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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the optics for producing a non-imaging spectrograph as found in claims 13 and 24 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 9 and 20 are objected to because of the following informalities:
As for claims 9 and 20, the acronyms CCD, CMOS, and CQD need to be defined.
Appropriate correction is required.
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 13 and 24-28 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.
As for claims 13 and 24, each claim recites that the system further comprises optics for producing a non-imaging spectrograph. To begin, it is unclear what optics are required for producing a non-imaging spectrograph, particularly as the specification does not appear to provide any guidance as to what specific optics are needed to produce a non-imaging spectrograph. Paragraph 0063 of the instant specification states that “there are additional optics that are configured to produce a non-imaging spectrograph”, but the specification gives no details to these optics. Additionally, any other optics appear to be image receiving optics 315, so it is unclear how “image receiving optics” would be optics for producing a non-imaging spectrograph.
Claim 25 recites the limitation "the filtered reflected light" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim. What filtered reflected light is being referred to here? Claim 25 only recites light that is reflected from the subject tissue; there is no step of filtering the light in order to provide antecedent basis for “the filtered reflected light” as claimed here.
Claims 26-28 are rejected by virtue of their dependence on claim 25, thereby containing all the limitations of the claim on which they depend.
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 1-8, 10-12, 14-19, 21-23, and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,295,743. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘743 patent claim the limitations of the claims of the instant application as follows.
Regarding claim 1, claim 1 of the ‘743 patent claims a system for detecting edema in a patient (see line 1 of the ‘743 claim), the system comprising: a light source configured to irradiate a subject's tissue with light (see lines 3-4 of the ‘743 claim); an image detector configured to collect reflected light from the subject's tissue and generate data associated with the reflected light (see lines 8-10 of the ‘743 claim); and a processing device operably connected to the image detector and configured to (see lines 11-12 of the ‘743 claim): receive the data associated with the reflected light, wherein the data comprises at least one hypercube (see lines 13-15 of the ‘743 claim), calculate the intensity of the reflected light (see line 16 of the ‘743 claim), make hypercube masks using a raw hypercube and a preprocessed hypercube (see lines 17-18 of the ‘743 claim), build a partial least squares regression model using the hypercube masks and the data associated with the reflected light (see lines 19-21 of the ‘743 claim), and determine whether the subject's tissue exhibits symptoms of edema by applying the partial least squares regression model to the at least one hypercube (see lines 22-24 of the ‘743 claim).
Further claim correspondence is as follows:
Claim 2 of the instant application with claim 2 of the ‘743 patent.
Claim 3 of the instant application with claim 3 of the ‘743 patent.
Claim 4 of the instant application with claim 1 of the ‘743 patent (see lines 5-7 of that claim).
Claim 5 of the instant application with claim 1 of the ‘743 patent (see lines 5-7 of that claim).
Claim 6 of the instant application with claim 4 of the ‘743 patent.
Claim 7 of the instant application with claim 1 of the ‘743 patent (see lines 5-7 of that claim).
Claim 8 of the instant application with claim 5 of the ‘743 patent.
Claim 10 of the instant application with claim 6 of the ‘743 patent.
Claim 11 of the instant application with claim 7 of the ‘743 patent.
Claim 12 of the instant application with claim 8 of the ‘743 patent.
Regarding claim 14, claim 9 of the ‘743 patent claims a method for detecting edema in a subject (see line 1 of the ‘743 claim), the method comprising: irradiating, by a light source, a subject's tissue with light (see line 3 of the ‘743 claim); collecting, by an image detector, reflected light from the subject's tissue (see lines 4-5 of the ‘743 claim); generating, by the image detector, data associated with the reflected light, wherein the data comprises at least one hypercube (see lines 8-10 of the ‘743 claim); receiving, by a processing device operably connected to the image detector, the reflected light (see lines 11-12 of the ‘743 claim); calculating, by the processing device, the intensity of the reflected light (see lines 13-14 of the ‘743 claim); making, by the processing device, hypercube masks using a raw hypercube and a preprocessed hypercube (see line 15-16 of the ‘743 claim); building, by the processing device, a partial least squares regression model using the hypercube masks and the data associated with the filtered reflected light (see lines 17-19 of the ‘743 claim); and determining, by the processing device, whether the subject's tissue exhibits symptoms of edema by using the partial least squares regression model (see lines 20-22 of the ‘743 claim).
Further claim correspondence is as follows:
Claim 15 of the instant application with claim 10 of the ‘743 patent.
