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 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 11 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The recitation “lines of weakness” is considered indefinite since it is unclear what applicant means between capacity to bend, conform, deform or propensity to break. If applicant means propensity to break, it is unclear if it correlates to area and degree for breaking. The recitation “lines of weakness” is not defined in the specification or 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 claim and Specification of the current application fails to disclosed or define the term weakness or the degree that render the configuration to be weak in order to understand what the lines for weakness encompass. Therefore, the metes and bounds of the invention are not clear in order to understand the invention sought.
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 11 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.
The recitation “lines of weakness” in claim 14 is a relative term which renders the claim indefinite. The recitation “lines of weakness” 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 claim and Specification of the current application fails to disclosed or define the term weakness or the degree that render the configuration to be weak in order to understand what the lines for weakness encompass.
The claim recitation “lines of weakness” is considered indefinite since it is unclear what applicant means between capacity to bend, conform, deform or propensity to break. If applicant means propensity to break, it is unclear if it correlates to area and degree for breaking. The metes and bound are not clear in order to understand the invention sought.
Claim 11 has not been rejected over the prior art because, in light of the 35 U.S.C. 112 rejections supra, there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of the claims; hence, it would not be proper to reject the claims on the basis of prior art. As stated in, In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
Double Patenting
Claims 1-19 are directed to the same invention as that of claims 1-19 of commonly assigned US 12,514,474 B2. Under 35 U.S.C. 101, more than one patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention. The identical claims are matched below:
Current application 19/408,302
US 12,514,474 B2
1. A near infrared spectroscopy (NIRS) sensor comprising: a body having a dorsal face, a ventral face, and proximal and distal ends, the body supporting a light source and a photodetector in a spaced apart relationship, the light source operative to emit light from the ventral face of the body and the photodetector operative to detect light incident on the ventral face of the body and to generate an output signal; a flexible flap extending laterally from the body along opposed first and second sides of the body.
1. A near infrared spectroscopy (NIRS) sensor comprising: a body having a dorsal face, a ventral face, and proximal and distal ends, the body supporting a light source and a photodetector in a spaced apart relationship, the light source operative to emit light from the ventral face of the body and the photodetector operative to detect light incident on the ventral face of the body and to generate an output signal; a flexible flap extending laterally from the body along opposed first and second sides of the body; and a NIRS controller comprising electronic circuits connected to control the light source to emit light of different wavelengths at different times wherein the NIRS controller is configured to control the light source to emit light of each of five distinct wavelengths, λ1 to λ5, in a sequence and to sample the output signal of the photodetector in coordination with the operation of the light sources to obtain a sequence of light intensity readings each of the light intensity readings corresponding to one of the wavelengths and the NIRS controller is configured to drive each of a plurality of light emitters of the light source with a corresponding driving signal wherein the corresponding driving signals for different ones of the light emitters vary in one or more of waveform, duty cycle, amplitude, and frequency.
2. The NIRS sensor according to claim 1 wherein the flap extends between the first and second sides around the distal end of the body.
2. The NIRS sensor according to claim 1 wherein the flap extends between the first and second sides around the distal end of the body.
3. The NIRS sensor according to claim 1 wherein the flap has a thickness that is less than a thickness of the body.
3. The NIRS sensor according to claim 1 wherein the flap has a thickness that is less than a thickness of the body.
4. The NIRS sensor according to claim 1 wherein the flap has a thickness in the range of 0.2 mm to 0.4mm.
4. The NIRS sensor according to claim 1 wherein the flap has a thickness in the range of 0.2 mm to 0.4 mm.
5. The NIRS sensor according to claim 1 wherein a material of the flap extends continuously across the dorsal face of the body and encapsulates the light source and the photodetector.
5. The NIRS sensor according to claim 1 wherein a material of the flap extends continuously across the dorsal face of the body and encapsulates the light source and the photodetector.
6. The NIRS sensor according to claim 5 wherein the flap comprises a flexible mesh.
6. The NIRS sensor according to claim 5 wherein the flap comprises a flexible mesh.
7. The NIRS sensor according to claim 1 wherein the flap is formed with a curvature such that a ventral face of the flap is concave and has a cylindrical geometry.
7. The NIRS sensor according to claim 1 wherein the flap is formed with a curvature such that a ventral face of the flap is concave and has a cylindrical geometry.
8. The NIRS sensor according to claim 1 wherein the flap is wider at the distal end of the body and tapers in width along the body toward the proximal end of the body.
8. The NIRS sensor according to claim 1 wherein the flap is wider at the distal end of the body and tapers in width along the body toward the proximal end of the body.
