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 .
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.
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Claims 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of U.S. Patent No. 12313549, hereinafter “549” in view of Corwin et al. (US 2012/0135458 A1), hereinafter “Corwin”. The pending claims are rendered obvious in view of ‘549 and Corwin.
Regarding claim 21, ‘549 claims a method for analyzing a biological sample using fluorescence microscopy (claim 12, col. 24, lines 48-49), the method comprising:
(a) generating, by an entangled photon source, an entangled photon pair comprising a signal photon and an idler photon (lines 50-53);
(b) introducing the entangled photon pair to a temporal delay line to induce a relative temporal delay between the signal photon and the idler photon (lines 54-56);
(c) directing the temporally delayed entangled photon pair into a sample (lines 57-59);
(d) inducing two-photon absorption within the sample, wherein the biological sample emits fluorescence in response to the entangled photon pair (lines 57-59);
(e) detecting, by a photon-sensitive detector, fluorescence emitted from the biological sample (lines 60-63);
(f) generating a signal indicative of sample based on the detected fluorescence (lines 64-65).
‘549 does not claim a biological sample comprising tissue or cells; a signal indicative of one or more spatial or molecular properties of the biological sample; and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample.
However, Corwin teaches fluorescence microscopy including a biological sample comprising tissue or cells (paragraphs [0014], [0016]); a signal indicative of one or more spatial or molecular properties of the biological sample (paragraphs [0022]); and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample (paragraphs [0014], [0016])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim a biological sample comprising tissue or cells; a signal indicative of one or more spatial or molecular properties of the biological sample; and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample in order to diagnose a human’s medical condition.
Regarding claim 22, ‘549 claims wherein the temporal delay line comprises a birefringent delay line (claim 13).
Regarding claim 23, ‘549 claims wherein the entangled photon source comprises a nonlinear optical medium configured to generate spontaneous parametric downconversion entangled photon pairs (claim 14).
Regarding claim 24, ‘549 claims wherein the entangled photon pair comprises near-infrared photons (claim 15).
Regarding claim 25, ‘549 claims wherein the temporal delay line provides a temporal delay having a temporal resolution of less than 1 femtosecond (claim 16).
Regarding claim 26, ‘549 claims scanning, by a scanner, the entangled photon pair to provide the entangled photon pair to different regions of the biological sample in a transverse plane of the biological sample (claim 17).
Regarding claim 27, ‘549 claims wherein the detector is configured to provide the signal indicative of the fluorescent light to a processor, and the method further comprises: collecting, by the processor, the signal indicative of the fluorescent light from the detector; and generating, by the processor, an image comprising a plurality pixels, each pixel being indicative of a received signal from the detector, and each pixel having a corresponding location in the transverse plane of the biological sample (claim 18).
Regarding claim 28, ‘549 claims generating, by the processor, a plurality of images, each image comprising a plurality of pixels with each pixel being indicative of a received signal from the detector; and generating, by the processor, a differential image from at least two images of the plurality of images (claim 19).
Regarding claim 29, ‘549 claims before generating the differential image, normalizing, by the processor, two or more images of the plurality of images to a background of each of the two or more images (claim 20).
Regarding claim 30, ‘549 does not claim wherein the biological sample is a living sample.
However, Corwin teaches wherein the biological sample is a living sample (paragraph [0013]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the biological sample is a living sample in order to diagnose a human condition.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over ‘549 and Corwin in view of Min et al (US 2016/0243261 A1), hereinafter “Min”.
Regarding claim 31, ‘549 does not claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample.
However, Min teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample (paragraphs [0054]. [0163]-[0164]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample
Claims 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over ‘549 and Corwin in view of Carriere et al (US 2017/0191939 A1), hereinafter “Carriere”.
Regarding claim 32, ‘549 does not claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample.
However, Carriere teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample (paragraphs [0045]-[0055]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample in order to determine the molecular content by comparing the fingerprint to a known library of fingerprints.
Regarding claim 33, ‘549 does not claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample.
However, Carriere teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample (paragraphs [0014]-[0015]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to claim wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample in order to determine what the sample is.
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.
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 21-25, 27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Varnavski, Oleg, Brian Pinsky, and Theodore Goodson III. "Entangled photon excited fluorescence in organic materials: an ultrafast coincidence detector." The journal of physical chemistry letters 8.2 (2017): 388-393, hereinafter “Varnavski”, and further in view of Corwin et al. (US 2012/0135458 A1), hereinafter “Corwin”.
Regarding claim 21, Varnavski teaches a method for analyzing a biological sample using fluorescence microscopy (abstract, Fig. 1), the method comprising:
(a) generating, by an entangled photon source (ref SPDC unit), an entangled photon pair comprising a signal photon and an idler photon (page 388, col. 2, - page 389, col. 1);
(b) introducing the entangled photon pair to a temporal delay line to induce a relative temporal delay between the signal photon and the idler photon (page 388, col. 2);
(c) directing the temporally delayed entangled photon pair into a sample (page 389, col. 2);
(d) inducing two-photon absorption within the sample, wherein the sample emits fluorescence in response to the entangled photon pair (Fig. 1, page 389, col. 2);
(e) detecting, by a photon-sensitive detector, fluorescence emitted from the sample (Fig. 1, page 389, col. 2);
(f) generating a signal indicative of one or more spatial or molecular properties of the sample based on the detected fluorescence (Fig. 1, page 389, col. 2 – page 390.col. 1).
Varnavski is silent regarding a biological sample comprising tissue or cells; a signal indicative of one or more spatial or molecular properties of the biological sample; and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample.
