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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “element comprising non-transparent material and transparent material” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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: “the user input element configured to activate” in claim 20.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. In regards to claim 20, the claimed subject matter “input user element” fails to comply with a written description requirement. Examiner notes the claimed subject matter lacks written description since the specification does not provide the structure for the input user element to perform the claimed functions. A means- (or step-) plus-function limitation that is found to be indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, based on failure of the specification to disclose corresponding structure, material or act that performs the entire claimed function may also lack adequate written description and/or not be sufficiently enabled to support the full scope of the claim. The principal function of claims is to provide notice of the boundaries of the right to exclude by defining the limits of the invention, and means-plus-function claims rely on the disclosure to define those limits. Accordingly, an inadequate disclosure may give rise to both an indefiniteness rejection for a means-plus-function limitation and a failure to satisfy the written description and enablement requirements of section 112(a) or pre-AIA section 112, first paragraph. See MPEP 2181 IV. Clarification is required.
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.
Claim 20 is 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. In regards to claim 20, the claimed subject matter “input user element” is rendered indefinite. Examiner notes the specification does not provide the structure for the “input user element” to perform the claimed functions. Based upon the specification, there is no way to determine the metes and bounds of this limitation since there are no limits imposed by structure, material or acts, and can therefore be performed by any means capable of performing the function, both known and unknown. Clarification is required.
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) 8,10-12,15,18, & 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by KEIPER DE 102007018224.
With respect to claim 8, Keiper teaches an apparatus for determining a concentration of an analyte in a sample, the apparatus comprising:
at least three emitters “LED” (fig 1, 3-5) having at least three different wavelength “red, green, blue” characteristics, each emitter being an optical emitter; and
at least three detectors “photodiode” (fig 1,6-8),
wherein the at least three emitters and the at least three detectors are distributed on a two-dimensional surface “circuit board” (fig 1, 2).
With respect to claim 10 according to claim 8, Keiper teaches the apparatus wherein:
the at least three emitters and the at least three detectors form a plurality of emitter-detector pairs “reading the signal of the remaining photodiodes” (pg. 7, ¶ 9, lines 1-3) in such a way that a group of similar emitter-detector pairs “reading the signal of the remaining photodiodes” (pg. 7, ¶ 9, lines 1-3) with at least four different orientations of connecting vectors oriented from the emitter to the detector is formed (fig 1),
wherein similar emitter-detector pairs are defined as having approximately the same emitter-detector distance (fig 1, 3 & 6) (fig 1, 3 & 7) and approximately the same wavelength characteristics,
wherein an emitter-detector distance of an emitter-detector pair is defined as a distance between the emitter and the detector in the emitter-detector pair.
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With respect to claim 11 according to claim 10, Keiper teaches the apparatus wherein wherein the at least three emitters and the at least three detectors are configured so that for each of the at least three different wavelength characteristics, a first group of similar emitter-detector pairs (fig 1, 3 & 6) is formed which has a shorter emitter-detector distance than a second group (fig 1, 3 & 8) of similar emitter-detector pairs which has the same wavelength characteristics.
With respect to claim 12 according to claim 11, Keiper teaches the apparatus wherein the first group of similar emitter detector pairs “reading the signal of the remaining photodiodes” (pg. 7, ¶ 9, lines 1-3) and the second group of similar emitter-detector pairs “reading the signal of the remaining photodiodes” (pg. 7, ¶ 9, lines 1-3) for each wavelength characteristic of the at least three wavelength characteristics of emitters of the group of similar emitter-detector pairs include at least four similar emitter-detector pairs such that connecting vectors from the emitter to the detector in the at least four emitter-detector pairs are oriented in angles that are approximately equally distributed between 0 degrees and 360 degrees (fig 1).
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With respect to claim 18 according to claim 8, Keiper teaches the apparatus wherein the two-dimensional surface on which the at least three emitters and the at least three detectors are distributed comprises a surface of a printed circuit board (fig 1, 2) (pg. 4, ¶ 4).
