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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/21/2026 has been entered.
2. Claim 1 is amended. New claim 20 is added. Claims 3, 13 are withdrawn. Claims 11, 12, 14-18 are canceled. Claims 1, 2, 4-10, 19, 20 are under consideration.
Claim Objections
3. (new objection) Claim 8 is objected to because of the following informalities: Claim 8 appears to contain an errant mark (“=”) before “wherein”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claims 1, 2, 4-10, 19 were rejected under 35 U.S.C.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.
Applicant contends: claim 1 has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
5. (previous rejection, withdrawn) Claims 1, 2, 4-10, 19 were rejected under 35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.
Applicant contends: the amended claims are adequately supported by the specification; no new matter has been added.
The rejection with respect to the previously recited enricher or elastic polymer mesh is withdrawn.
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.
6. (new rejection) Claims 1, 2, 4-10, 19, 20 are 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.
See claims 1, 2, 4-10, 19, 20 as submitted 5/21/2026.
As to claim 1, the claim recites “polymer-excluded flow through”. It is not clear if polymer refers to the SAP polymer material or another polymer or a polymer that has been excluded or filtered from the sample. Claims 2, 4-10, 19, 20 depend on this claim.
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.
7. (new rejection) Claims 1, 2, 4-10, 19, 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.
See claims 1, 2, 4-10, 19, 20 as submitted 5/21/2026.
See also the 35 U.S.C. 112(b) rejection above.
Each of the claims is drawn, inherently or explicitly, to a method for detection of a virus, comprising the steps of: (a) collecting a biological sample from a patient; (b) adding the biological sample to a buffer: (c) heating the buffer containing the biological sample at a temperature and for a time sufficient to lyse cells and viral particles in the biological sample; (d) contacting the lysed sample with a super-absorbent polymer (SAP) material configured to absorb a substantial portion of the aqueous phase of the biological sample and to yield a polymer-excluded flow-through comprising concentrated viral RNA; (e) transferring the polymer-excluded flow-through comprising concentrated viral RNA to a reaction vessel: (f) converting the viral RNA in the flow-through to cDNA using a reverse transcriptase; (g) amplifying the cDNA via a loop-mediated isothermal amplification (LAMP) reaction using a primer set; and (h) evaluating results of the LAMP reaction; and wherein the method does not include an RNA isolation or RNA purification step. Such a recitation reads on any configured super absorbent polymer material as well as any virus, and wherein such a recited method reads on method of detection of any virus without RNA isolation step or RNA purification step. Thus, the claims are drawn to a genus of methods using any configured super absorbent polymer material and detecting any virus using the recited steps, without RNA isolation or RNA purification step.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written
description support for the entire scope of the genus. Support for a genus is generally found
where the applicant has provided a number of examples sufficient so that one in the art would
recognize from the specification the scope of what is being claimed.
In the present case, the application still teaches: only one example of polymer (MyMagiCon-RW-100 kit), while suggesting any other polymers with similar properties (p. 4); one example of virus (SARS-CoV-2)(p. 5).
However, the application still does not teach a representative set of samples of the method, or appear to provide data or examples beyond recitation of embodiments. There is no apparent common structure to the configured super absorbent polymer material that distinguishes those that are able to absorb a substantial portion of the aqueous phase of the biological sample and to yield a polymer-excluded flow through comprising concentrated viral RNA from those that do not. There is therefore a high level of uncertainty as to which super absorbent polymer material and viruses fall within the scope of the indicated genus of methods and components.
The prior art still teaches challenges and great variability with respect to the claimed
components. For example, Mignon et al. ("Superabsorbent polymers: A review on the
characteristics and applications of synthetic, polysaccharide-based, semi-synthetic and 'smart'
derivatives," European Polymer Journal 117:165-178 (2019) previously cited) teaches: superabsorbent polymers (abstract); hydrogels and SAPs, wherein both terminologies are often inappropriately used in literature (p. 165); different morphologies for SAPs (p. 166); wherein SAPs can be synthetic, natural or a combination thereof (p. 166); natural SAPs including polypeptides and polysaccharides; wherein semi-synthetic SAPs include methacrylated polysaccharides, cationic guar gum/poly(acrylic acid) polyelectrolyte hydrogels or
chitosan cross-linked poly(acrylic acid) hydrogels; calcium alginate (p. 166); agarose (p. 166);
fibers, powders, granules or even sheets (p. 166); starch (p. 172). Further, it is known in the art
that intact RNA is a key challenge for application of biological methods. For example, Fleige et
al. ("RNA integrity and the effect on the real-time qRT-PCR performance," Molecular Aspects
of Medicine, 27:126-129 (2006); previously cited) teaches: assessment of RNA integrity is a critical first step in obtaining meaningful gene expression data (abstract); the quality and quantity of purified RNA is variable and after the extraction during long storage rather unstable; especially long mRNA fragments up to 10kb are very sensitive to degradation; this can happen through cleavage of RNAses introduced by handling with RNA samples (p. 128).
In view of the fact that the specification does not demonstrate possession of such a method, and that the application has not identified structure correlating with such super absorbent polymer materials or viruses, there is insufficient written description support for the indicated genus of methods using the claimed components and detecting the claimed viruses, without RNA isolation or RNA purification step.
In the present case, applicant has identified configured super absorbent polymer material useful in the claimed methods only by function: the ability to absorb a substantial portion of the aqueous phase of the biological sample and to yield a polymer-excluded flow-through comprising concentrated viral RNA. However, while the application identifies MyMagiCon-RW-100, in view of the breadth of super absorbent polymers known in the art above, it does not identify a representative sample. Thus, the application does not identify species clearly within the claimed genus. Further, while the application identifies detection of SARS-CoV-2 virus without an RNA isolation step using a polymer (MyMagiCon-RW-100), it does not identify a representative sample of said method either.
Additionally, because there is no identification of structures common to each super absorbent polymer material or configurations thereof, nor sufficient representative examples by which such a structure may be determined, the application also fails to provide sufficient written description support for the identified genus of super absorbent polymer material, through identification of a structure and function. While all of the super absorbent polymer materials are required to when configured absorb a substantial portion of the aqueous phase of the biological sample and to yield a polymer-excluded flow-through comprising concentrated viral RNA, this is not alone sufficient structure to correlate with the function. This is because, the mere presence of any super absorbent polymer material does not demonstrate that such a polymer would be able to when configured absorb a substantial portion of the aqueous phase of the biological sample and to yield a polymer-excluded flow-through comprising concentrated viral RNA.
For the reasons above, and in view of the uncertainty as to which super absorbent polymer materials and viruses are within the scope of the claims, the application has not provided sufficient written description support for the method as recited in claim 1. The application therefore fails to provide adequate support for methods of using this genus.
Conclusion
8. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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