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. Claim 1 is amended. Claims 3, 13 are withdrawn. Claims 11, 12, 14-18 are canceled. New claim 19 is added. Claims 1, 2, 4-10, 19 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 9/5/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
3. (previous rejection, withdrawn) Claims 1, 2, 4-10 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point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: the claims have been amended.
The rejection is withdrawn.
4. (previous rejection, withdrawn) Claims 1, 2, 4-10 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description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 claims have been amended.
The rejection is withdrawn.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.
5. (new, necessitated by amendment) Claims 1, 2, 4-10, 19 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 as submitted 9/5/2025.
As to claim 1, the amended claim recites “that absorbs water and other small molecules with molecular weight less than 500 Daltons.” The term “small” is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Further, it is not clear what the metes and bounds of “elastic polymer mesh” or “elastic polymer mesh that absorbs water and other small molecules with molecular weight less than 500 Daltons” are (See also Peniston et al, (US20130267137A1)(See PTO-892: Notice of References Cited) teaching polymeric mesh of fiber construction (Figure 2C); polymeric mesh comprising an absorbable polymeric fiber … wherein the absorbable polymeric fiber and the non-absorbable polymeric fiber are co-knit to form an interdependent mesh structure [0006]; See also 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) teaching hydrogels and SAPs (p. 165); different morphologies for SAPs (p. 166); agarose (p. 166); fibers, powders, granules or even sheets (p. 172); … See also MPEP 2145: Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)).
Further, it is not clear how a mesh (such as a fibrous mesh as taught by Peniston et al. or sheet as taught by Mignon et al. above as read upon by the instant claim language) enriches viral RNA by absorbing water and other small molecules. It is not clear whether enriching is intended to read upon isolating said viral RNA or not.
It is suggested that applicant consider claim language more closely aligned with concentrating steps and particular super absorbent polymer embodiment features more specific to the MyMagiCon-RW100 embodiment supported by the instant specification and well known in the art at the time of filing.
Further, claim 1 recites “RNA to cDNA” but previously recites “viral RNA”. It is not clear if the second and third recitations of RNA are referring to the “viral RNA” or not.
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.
6. (new, necessitated by amendment) Claims 1, 2, 4-10, 19 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 as submitted 9/5/2025.
See also the 35 U.S.C. 112(b) rejection above.
Claim 1 recites “enricher, wherein the super absorbent polymer enricher is an elastic
polymer mesh that absorbs water and other small molecules with molecular weight less than 500 Daltons”. Such language reading upon a genus of enrichers or elastic polymer meshes is not recited in or taught or supported by the instant specification.
This is a new matter rejection.
‘Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Huang et al. (“Smartphone—Based in-Gel Loop-Mediated Isothermal Amplification (gLAMP) System Enables Rapid ColiphageMS2 Quantification in Environmental Waters,” Environ. Sci. Technol. 52: 6399-6407 (2018))(See PTO-892: Notice of References Cited) teaches: gLAMP system; immobilizing LAMP reagents in polyethylene glycol hydrogel, then viral RNAs amplified through LAMP reaction (abstract).
B. Broughton et al. (WO2020257356A2)(See PTO-892:Notice of References Cited) teaches: detecting target nucleic acids (abstract); from virus [0030]; microfluidic cartridge [0034]; comprising sample chamber with lysis buffer [0395]; heating step [0276]; use of sample pad; woven meshes … polymer-based matrices [0419]; LAMP step [0433].
8. No claims are allowed.
9. 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 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, Janet Andres can be reached at 571-272-0867. 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