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 .
Election/Restrictions
Claim 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/13/2026.
Applicant's election with traverse of Group I, claims 1-11 in the reply filed on 1/13/2026 is acknowledged. The traversal is on the ground(s) there would not be a serious search burden. This is not found persuasive because while Inventions I and Il are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed by practiced by another and materially different apparatus, specifically an apparatus which comprises a waveguide comprising a top surface; and a fluid cover disposed on the top surface of the waveguide, wherein the fluid cover comprises an inner bottom surface defining a plurality of polynomial curve grooves (which are required in the apparatus of invention II).
Furthermore, examiner Wecker notes that searching for group II would present a search burden as Group I vs II are found in different CPC classes (G01N 2333/005 vs G01N33/0068), as well as the fact that searching for Group II would require search terms such as waveguide and polynomial curve grooves, which would not be required in the search of Group I.
The requirement is still deemed proper and is therefore made FINAL.
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 1-11 are rejected under 35 U.S.C. 101 because:
The claimed invention (claims 1-11) are process/method claims, and claims 1-11 are directed to an abstract idea without significantly more. The claim(s) recite(s) the limitation, “in response to determining that at least one sample signal magnitude satisfies a predetermined threshold value, determining the optimal treatment based at least in part on relative sample signal magnitudes for each of the plurality of sample channels” and this limitation has been interpreted as an abstract idea, since determining whether the sample signal meets a threshold value and then determining an optimal treatment are mental steps that could be done in the mind or using a black box computer.
Furthermore, According to MPEP 2106.04(a)(2)(III)(C), Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675. See also Mortgage Grader, 811 F.3d at 1324, 117 USPQ2d at 1699 (concluding that concept of "anonymous loan shopping" recited in a computer system claim is an abstract idea because it could be "performed by humans without a computer"
In addition, Claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions (as shown in claim 1). Examples of claims that recite mental processes include a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);
Furthermore, this judicial exception (as detailed above) is not integrated into a practical application because determining whether the sample signal meets a threshold value and then determining an optimal treatment are mental steps that could be done in the mind or using a black box computer.
In addition, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps of recording and providing a known virus sample are mere data gathering steps and it is noted that data gathering to be used in the abstract idea is insignificant extrasolution activity, and not a particular practical application. See MPEP 2106.05(g).
Therefore claims 1-11 are ineligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ingber et al (WO 2013/086502 A1).
Regarding Claim 1, Ingber et al teaches a computer-implemented method for determining an optimal treatment for a known virus sample (see [0012] and [0190]) using a sample testing device (referred to as an organ chip) comprising a plurality of sample channels (wherein channels are disposed in the microfluidic device of the organ chip), the computer-implemented method comprising:
causing the known virus sample to be provided to the plurality of sample channels (see [0063], [0100] and [0186]) wherein each of the plurality of sample channels comprises antibodies or nanobodies associated with a particular variant (see [0100] and [0186]) ;
recording a plurality of sample signals received from the plurality of sample channels using the sample testing device (see [0064]) ;
and in response to determining that at least one sample signal magnitude satisfies a predetermined threshold value, determining the optimal treatment based at least in part on relative sample signal magnitudes for each of the plurality of sample channels (see [0012] and [0190]).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al (US PGPub 2019/0303760).
Regarding Claim 1, Kumar et al teaches a computer-implemented method for determining an optimal treatment for a known virus sample (see [0008]-[0009], [0018] and [0298]);
using a sample testing device (referred to as a flow cytometer) comprising a plurality of sample channels ([0006],[0018], [0049] and [0105]), the computer-implemented method comprising:
causing the known virus sample to be provided to the plurality of sample channels, wherein each of the plurality of sample channels comprises antibodies or nanobodies associated with a particular variant (see [0068], [0079], [0105], [0107] and [0255]),
recording a plurality of sample signals received from the plurality of sample channels using the sample testing device (see [0048], [0069], [0084] and [0093]),
and in response to determining that at least one sample signal magnitude satisfies a predetermined threshold value, determining the optimal treatment based at least in part on relative sample signal magnitudes for each of the plurality of sample channels (see [0008], [0018], [0021], [0220] and [0298]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (or Ingber et al) as applied to claim 1 above, and further in view of Howard (US PGPub 2021/0285943).
Regarding Claims 2-4, neither Kumar et al nor Ingber et al teaches that the known virus sample is SARS-CoV2, wherein each sample signal magnitude is associated with a spike protein variant of the known virus sample and wherein each of the plurality of sample channels comprises antibodies or nanobodies that are selective to spike proteins associated with each variant.
