DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Applicant is advised that should claim 3 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). There does not appear to be any difference in scope between claims 3 and 20.
Specification
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.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 - 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 31 of U.S. Patent No. 12,383,140. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to methods/systems for:
identifying a target tissue using autofluorescence detection with a fiber optic probe-based fluorescence detection system (reference claims 1, 20);
administering a dose of a contrast agent to the living subject (reference claims 1, 20);
detecting fluorescence emitted from the contrast agent in the target tissue using the fiber optic probe-based fluorescence detection system (reference claims 1, 20), without acquiring an image of the target tissue (reference claims 3, 20);
quantifying the detected fluorescence to obtain a detection level and/or detection ratio (reference claims 1, 20); and
determining a degree of perfusion of the target tissue based on the detection level and/or detection ratio (reference claims 1, 20).
In general, the reference claims are specific to parathyroid tissue, whereas the instant claims are largely generic to any target tissue, and recite parathyroid tissue, only in dependent claim 11. Specifically:
Claims 1, 3, 9, 11, 12, 14, and 20 are suggested by reference claims 1 and/or 20. Contrast agent dosage is suggested by reference claims 12 - 13 and/or 29. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the specific contrast agent dosage/volume of the instant claims, in order to administer an appropriate amount to the patient.
Claims 2 and 13 are suggested by reference claims 15 and/or 31.
Claim 4 is suggested by reference claims 11 - 12, 26, and/or 28.
Claim 5 and 18 are suggested by reference claims 9 and/or 27.
Claims 6 - 7 and 17 are suggested by reference claims 4 - 5 and/or 22 - 23.
Claim 8 and 19 are suggested by reference claim 16.
Claim 10 is suggested by reference claims 2 and/or 21.
Claim 15 is suggested by reference claims 18 - 19.
Regarding claim 16, It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include a long-pass filter and a band-pass filter embedded within a probe tip assembly for spectral selection, in order to filter the spectra.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 - 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 is indefinite because it recites an optional limitation (last line). It is unclear whether the optional limitation is part of the claimed invention.
Claim 18 is indefinite because it is unclear what structural feature of the claimed system is intended by “wherein the detection ratio of a well-perfused tissue is at least 2.5 times greater than that of a poorly perfused tissue.” The limitation appears to attempt to characterize human physiology as opposed to clearly setting forth any structural features. It is unclear what is required.
Claim Rejections - 35 USC § 101
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 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.
Independent claims 1 and 20:
With regard to Step 1, the claims are directed to one of the four statutory categories of invention, i.e., a method for assessing tissue perfusion.
With regard to Step 2A: Prong 1, the claims recite:
quantifying the detected fluorescence to obtain a detection level and/or detection ratio; and
determining a degree of perfusion of the target tissue based on the detection level and/or detection ratio
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper. Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claims recite additional elements as follows:
The claims recite “identifying a target tissue using autofluorescence detection with a fiber optic probe-based fluorescence detection system”, which is extra-solution activity.
The claims recite limitations directed towards administering a dose of a contrast agent, which is extra-solution activity.
The claims recite “detecting fluorescence emitted from the contrast agent in the target tissue using the fiber optic probe-based fluorescence detection system”, which is extra-solution activity.
The claims recite “without acquiring an image of the target tissue”, which merely limits the judicial exception to a particular technological environment or field of use.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards extra-solution activity and/or limiting the judicial exception to a particular technological environment. Therefore, when considered separately and in combination, the additional limitations do not result in the claims, as a whole, amounting to significantly more than the judicial exception.
Dependent claims
Claims 2 - 3 and 4 recite additional limitations directed towards characteristics of the contrast agent and/or fluorescence signal, which merely limit the judicial exception to a particular technological environment or field of use.
Claim 5 recites features of the determination, which merely modifies the abstract idea.
Claim 6 recites additional limitations directed towards establishing a baseline fluorescence, which reads on a mental step.
Claim 7 recites characteristics of the detection level/ratio, which merely modifies the abstract idea.
Claim 8 recites displaying the detection level and/or detection ratio on a user interface and/or providing auditory feedback when a perfusion threshold is met, which is extra-solution activity.
Claim 9 recites features of the detection system. However, the features are recited at a high level of generality, and merely limit the judicial exception to a particular technological environment or field of use.
Claims 10 - 11 recite additional limitations directed towards ambient light conditions and/or the target tissue, which merely limit the judicial exception to a particular technological environment or field of use.
Therefore, when considered separately and in combination, the additional limitations do not integrate the judicial exception into a practical application, or result in the claims amounting to significantly more than the judicial exception.