With respect to claim 19 according to claim 8, Keiper teaches the apparatus wherein for at least one emitter-detector pair of the plurality of emitter-detector pairs there are at least two optical paths from the respective emitter to the respective detector (fig 1).
Examiner notes since an LED transmits several rays, there would inherently be two optical paths from the emitter to the respective detector.
Claim(s) 8 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruinsma US 20100030041.
With respect to claim 8 Bruinsma, teaches an apparatus for determining a concentration of an analyte in a sample, the apparatus comprising:
at least three emitters (fig 2A, 204), “one or more optical sources” (0065, lines 1-2) having at least three different wavelength characteristics “at three (3) or more wavelengths” (0067, lines 5-6), each emitter being an optical emitter (0088); and
at least three detectors (fig 1,106), wherein the at least three emitters and the at least three detectors are
distributed on a two-dimensional surface (fig 2A, 206).
With respect to claim 20 according to claim 8, Bruinsma teaches the apparatus further comprising:
a sensor contact surface (fig 2A, 304A) configured to be brought in contact with the
sample (fig 7a, 102); and
a user input element (fig 2a, 208A) positioned on a side of the apparatus that is opposite
the sensor contact surface, the user input element configured to activate a measurement “control the operation of the device” “view one or more measurements” by the apparatus (fig 2A, 210A)(0093).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Bruinsma US 20100030041.
With respect to claim 21 according to claim 8, Bruinsma teaches a lateral guide (fig 2A) configured to ensure a relative position of measurement in one direction relative to a user of the apparatus.
Bruinsma does not specifically teach the lateral guide is adjustable to the user.
Bruinsma in a second embodiment teaches a pivot (fig 3A, 303A) designed to adjustably guide a lateral guide (fig 3a, 307). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine a pivot with Bruinsma’s lateral guide to adjust to different size fingers during measurements of blood content.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruinsma US 20100030041 in view of PulseOximeter.org, https://www.pulseoximeter.org/?srsltid=AfmBOoq_X7AGTHv0YTtQDTa7M-VUEWMAkmqdArmbsrORfSk7F5aLm8ue, September 22, 2010 hereafter Pulse Oximeter.
With respect to claim 25 according to claim 8, Bruinsma teaches the apparatus further comprising:
a sensor contact surface configured to be brought in contact with the sample “patient's finger” (0090, line 5 Bruinsma);
Bruinsma does not teach at least three cavities that each contain at least one of the at least three detectors.
Bruinsma in a second embodiment teaches three cavities (fig 3C) respectively containing a detector (0109). At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to combine three cavities with the combination’s housing to keep the photodetector fixed during measurements.
Bruinsma does not teach at least one non-transparent material, wherein each cavity is a volume that is enclosed by surfaces that consist of a non-transparent material of the at least one non-transparent materials and the sensor contact surface.
Pulse Oximeter, in the same field of endeavor of Bruinsma of finger clip blood measurements, teaches a finger clip housing is made from a non-transparent plastic (fig 1). Examiner notes one of ordinary skill would understand the material which forms the housing i.e. sensor contact surface and cavity may be made out of a non-transparent housing to avoid outside light sources from interfering with measurements. At the time prior to the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to form the combination’s cavities from a non-transparent plastic to yield predictable results of preventing outside light from interfering with measurements.
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With respect to claim 26 according to claim 8, the combination teaches the apparatus wherein the sensor contact surface is curved (fig 2A, 206 Bruinsma).
Allowable Subject Matter
Claims 2-7 & 27-34 are allowed. Claims 9, 13-17, & 22-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims or to include the limitation(s) and any intervening claims into the base claim. The following is a statement of reasons for the indication of allowable subject matter:
As to claim 2, the prior art of record, taken alone or in combination, fails to disclose or render obvious “wherein next to each of the at least three emitters of the first wavelength characteristic, one of the at least three emitters of the second wavelength characteristic is arranged so that the respective emitters are not separated by nontransparent
material, wherein the at least three emitters of the first wavelength characteristic, the at least three emitters of the second wavelength characteristic, and the at least three detectors form a plurality of emitter-detector pairs in such a way that groups of similar emitter-detector pairs are formed, wherein similar emitter-detector pairs are defined as having approximately the same emitter-detector distance and approximately the same wavelength characteristic”, in combination with the rest of the limitations of claim 2.
