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 .
Election/Restrictions
Applicant’s election of Group III, drawn to the system comprising a casing including components for non-invasive sensor for temperature compensated IR emission-detection for determining a physiological parameter, and Species K, embodiment drawn to Figure 18, in the reply filed on 10/6/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-28 and 45-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/6/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a radiation source” in claim 1,
“a sensing unit” in claim 1, and
“an analyzing unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 29 is objected to because of the following informalities: the recitation in line 7 of “wherein the source is further adapted the irradiated body part absorbs” appears to contain grammatical error or a missing word. Applicant may have been intended to recite “wherein the source is further adapted so the irradiated body part absorbs”, or the like. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: the recitation of “where-in” may have been intended to read “wherein”, or the like. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: the recitation of “the physiological parameter is glucose, and the bodily fluid is glucose” may have been intended to read “the physiological parameter is a glucose concentration, and the bodily fluid is glucose”, “the physiological parameter is a glucose concentration, and the bodily fluid is blood”, or the like. 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 29-44 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 term “particularly” in claim 29 line 6 is a relative/conditional term which renders the claim indefinite. The term “particularly” 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 scope of the claim is indeterminate with respect to if the relative/conditional limitations of “the body part is particularly selected from a fingertip, a plurality of finger tips, and a palm”. It is unclear if only the “particulars” are explicitly, implicitly, inherently and/or inferentially required and/or what other body parts may be explicitly, implicitly, inherently and/or inferentially excluded from the scope of the claim. Depending claims 30-44 inherit and do not remedy the indefiniteness.
For claim 32, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 32 recites the broad recitation “a size of about 1 cm2 to about 500 cm2”, and the claim also recites “particularly about 2 cm2 to about 200 cm2“ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 37, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For claim 38, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 32 recites the broad recitation “a thickness of about 0.2 mm to about 2 mm”, and the claim also recites “particularly of about 0.3 mm to about 1 mm“ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “particularly” in claim 41 line 3 and line 4 is a relative/conditional term which renders the claim indefinite. The term “particularly” 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 scope of the claim is indeterminate with respect to if the relative/conditional “particulars” are explicitly, implicitly, inherently and/or inferentially required or excluded from the scope of the claim.
Claim 44 recites the limitation "the alteration rate" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the amount of glucose" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 44 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 44 recites “Use of the device of claim 29, for non-invasively determining a physiological parameter in a bodily fluid of a subject, wherein the physiological parameter is glucose, and the bodily fluid is blood, and wherein the alteration rate of the amount of glucose in blood is determined.”
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it appears to positively recite both a process (“Use of”) and an apparatus (“the device of claim 2”), mixing statutory classes of invention and rending the claim non-statutory subject matter. Assuming arguendo it was intended to be a process or method claim, no process or method steps are recited. Assuming arguendo it was intended to be further limiting apparatus claim, further subject matter limitations are recited.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 29-31, 33, 35-37, and 39-44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (WO 2019/160272 A1 to Tempus Inc. from 5/2/23 IDS Foreign Patent Doc cite 1) .
For claim 29, Lee discloses a device comprising a non-invasive system for determining a physiological parameter in a bodily fluid of a subject (Figs 1-2) (Pgs 4-8), wherein the device comprises a casing (10), wherein the device includes:
(a) a radiation source (irradiating optical module 20) adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of about 400 nm to about 1500 nm into a body part of said subject (Figs 1-2) (Pgs 4-8), wherein the body part is a palm (Figs 1-2) (Pgs 4-8), and wherein the radiation source is further adapted the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wave-length range of about 5 micron to about 12 micron (Figs 1-2) (Pgs 4-8),
(b) a sensing unit (light receiving optical module 20) for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of about 5 micron to about 12 micron(Figs 1-2) (Pgs 4-8), wherein said sensing unit is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid of said subject (Figs 1-2) (Pgs 4-8), wherein the intensity of the emitted IR decreases with an increasing concentration of the physiological parameter and the intensity of the emitted IR radiation increases with a decreasing concentration of the physiological parameter (Figs 1-2) (Pgs 4-8), and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is substantially independent from the concentration of the physiological parameter in the bodily fluid of said subject (Figs 1-2) (Pgs 4-8), and
(c) an analyzing unit (controller for calculating blood glucose level from 20, Pg 7) for the qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in the sensing unit (b) (Figs 1-2) (Pgs 4-8), and
wherein the casing comprises a first face (upper face of 10 in Fig 2) comprising a screen (80), wherein the screen is at least partially made of a material, which is optically transparent for NIR/VIS radiation emitted by the radiation source (a) and for IR radiation detected by the sensing unit (b), (Figs 1-2) (Pgs 4-8)
wherein the radiation source (a), the sensing unit (b) and the analyzing unit (c) are incorporated within the casing (Fig 2).
