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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/28/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
Limitation “means for steering the first light beam” in claims 18 and 19, the claims does not recite enough structure that corresponds to the claimed “means” to perform the claimed function of steering. However, the specification discloses a lens or an optical grating as the light steering means (par.0020) that can be interpreted as the structure that corresponds to the claimed “means”.
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 § 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, 2, 4-8, 10, 12-13 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US 2009/0156918).
As to claims 1, 18 and 19, Davis teaches an implantable medical device (IMD) (IMD optical sensor 10 and/or medical lead 300 including an optical sensor similar to sensor in fig.1, abstract, par.16 and par.28, fig.1-6) comprising:
an optical module (optical sensor 10 and/or 304, par.16 and par.28, fig.1 and 6) that includes:
a first light emitter (light source LED 26 generating light with first wavelength, par.18-19, fig.1) arranged to generate a first beam of emitted light,
a second light emitter (light source LED 28 generating light with second wavelength, par.18-19, fig.1) arranged to generate a second beam of emitted light,
a light detector (two light detectors embodied as LEDs 46 and 48, par.20, fig.1) arranged to sense backscattered light responsive to the first beam and the second beam (EDs 46 and 48 are selected to match light emitting LEDs 26 and 28 such that one light-detecting LED 46 is sensitive to the same color of light emitted by LED 26 and the other light-detecting LED 48 is sensitive to the same color wavelength emitted by LED 28, par.21), and
at least one optical layer (emitting portions 14 and 16, having lenses 18 and 38 and two walls 24 surrounding LEDs 26 and 28, and two walls 44 surrounding the LEDs 46 and 48, par.18 and par.20, fig.1) comprising a beam steering feature for steering the first and second beam (lens 18 and 38, respectively, for passing emitted light from the light emitting portion 14 and scattered light to the light detecting portion 16, par.16-20 and par.22, fig.1),
and/or a cross-talk feature for reducing interference with the backscattered light (outer left wall 24 adjacent to LED 26, and outer right wall 44 adjacent to detector 48, par.18 and par.20, fig.1).
As to claim 2, Davis teaches the IMD, wherein the at least one optical layer includes the beam steering feature, wherein the beam steering feature is a lens or an optical grating (lens 18 and 38, respectively, for passing emitted light from the light emitting portion 14 and scattered light to the light detecting portion 16, par.16-20 and par.22, fig.1).
As to claim 4, Davis teaches the IMD, further comprising a first wall positioned between the first light emitter and the light detector, wherein the first wall is arranged to at least partially block non-backscattered light (inner left wall 24 adjacent to LED 28, positioned between LED 26 and detectors 46 and 48, par.18 and par.20, fig.1).
As to claim 5, Davis teaches the IMD, wherein the first wall is positioned between the second light emitter and the detector (inner left wall 24 adjacent to LED 28, positioned between LED 28 and detectors 46 and 48, par.18 and par.20, fig.1).
As to claim 6, Davis teaches the IMD, further comprising a second wall positioned between the second light emitter and the light detector (inner right wall 44 adjacent to detector 46, positioned between LED 28 and detectors 46 and 48, par.18 and par.20, fig.1).
As to claim 7, Davis teaches the IMD, wherein the at least one optical layer includes the cross-talk feature, wherein the cross-talk feature is an area of dark material (walls 24 and 44 may be formed from rigid, opaque material, such as a liquid crystal polymer, or can be formed from other, non-rigid, materials, for example a polymer material formed as a molded component, par.20).
As to claim 8, Davis teaches the IMD, wherein the first emitter and the second emitter are light-emitting diodes (two LEDs 26 and 28 typically emit light corresponding to two different wavelengths or colors, par.18-20).
As to claim 10, Davis teaches the IMD, wherein the first light emitter, the second light emitter, and the detector are coupled to a single circuit board (circuit board 52 is shown as a single circuit board on which both emitting portion 14 and detecting portion 16 are assembled, par.18, end of par.20 and par.23).
As to claims 12 and 20, Davis teaches the IMD, wherein the first beam comprises infrared light, wherein the second beam comprises red light (one of LEDs 26 and 28 emits red light and the other emits infrared light, par.19 and 21).
As to claim 13, Davis teaches the IMD, further comprising a housing (housing 302 of lead 300, apr.28, fig.6) and electrodes (electrodes and sensors in lead 300, par.30), wherein the optical module is positioned within the housing (sensor 304 is positioned along lead body 302, wherein sensor 304 is similar to sensor 10 shown in fig.1, par.28), wherein the electrodes are coupled to the housing (as best seen in fig.6-7, par.30-31).
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) 11 and 16 is/are rejected under 35 U.S.C. 103 as being obvious over Davis et al (US 2009/0156918).
