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 .
Amendment
1- The amendment filed on 10/23/2025 has been entered and fully considered. Claims 1-23 remain pending in the application, where the independent claims have been amended.
Response to Arguments
2- Applicant’s amendments and their corresponding arguments, with respect to the rejection of the pending claims under 35 USC 102 and 103 have been fully considered and are persuasive.
Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground of rejection is made over the prior art used in the previous office action in view of Li (PGPUB 20240094220).
Claim Rejections - 35 USC § 103
3- 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).
4- Claims 9-13, 15, 1-5, 7-8, 16-19, and 21-23 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Chou et al. (US PGPUB No. 20150338346, cited by Applicants) in view of Li (PGPUB 20240094220).
As to amended claims 9-13, 15, 1-5, 7-8, 16-19, and 21-23, Chou teaches an apparatus, and its method of use, for evaluating a test article provided by a patient (Abstract and Figs. 1-21, different clinical and biochemical disorders are considered as attributes to be diagnosed, ¶ 164-165 for ex.), comprising a cassette (Fig. 1; nanodevice 100 and equivalents in the other figures); at least one ligand provided in the cassette (160) selected to match the attribute (¶ 105, 108-110), wherein the test article provided by the patient is applied to the at least one ligand of the cassette (¶ 4, 105; ligand attaches to agent that captures specific targeted analytes from a patient), wherein each ligand comprises a substance selected for having specific binding affinity for antibodies, cells, tissues, viruses, or microbials such as bacteria (¶ 44, 129, 173 for ex.; antibodies and cells are proposed as examples biological units binding with the ligands); a light energy transmitter (laser and optical system in Fig. 2) configured to transmit light energy toward the test article applied to the at least one ligand (Fig. 2); a sensor (Spectrometer and associated optical system in Fig. 2) configured to sense optical attributes of resultant light energy received from the test article applied to the at least one ligand; wherein changes in observable optical attributes resulting from the presence of the test article and the at least one ligand indicate an active infection (¶ 59, 165, 173, biomarkers, related to the ligands, are specifically chosen for detection of specification diseases/infections when optical emission of light, i.e. changes in observable optical attributes); and an electronic device configured to receive sensed attributes of the resultant light energy from the sensor (electronics, computer system and hardware/software is used with the spectrometer for data analysis, such as in Figs. 8-19, and detection of the patient condition); using multiple measurements of the test article based on attributes of the test article (¶ 48, 144, 157 and claims 94-95; the ligands and attributes are measured via electro/chemi-luminescence and/or Surface Raman scattering i.e. SERS).
Chou does not teach expressly evaluating the test article provided by the patient for presence of SARS-CoV-2; and wherein each ligand comprises antigens comprising glycoproteins associated with SARS-CoV-2.
However, in a similar field of endeavor, Li teaches biological diagnostics testing (Abstract, ¶ 2, 4, 12-15) using spectrophotometry (¶ 275), similar to the optical means/methods of Chou, and targeting the detection of SARS-CoV-2 with ligands comprising antigens comprising glycoproteins associated with SARS-CoV-2 (¶ 15, 26, 29-30, 111, 116-117, 257-265 for ex.)
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/method of Chou in view of Li’s suggestions so that the system/method comprises evaluating the test article provided by the patient for presence of SARS-CoV-2; and wherein each ligand comprises antigens comprising glycoproteins associated with SARS-CoV-2, with the advantage taught by Li of effectively offering a highly reliable diagnostic methods (¶ 2).
Moreover, Chou discloses:
(claims 10, 2, 18) wherein the at least one ligand comprises a ligand coating (¶ 32-34, 55-56, 103-105, 116-118, 156-158 for ex.; fluorophore and/or fluorescence labels, attached to peptides and/or DNA/RNA strands, are used for the analysis of cellular activities/interactions, i.e. proteomic);
(claims 11-12, 3-4, 19) wherein the cassette comprises a positive permittivity material and the sensing comprises performing an SPR (surface plasmon resonance) evaluation (¶ 77-78, 101, 145, 176-178, 192-193);
(claims 13, 5) wherein the electronic device assesses presence or absence of the attribute in the test article based on comparison of optical characteristics received the sensing with known optical properties of the attribute (¶ 165, 172-173);
(claim 15, 7) wherein the cassette receives the test article by the patient blowing into the cassette (¶ 152);
(claims 16, 8, 21) wherein the sensor senses absorption characteristics of the test article (¶ 13, 75-78 for ex.);
(claim 22) wherein said light energy is provided by a light emitting diode -LED- (¶ 144);
(claim 23) further comprising an arrangement of reflective surfaces employed with the cassette (Fig. 2, ¶ 65).
5- Claims 14, 6 and 20 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Chou and Li in view of Schermer et al. (US PGPUB No. 20050110989, cited by Applicants)
As to claims 14, 6 and 20, the combination of Chou and Li teaches apparatus and methods of claims 9, 1 and 17, respectively.
The combination does not teach expressly further comprising additional light energy sources configured to illuminate the test article, even though using multiple illumination wavelengths is disclosed (¶ 90, 178 for ex.), which suggests possibly the use of multiple light energy sources.
However, in a similar field of endeavor, Schermer teaches a plasmon sensor and its method of use (Abstract, ¶ 126-127 and Figs. 1-16) so that the sensor system comprises additional light energy sources configured to illuminate the test article (¶ 14, 22, 55 for ex.)
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/method of Chou and Li in view of Schermer’s suggestions so that the system comprises additional light energy sources configured to illuminate the test article, with the advantage taught by Schermer of effectively optimizing the optical measurements at different wavelengths (¶ 55).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Mohamed K AMARA/
Primary Examiner, Art Unit 2877