DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination
1-A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/06/2026 has been entered.
Amendment
2- The Request for Continued Examination amendment filed has been entered and fully considered. Claims 1,3,5-9,12-38,40-44 and 46-53 remain pending in the application, where the independent claims have been amended.
Response to Arguments
3- Applicant’s amendments and their corresponding arguments, with respect to the rejection of the pending claims under 102 and 103 have been fully considered and are persuasive.
4- Therefore, the rejection has been withdrawn.
5- However, upon further consideration, a new ground of rejection, based on the change of scope of the claimed invention, is made over the prior art used in the previous office action in view of Ramanujam et al. US 7570988.
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Annotated Fig. 2
Claim Rejections - 35 USC § 103
6- 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
In addition, the functional recitation in the claims (e.g. "configured to" or "adapted to" or the like) that does not limit a claim limitation to a particular structure does not limit the scope of the claim. It has been held that the recitation that an element is "adapted to", "configured to", "designed to", or "operable to" perform a function is not a positive limitation but only requires the ability to so perform and may not constitute a limitation in a patentable sense. In re Hutchinson, 69 USPQ 139. (See MPEP 2111.04); see also In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014).
Also, it should be noted that it has been held that a recitation with respect to the manner in which a claimed device is intended to be employed does not differentiate the claimed device from a prior art apparatus satisfying the claimed structural limitations Ex-parte Masham 2 USPQ2d 1647 1987).
The claimed system in the instant application is capable of performing the claimed functionality, as is the prior art used in the present office action. The Examiner notes that where the patent office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. In re Swinehart and sfiligoj, 169 USPQ 226 (C.C.P.A. 1971).
6- Claims 1, 3, 5-9, 12-16, 21-22, 27-29, 30-33, 35-36, 41-44, and 46-48 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Yazdanfar et al. (PGPUB No. 2015/0182204, cited by Applicants), hereinafter GE in view of Ramanujam et al. US 7570988.
As to amended claims 33, 1, 14-15, 44, GE teaches a biopsy device, a system for identifying a biological sample in a sample holder therein, and its method of use, for obtaining a biological sample of tissue (Abstract, Figs. 1-11), the biopsy device comprising: a biopsy needle (¶ 2, 7, 21-24, 30 for ex.; needle 112/200/302 and equivalents in system 104, 200, 300, 600); a sample holder and (claim 14) wherein the system comprises the sample holder; (claim 15) wherein the sample holder is a cuvette (208) for holding the biological sample; the system (100 or equivalents) comprising: a light blocking structure comprising a body defining a bore for receiving the sample holder, the body surrounding he biological sample to block ambient light from the biological sample when the same holder is received therein (Figs. 2-6 and ¶ 30-32; cannula 204 blocks ambient light from reaching the sample in stylet 206 when retracted in for optical measurement through the cannula varying-width opening and rectangular opening 208, indicated in the annotated fig. 2);
a light source (108) positioned at an end opening of the bore to emit substantially monochrome light into the light blocking structure from the end opening along a length of the bore, the substantially monochrome light directed at the sample holder in the bore (Figs. 1-2, 6; ¶ 23; a narrowband light source is used); a light sensor (116 or 608) positioned at an end opening of the bore to detect an amount of light reflected or transmitted by the biological sample and configured to output measurements indicative of the amount of light detected (¶ 27, 38); wherein the light source and the light sensor are positioned on a same side of the sample holder (Fig. 2; the source and sensor appear to be on the same open side of the sample holder in a vertical direction. Should the claim be amended in the future to claim the source/sensor to be transversally on the same side with respect to the sample holder, such as in Figs. 4, 6 of the instant disclosure, Examiner will consider using references such as the one cited in the Conclusion of the instant office action and that is not used in the rejection); and a controller (118 or 610) connected to the light sensor and configured to identify the biological sample based on the output measurements of the light sensor (¶ 27-28, 38, 41, 43 for ex.)
GE does not teach expressly wherein the biological sample is exposed only to the substantially monochrome light and no ambient light in the bore; the light sensor positioned at the same end opening of the bore.
However, in a similar field of endeavor, Ramanujam teaches an apparatus and method for extraction of optical properties from reflectance spectra (Abstract and Figs. 1-8) wherein two fiber cables 50/56 project directly monochromatic light from light source 11/15 and collect directly reflected/emitted light, from the same end of a probe 54, directly connected to the sample and avoid any ambient light to be collected, towards sensor 16/17.