For claim 30, Lee discloses the device of claim 29, wherein the radiation source (a) is adapted for emitting radiation through the screen (Figs 1-2) (Pgs 4-8).
For claim 31, Lee discloses the device of claim 29, wherein the sensing unit (b) is adapted for detecting radiation entering the casing through the screen (Figs 1-2) (Pgs 4-8).
For claim 33, Lee discloses the device of claim 29, wherein the screen is substantially planar (Fig 2).
For claim 35, Lee discloses the device of claim 29, which is a mobile device (Figs 1-2) (Pgs 4-8).
For claim 36, Lee discloses the device of claim 29, which is selected from a smart phone, a smart watch, a tablet, and a fitness tracker device (Figs 1-2) (Pgs 4-8).
For claim 37, Lee discloses the device of claim 29, wherein the optically transparent material is a plastic material (Figs 1-2) (Pgs 4-8).
For claim 39, Lee discloses the device of claim 29, which does not comprise a radiation source for emitting IR radiation in the wavelength range of about 5 micron to about 12 micron (Figs 1-2) (Pgs 4-8).
For claim 40, Lee discloses the device of claim 29, wherein the physiological parameter is glucose, and the bodily fluid is glucose (Figs 1-2) (Pgs 4-8).
For claim 41, Lee discloses the device of claim 29, which further comprises lens (40, 70) element adapted for focusing IR radiation from the body part to the sensing unit (b) (Figs 1-2) (Pgs 4-8), particularly to the at least one sensor of the sensing unit (b) (Figs 1-2) (Pgs 4-8), wherein the lens element is incorporated within the casing and particularly wherein the lens element comprises an IR Fresnel lens or an array comprising a plurality of IR Fresnel lenses (Figs 1-2) (Pgs 4-8).
For claim 42, Lee discloses the device of claim 29, wherein the sensing unit (b) is adapted for detecting IR radiation emitted from the irradiated body part over a time period (Figs 1-2) (Pgs 4-8), wherein the body part is irradiated by VIS/NIR radiation during at least a part of said time period (Figs 1-2) (Pgs 4-8).
For claim 43, Lee discloses the device of claim 29, wherein the analyzing unit (c) is adapted for a time-dependent analysis of the detected IR radiation (Figs 1-2) (Pgs 4-8), wherein a measurement signal is recorded over a time period (Figs 1-2) (Pgs 4-8).
For claim 44, Lee discloses a use of the device of claim 29, for non-invasively determining a physiological parameter in a bodily fluid of a subject (Figs 1-2) (Pgs 4-8), wherein the physiological parameter is glucose (Figs 1-2) (Pgs 4-8), and the bodily fluid is blood (Figs 1-2) (Pgs 4-8), and wherein the alteration rate of the amount of glucose in blood is determined (Figs 1-2) (Pgs 4-8).
Claim Rejections - 35 USC § 103
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 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) 32, 34, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mouradian et al. (US 20180235489 A1, hereinafter Mouradian).
For claims 32, 34, and 38, Lee discloses the claimed invention as set forth hereinabove, except for explicitly disclosing (for claim 32) the screen has a size of about 2 cm2 to about 200 cm2, (for claim 34) adapted for displaying a contact position for the body part on the screen, or (for claim 38) the optically transparent material has a thickness of about 0.3 mm to about 1 mm.
However, for claims 32, 34, and 38, Mouradian in the same field of smart wearable physiological measurement devices teaches (for claim 32) a screen (112) has a size of about 2 cm2 to about 200 cm2 ([0026]), (for claim 34) adapted for displaying a contact position for the body part on the screen ([0041]), or (for claim 38) the optically transparent material has a thickness of about 0.3 mm to about 1 mm ([0026, 0041]).
Thus, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to incorporate the smartwatch sensing teachings of Mourdian to provide an appropriately sized smartwatch screen because doing so would aid in permitting a user to complete noninvasive physiological sensing.
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for determining glucose concentration of a user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. 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.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/Primary Examiner, Art Unit 3791