NON-FINAL REJECTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/15/2025 is being considered by the examiner.
It is noted that this IDS cites patents granted on parent applications of this application, but the IDS does not contain any of the references cited in said parent application.
MPEP 609.02 recites in part:
The examiner will consider information which has been considered by the Office in a parent application (other than an international application; see subsection I., above) when examining: (A) a continuation application filed under 37 CFR 1.53(b), (B) a divisional application filed under 37 CFR 1.53(b), or (C) a continuation-in-part application filed under 37 CFR 1.53(b). A listing of the information need not be resubmitted in the continuing application unless the applicant desires the information to be printed on the patent.
Although Applicant need not resubmit information considered in the parent applications, such information will not be printed on any patent granted on this application unless resubmitted in an IDS or listed by the examiner in a PTO-892 form.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gulati et al., US 2016/0242682 A1 (hereinafter, “Gulati”).
Regarding claim 1: Gulati discloses a method for simultaneously detecting scattered light, deflected light, or a combination thereof from a target in a subject at a plurality of detection locations, the method comprising:
placing a sensor head (150/152) on the subject proximal to the target, the sensor head comprising:
a housing (implied from probe 152 and interface 150);
an illumination output (photon transport system 120 that is connected to the source system 110, Fig. 1) disposed on the housing, the illumination output coupled to an illumination source (110, Fig. 1) to supply light energy having an illumination wavelength range (see ¶ [0126]-[0129]);
a plurality of light collection units (photon transport system 120 that is connected to detector system 130, Fig. 1) disposed on the housing, each light collection unit comprising one or more polished ends of one or more respective optical fibers, each light collection unit disposed at a respective predetermined radial distance from the illumination output (¶ [0127]-[0129]); and
wherein a number of polished ends in each light collection unit corresponds to the respective predetermined radial distance (see embodiment of Fig. 22B; the number of ends in detection zones 2225, 2226, and 2227 appears to correspond to their respective radial distances from the central illumination output);
generating, with the illumination source, the light energy (¶ [0126]);
collecting, with at least one of the light collection units, at least one of scattered light and/or refracted light to provide collected light (¶ [0127]-[0130]); and
passing at least a portion of the collected light through a spectrometer to determine a spectral profile of the at least a portion of the collected light (¶ [0052], [0054]-[0058], [0069], [0127]-[0129], [0131]).
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Regarding claim 2: Gulati further discloses detecting the collected light with an optical sensor, the optical sensor (130, Fig. 1) electrically coupled to a computer (140, 180, 194, Fig. 1); see ¶ [0127]-[0129] and [0131]-[0135].
Regarding claim 3: Gulati further discloses comparing, with the computer, current spectral scan data of the subject at the target with prior spectral scan data of the target to determine if a change in a spectral property of the target has occurred:
For example, Gulati discloses analyzing the spectral data over time to determine temporal trends in glucose concentration in the subject using time series analysis and/or through the glucose history (¶ [0119] and [0141]).
Otherwise, Gulati also discloses analyzing the spectral data over time to monitor shaking or other vibrational disturbances (¶ [0165]).
Claim Rejections - 35 USC § 102 or 103
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.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gulati.
The ordinarily skilled artisan would have understood that the spectral data comparison over time as discussed above is compared over the same wavelength range (e.g., in the case of glucose, wavelength(s) that is/are specifically relevant to glucose, ¶ [0066], [0119], [0174]) so that variation of wavelength between the two measurements is blocked as a confounding variable in order to isolate the spectral property of interest (e.g., a spectral property related to glucose concentration). Otherwise, if the same wavelength range isn’t used between the current and prior spectral scan data, then it would not be clear whether a difference/change in the spectral data was due to a change in the spectral property of interest instead of the change in the wavelength range.