As to claim 9, the prior art of record, taken alone or in combination, fails to disclose or render obvious “an element configured to influence a direction of photons emitted from the at least three emitters, wherein the element comprises a plurality of materials including a non-transparent material and a transparent material, the transparent material containing a dye”, in combination with the rest of the limitations of claim 19.
As to claim 13, the prior art of record, taken alone or in combination, fails to disclose or render obvious “at least four different orientations of connecting vectors are approximately equally distributed between 0 degrees and 360 degrees”, in combination with the rest of the limitations of claim 13.
As to claim 15, the prior art of record, taken alone or in combination, fails to disclose or render obvious “each of the at least three emitters is a member of at least two different groups of similar emitter-detector pairs, each of the at least three detectors is a member of at least six different groups of similar emitter-detector pairs”, in combination with the rest of the limitations of claim 15.
As to claim 16, the prior art of record, taken alone or in combination, fails to disclose or render obvious “such that measurements that determine the concentration of the analyte in the sample provide equivalent results where
acquired measurements differ in a relative orientation between the sample and the apparatus.”, in combination with the rest of the limitations of claim 16.
As to claim 17, the prior art of record, taken alone or in combination, fails to disclose or render obvious “the at least three emitters and the at least three detectors are arranged such that, for each of three different wavelengths,
at least one group of similar emitter-detector pairs is formed with connecting vectors from the respective emitter to the respective detector having the same length and at least four different orientations”, in combination with the rest of the limitations of claim 17.
As to claim 22, the prior art of record, taken alone or in combination, fails to disclose or render obvious “wherein there are at least two detectors that are not within the cavity; at least one non-transparent material; and at least one transparent material, wherein the cavity comprises a volume that is enclosed by a surface of a transparent material of the at least one transparent material and by at least one surface of a non-transparent material of the at least one non-transparent material”, in combination with the rest of the limitations of claim 22.
As to claim 23, the prior art of record, taken alone or in combination, fails to disclose or render obvious “for each wavelength group, there is a plurality of subgroups of emitter detector pairs of the wavelength group, each subgroup of emitter-detector pairs includes all emitter-detector pairs of the wavelength group having the same characteristic distance, the characteristic distance defined as a distance between respective emitters and detectors in a subgroup of emitter-detector”, in combination with the rest of the limitations of claim 23.
As to claim 24, the prior art of record, taken alone or in combination, fails to disclose or render obvious “wherein the at least six emitters and the at least three detectors are distributed on a two-dimensional surface forming a plurality of emitter-detector pairs in such a way that at least three groups of similar emitter-detector pairs are formed where each emitter-detector pair in an individual group of similar emitter detector pairs has the same emitter-detector distance, referred to as a characteristic emitter-detector distance of the group, and the same wavelength characteristic, referred to as a characteristic wavelength of the group, and wherein each group of the at least three groups of similar emitter-detector pairs has a different characteristic emitter-detector distance”, in combination with the rest of the limitations of claim 24.
As to claim 27, the prior art of record, taken alone or in combination, fails to disclose or render obvious “measuring light intensities by the at least three semiconductor light detectors during activation of a second of the at least three emitters; measuring light intensities by the at least three semiconductor light detectors during activation of a third of the at least three emitters; and deriving information from the measured light intensities, wherein similar emitter-detector pairs are defined as having approximately the same emitter-detector distance and approximately the same wavelength characteristics, wherein there is a plurality of groups of similar emitter-detector pairs such that different groups of similar emitter-detector pairs have different wavelength characteristics or different emitter-detector distances”, in combination with the rest of the limitations of claim 27.
Conclusion
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/MAURICE C SMITH/Examiner, Art Unit 2877