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 .
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s arguments concerning the rejection under 35 USC 101, the Examiner disagrees. Humans can do pixel by pixel analysis of images in the human mind, although it would take longer than a computer would take for larger images. Humans also have the ability to visualize pixels with or without a magnifying glass.
Regarding the technical improvement argument, there is an improvement shown in th Specification, but it is not shown in the claims. Considering Applicant’s disclosure (pg. 11 lines 15-19), (pg. 12, line 25 -pg. 13, line 11) and (pg. 15 line 26- pg. 16 line 20), incorporating the detection mechanism (either exothermic or thermochemical binding) , replacing chemically with reagent, replace camera with camera with IR-senstive lens, replace hyperspectral imaging processing with deconvolve spatial and spectral imaging and
Add “output a result of negative or positive based on the change in IR signal”, would clearly direct the claims to the improvement in the specification.
These suggestions incorporate the improvement shown in the Specification into the claims in order to overcome the rejection under 101.
Additionally Applicant can remove the whereby statement and the pixel by pixel.
Regarding, Applicant’s argument about the IR-LED transmission, IR-LED without the above limitations above, would not be sufficient for the claim to be directed to the technical improvement.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) of determining the presence of an analyte in a sample without significantly more. The claim(s) recite(s)
“The claim recites the SSA "automatically determine the presence of the analyte by hyperspectral imaging processing analysis of the digital image that identifies, on a pixel-by-pixel basis, a change in an IR signal ... between one or more multivariate images created on the specimen side against the juxtaposed one or more multivariate images of the reference side." Under its broadest reasonable interpretation, this is a mental process. This can be reasonably interpreted as a person comparing pixel by pixel two images to determine whether an analyte is present.
The additional elements, considered individually and as an ordered combination, do not amount to significantly more. Mobile devices with cameras, IR-LEDs, IR-sensitive lenses, and transparent test sheets with chemical reagents are well-understood, routine, and conventional components in the diagnostic testing field. See Burns (US 2010/0304397) discussing saliva-based diagnostic test kits with chromogenic panels. The specification admits that IR-sensitive camera lenses are "already part of the standard manufactured features for many cell phones" (page 17, lines 1-5) and that IR-LED circuits "are already in mass production used abundantly in in-home remote controller applications" (page 18, lines 19-20). Therefore, the claim does not recite significantly more than the abstract idea.
This judicial exception is not integrated into a practical application. Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 2-8 are directed to additional elements (data gathering) that are not significantly more than the judicial exception.
Claim 9 is directed to the judicial exception. There are no additional elements which amount to significantly more.
Claim 20 is rejected under similar grounds as claim 1. GPS is well-understood, routine, conventional activity in the field,
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.
Claims 1-9 and 20 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites "hyperspectral imaging processing analysis": The specification uses the qualifier "like." For example paragraph [0042]: "the pathogen test application 3 then proceeds to execute an automated "hyperspectral-like imaging processing analysis 14 of the captured digital image 13 (emphasis added). See also paragraph [0044]: "the multivariate, "hyperspectral-like imaging processing analysis 14 is completed”. Removing the “like” narrows the claim compared to the original filing.
Additionally, the specification discloses no details on what constitutes hyperspectral(-like) image processing.. Furthermore the Specification fails to disclose “pixel-by-pixel”
Claim 3 recites "whereby having chemical treatment on both the specimen side and the reference side furthers the elimination of error of the self-testing when performing the hyperspectral imaging processing analysis." The Examiner is unable to find support for this limitation
Claim 20 recites a system "for enabling mass-testing" with a GPS component that "identifies a global position when the determination of the presence of the analyte is positive, and wherein the global position is exported to an end user." The Examiner is unable to find support for this limitation. The only disclosure of GPS could be found in page 4 lines 13-26.
Claims 2-9 are rejected as dependent on a rejected claim.
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.
Claims 1-9, and 20 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.
Claim 1 recites "hyperspectral imaging processing analysis of the digital image that identifies, on a pixel-by-pixel basis, a change in an IR signal of the transmit infrared light between one or more multivariate images created on the specimen side against the juxtaposed one or more multivariate images of the reference side."
Claim 1, 3 and 20 recites “whereby, …”, which is a statement of intended result or advantage rather than a structural or functional limitation. It is unclear whether this clause imposes any additional structural or method limitations on the claim. See MPEP 2173.05(d).
Claims 2-9 are rejected as dependent on a rejected claim.
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.