Otherwise, even if not implied in Gulati itself, using the same wavelength range for current and prior spectral data is well-understood, routine, and conventional in the art for the purposes described above and therefore would have been obvious to the one having ordinary skill in the art before the effective filing date of the claimed invention.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 9 of U.S. Patent No. 12,295,737 B2 (hereinafter “Reference Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application (19/034,752)
Reference Patent (US 12,295,737 B2)
1. A method for simultaneously detecting scattered light, deflected light, or a combination thereof from a target in a subject at a plurality of detection locations, the method comprising:
7. A method for simultaneously detecting scattered light, deflected light, or a combination thereof from a target in a subject at a plurality of detection locations, the method comprising:
placing a sensor head on the subject proximal to the target, the sensor head comprising:
a housing;
an illumination output disposed on the housing, the illumination output coupled to an illumination source to supply light energy having an illumination wavelength range;
a plurality of light collection units disposed on the housing, each light collection unit comprising one or more polished ends of one or more respective optical fibers, each light collection unit disposed at a respective predetermined radial distance from the illumination output; and
wherein a number of polished ends in each light collection unit corresponds to the respective predetermined radial distance;
placing a sensor head on the subject proximal to the target, the sensor head comprising:
a housing;
an illumination output disposed on the housing, the illumination output coupled to an illumination source to supply light energy having an illumination wavelength range;
a plurality of light collection units disposed on the housing, each light collection unit comprising one or more polished ends of one or more respective optical fibers, each light collection unit disposed at a respective predetermined radial distance from the illumination output; and
wherein a number of polished ends in each light collection unit corresponds to the respective predetermined radial distance;
generating, with the illumination source, the light energy;
generating, with the illumination source, the light energy;
collecting, with at least one of the light collection units, at least one of scattered light and/or refracted light to provide collected light; and
collecting, with at least one of the light collection units, at least one of scattered light and/or refracted light to provide collected light;
passing at least a portion of the collected light through a spectrometer to determine a spectral profile of the at least a portion of the collected light.
passing at least a portion of the collected light through a spectrometer to determine a spectral profile of the at least a portion of the collected light;
2. The method of claim 1, further comprising
detecting the collected light with an optical sensor, the optical sensor electrically coupled to a computer.
detecting the collected light with an optical sensor, the optical sensor electrically coupled to a computer;
3. The method of claim 2, further comprising
comparing, with the computer, current spectral scan data of the subject at the target with prior spectral scan data of the target to determine if a change in a spectral property of the target has occurred.
comparing, with the computer, current spectral scan data of the subject at the target with prior spectral scan data of the target to determine if a change in a spectral property of the target has occurred; and
wherein the change in the spectral property corresponds to neurological damage to or a neurological disease of a brain.
4. The method of claim 3, further comprising
comparing, with the computer, the current spectral scan data over a comparison wavelength range with prior spectral scan data over the comparison wavelength range.
9. The method of claim 7, further comprising
comparing, with the computer, the current spectral scan data of the subject at the target over a comparison wavelength range with prior spectral scan data over the comparison wavelength range.
As can be easily seen in the table above which matches the claims of the instant application to claims of the reference patent, limitation by limitation:
Claim 1 of the instant application is anticipated by claim 7 of the reference patent.
Claim 2 of the instant application is anticipated by claim 7 of the reference patent.
Claim 3 of the instant application is anticipated by claim 7 of the reference patent.
Claim 4 of the instant application is anticipated by claim 9 of the reference patent.
Examiner Remarks on Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanlon et al., US 2015/0073282 A1 (hereinafter, “Hanlon”) is cited for teaching detecting scattered light and deflected light from a target (head) in a subject using an illumination source, and illumination output, light collection units comprising polished ends of optical fibers, and a spectrometer (see Fig. 11; ¶ [0082]-[0095]). Hanlon further teaches using the spectral data to detect/diagnose a neurological disease such as Alzheimer’s Disease (see Fig. 1 which illustrates spectral differences between AD and non-AD subjects).
This relevant to Applicant’s disclosure because Applicant’s disclosure is also concerned with neurological diseases such as Alzheimer’s Disease (see ¶ [0002] of the Specification).
However, Hanlon does not teach the limitation regarding the number of polished ends in each light collection unit corresponding to the respective predetermined radial distance (as recited in claim 1 of the instant application), and further does not teach comparing current spectral scan data of the subject at the target with prior spectral scan data of the target to determined a change in a spectral property of the target has occurred (as recited in claim 3 of the instant application).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
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