Claim 16 of the instant application with claim 11 of the ‘743 patent.
Claim 17 of the instant application with claim 9 of the ‘743 patent (see lines 6-7 of that claim).
Claim 18 of the instant application with claim 12 of the ‘743 patent.
Claim 19 of the instant application with claim 13 of the ‘743 patent.
Claim 21 of the instant application with claim 14 of the ‘743 patent.
Claim 22 of the instant application with claim 15 of the ‘743 patent.
Claim 23 of the instant application with claim 16 of the ‘743 patent.
Regarding claim 25, claim 17 of the ‘743 patent claims a method for monitoring edema in a subject (see line 1 of the ‘743 claim) the method comprising: irradiating, by a light source, a subject's tissue with light (see line 3 of the ‘743 claim); collecting, by an image detector, reflected light from the subject's tissue (see lines 6-7 of the ‘743 claim); generating, by the image detector, data associated with the reflected light, wherein the data comprises at least one hypercube (see lines 8-10 of the ‘743 claim); receiving, by a processing device operably connected to the image detector, the reflected light (see lines 11-12 of the ‘743 claim); calculating, by the processing device, the intensity of the reflected light (see lines 13-14 of the ‘743 claim); comparing, by the processing device, the intensity of the reflected light to a control measurement to determine a current edema score (see lines 15-17 of the ‘743 claim); making, by the processing device, hypercube masks using a raw hypercube and a preprocessed hypercube (see lines 18-19 of the ‘743 claim); building, by the processing device, a partial least squares regression model using the hypercube masks and the data associated with the filtered reflected light (see lines 20-22 of the ‘743 claim); and determining a change in an edema level for the subject based upon a comparison of the current edema score and previously collected edema information by using the partial least squares regression model (see lines 23-26 of the ‘743 claim).
Further claim correspondence is as follows:
Claim 26 of the instant application with claim 18 of the ‘743 patent.
Claim 27 of the instant application with claim 19 of the ‘743 patent.
Claim 28 of the instant application with claim 20 of the ‘743 patent.
Claims 9, 13, 20, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,295,743 in view of Stewart et al (WO 2018/009670).
As for claim 9, claim 1 of the ‘743 patent claims the invention as set forth above regarding claim 1. Claim 1 of the ‘743 patent also claims that the image detector is at least one of a PtSi CCD or a PtSi CMOS (see lines 25-27 of the ‘743 claim). However, that claim fails to claim the specific image detector types found in instant claim 9.
Stewart, in a system for detecting edema, discloses detectors such as a CCD, a CMOS, and an InGaAs detector (see paragraph 0013).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the PtSi CCD or CMOS of the ‘743 patent with one of the various CCD or CMOS detectors of Stewart such as an InGaAs detector since the examiner takes Official notice of the equivalence of various types of CCDs and CMOSes for performing optical measurement, and the selection of any of these known equivalents to the detector of the ‘743 patent would be within the level of ordinary skill in the art. Additionally, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
As for claim 13, claim 1 of the ‘743 patent claims the invention as set forth above regarding claim 1, but fails to disclose optics for producing a non-imaging spectrograph.
Stewart, in a system for detecting edema, discloses, in the best understanding of the examiner, optics for producing a non-imaging spectrograph (see the non-imaging spectrograph that can be seen in Fig. 7 along with paragraph 0080).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to provide optics for producing a non-imaging spectrograph in the ‘743 patent as disclosed by Stewart, the motivation being to provide an additional data point to determine whether the subject has edema or not by providing a spectrograph that can be compared to a spectrograph of normal tissue to assist in the diagnosis (see paragraph 0080).
As for claim 20, claim 9 of the ‘743 patent claims the invention as set forth above regarding claim 14. Claim 9 of the ‘743 patent also claims that the image detector is at least one of a PtSi CCD or a PtSi CMOS (see lines 22-24 of the ‘743 claim). However, that claim fails to claim the specific image detector types found in instant claim 9.
Stewart, in a system for detecting edema, discloses detectors such as a CCD, a CMOS, and an InGaAs detector (see paragraph 0013).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the PtSi CCD or CMOS of the ‘743 patent with one of the various CCD or CMOS detectors of Stewart such as an InGaAs detector since the examiner takes Official notice of the equivalence of various types of CCDs and CMOSes for performing optical measurement, and the selection of any of these known equivalents to the detector of the ‘743 patent would be within the level of ordinary skill in the art. Additionally, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
As for claim 24, claim 9 of the ‘743 patent claims the invention as set forth above regarding claim 14, but fails to disclose optics for producing a non-imaging spectrograph.