9. The NIRS sensor according to claim 8 wherein a profile of a perimeter of the flap is teardrop shaped.
9. The NIRS sensor according to claim 8 wherein a profile of a perimeter of the flap is teardrop shaped.
10. The NIRS sensor according to claim 8 wherein a perimeter of the flap has a convex portion adjacent to the distal end of the body that joins onto concave tapering portions on both sides of the body.
10. The NIRS sensor according to claim 8 wherein a perimeter of the flap has a convex portion adjacent to the distal end of the body that joins onto concave tapering portions on both sides of the body.
11. The NIRS sensor according to claim 10 comprising lines of weakness in the flap that extend along both sides of the body.
11. The NIRS sensor according to claim 10 comprising grooves in the flap that extend along both sides of the body.
12. The NIRS sensor according to claim 1 wherein the flap is formed with shallow grooves that extend along both sides of the body on a dorsal face of the flap.
12. The NIRS sensor according to claim 1 wherein the flap is formed with shallow grooves that extend along both sides of the body on the dorsal face of the flap.
13. The NIRS sensor according to claim 1 wherein a portion of the body between the light source and the photodetector is opaque to the light emitted by the light source and blocks direct transmission of light from the light source to the photodetector and the light source is operative to emit light having wavelengths in the range of 600 nm to 1000 nm.
13. The NIRS sensor according to claim 1 wherein a portion of the body between the light source and the photodetector is opaque to the light emitted by the light source and blocks direct transmission of light from the light source to the photodetector and the light source is operative to emit light having wavelengths in the range of 600 nm to 1000 nm.
14. The NIRS sensor according to claim 1 wherein the light source comprises a plurality of light emitters, the plurality of light emitters each emit a different one of a plurality of wavelengths of light, the plurality of wavelengths of light are distributed around an isosbestic point, and the plurality of wavelengths includes one or more wavelengths above the isobestic point and one or more wavelengths below the isosbestic point.
14. The NIRS sensor according to claim 1 wherein the light source comprises a plurality of light emitters, the plurality of light emitters each emit a different one of a plurality of wavelengths of light, the plurality of wavelengths of light are distributed around an isosbestic point, and the plurality of wavelengths includes one or more wavelengths above the isosbestic point and one or more wavelengths below the isosbestic point.
15. The NIRS sensor according to claim 14 wherein the plurality of wavelengths includes two or more wavelengths selected from 660 ± 10nm, 730 ± 10nm, 810 ± 10nm, 850 ± 10nm, and 940 ± 10nm.
15. The NIRS sensor according to claim 14 wherein the plurality of wavelengths includes two or more wavelengths selected from 660±10 nm, 730±10 nm, 810±10 nm, 850±10 nm, and 940±10 nm.
16. The NIRS sensor according to claim 1 wherein the light source is spaced apart from the photodetector by a first distance in the range of 5 mm to 20 mm, the photodetector is a first photodetector and the NIRS sensor comprises a second photodetector spaced apart from the light source, the second photodetector operative to detect light incident on the ventral face of the body, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance.
16. The NIRS sensor according to claim 1 wherein the light source is spaced apart from the photodetector by a first distance in the range of 5 mm to 20 mm, the photodetector is a first photodetector and the NIRS sensor comprises a second photodetector spaced apart from the light source, the second photodetector operative to detect light incident on the ventral face of the body, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance.
17. The NIRS sensor according to claim 1 wherein the dorsal surface of the body is formed with a plurality of recesses and the recesses comprise a row of shallow dimples.
17. The NIRS sensor according to claim 1 wherein the dorsal surface of the body is formed with a plurality of recesses and the recesses comprise a row of shallow dimples.
18. The NIRS sensor according to claim 1 comprising a cable connected to the proximal end of the body, wherein the cable comprises first electrical conductors connected to drive the light source and second electrical conductors connected to carry an output signal from the photodetector and the cable comprises a sheath enclosing the first and second conductors, the first conductors run within a first electrically conductive shield inside the sheath and the second conductors run within a second electrically conductive shield inside the sheath.
18. The NIRS sensor according to claim 1 comprising a cable connected to the proximal end of the body, wherein the cable comprises first electrical conductors connected to drive the light source and second electrical conductors connected to carry an output signal from the photodetector and the cable comprises a sheath enclosing the first and second conductors, the first conductors run within a first electrically conductive shield inside the sheath and the second conductors run within a second electrically conductive shield inside the sheath.
19. The NIRS sensor according to claim 1 comprising a trans-amplifier within the body and connected to convert a current signal output by the photodetector to a voltage signal.