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the apparatus of GE in view of Ramanujam’s suggestions so that the biological sample is exposed only to the substantially monochrome light and no ambient light in the bore; the light sensor positioned at the same end opening of the bore, with the advantage of effectively optimizing reflected spectral measurements, and increasing the SNR of the measured signals.
Moreover, GE teaches:
(claims 3, 5-6, 12, 48) wherein the light blocking structure is non-transparent; (claim 5) wherein the end opening of bore is a single opening in the body of the light blocking structure; (claim 6), wherein the bore comprises a first section and a second section wherein the first section has a wider diagonal width than the second section (see annotated Fig. 2 here enclosed); (claim 12) wherein the light blocking structure further comprises a lid removably disposed over the end opening of the bore, the light source and/or the light detector sensor such that ambient light is blocked from reaching the sample holder; (claim 48) wherein the lid is formed from a light blocking material (Figs. 2-6 add ¶ 30-32; retractable cannula 204 blocks ambient light from reaching the sample in stylet 206 when retracted in for optical measurement through the cannula varying-width opening and rectangular opening 208, indicated in the annotated fig. 2).
(claim 7) wherein the second section is disposed further away from the end opening of the bore relative to the first section (Annotated fig. 2; the narrow section is farther down than the wide section corresponding to with of opening 208).
(claim 8) wherein the second section is configured to engage sides of the sample holder to hold the sample holder in place (Annotated fig. 2; the cannula with all its openings holds and engages the stylet to hold the sample in place).
(claim 9) wherein the bore has a rectangular cross section (the rectangular opening 208).
(claim 13) wherein the light blocking structure is a 3D-printed structure (product by process thought by GE since it has been held that if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), MPEP 2113).
(claim 16) wherein the cuvette comprises a plurality of straight, transparent sides (Fig. 2; the containing volume of the sample in 208 presents transparent sides for the optical light to illuminate and to be collected from the sides of the cuvette).
(claims 21, 35) wherein the substantially monochromatic monochrome light emitted by the light source has a peak intensity at a wavelength in a range of 300nm to 5000nm (¶ 46 for ex.; the emitting spectrum of 400-700nm reads on the claimed range).
(claims 27, 41, 46) wherein the controller is configured to: calculate an absorption value based on a ratio of the emitted light and the detected light or calculate an absorption value based on a ratio of an output measurement of the light sensor and a maximum output of the light sensor (¶ 27, 46-47); and identify the biological sample based on the absorption value; (Claim 46) wherein identifying the biological sample comprises: calculating an absorption value based on a ratio of the substantially monochrome light that is emitted and the detected or calculating an absorption value based on a ratio of an output measurement of the light detector and a maximum output of the light detector; and identifying the biological sample based on the absorption value (¶ 22, 27, 49, 51-52).
(claim 28, 42) wherein the controller identifies biological tissue from a look-up table of known biological tissues based on the calculated absorption value (¶ 51-52).
(Claims 30-31) further comprising a display (120/712) connectable to the controller for showing the identified biological sample to a user; (claim 31) wherein the controller is further configured to show the measurements acquired by the light sensor on a display (Figs. 1, 7).
(claim 32) further comprising an input device (716) connectable to the display and the controller to allow a user to begin taking the measurements of the biological sample, and/or load previously acquired measurements for analysis, and/or export the measurements to a different program, and/or clear the measurements (Fig. 7, ¶ 51-55).
As to claim 22, 29, 36, 43, 47, the combination of GE and Ramanujam teaches the system of claim 1 and the biopsy device of claim 33.
The combination does not teach expressly wherein the substantially monochromatic monochrome light emitted by the light source has a spectral bandwidth below 200nm, preferably below 100 nm, even more preferably below 50 nm; (claims 29, 43, 47) wherein the controller is configured to make a plurality of measurements using the light sensor and calculate an average absorption value.
However, GE teaches using narrowband light (¶ 23), which one PHOSITA would find it obvious to correspond to tens or hundreds of nm, and would find it as a mere aspect of optimization of the measurement since it has been held that where the general condition of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. As to claims 29, 43, 47, GE discloses using statistical means to process the data and evaluate the specimen, which would suggest to one PHOSITA to use averages/means to reduce data noise effects and increase the accuracy of the evaluation (See MPEP 2143 Sect. I. B-D).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the apparatus of GE so that the substantially monochromatic monochrome light emitted by the light source has a spectral bandwidth below 200nm, preferably below 100 nm, even more preferably below 50 nm; the controller is configured to make a plurality of measurements using the light sensor and calculate an average absorption value, with the advantage of effectively optimizing the spectral measurements, and the accuracy of the specimen evaluation.