Stewart, in a system for detecting edema, discloses, in the best understanding of the examiner, optics for producing a non-imaging spectrograph (see the non-imaging spectrograph that can be seen in Fig. 7 along with paragraph 0080).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to provide optics for producing a non-imaging spectrograph in the ‘743 patent as disclosed by Stewart, the motivation being to provide an additional data point to determine whether the subject has edema or not by providing a spectrograph that can be compared to a spectrograph of normal tissue to assist in the diagnosis (see paragraph 0080).
Allowable Subject Matter
Claims 1-12 and 14-23 would be allowable in view of the prior art should the double patenting rejection set forth above be properly overcome.
The examiner notes that claims 13 and 24 would be allowable for the reasons given below regarding claims 1 and 13, respectively, should the 35 USC 112(b) rejection of those claims be properly overcome.
Claims 25-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, along with the double patenting rejection, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 1, the prior art of record, taken either alone or in combination, fails to disclose or render obvious a system for detecting edema in a patient, the system comprising, among other essential features, a processing device operably connected to the image detector and configured to, among other functions, make hypercube masks using a raw hypercube and a preprocessed hypercube; build a partial least squares regression model using the hypercube masks and the data associated with the reflected light; and determine whether the subject’s tissue exhibits symptoms of edema by applying the partial least squares regression model to the at least one hypercube, in combination with the rest of the limitations of the above claim.
As to claim 14, the prior art of record, taken either alone or in combination, fails to disclose or render obvious a method for detecting edema in a subject, the method comprising, among other essential steps, making, by the processing device, hypercube masks using a raw hypercube and a preprocessed hypercube; building, by the processing device, a partial least squares regression model using the hypercube masks and the data associated with the reflected light; and determining, by the processing device, whether the subject’s tissue exhibits symptoms of edema by applying the partial least squares regression model to the at least one hypercube, in combination with the rest of the limitations of the above claim.
As to claim 25, the prior art of record, taken either alone or in combination, fails to disclose or render obvious a method for monitoring edema in a subject, the method comprising, among other essential steps, making, by the processing device, hypercube masks using a raw hypercube and a preprocessed hypercube; building, by the processing device, a partial least squares regression model using the hypercube masks and the data associated with the reflected light; and determining a change in an edema level for the subject based on a comparison of the current edema score and previously collected edema information by using the partial least squares regression model, in combination with the rest of the limitations of the above claim.
Regarding the above claims, WO 2018/009670 to Stewart teaches a system and corresponding method for detecting edema in a patient (abstract), the system and method comprising a light source configured to irradiate a subject's tissue with light; an image detector configured to collect reflected light from the subject's tissue and generate data associated with the reflected light; and a processing device operably connected to the image detector and configured to receive the data associated with the filtered reflected light, calculate the intensity of the reflected light, and determine whether the subject's tissue exhibits symptoms of edema (paragraph 8, 10-11, and 51; paragraph 22 teaches the reflected data is an image). Furthermore, paragraph 24 of Stewart teaches determining a current edema score and determining a change in an edema level for the patient based on a comparison of the current edema score and previously collected edema information.
Additionally, “Recent Developments in Hyperspectral Imaging for Assessment of Food Quality and Safety” by Huang et al. discloses performing qualitative or quantitative analysis of a hypercube in hyperspectral imaging due to the computationally excessive nature of the hypercube in order to explore the relationship between features in food and spectral characteristics. Huang discloses that least squares analysis can be used to extract the hyperspectral feature of defective food (see section 3.4). Huang points to Ariana et al. and “Hyperspectral waveband selection for internal defect detection of pickling cucumbers and whole pickles” for details as to the least squares analysis for extracting hyperspectral features (see section 2.4 for example).
However, this prior art, taken either alone or in combination, fails to disclose the specific processing of making hypercube masks, building a partial least squares regression model using at least those hypercube masks, and determining symptoms of edema by applying the regression model to the at least one generated hypercube from light reflected from the patient, in combination with the rest of the limitations of the above claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. All cited references on form PTO-892 other than the ones discussed above were used in various stages of prosecution of application 16/781610, the parent application for the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
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/Michael A Lyons/Primary Examiner, Art Unit 2877 June 26, 2026
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