DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
As required by M.P.E.P. 609, the applicant’s submissions of the Information Disclosure Statement dated 8/08/2025, 11/19/2025, and 5/14/2026 is acknowledged by the examiner and the cited references have been considered in the examination of the claims now pending.
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 45-64 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 regards to claims 45 and 55, the term “associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “associated” is a relative term which renders the claim indefinite (MPEP 2173.05(b).
Furthermore, it is unclear what establishes an “association”. Is this a suggestion meant to describe a difference or variance between the two? How can they be related or connected? In other words, the claim term is both relative and subjective.
Finally, depending claim(s) 46-54 and 56-64 inherit deficiencies from the parent claim(s) 45 and 55.
Appropriate correction 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 45-64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter, as they do not fall under any of the statutory classes of inventions. This claim is directed towards “machine-readable instructions” which is not limited to falling under the statutory classes of invention set forth. This claim in using the term “ machine-readable instructions” allows for the memory stored instructions to be interpreted as signals, thus non-statutory. Based on current USPTO Policy, when the “machine-readable instructions” is not specifically defined as non-transitory, the broadest reasonable interpretation is used according to MPEP 2111, thus a program may embody signals, i.e. transitory media. Examiner suggests that Applicants amend the claims to add a limitation to direct the language of the “machine-readable instructions” claims to only include the non-transitory embodiment which would remove the possibility of claiming signals. The “machine-readable instructions” needs to be embodied on a non-transitory computer readable medium, as the claim now is directed to software per se which is not patent eligible under 101.
Claims 46-54 and 56-64 are rejected as being dependent on claim 45 and 55 and failing to cure the deficiencies of the independent claim, as the claims do add any additional elements beyond the abstract idea.
Claim Rejections - 35 USC § 102
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 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) 45, 46, 55, and 56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiley (20190012784).
Regarding claim 45, Wiley discloses (see at least Fig 1, [0042]-[0050]) a system (Fig 1, handheld digital device 10) for determining a health condition associated with a user ([0009], providing clinical information to eye care practitioners; monitoring the near working distance that a patient is using and providing information to the eye care practitioner by communication options), the system (10) comprising: a single device having a front and a back (Fig 1, [0044], 10 has a front and back), the single device carried or worn by the user (Fig 1, [0044], handheld digital device 10 is held at working distance 22 from patient's face 24 and eyes 26 when in use); at least one sensor (18) located on the front of the device (Fig 1, [0043], handheld digital devices 10 include camera 18 that faces a user); a display (16) located on the front of the device (Fig 1, [0043], faces a user when the user is viewing display 16); a memory (14) storing machine-readable instructions ([0052], working distance 22 is then saved to memory 14 by image analysis engine 38); and a control system (12) including one or more processors configured to execute the machine-readable instructions ([0043], processor 12 and memory 14 are provided within body 20) to: receive, from the at least one sensor, data associated with at least one biomarker of a user ([0056], image data used to identify structures of face 24 such as eyes 26 and to determine a distance between handheld digital device 10 and eye 26 structures); process the data to determine a metric associated with the at least one biomarker; and based at least in part on the metric ([0052], time, date, lighting conditions, apparent pupil size and whether the user is wearing glasses at the time of recording can be captured and saved), determine a health condition associated with the user ([0075], Pupil size and its correlation may assist in determining how well a particular treatment for presbyopia is working).
Regarding claim 46, Wiley discloses wherein the display is configured to emit a light stimulus ([0055], illumination assembly 40 having coherent light source 42 and diffuser 44 which are arranged to project an illuminated speckle pattern on face 24).
Regarding claim 55, Wiley discloses (see at least Fig 1, [0042]-[0050]) a method (Fig 1, handheld digital device 10) for determining a health condition associated with a user ([0009], providing clinical information to eye care practitioners; monitoring the near working distance that a patient is using and providing information to the eye care practitioner by communication options), the method (10) utilizing: a single device having a front and a back (Fig 1, [0044], 10 has a front and back), the single device carried or worn by the user (Fig 1, [0044], handheld digital device 10 is held at working distance 22 from patient's face 24 and eyes 26 when in use); at least one sensor (18) located on the front of the device (Fig 1, [0043], handheld digital devices 10 include camera 18 that faces a user); a display (16) located on the front of the device (Fig 1, [0043], faces a user when the user is viewing display 16); a memory (14) storing machine-readable instructions ([0052], working distance 22 is then saved to memory 14 by image analysis engine 38); and a control system (12) including one or more processors configured to execute the machine-readable instructions ([0043], processor 12 and memory 14 are provided within body 20); the method comprising: receiving, from the at least one sensor, data associated with at least one biomarker of a user ([0056], image data used to identify structures of face 24 such as eyes 26 and to determine a distance between handheld digital device 10 and eye 26 structures); processing the data to determine a metric associated with the at least one biomarker; and based at least in part on the metric ([0052], time, date, lighting conditions, apparent pupil size and whether the user is wearing glasses at the time of recording can be captured and saved), determining a health condition associated with the user ([0075], Pupil size and its correlation may assist in determining how well a particular treatment for presbyopia is working).
Regarding claim 56, Wiley discloses wherein the display is configured to emit a light stimulus ([0055], illumination assembly 40 having coherent light source 42 and diffuser 44 which are arranged to project an illuminated speckle pattern on face 24).
Allowable Subject Matter
Claims 47-54 and 57-64 are allowed, pending applicant’s overcoming of the 112(b) and 101 rejections above.
The following is a statement of reasons for the indication of allowable subject matter: with respect to the allowable subject matter, none of the prior art either alone or in combination disclose or teach of the claimed combination of limitations to warrant a rejection under 35 USC 102 or 103.
Specifically, with respect to dependent claim 47, the prior art of Wiley taken either singly or in combination with any other prior art fails to suggest such a system including the specific arrangement: “wherein the at least one sensor includes a light sensor, a camera, an acoustic sensor, a temperature sensor, a mechanical sensor, a physical sensor, a position sensor, an accelerometer, a gyroscope, an infrared sensor, a photoplethysmograph (PPG) sensor, an electrocardiogram (ECG) sensor, a moisture sensor, a humidity sensor, adigital barometric pressure sensor, a fingerprint identity sensor, a proximity sensor, a magnetometer, a galvanic skin response sensor, a bioimpedance sensor, or any combination thereof”. Claims 48-54 are allowable due to pendency on dependent claim 47.
Specifically, with respect to dependent claim 57, the prior art of Wiley taken either singly or in combination with any other prior art fails to suggest such a method including the specific arrangement: “wherein the at least one sensor includes a light sensor, a camera, an acoustic sensor, a temperature sensor, a mechanical sensor, a physical sensor, a position sensor, an accelerometer, a gyroscope, an infrared sensor, a photoplethysmograph (PPG) sensor, an electrocardiogram (ECG) sensor, a moisture sensor, a humidity sensor, a digital barometric pressure sensor, a fingerprint identity sensor, a proximity sensor, a magnetometer, a galvanic skin response sensor, a bioimpedance sensor, or any combination thereof”. Claims 58-64 are allowable due to pendency on dependent claim 57.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Berestka (20190053703), Dreher (6112114), Rowe (5206672), and Daly (4638801) are examples of an ophthalmic system that includes an illumination source with a plurality of lights.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharrief I Broome whose telephone number is (571)272-3454. The examiner can normally be reached Monday-Friday 8am-5pm, EST.
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, Ricky Mack can be reached at 571-272-2333. 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.
Sharrief I. Broome
Primary Examiner
Art Unit 2872
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872
Prosecution Insights