19. The NIRS sensor according to claim 1 comprising a trans-amplifier within the body and connected to convert a current signal output by the photodetector to a voltage signal.
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.
Claims 1-2, 5-10, 12-13, and 17-20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoarau et al. (US 2007/0078316 A1).
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With respect to claim 1, Hoarau discloses a near infrared spectroscopy (NIRS) sensor comprising (see Figures 1A-1C see configuration 10A, the examiner is providing a copy of Figure 1A herein for showing the configuration as discussed herein): a body having a dorsal face, a ventral face (see body #16 having front and back sides considered as the ventral face #22 and dorsal face #20), and proximal and distal ends (see proximal and distal ends labeled by the examiner herein), the body supporting a light source (see emitter #24 considered as the light source) and a photodetector (see detector #26 considered as the claimed photodetector as disclosed in paragraph 0053) in a spaced apart relationship (as seen on Figure 1A wherein the detector #26 spaced apart from emitter #24), the light source operative to emit light from the ventral face of the body (see Figure 1B showing emitter #24 to emit light from side #22 to finger #18 according to paragraph 0013) and the photodetector operative to detect light incident on the ventral face of the body and to generate an output signal (detector #26 detects light from emitter #24 see paragraphs 0013, 0053 and 0056); a flexible flap extending laterally from the body along opposed first and second sides of the body (see sections A and B labeled by the examiner considered as the claimed flaps from the body extending laterally from the body along opposed first and second sides labeled by the examiner).
With respect to claim 2, Hoarau discloses the flap extends between the first and second sides around the distal end of the body (see flaps A and B from the body extending between the first and second sides around the distal end of the body).
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With respect to claim 5, Hoarau discloses a material of the flap extends continuously across the dorsal face of the body and encapsulates the light source and the photodetector (as seen on Figure 1B).
With respect to claim 6, Hoarau discloses the flap comprises a flexible mesh (see mesh regions #12 and #14 in the flaps of the body; see paragraph 0036).
With respect to claim 7, Hoarau discloses the flap is formed with a curvature such that a ventral face of the flap is concave and has a cylindrical geometry (see Figure 1B for a concave flap in a cylindrical body geometry).
With respect to claim 8, Hoarau discloses the flap is wider at the distal end of the body (see Figure 1A labeled by the examiner showing flap B is wider at the distal end D with respect to region #12) and tapers in width along the body toward the proximal end of the body (see Figure 1A showing flap B tapers/decrease in size towards region #12 toward the proximal end P).
With respect to claim 9, Hoarau discloses a profile of a perimeter of the flap is teardrop shaped (see Figure 1A labeled by the examiner showing flap B is wider at the distal end D with respect to region #12 considered as the claimed teardrop shape like).
With respect to claim 10, Hoarau discloses a perimeter of the flap has a convex portion adjacent to the distal end of the body that joins onto concave tapering portions on both sides of the body (as seen on Figure 1B showing dorsal face #20 in region #12 having a concave tapering portions that joins the ventral face #22 portion on the other side wherein the convex portion adjacent to the distal end D).
With respect to claim 12, Hoarau discloses the flap is formed with shallow grooves that extend along both sides of the body on a dorsal face of the flap (as seen on Figure 1B showing dorsal face #20 having a flap B that decrease in size towards region #12 wherein the decrease sized region #12 is considered as the claimed shallow grooves that extend along both sides of flap B in the body on a dorsal face #20).
With respect to claim 13, Hoarau discloses a portion of the body between the light source and the photodetector is opaque to the light emitted by the light source and blocks direct transmission of light from the light source to the photodetector (see paragraph 0054 disclosing opaque materials for the body) and the light source is operative to emit light having wavelengths in the range of 600 nm to 1000 nm (see paragraph 0053).
With respect to claim 17, Hoarau discloses the dorsal surface of the body is formed with a plurality of recesses and the recesses comprise a row of shallow dimples (see Figure 2 showing a mesh structure in regions #12 and #14 wherein the holes forming the mesh material is considered as the claimed recesses comprise a row of shallow dimples; see paragraph 0038 disclosing the mesh material forming peak structures, hence it is understood to have dimples between the peaks).
With respect to claim 18, Hoarau discloses a cable connected to the proximal end of the body (see Figure 1A showing cable #36 connected to the proximal end P of the body #16), wherein the cable comprises first electrical conductors connected to drive the light source and second electrical conductors connected to carry an output signal from the photodetector and the cable comprises a sheath enclosing the first and second conductors, the first conductors run within a first electrically conductive shield inside the sheath and the second conductors run within a second electrically conductive shield inside the sheath (see paragraph 0036, Figure 1A showing conductors #32 and #34 connected to the emitter #24 and detector #26 respectively running within cable #36 considered as the claimed sheath to shield the conductors within).