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 - 5, 9 - 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Almquist et al. (“Surgical management of cytologically indeterminate thyroid nodules. Gland Surg. 2019 Aug; 8(Suppl 2):S105-S111) in view of Elings (US 4,608,990) and Eggers et al. (US 2010/0016731).
Regarding claims 1 and 20, Almquist shows a method for assessing tissue perfusion in a living subject, comprising:
identifying a target tissue using autofluorescence detection with a fiber optic probe-based fluorescence detection system (“Fluoptics and PTEye … adjuncts for parathyroid identification … take advantage of the fact that parathyroid glands fluoresce, i.e., they emit light of a different wavelength when illuminated with near-infra red light … parathyroid identification increases when these adjuncts are used”, pg. S108, “Parathyroid identification and preservation: 3rd paragraph);
administering a dose of a contrast agent to the living subject (“parathyroid angiography with the autofluorescent dye indocyanine green (ICG). ICG is injected intravenously … well vascularized, the ICG will fluoresce and can be detected with special optical equipment”, pg. S108, “Parathyroid identification and preservation: last paragraph); and
detecting fluorescence emitted from the contrast agent in the target tissue (“… the ICG will fluoresce and can be detected with special optical equipment”, pg. S108, “Parathyroid identification and preservation: last paragraph).
While Almquist discusses (1) identifying the target tissue using autofluorescence, and (2) assessing target tissue perfusion using a contrast agent, as discussed above, Almquist is not specific to the detecting of the fluorescence emitted from the contrast agent using the fiber optic probe-based fluorescence detection system, without acquiring an image of the target tissue; quantifying the detected fluorescence to obtain a detection level and/or detection ratio; and determining a degree of perfusion of the target tissue based on the detection level and/or detection ratio. In addition, Almquist is not specific to the dosage of the contrast agent being about 0.6 mg1 and having volume between about 0.25 cc and about 3.50 cc at a concentration of about 2.5 mg/mL.
Elings discloses a fluorometer and method of fluorometry for illuminating an area containing fluorescent material (abstract). Elings teaches detecting fluorescence emitted from a contrast agent (abstract) using a fiber optic probe-based fluorescence detection system (fig. 1); quantifying the detected fluorescence to obtain a detection level and/or detection ratio (“reading of the fluorescent energy …”, col. 5, lines 53 - 68); and determining a degree of perfusion of the target tissue based on the detection level and/or detection ratio (“using the magnitude of the second signal as a measure of the relative blood perfusion in the skin tissue”, claim 1). The detection is performed without acquiring an image of the target tissue, as the “magnitude of the second signal” is used “as a measure of the relative blood perfusion in the skin tissue” (claim 1).
Eggers discloses detection of circulatory anomalies using indocyanine green dye (abstract). Eggers teaches a dosage of contrast agent being about 0.6 mg and having volume between about 0.25 cc and about 3.50 cc at a concentration of about 2.5 mg/mL (“injection of the indicator bolus (e.g., 2 ml of 2.5 mg/ml) indocyanine green dye”, [0095]; [0278]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Almquist to have the detecting of the fluorescence emitted from the contrast agent use the fiber optic probe-based fluorescence detection system, without acquiring an image of the target tissue, as taught by Elings, in order to use a single fiber optic probe-based fluorescence detection system to determine blood flow from the fluorescence data without requiring the time and computational expense of image generation.
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Almquist to include quantifying the detected fluorescence to obtain a detection level and/or detection ratio; and determining a degree of perfusion of the target tissue based on the detection level and/or detection ratio, as taught by Elings, in order to determine if a portion of the body is receiving an adequate supply of blood such as after a surgical procedure, as suggested by Elings (col. 1, lines 11 - 25).
In addition, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Almquist and Elings to have the dosage of contrast agent be about 0.6 mg and have a volume between about 0.25 cc and about 3.50 cc at a concentration of about 2.5 mg/mL, as taught by Eggers, in order to provide a clinically suitable amount of the contrast agent to the patient, as is well-understood and conventional in the art.
Regarding claim 2, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. Almquist further shows the contrast agent comprises indocyanine green (ICG, pg. S108, “Parathyroid identification and preservation: last paragraph).
Regarding claim 3, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. The prior art further shows the claimed volume, as discussed in the art rejection of claim 1, above.
Regarding claim 4, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. Almquist further shows that the fluorescence detection system is the PTEye (PTEye, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). Almquist further shows the contrast agent comprises indocyanine green (ICG, pg. S108, “Parathyroid identification and preservation: last paragraph). Applicant’s specification explains that “PTeye can detect ICG even 60 minutes after a first injection” ([0099], as published). Almquist thus further shows that the fluorescence signal remains detectable as short as 10 minutes, and as long as about 60 minutes, after administration, and therefore meets the claim.
