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 1, 5, 7-24 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. Further, all of the claims are required to be rewritten as the language and the content of the claims are vague and full of numerous errors.
Claim 1 is directed towards a wearable system and only positively recited one structure, “one or more optoelectronic devices”. Therefore, claims 16 and 17 are not further limiting the positively recited limitation. Clarification is requested via amendments.
Claim 8 recites “further comprising an optoelectronic device”. It is unclear whether it is referring to the one or more optoelectronic device of claim 1 or intends to claim additional optoelectronic device. Claim should amend the claim language to recite “…wherein said one or more optoelectronic devices comprises an infrared light emitting diode-enabled device (IR LED)”.
Claim 9 recites “a photodetector”. However, it is unclear it is an additional detector or is referring to the detector of claim 5. Clarification is requested via amendments.
Regarding claim 10, Applicant is advised to read on pulse oximeter. Pulse oximeter is a device that measures oxygen saturation and it includes light source(s) and detector(s). Therefore, an IR LED (light emitting diode) is not a pulse oximeter. Clarification is requested via amendments. Additionally, heart rate, respiratory rate, heart rate variability, pulse are not measurements obtained from a pulse oximeter. Clarification is requested via amendments.
Claim 15 does not make sense. Clarification is requested via amendments.
Claim 16 does not make sense. Clarification is requested via amendments.
Claim 17 does not make sense. Clarification is requested via amendments.
Claim 18 does not make sense. Clarification is requested via amendments.
Claim 19 does not make sense. Clarification is requested via amendments.
Claim 20 does not make sense. Clarification is requested via amendments.
Claims 11,12, 16-22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
The term “preferably” in claims 23-24 is a relative term which renders the claim indefinite. The term “preferably” 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.
Claim limitations “means to detect” and “means to measure” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification simply does not provide any examples of devices/structures that could correspond to the claimed units based on common knowledge in the art, and fails to correlate any specific structures with the claimed "means" that would serve to differentiate these limitations from the prior art. In addition, a consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification for such means plus function. For the instant indefiniteness analysis it is asked first whether a structure is described in the specification, and, if so, whether one skilled in the art would identify the structure from the description. The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure. Accordingly, a bare statement that known techniques or methods can be used does not disclose structure.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 5, 7-16,18-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Menon (USPN 2019/0192086).
Regarding claim 1, Menon discloses wearable system that measures blood glucose levels in a patient diagnosed with diabetes comprising: means to detect blood glucose levels ([0035], [0043], [0048]); and means to measure blood glucose levels in real time ([0034], figure 1); and one or more optoelectronic devices ([0003], [0006],[0012], [0034], figure 1); wherein said system is wireless, non-invasive and is designed to measure blood glucose levels in real time ([0007], [0011]).
Regarding claim 5, said system further comprises a photodiode labeled detector designed to take measurements from one or more blood vessels selected from the group consisting of veins, arteries, capillaries and combinations thereof (the device of Menon is configured to be placed in any location and obtain measurements from any desired location).
Regarding claim 7, said one or more blood vessels are palmer arteries (the device of Menon is configured to be placed in any location and obtain measurements from any desired location)..
Regarding claim 8, said further comprising an optoelectronic device comprises comprising an infrared light emitting diode-enabled device (IR LED) (([0003], [0006],[0012], [0034], figure 1)).
Regarding claim 9, a photo detector wherein said photo detector measures the infrared light emitting diode waveforms and amplitude ([0035], [0043], [0048]).
Regarding claim10, said infrared light emitting diode-enabled (IR LED) device is a pulse oximeter ([0034]-[0035], [0043], [0048]).
Regarding claim 11, said pulse oximeter optically measures the wearer's blood flow using photoplethysmography (PPG) ([0034]-[0035], [0043], [0048]).
Regarding claim 12, said optical measurements are health-related parameters selected from a group consisting of oxygen saturation, heart rate, pulse, respiratory rate, heart rate variability and combinations thereof ([0034]-[0035], [0043], [0048]).
Regarding claim 13, said measurements are recorded at various locations on the body of the patient ([0034]-[0035], [0043], [0048]).
Regarding claim 14, said various locations of the body of the patient is selected from a group consisting of the ears, hands, fingers, arm, forearm, cheek and combinations thereof ([0034]-[0035], [0043], [0048]).
Regarding claim 15, said wireless non-invasive system is a ring, watch, wristband, implantable radio-frequency identification (RFID) device, headphones, headbands, earrings, mask or any combinations thereof ([0034]-[0035], [0043], [0048]).
Regarding claim 16, said means to measure the blood glucose levels in real time of a patient is accomplished by a technique selected from a group consisting of machine learning algorithms, neural networks, genetic algorithms, big data statistical analytic methods and combinations thereof ([0011], [0039], [0041]-[0042]).
Regarding claim 18, said system is manufactured using a manufacturing process selected from the group consisting of one-shot molding, two-shot molding, multi-material injection molding and combinations thereof ([0011], [0039], [0041]-[0042]).
Regarding claim 19, said system is manufactured using a manufacturing process selected from the group consisting of ejection molding, 3D printing, injection molding, thermoforming, compression molding, rotational molding, vacuum casting, resin casting and combinations thereof ([0011], [0039], [0041]-[0042]).
Regarding claim 20, said system is manufactured from a material selected from a group consisting of polymers, metals, nonmetals, metalloids and combinations thereof ([0011], [0039], [0041]-[0042]).
Regarding claim 21, said system is used to determine blood glucose levels in a patient diagnosed with diabetes ([0054]).
Regarding claim 22, said use is applied to the healthcare industry, education industry, retail industry, business industry and combinations thereof ([0054]).
Regarding claim 23, said optoelectronic device emits IR radiation between 700 and 1600 nanometers, preferably, 930 nanometers, provided said IR radiation penetrates the wearer's skin to a depth of several millimeters ([0012], [0034]).
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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon.
Menon discloses utilizing machine learning algorithms (e.g. [0011]; [0039]; [0041]-[0042] Fig 3b:436) and obtaining blood glucose value measurements greater than 70% (e.g. [(0051) and maximum error rates of 7% and 23% (e.g. [0054)). Accordingly, with an error rate between 7% and 23% the system has the capability of achieving the determined blood glucose levels above 90% (i.e. error rate between 7% and 9%). Therefore, one of ordinary skill in the art would be able to achieve accuracy of the machine learning algorithm exceeding 90%.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon as applied to claim 8 above, and further in view of Monfre (USPN 2003/0060693).
Regarding claim 24, Monfre discloses an apparatus and method for near infrared light spectroscopy wherein the distance from the infrared light emitting diode-enabled (IR LED) device to the photodiode labeled detector ranges from 0.1 to 5 millimeters, preferably between 1 to 2 millimeters (e.g. [0055] maximum of 1 mm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Menon to incorporate the teachings of wherein the distance from the infrared light emitting diode-enabled (IR LED) device to the photodiode labeled detector ranges from 0.1 to 5 millimeters, preferably between 1 to 2 millimeters for the purpose of avoiding too much penetration of the radiation (e.g. Monfre: [0055)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791