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 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 7 – 20 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. With regard to claim 7, the claim does not end with a period and thus is not properly set forth as a single sentence. With regard to claims 8, 10, 11, and 17, by reciting “is selected from” the claim partially, but does not fully, set forth a Markush-type limitation (see MPEP 2117 and 2173.05(h)), and thus it is unclear whether Applicant intends to rely on a Markush group for defining the claim details.
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.
Claim(s) 1 – 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dey (USPGPub 2021/0267507). Dey teach a wearable device for continuous and non-invasive monitoring of bilirubin in real-time (Figures 1, 2), wherein the device comprises optical sensing, processing, display, battery, and charging elements (paragraphs [0020] – [0021]). The detection and data processing of Dey are consistent with and meet the broadly recited ‘spectral subtraction’ aspects of the claimed invention (paragraphs [0022] – [0027]). Dey indicate their device is wearable at body locations meeting the claim details (paragraph [0039]).
Claim Rejections - 35 USC § 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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dey as applied to claim 11 above. Dey teach a wearable bilirubin spectral detection device for real-time measurement, as discussed above. While Dey provide details and guidance regarding the optical measurement components, and indicate that detected range would be consistent with the claimed spectral range, they do not particularly indicate the resolution of the spectral detection. However, without a showing of unexpected results or criticality, it would have been within the skill level of the art before the effective filing date to have determined a required spectral resolution for providing a desired measurement accuracy, consistent with known optimization techniques, as it has generally been held to be obvious to perform such routine optimization regarding results-effective variables associated with components of a system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ferber et al. (USPN 10,463,283) teach a multispectral blood measurement method, where plural analyzes may be measured including bilirubin. Guillory et al. (USPGPub 2008/0091090) teach a wearable physiological sensor that includes a display element on opposite side from the sensing elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chuck Marmor, II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
Prosecution Insights