As to claim 11, Davis teaches the invention substantially as claimed above, but failed to explicitly teach an edge of the first light emitter is positioned 3-6 mm from an adjacent edge of the detector.
However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to position the edge of the first light emitter 3-6 mm from an adjacent edge of the detector because the Applicant has not disclosed that this specific distance between the first light emitter and the detector provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the distance between the light emitter and detector taught by Davis’s invention and the Applicant’s invention, to perform equally well with either the distance taught by Davis’s invention or the claimed distance because both optical sensors would perform the same function of emitting light through the body tissue and detect the back scattered light with the detector.
As to claim 16, Davis teaches the invention substantially as claimed above, but failed to explicitly teach the optical module is configured to consume a maximum of 5 milliamps of power during operation. However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to allow the optical module to consume a maximum of 5 milliamps of power during operation, since it has been held that discovering the optimum value of a result of effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215(CCPA 1980).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being obvious over Davis et al (US 2009/0156918), in view of Prins et al (US 2021/0290110).
As to claim 3, Davis teaches the beam steering feature is a lens (lens 18 and 38, par.18-20), but failed to explicitly teach the lens is a Fresnel lens. However, Prins teaches an analogous implanted optical sensor (Abstarct, par.67-68, fig.1-3), wherein the lens is Fresnel lens (imaging element(s) 412 comprise one or multiple optical components, e.g., a single lens or a set of lenses, a light blocking element, an aperture, etc. A lens can have a 3-dimensional shape, or it can for example be a flat lens such as a Fresnel lens, par.72, fig.4).
Since Fresnel lenses are well-known in the art to steer light, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to replace lenses 18 and 38 taught by Davis’s invention with Fresnel lens, as taught by Prins’s invention, without changing its respective reason to steer emitted light, as taught by Prins’s invention (par.72).
Claim(s) 9, 14 and 15 is/are rejected under 35 U.S.C. 103 as being obvious over Davis et al (US 2009/0156918), in view of Duan et al (US 12,089,931).
As to claim 9, Davis teaches the invention substantially as claimed above, but failed to explicitly teach the at least one optical layer includes the cross-talk feature, wherein the cross-talk feature includes multiple filter layers. However, Duan teaches an analogous optical sensing assembly (100 having optical sensor 101, abstract, col.5-6, fig.1A) comprising light emitters and detectors (110 and 120, col.5-6, fig.1A), wherein the optical sensing assembly 101 may include one or more physical components that allow the light detector(s) 120 to sense light from multiple emitters, including filters and the like (col.6, lines 55-61).
Since having filters to filter emitted and backscattered light is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to include light filters in the optical sensor taught by Davis’s invention, as light filter taught by Duan’s invention to filter the light and allow selected light wavelength to pass.
As to claims 14 and 15, Davis teaches the invention substantially as claimed above, but failed to explicitly teach the at least one optical layer is part of a single window wherein the single window is arranged such that the first beam, the second beam, and the backscattered light pass through the single window, further comprising a single seal surrounding a perimeter of the single window.
However, Duan teaches an analogous optical sensing assembly (100 having optical sensor 101, abstract, col.5-6, fig.1A) comprising light emitters and detectors (110 and 120, col.5-6, fig.1A) wherein both the emitted lights and backscattered light are passing through a single window (150 and 150a, col.5-6, fig.1A), further comprising a single seal surrounding a perimeter of the single window (enclosure 102 surrounding optical assembly 101, as best seen in fig.1A).
Since having single window for passing emitted and backscattered light is well-known in the art, so at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to design optical sensor 10 taught by Davis’s invention to have only sone single window because the Applicant has not disclosed that having a single window provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the optical sensor taught by Davis’s invention and the Applicant’s invention, to perform equally well with either the two window sensor taught by Davis’s invention or the claimed single window sensor because both optical sensors would perform the same function of emitting light through the body tissue and detect the back scattered light with the detector.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being obvious over Davis et al (US 2009/0156918), in view of Cinbis et al (US 2008/0306390).
As to claim 17, Davis teaches the invention substantially as claimed above, but failed to explicitly teach the light detector is a single light detector, wherein the light detector is the only light detector of the IMD.
However, Cinbis teaches an analogous IMD sensor (17, abstract, par.21-22, fig.3), where the light detector is a single light detector, wherein the light detector is the only light detector of the IMD (detector 212 is the only single detector in the IMD, par.40-44, fig.3).
Since the use of a single photodetector to detect light emitted from two light sources is well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to replace the two detectors taught by Davis’s invention, with one detector as taught by Cinbis’s invention, to sense light emitted from two light sources having different wavelength, as taught by Cinbis’s invention (par.42-44).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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