Claim(s) 1-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (2019/0324027) in view of Burns(2010/0304397) in view of Mooradian (5,782,770).
Lee discloses 1. (Currently Amended) A mobile device-based system for self- testing for a presence of an analyte in a specimen, the system comprising:
a mobile device comprising a camera; (Lee, “[0074] The housing 310 constitutes the outer shape of the infrared light reader 300, and the housing 310 has an insertion groove 311 into which the diagnostic kit 200 is inserted. The cable 320 connects the controller 330 of the infrared light reader 300 to the terminal 400, and the terminal 400 displays information transmitted from the controller 330, and may include a smartphone, a laptop computer, a tablet computer, or the like.” )
a test apparatus comprising a photo stage, wherein the photo stage comprises: one or more infrared light emitting device (IR-LED), wherein the IR- LED are configured to selectively transmit infrared light when capturing a digital image of the photo stage by way of the camera; (Lee, “[0075] The controller 330 functions to apply infrared light to the diagnostic kit 200, which is located in the housing 330 and is inserted through the insertion groove 311 in the housing 310, and to measure infrared light emitted from the diagnostic kit 200 so as to provide the imaged data to the external terminal 400, and includes an interface unit 331 for exchanging information with the terminal 400, a battery 332 for supplying power necessary for the operation of the controller 330, an irradiation unit 333 for applying infrared light to the membrane 3 of the diagnostic kit 200 located in the housing 310, an optical unit 334 for photographing infrared light emitted from the membrane 200 after irradiation of the membrane 3 with infrared light by means of the irradiation unit 333, an image-processing unit 335 for digitizing and outputting the photographed image output from the optical unit 334, and a control unit 336 for controlling the overall operation of the controller 330. For example, the irradiation unit 333 plays a role in applying infrared light at a wavelength of 980 nm, and the optical unit 334 includes a visible-light-blocking filter and an ultraviolet-light-blocking filter in order to photograph infrared light. The diagnostic kit 200 where the specimen is dispensed is inserted into the insertion groove 311 in the infrared light reader 300 and the infrared light reader 300 is connected to the terminal 400, whereby the antigen detection result in the diagnostic kit 200 can be confirmed on the terminal 400.”)
a chemically treated functionalized transparent test sheet havinq a specimen side and a reference side juxtaposed thereto; and the specimen operatively associated with the specimen side but not the reference side; and (Lee, “[0064] The membrane 3 includes a test line 5, on which a second capture agent reactive to the target material contained in the specimen is immobilized, and a control line 6, on which a third capture agent reactive to the capture agent of the capture-agent/nanoparticle conjugate 100 is immobilized, the test line 5 being located closer to the conjugation pad 2 than the control line 6. The second capture agent may be configured to specifically bind to or react with the target material, and may include an antibody, an aptamer, etc., and the third capture agent may be configured to specifically bind to or react with the capture agent, and may include an antibody, an aptamer, etc.”)
Lee does not explicitly disclose whether the test sheet is transparent or not,
Burns discloses “a transparent chromogenic panel” (Burns, paragraph 63)
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to use a transparent test sheet as shown by Burns.
The suggestion/motivation for doing so would have been so a person can see what is on the other side..
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
a systemic software application (SSA) loaded on the mobile device, wherein the SSA is configured to receive the captured digital image automatically determine the presence of the analyte by (Lee, “[0075] The controller 330 functions to apply infrared light to the diagnostic kit 200, which is located in the housing 330 and is inserted through the insertion groove 311 in the housing 310, and to measure infrared light emitted from the diagnostic kit 200 so as to provide the imaged data to the external terminal 400, and includes an interface unit 331 for exchanging information with the terminal 400, a battery 332 for supplying power necessary for the operation of the controller 330, an irradiation unit 333 for applying infrared light to the membrane 3 of the diagnostic kit 200 located in the housing 310, an optical unit 334 for photographing infrared light emitted from the membrane 200 after irradiation of the membrane 3 with infrared light by means of the irradiation unit 333, an image-processing unit 335 for digitizing and outputting the photographed image output from the optical unit 334, and a control unit 336 for controlling the overall operation of the controller 330. For example, the irradiation unit 333 plays a role in applying infrared light at a wavelength of 980 nm, and the optical unit 334 includes a visible-light-blocking filter and an ultraviolet-light-blocking filter in order to photograph infrared light. The diagnostic kit 200 where the specimen is dispensed is inserted into the insertion groove 311 in the infrared light reader 300 and the infrared light reader 300 is connected to the terminal 400, whereby the antigen detection result in the diagnostic kit 200 can be confirmed on the terminal 400.”)