Regarding claim 5, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. The tissue of the prior art would be determined a well-perfused target tissue if the detection level and/or detection ratio are at least 2.5 times higher than that for a poorly perfused target tissue because this is merely a description of relative perfusion characteristics. The prior art therefore meets the claim.
Regarding claim 9, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. Almquist further shows that the fluorescence detection system is the PTEye (“… PTEye … adjuncts for parathyroid identification … take advantage of the fact that parathyroid glands fluoresce, i.e., they emit light of a different wavelength when illuminated with near-infra red light … parathyroid identification increases when these adjuncts are used”, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). The fiber optic fluorescence detection system of Almquist therefore comprises the light source, fibers, and detector recited in claim 19 (see [0078] - [0095] of the instant specification, which describe the claimed features of the PTEye). Moreover, the system of the prior art includes a processor as recited, as the system of the prior art is configured to implement the method of claim 1. The prior art therefore meets the claim.
Regarding claim 10, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. Almquist further shows that the fluorescence detection system is the PTEye (“… PTEye … adjuncts for parathyroid identification … take advantage of the fact that parathyroid glands fluoresce, i.e., they emit light of a different wavelength when illuminated with near-infra red light … parathyroid identification increases when these adjuncts are used”, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). Almquist therefore meets the claim. However, in the interest of compact prosecution, it is noted that Elings also provides the claimed feature (“not sensitive to ambient light…”, col. 5, lines 53 - 68).
Regarding claim 11, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above. Almquist further shows that the target tissue comprises a parathyroid gland (“… parathyroid …”, pg. S108, “Parathyroid identification and preservation: 3rd paragraph).
Claims 6 - 8 are rejected under 35 U.S.C. 103 as being unpatentable over Almquist, Elings, and Eggers as applied to claim 1 above, and further in view of Thomas et al. ("Innovative operative guidance for label-free, real-time parathyroid identification-the PTeye," Published in final edited form as: Surgery, 2019 January; 165(1): 114-123).
Regarding claims 6 - 7, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above
Almquist fails to show, prior to said administering the dose of the contrast agent to the living subject, establishing a baseline fluorescence measurement from the target tissue, wherein the detection level is an absolute tissue fluorescence intensity, and wherein the detection ratio is a ratio of the detected fluorescence normalized to the baseline.
Thomas discloses parathyroid identification. Thomas teaches establishing a baseline fluorescence measurement from the target tissue (“NIRAF intensity was normalized to the thyroid NIRAF baseline to generate ‘Detection ratio’ for the PTeye,”, pg. 5, top paragraph; “first establish a thyroid NIRAF baseline (Figure 4B)”, pg. 5, 3rd paragraph), wherein the detection level is an absolute tissue fluorescence intensity, and wherein the detection ratio is a ratio of the detected fluorescence normalized to the baseline (“(i) the ‘Detection Level’ – absolute tissue NIRAF intensity, (ii) the ‘Detection Ratio’ – tissue NIRAF normalized to the thyroid NIRAF intensity”, pg. 3, 4th paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified combined invention of Almquist, Elings, and Eggers to include, prior to said administering the dose of the contrast agent to the living subject, establishing a baseline fluorescence measurement from the target tissue, wherein the detection level is an absolute tissue fluorescence intensity, and wherein the detection ratio is a ratio of the detected fluorescence normalized to the baseline, as taught by Thomas, in order to facilitate quantitative measurements, to thereby improve accuracy of perfusion assessment.
Regarding claim 8, the combined invention of Almquist, Elings, and Eggers
discloses the claimed invention substantially as noted above
Almquist fails to show displaying the detection level and/or detection ratio on a user interface and/or providing auditory feedback when a perfusion threshold is met.
Thomas discloses parathyroid identification. Thomas teaches providing an auditory feedback when a perfusion threshold is met (“auditory feedback commences once the ‘Detection Ratio’ reaches a threshold value set for PG identification”, pg. 3, 4th paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Almquist, Elings, and Eggers to include providing auditory feedback when a perfusion threshold is met, as taught by Thomas, in order to inform the surgeon of the results, as is understood in the art.
Claims 12 - 19 are rejected under 35 U.S.C. 103 as being unpatentable over Almquist et al. (“Surgical management of cytologically indeterminate thyroid nodules. Gland Surg. 2019 Aug; 8(Suppl 2):S105-S111) in view of Thomas et al. ("Innovative operative guidance for label-free, real-time parathyroid identification-the PTeye," Published in final edited form as: Surgery, 2019 January; 165(1): 114-123).