However, Corwin teaches fluorescence microscopy including a biological sample comprising tissue or cells (paragraphs [0014], [0016]); a signal indicative of one or more spatial or molecular properties of the biological sample (paragraphs [0022]); and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample (paragraphs [0014], [0016])
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Corwin by including a biological sample comprising tissue or cells; a signal indicative of one or more spatial or molecular properties of the biological sample; and (g) analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample in order to diagnose a human’s medical condition.
Regarding claim 22, Varnavski teaches wherein the temporal delay line comprises a birefringent delay line (page 388, col. 2; page 391, col. 2).
Regarding claim 23, Varnavski teaches wherein the entangled photon source comprises a nonlinear optical medium configured to generate spontaneous parametric downconversion entangled photon pairs (page 389, col. 1).
Regarding claim 24, Varnavski teaches wherein the entangled photon pair comprises near-infrared photons (page 389, col. 1).
Regarding claim 25, Varnavski is silent regarding wherein the temporal delay line provides a temporal delay having a temporal resolution of less than 1 femtosecond.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein the temporal delay line provides a temporal delay having a temporal resolution of less than 1 femtosecond as it has been held that where "the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, one would choose a resolution less than 1 fs in order to have a more accurate measurement.
Regarding claim 27, Varnavski teaches wherein the detector is configured to provide the signal indicative of the fluorescent light to a processor, and the method further comprises: collecting, by the processor (Fig. 1, computer), the signal indicative of the fluorescent light from the detector; and generating, by the processor, an image comprising a plurality pixels, each pixel being indicative of a received signal from the detector, and each pixel having a corresponding location in the transverse plane of the biological sample (Figs. 1, 5, page 391, col. 2).
Regarding claim 29, Varnavski is silent regarding before generating the differential image, normalizing, by the processor, two or more images of the plurality of images to a background of each of the two or more images.
However, Corwin teaches before generating the differential image, normalizing, by the processor, two or more images of the plurality of images to a background of each of the two or more images (paragraphs [0022], [0048], Fig. 2, ref 51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Corwin by including before generating the differential image, normalizing, by the processor, two or more images of the plurality of images to a background of each of the two or more images in order to have improved image processing.
Regarding claim 30, Varnavski is silent regarding wherein the biological sample is a living sample.
However, Corwin wherein the biological sample is a living sample (paragraph [0013]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Corwin by wherein the biological sample is a living sample in order to diagnose a human condition.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Varnavski and Corwin as applied to claim 21 above, and further in view of Ichimura (US 2005/0213107 A1), hereinafter “Ichimura”.
Regarding claim 26, Varnavski is silent regarding scanning, by a scanner, the entangled photon pair to provide the entangled photon pair to different regions of the biological sample in a transverse plane of the biological sample.
However, Ichimura teaches quantum entangled photon microscopy (abstract. Fig. 6), including scanning, by a scanner, the entangled photon pair to provide the entangled photon pair to different regions of the biological sample in a transverse plane of the biological sample (refs 112, 102, paragraphs [0060]-[0061]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Ichimura by including scanning, by a scanner, the entangled photon pair to provide the entangled photon pair to different regions of the biological sample in a transverse plane of the biological sample in order to increase the range of the observable area.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Varnavski and Corwin as applied to claims 21 and 27 above, and further in view of Levenson et al. (US 2017/0191937 A1), hereinafter “Levenson”.
Regarding claim 28, Varnavski is silent regarding generating, by the processor, a plurality of images, each image comprising a plurality of pixels with each pixel being indicative of a received signal from the detector; and generating, by the processor, a differential image from at least two images of the plurality of images.
However, Levenson teaches fluorescence microscopy (abstract, Figs. 1, 3) including generating, by the processor, a plurality of images, each image comprising a plurality of pixels with each pixel being indicative of a received signal from the detector; and generating, by the processor, a differential image from at least two images of the plurality of images (paragraphs [0046], [0063]-[0064], [0082]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Levenson by including generating, by the processor, a plurality of images, each image comprising a plurality of pixels with each pixel being indicative of a received signal from the detector; and generating, by the processor, a differential image from at least two images of the plurality of images in order to improve the efficiency of the measurement.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Varnavski and Corwin as applied to claim 21 above, and further in view of Min et al (US 2016/0243261 A1), hereinafter “Min”.
Regarding claim 31, Varnavski does not teach wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample.
However, Min teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample (paragraphs [0054], [0163]-[0164]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Min by including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing biological function occurring within the biological sample
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Varnavski and Corwin as applied to claim 21 above, and further in view of Carriere et al (US 2017/0191939 A1), hereinafter “Carriere”.
Regarding claim 32, Varnavski does not teach wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample.
However, Carriere teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample (paragraphs [0045]-[0055]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Carriere by including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular characteristics by determining a spectral fingerprint of a molecular within the biological sample in order to determine the molecular content by comparing the fingerprint to a known library of fingerprints.
Regarding claim 33, Varnavski does not teach wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample.
However, Carriere teaches Raman imaging (abstract) including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample (paragraphs [0014]-[0015]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Varnavski with the teaching of Carriere by including wherein analyzing the signal to assess structural, functional, or molecular characteristics of the biological sample comprises analyzing molecular structure within the biological sample in order to determine what the sample is.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Teich (US 5796477) teaches a conventional Entangled, two-photon fluorescence microscopy device.
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/DOMINIC J BOLOGNA/Primary Examiner, Art Unit 2877