seen in ¶¶ 75-76 and Figs. 1A and 2).
Prater does not expressly disclose the light source is ultrafast.
Cheng discloses a photothermal infrared spectroscopy system comprising an infrared source (110) and an ultrafast light source (520 nm femtosecond pulse laser 150, with a femtosecond pulse generally considered ultrafast; ¶¶ 2, 40-43; Figs. 3A).
It would have been obvious to one of ordinary skill in the art in view of the teachings of Cheng to have modified the invention of Prater to use an ultrafast light source.
One would have been motivated to do so provide more precise illumination of the sample as compared to when using slower light sources.
Claims 11-12 and 14
Claims 11-12 and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Prater in view of Cheng as applied to claim 1 above, and further in view of Li (Li, C. et al., “Mid-Infrared Photothermal Imaging of Active Pharmaceutical Ingredients at Submicrometer Spatial Resolution”, 11 April 2017, Anal. Chem. 89 (9): 4863-4867; a copy is attached).
Claim 11
Regarding claim 11, Prater modified teaches the method of claim 1, but does not expressly disclose classifying individual particles within a pharmaceutical mixture.
Li discloses a photothermal infrared spectroscopy system configured to classify individual particles within a pharmaceutical mixture (mapping both active and excipient pharmaceutical ingredients; Abstract; Experimental Section; Conclusion).
It would have been obvious to one of ordinary skill in the art in view of the teachings of Li to have further modified the invention of Prater to include classifying individual particles within a pharmaceutical mixture.
One would have been motivated to do so to gain an advantage recited in Li of permitting improved imaging resolution for determining drug efficacy while mapping both active and excipient pharmaceutical ingredients (Abstract; Conclusion).
Claim 12
Regarding claim 12, Prater modified teaches the method of claim 11, wherein classifying individual particles comprises distinguishing excipient materials from active pharmaceutical ingredients (see rejection of claim 11 above).
Claim 14
Regarding claim 14, Prater modified teaches the method of claim 12, wherein the sample is a pharmaceutical formulation (see rejection of claim 11 above).
Claim 13
Claim 13 is rejected under 35 U.S.C. § 103 as being unpatentable over Prater in view of Cheng and Li as applied to claim 11 above, and further in view of Suresh (Suresh, K. et al., “Far-Infrared Spectroscopy as A Probe for Polymorph Discrimination”, 2019, J Pharm Sci. 108(5): 1915-1920; a copy is attached).
Regarding claim 13, Prater modified teaches the method of claim 11, but does not expressly disclose classifying individual particles comprises distinguishing between different forms or polymorphs of active pharmaceutical ingredients.
However, Suresh discloses (Abstract):
Pharmaceutical crystalline polymorph and amorphous form detection and quantification is a standard requirement in the pharmaceutical industry. Infrared (IR) spectroscopy provides an important probe for the characterization of polymorphs.
Therefore, it would have been obvious to one of ordinary skill in the art to have further modified the invention of Prater in view of the teachings of Suresh so that classifying individual particles comprises distinguishing between different forms or polymorphs of active pharmaceutical ingredients, as pharmaceutical polymorph detection was a standard requirement in the industry and the use of infrared spectroscopy to do so was known, as disclosed by Suresh.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ammar (US 2013/0149734 A1) discloses an infrared system and method for multi-photon microscopy (¶¶ 7, 39).
Cullum (US 2005/0070803 A1) discloses A system and method for performing multispectral imaging locates features of interest in a specimen using multiphoton photoacoustic spectroscopy (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE RIDDICK whose telephone number is (571)270-1865. The examiner can normally be reached M - Th 6:30 am - 5:00 pm ET, with flexible scheduling.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-2995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Blake C. Riddick, Ph.D.
Primary Examiner
Art Unit 2884
/BLAKE C RIDDICK/Primary Examiner, Art Unit 2884
Prosecution Insights