Regarding claim 12, Almquist shows a fiber optic fluorescence detection system comprising the PTEye (“… PTEye … adjuncts for parathyroid identification … take advantage of the fact that parathyroid glands fluoresce, i.e., they emit light of a different wavelength when illuminated with near-infra red light … parathyroid identification increases when these adjuncts are used”, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). The fiber optic fluorescence detection system of Almquist therefore comprises the light source, fiber-optic probe, detector, a controller operably coupled to the light source and the detector, the controller being configured to: activate fluorescence excitation and acquisition, quantify the detected fluorescence to obtain a detection level and/or detection ratio; and an interface configured to output the detection level and/or detection ratio in real time and optionally generate auditory feedback when the threshold is reached as recited in claim 12 (see [0078] - [0095] of the instant specification, which describe the claimed features of the PTEye).
Almquist fails to show comparing the detection ratio to a perfusion threshold value.
Thomas discloses parathyroid identification. Thomas teaches comparing the detection ratio to a threshold value (“… ‘Detection Ratio’ reaches a threshold value set for PG identification”, pg. 3, 4th paragraph). The threshold is interpreted as being a “perfusion threshold”, lacking any limiting features in the claim.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Almquist to include comparing the detection ratio to a perfusion threshold value, as taught by Thomas, in order to facilitate controlling feedback, as suggested by Thomas (pg. 3, 4th paragraph).
In the combined invention of Almquist and Thomas, the system is at least physically capable of being used “for assessing tissue perfusion in a living subject in conjunction with a contrast agent administered at a dose being about 0.6 mg”, as recited in the preamble of claim 12.
Regarding claim 13, the combined invention of Almquist and Thomas
discloses the claimed invention substantially as noted above. Almquist further shows the contrast agent comprises indocyanine green (ICG, pg. S108, “Parathyroid identification and preservation: last paragraph).
Regarding claim 14, the combined invention of Almquist and Thomas
discloses the claimed invention substantially as noted above. Further, the system of the prior art is at least physically capable of being used with a dose of the contrast agent that “is in a volume between about 0.25 cc and about 3.50 cc at a concentration of about 2.5 mg/mL”, and therefore meets the claim.
Regarding claims 15 - 16, the combined invention of Almquist and Thomas discloses the claimed invention substantially as noted above. Almquist further shows that the fluorescence detection system is the PTEye (PTEye, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). Applicant’s specification explains that the PTEye provides excitation light, a wavelength range, and filters in the probe tip as recited (see [0078] - [0095] of the instant specification, which describe the claimed features of the PTEye).
Regarding claim 17, the combined invention of Almquist and Thomas discloses the claimed invention substantially as noted above.
Almquist is not specific to normalizing detected fluorescence intensity to a baseline measurement from the target tissue.
Thomas teaches normalizing detected fluorescence intensity to a baseline measurement from the target tissue (“NIRAF intensity was normalized to the thyroid NIRAF baseline to generate ‘Detection ratio’ for the PTeye,”, pg. 5, top paragraph; “first establish a thyroid NIRAF baseline (Figure 4B)”, pg. 5, 3rd paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified combined invention of Almquist and Thomas to include normalizing detected fluorescence intensity to a baseline measurement from the target tissue, as taught by Thomas, in order to facilitate quantitative measurements, to thereby improve accuracy of perfusion assessment.
Regarding claim 18, the combined invention of Almquist and Thomas
discloses the claimed invention substantially as noted above. The detection ratio of a well-perfused tissue of the prior art would be at least 2.5 times greater than that of a poorly perfused tissue because this is merely a description of relative perfusion characteristics. The system of the prior art therefore meets the claim.
Regarding claim 19, the combined invention of Almquist and Thomas discloses the claimed invention substantially as noted above. Almquist further shows that the fluorescence detection system is the PTEye (PTEye, pg. S108, “Parathyroid identification and preservation: 3rd paragraph), which applicant discloses as the instant fluorescence detection system ([0057], of the published instant specification; “the fluorescence detection system is a parathyroid detection system, also known as PTeye (AiBiomed, Santa Barbara, Calif.), [0078]). Applicant’s specification explains that the PTEye includes a display for showing numerical detection metrics and a speaker for real-time auditory feedback (see [0078] - [0095] of the instant specification, which describe the claimed features of the PTEye).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 It is noted that claim 3 recites “the contrast agent is in a volume between about 0.25 cc and about 3.50 cc at a concentration of about 2.5 mg/mL”, which corresponds to a dosage of between about (.25mL*2.5mg/mL=)0.625mg and about (3.50mL*2.5mg/mL=)8.75mg. Since claim 3 depends from claim 1, the claim requires that the dosage of “about 0.6 mg” that is recited in claim 1 has a range of about 0.625 - 8.75mg. It thus follows that any dosage of about 0.625 - 8.75mg meets the limitations of “about 0.6 mg”, based on applicant’s claims 1 and 3.
Prosecution Insights