whereby self-testing obviates sending the specimen through an external chain of custody.(carries no patentable weight; see paragraph 31 “:on site”)
Lee fails to disclose ““hyperspectral imaging processing” and “pixel-by-pixel”
Mooradian discloses “hyperspectral imaging processing” and “pixel-by-pixel” (Mooradian, Abstract,” Techniques and devices for diagnosing tissue via hyperspectral imaging are presented. A three dimensional "image" where one dimension contains spectral information is formed from a region of interest. The spectral content of the image can be analyzed on a pixel-by-pixel basis to determine the presence of certain matter and the spatial extend thereof The techniques are non-invasive and do not require introduction of agents typically required to facilitate interaction with illumination sources.”)
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to use pixel-by-pixel hyperspectral imaging processing as shown by Mooradian for the process of comparing the test line (specimen) and control line (reference side) of Lee.
The suggestion/motivation for doing so would have been a pixel-by-pixel analysis would provide a more accurate result.
Further, one skilled in the art could have combined the elements as described above by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Lee with Burns and Mooradian to obtain the invention as specified in claim 1.
Lee in view of Burns in view of Mooradian discloses 2. (Original) The system of claim 1, wherein the digital image captures the specimen operatively associated with the photo stage. (Lee, paragraph 75, “r applying infrared light to the membrane 3 of the diagnostic kit 200 located in the housing 310, an optical unit 334 for photographing infrared light emitted from the membrane 200 after irradiation of the membrane 3 with infrared light by means of the irradiation unit 333, an image-processing unit 335 for digitizing and outputting the photographed image output from the optical unit 334, ”)
Lee in view of Burns in view of Mooradian discloses 3. (Currently Amended) The system of claim 2, further comprising a chemically treated functionalized transparent test sheet, on both the specimen side and the reference side, wherein said test sheet receives the specimen to operatively associate the specimen with the photo stage, whereby having chemical treatment on both the specimen side and the reference side furthers the elimination of error of the self-testing when performing the hyperspectral imaging processing analysis. (Lee,paragraph 64,” [0064] The membrane 3 includes a test line 5, on which a second capture agent reactive to the target material contained in the specimen is immobilized, and a control line 6, on which a third capture agent reactive to the capture agent of the capture-agent/nanoparticle conjugate 100 is immobilized, the test line 5 being located closer to the conjugation pad 2 than the control line 6.”)
Lee in view of Burns in view of Mooradian discloses 4. (Original) The system of claim 3, wherein said test sheet has a specimen side and a reference side juxtaposed thereto, wherein the specimen side receives an entirety of the specimen. (Lee, Fig. 1)
Lee in view of Burns in view of Mooradian discloses 5. (Original) The system of claim 4, further comprising one or more infrared light emitting device (IR-LED) selectively transmitting infrared light against said test sheet. (see claim 1)
Lee in view of Burns in view of Mooradian discloses 6. (Original) The system of claim 5, wherein the IR-LED is selectively arranged so that the test sheet absorbs infrared. (Lee, paragraph 56)
Lee in view of Burns in view of Mooradian discloses 7. (Original) The system of claim 6, further comprising an infrared sensitive lens optically associated with the camera. (Lee, paragraph 103, “an infrared light camera for photographing an infrared light image at 800 nm.”)
Lee in view of Burns in view of Mooradian discloses 8. (Original) The system of claim 7, wherein the specimen is saliva.(Lee, paragraph 55, Saliva)
Lee in view of Burns in view of Mooradian discloses 9. (Currently Amended) The system of claim 8, wherein the IR-LED is selectively arranged to have a wavelength between 700-900 nm (Lee, paragraph 56, 750-850nm)
Claim20 is rejected under similar grounds as claim 1. Claim 20 contains an additional element of GPS. GPS is notoriously well known and commonly used component of a smartphone. Applicant’s background (pg. 4 lines 13-26) acknowledges that “Furthermore, the GPS and other mobile device locating functionality, say in a potential ‘outbreak hotspot’ or the like, can further aid an overseeing (governmental) body access risk and plan a coordinated, efficient response based on the statistical compilation that the present invention can enable when coupled to a global system of overseeing body.”
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).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANDHI THIRUGNANAM whose telephone number is (571)270-3261. The examiner can normally be reached M-F 8:30-5PM.
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/GANDHI THIRUGNANAM/Primary Examiner, Art Unit 2672