With respect to claim 19, Hoarau discloses a trans-amplifier within the body and connected to convert a current signal output by the photodetector to a voltage signal (see paragraph 0046).
With respect to claim 20, Hoarau discloses a method for monitoring one or more characteristics of tissue by near infrared spectroscopy (NIRS) the method comprising: controlling a light source to sequentially illuminate the tissue with light of a plurality of different wavelengths and (see paragraph 0055 disclosing a processor to control and process the received signal data from the light illuminating the tissue with a light of a plurality of different wavelengths; see Figure 1B showing emitter #24 to emit light from side #22 to finger #18 according to paragraph 0013), for each of the wavelengths detecting a portion of the light that is backscattered from the tissue at a photodetector (see paragraph 0056 and 0053 discussing the device to produce Rayleigh scattering as backscattering effect; see detector #26 as seen on Figures 1A-1C considered as the claimed photodetector as disclosed in paragraph 0053); processing an output signal of the photodetector (see paragraph 0046-0049) to yield a measure of one or more NIRS parameters (see paragraph 0053 discussing the emitter signal is NIR or near infrared to measure one or more parameters).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hoarau et al. (US 2007/0078316 A1) in view of Khanicheh et al. (US 2014/0276014 A1).
With respect to claims 3-4, Hoarau discloses the claimed invention as stated above except for specifying that the flap has a thickness that is less than a thickness of the body wherein the flap has a thickness in the range of 0.2 mm to 0.4mm. However, Khanicheh discloses the flap has a thickness that is less than a thickness of the body wherein the flap has a thickness in the range of 0.2 mm to 0.4mm (see paragraph 0340). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a flap has a thickness that is less than a thickness of the body wherein the flap has a thickness in the range of 0.2 mm to 0.4mm as taught by Khanicheh in combination with Hoarau’s dimensions because choosing a small thickness may facilitate flexing of the liner and to facilitate positioning of the optical sources and/or optical detectors close to a subject (see paragraph 0340 from Khanicheh). Furthermore, one of ordinary skill in art at the time the invention was made to have a flap with a thickness that is less than a thickness of the body wherein the flap has a thickness in the range of 0.2 mm to 0.4mm as taught by Khanicheh with Hoarau’s dimensions for the purpose of disclosing a particular size/dimension option between all the sizes or dimensions known in the art since any size or dimensionality will perform equally well or perform the same function of having a body to hold the emitter and detectors components wherein the size is selected according to its suitability and preference of the person skill in the art at the time of the invention. It is understood that the change in size is common practice in the art as a matter of design choice in which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed shape was significant. In re Rose 105 USPQ 237 (CCPA 1955); Fields 134 USPQ 242 (CCPA1962), In re Reese 129 USPQ 402 (CCPA 1961) and Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
With respect to claim 14, Hoarau discloses the light source comprises a plurality of light emitters (see claim 4 stating to have at least one, indicating that more than one is included, namely a plurality of emitters is disclosed). Furthermore, Hoarau discloses the claimed invention as stated above except for the plurality of light emitters each emit a different one of a plurality of wavelengths of light, the plurality of wavelengths of light are distributed around an isosbestic point, and the plurality of wavelengths includes one or more wavelengths above the isosbestic point and one or more wavelengths below the isosbestic point. However, Khanicheh discloses the plurality of light emitters each emit a different one of a plurality of wavelengths of light, the plurality of wavelengths of light are distributed around an isosbestic point, and the plurality of wavelengths includes one or more wavelengths above the isosbestic point and one or more wavelengths below the isosbestic point (see paragraph 0112). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the plurality of light emitters each emit a different one of a plurality of wavelengths of light, the plurality of wavelengths of light are distributed around an isosbestic point, and the plurality of wavelengths includes one or more wavelengths above the isosbestic point and one or more wavelengths below the isosbestic point as taught by Khanicheh in combination with Hoarau for the purpose of having a configuration that provides information about the concentration of oxygenated or deoxygenated hemoglobin (or both) in tissue of a subject (e.g., the concentration of oxygenated and/or deoxygenated hemoglobin in a subject's tissues). Thus, the wavelengths of radiation used by the optical sensor may be selected to facilitate collection of such information (see paragraph 0112).