However, in the analogous art of virumeters for rapid detection of COVID-19 infection, Howard teaches a virumeter with micro-capillaries 308, wherein antibodies 309 towards SARS-CoV-2 specific proteins (which are spike proteins, see [0046] and [0053]) will be immobilized on the surface of micro-capillaries 308, microcolumns or etched silica channels on a lab-on-a-chip technology and then tagged with a low affinity competitive ligand 310 containing a fluorophore. A crude patient sample 302, such as saliva, oral or nasopharyngeal swab or blood, can be introduced onto the channel 308 and migrated through the device either by electric charge or a flow system (see [0064]). It would have been obvious to one of ordinary skill in the art to incorporate a sample containing a SARS-COV2 virus sample and antibodies into the channel such that the sample interacts with specific SARS-COV-2 spike proteins (as taught by Howard), for the benefit of enabling rapid detection of covid-19 and techniques for rapid assessment of a person's immunity to the virus.
Regarding Claim 5, the combination of Kumar et al (or Ingber et al) and Howard teaches that the optimal treatment comprises a therapeutic antibody cocktail (see [0038]).
Claim(s) 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (or Ingber et al) as applied to claim 1 above, and further in view of Liu et al (US PGPub 2021/0001339).
Regarding Claims 2-4, neither Kumar et al nor Ingber et al teaches that the known virus sample is SARS-CoV2, wherein each sample signal magnitude is associated with a spike protein variant of the known virus sample and wherein each of the plurality of sample channels comprises antibodies or nanobodies that are selective to spike proteins associated with each variant.
However, in the analogous art of systems for cell detection and sorting, Liu et al teaches a system 200, such as illustrated in FIG. 2A, may be used whereby after enrichment (210), cell detection (220) may be performed using the magnetic beads. FIG. 2B is another illustration of a system 250 that performs the stages of enrichment and detection using the magnetic beads. Specifically, whole blood 252 may be input to device 260 that includes enrichment system 262 and single cell identification and sorting 264 (see [0101]). In addition, Liu et al teaches that the platform may be configured for high-throughput isolation of single SARS-CoV-2 spike protein binding B-cells. In particular, single B cells from COVID-19 patient blood samples may be enriched and isolated by their ability to bind to magnetic bead-conjugated recombinant SARS-CoV-2 spike protein peptides by using the disclosed platform. Thus, the platform may be used for: optimization of SARS-CoV-2 spike protein sequence containing peptides as antigens; isolation of SARS-CoV-2 spike protein binding B cells from blood samples of convalescent COVID-19 patients using the platform; and determining the viability of isolated B cells and their ability to expand and produce reactive antibodies (see [0174]-[0175]).
It would have been obvious to one of ordinary skill in the art to incorporate a sample containing a SARS-COV2 virus sample and antibodies into the channel such that the sample interacts with specific SARS-COV-2 spike proteins (as taught by Liu et al), for the benefit of enabling rapid detection of covid-19 and techniques for rapid assessment of a person's immunity to the virus.
Regarding Claim 5, the combination of Kumar et al (or Ingber et al) and Liu et al teaches that the optimal treatment comprises a therapeutic antibody cocktail (see [0176]).
Allowable Subject Matter
Claims 6-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and if the presented 35 USC 101 rejections were overcome.
Regarding Claims 6-11, Ymeti et al (US PGPub 2012/0214707) discloses an interferometric based sensor, wherein light beam from a (monochromatic) light source LSO, e.g. a laser, is usually coupled to an optical (channel) waveguide structure WGS. In a waveguide structure WGS, usually consisting of three layers, i.e. substrate SUB, core COR and cover COV layer (see the side view of the waveguide structure WGS depicted in FIG. 1B), guiding of the light is performed due to appropriate refractive index contrast between the core layer and the cladding (substrate SUB and cover COV layers indicated in FIG. 1B). A higher refractive index of the core layer allows total internal reflection of the light at the core-cladding interface, in that way making possible propagation of the light through the (slab) waveguide (see [0084]).
However, Ymeti et al (nor any of the other cited prior art), alone or in combination teaches or fairly suggests that the computer-implemented method further includes receiving a plurality of interferometric sensing data sets associated with a plurality of light phases and a sample time period; for a sample time segment of the sample time period:(a) identifying, from the plurality of interferometric sensing data sets, a plurality of interferometric sensing data segments; (b) calculating a plurality of slope rates associated with the plurality of interferometric sensing data segments; (c) selecting an interferometric sensing data segment from the plurality of interferometric sensing data segments that is associated with a highest slope rate from the plurality of slope rates; and adding the interferometric sensing data segment to a linearized interferometric sensing data set.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797