7- Claims 17-20, 23-26, 34, 37-38, 40, 49-53 are rejected under AIA 35 U.S.C. 103 as being unpatentable over GE and Ramanujam in view of Mander et al. (PGPUB No. 2014/0233015, cited by Applicants)
As to claims 17-20, 23-26, 34, 37-38, 40, 49-53, the combination of GE and Ramanujam teaches the system of claim 1 and the biopsy device of claim 33.
The combination does not teach expressly wherein the light source comprises a laser diode and the substantially monochromatic monochrome light is a laser light; (claim 18) wherein the light source comprises a tunable laser; (claim 19) wherein the light source comprises an LED; (claim 20) wherein the light source comprises an infrared LED; (claims 25-26/49-53, 40) wherein the light source and the light detector sensor are provided in a single integrated circuit package; further comprising a base structure that supports for holding the light source and the light detector sensor; wherein the base structure is disposed outside of the light blocking structure; further comprising a sensor package comprising the light source and the light sensor; wherein the body of the light blocking structure defines a side opening (GE teaches the side opening in the blocking structure, Fig. 2 for ex.), and wherein a portion of the sensor package extends out of the side opening to the base structure; wherein: the controller is disposed outside of the light blocking structure; and the portion of the sensor package is an element carrying wires between the controller, the light source, and the light sensor; wherein the portion of the sensor package is a body element of the sensor package; (claims 23-24, 37-38) wherein the light detector sensor comprises a photodiode; wherein the photodiode has a maximum sensitivity at a wavelength in a range of 300nm to 5000nm, even though GE teaches using photodetectors which comprise photodiodes (¶ 47, 62).
However, in a similar field of endeavor, Mander teaches a device and its method of use to evaluate fluids using EM energy (Abstract and Figs. 1-13) wherein the light source comprises a laser diode and the substantially monochromatic monochrome light is a laser light; wherein the light source comprises a tunable laser; wherein the light source comprises an LED; wherein the light source comprises an infrared LED (¶ 73-74, 76, 89; types of tunable lasers and/or LEDs, that can emit in the IR spectrum, are considered for the evaluation). As to claims 23-24, 37-38, Mander teaches using one or more photodiodes operational in the infrared (¶ 61, 64, 78-83). As to claims 25-26/49-53, 40, Mander discloses (Fig. 8 and ¶ 55-58 for ex.; PCB assemblies being used with transducers, calibrators, sensors; i.e. package comprising source and sensor, with extension into the packaging body).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the apparatus of GE and Ramanujam in view of Mander’s suggestions so that the light source comprises a laser diode and the substantially monochromatic monochrome light is a laser light; wherein the light source comprises a tunable laser; wherein the light source comprises an LED; wherein the light detector sensor comprises a photodiode; wherein the photodiode has a maximum sensitivity at a wavelength in a range of 300nm to 5000nm, wherein the light source comprises an infrared LED; wherein the light source and the light detector sensor are provided in a single integrated circuit package; further comprising a base support for holding the light source and the light detector sensor; wherein the base structure is disposed outside of the light blocking structure; further comprising a sensor package comprising the light source and the light sensor; wherein a portion of the sensor package extends out of the side opening to the base structure; and wherein a portion of the sensor package extends out of the side opening to the base structure; wherein: the controller is disposed outside of the light blocking structure; and the portion of the sensor package is an element carrying wires between the controller, the light source, and the light sensor; wherein the portion of the sensor package is a body element of the sensor package; wherein the light detector sensor comprises a photodiode; wherein the photodiode has a maximum sensitivity at a wavelength in a range of the 300nm to 5000 nm, with the advantage of effectively optimizing the spectral measurements with compact sources.
Conclusion
The examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. Applicant should consider the entire prior art as applicable as to the limitations of the claims. It is respectfully requested from the applicant, in preparing the response, to consider fully the entire references as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED K AMARA whose telephone number is (571)272-7847. The examiner can normally be reached on Monday-Friday: 9:00-17:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached on (571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mohamed K AMARA/
Primary Examiner, Art Unit 2877
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