With respect to claim 15, Hoarau discloses the claimed invention as stated above except for specifying that the plurality of wavelengths include two or more wavelengths selected from 660 ±10nm, 730 ±10nm, 810 ±10nm, 850 ±10nm, and 940 ±10nm. However, Khanicheh discloses the plurality of wavelengths include the plurality of wavelengths include two or more wavelengths selected from 660 ±10nm, 730 ±10nm, 810 ±10nm, 850 ±10nm, and 940 ±10nm (see paragraph 0112 disclosing 650nm and 950nm, 800nm and 830 nm etc.). Therefore, it would have been obvious to one of ordinary skill in art at the time the invention was filed to have the plurality of wavelengths include the plurality of wavelengths include two or more wavelengths selected from 660 ±10nm, 730 ±10nm, 810 ±10nm, 850 ±10nm, and 940 ±10nm (value or range to be optimize) as taught by Khanicheh with Hoarau’s wavelengths for the purpose of value optimization since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Note that the specification contains no disclosure of either the critical nature of the claimed ranges or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen frequency range or upon another variable recited in a claim, the Applicant must show that the chosen range are critical. In re Woodruf, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
In addition, the selection of a wavelength, is obvious because it is a matter of determining optimum process conditions by routine experimentation with a limited number of species of result effective variables. These claims are prima facie obvious without showing that the claimed ranges achieve unexpected results relative to the prior art range. In re Woodruff, 16 USPQ2d 1935, 1937 (Fed. Cir. 1990). See also In re Huang, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996) (claimed ranges or a result effective variable, which do not overlap the prior art ranges, are unpatentable unless they produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art). See also In re Boesch, 205 USPQ 215 (CCPA) (discovery of optimum value of result effective variable in known process is ordinarily within skill or art) and In re Aller, 105 USPQ 233 (CCPA 1995) (selection of optimum ranges within prior art general conditions is obvious).
With respect to claim 16, Hoarau discloses the light source is spaced apart from the photodetector by a first distance in the range of 5 mm to 20 mm, the photodetector is a first photodetector (see paragraph 0041). Furthermore, Hoarau discloses the claimed invention as stated above except for a second photodetector spaced apart from the light source, the second photodetector operative to detect light incident on the ventral face of the body, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance. However, Khanicheh a second photodetector spaced apart from the light source, the second photodetector operative to detect light incident on the ventral face of the body, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance (see paragraph 0153). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a second photodetector spaced apart from the light source, the second photodetector operative to detect light incident on the ventral face of the body, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance as taught by Khanicheh in combination with Hoarau’s distance for the following reasons:
The depths to which the detected optical signals travel within the subject may depend on the distance between the optical source and the optical detector, using multiple optical detectors located at different distances from the optical source may provide information about different depths within the subject, and thus allow for comparison of such information (see paragraph 0095 of Khanicheh).
By configuring the optical sensor such that the distance is small, the light intensity lost as the optical signals pass from the optical sources into the subject and out to the optical detectors may be minimized (see paragraph 0100 of Khanicheh).
Having a value optimization since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Note that the specification contains no disclosure of either the critical nature of the claimed ranges or any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen frequency range or upon another variable recited in a claim, the Applicant must show that the chosen range are critical. In re Woodruf, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). In addition, the selection of a second photodetector spaced apart from the light source, and the second photodetector is spaced apart from the light source by a second distance in the range of 1½ to 2 times the first distance, is obvious because it is a matter of determining optimum process conditions by routine experimentation with a limited number of species of result effective variables. These claims are prima facie obvious without showing that the claimed ranges achieve unexpected results relative to the prior art range. In re Woodruff, 16 USPQ2d 1935, 1937 (Fed. Cir. 1990). See also In re Huang, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996) (claimed ranges or a result effective variable, which do not overlap the prior art ranges, are unpatentable unless they produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art). See also In re Boesch, 205 USPQ 215 (CCPA) (discovery of optimum value of result effective variable in known process is ordinarily within skill or art) and In re Aller, 105 USPQ 233 (CCPA 1995) (selection of optimum ranges within prior art general conditions is obvious).
Furthermore, the rearrangement of a part, like the distancing between the photodetector and the light source is held obvious since the rearrangement by distance would not modify the operation of said device/devices involved and is considered as a matter of design choice. In re Japikse 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) If applicant feels the distance is critical, applicant is reminded that no criticality or unexpected results have been disclose in the Specification of the current application that would make the distance or rearrangement of part nonobvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses different NIR device configurations embedded in different flexible thin housings to conform the patient’s region of interest. Furthermore, the NPL cited not relied upon discloses an Oximeter with a photodiode collecting backscattered light.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Raymond Keith can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798
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