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. Claims 1-15, 17-26 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 3/8/2023; 9/12/2023; 10/13/2023; 7/3/2024; 10/17/2024; 8/20/2025. 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 § 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.
3. Claims 1, 3, 11-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1, 3, 11-15 as submitted 3/8/2023.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 1, 3, 11-15 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, claims 1, 3, 11-15 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, a chaotrope) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A).
Claim 1 recites a receptable for body fluids comprising an anti-coronavirus deactivating
composition present in solid form inside the receptable. It is noted that anti-coronavirus deactivating composition merely reads on a chaotrope such as urea (p. 5 of the instant specification)(See EPA, “Toxicological Review of Urea (CAS No. 57-13-6),” EPA/635/R-10/005F, found at www.epa.gov/iris (2011))(See PTO-892: Notice of References Cited) teaching: urea is a naturally occurring product in mammals (p. 7)). As to the receptacle, there is no indication that mixing receptacle and chaotrope changes the structure, function, or other properties of the receptacle or chaotrope (See Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Further, the receptacle is recited at a high level of generality. Thus the claimed product does not display markedly different characteristics compared to the naturally occurring counterparts.
Thus, the claimed product of anti-coronavirus deactivating composition present in solid form is not markedly different from its naturally occurring counterpart (See Nature-Based Products, Example 4 (“Purified Proteins”) at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf ; see also Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Claims 1, 3, 11-15 read on naturally occurring chaotrope and does not show a difference in characteristics between the claimed chaotrope and naturally occurring chaotrope. Thus the claims also read upon naturally occurring chaotrope, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus the claimed product of anti-coronavirus deactivating composition present in solid form is not markedly different from its naturally occurring counterpart (see Part I. A.3 of the Interim Eligibility Guidance, Example 2, p. 29). Thus the claims also read upon naturally occurring anti-coronavirus deactivating composition present in solid form, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite a natural phenomenon.
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
As to claims 11-15 reciting tube, opening, cap, polystyrene, there is no indication that mixing these components changes the structure, function, or other properties of the deactivating composition or receptacle (See Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Thus the claimed mixture does not display markedly different characteristics compared to the naturally occurring counterparts.
Additionally, as receptacle is considered an additional element to the composition, mixing the deactivating composition with receptacle does not markedly change the characteristics of either component, because each component is considered to have the same properties as it had alone. In addition, using a receptacle is well-understood, routine and convention when recited at this high level of generality and does not meaningfully limit that claim. Thus, the claim as a whole does not amount to significantly more than each component by itself.
Therefore, claims 1, 3, 11-15 do not recite eligible subject matter under 35 U.S.C.101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
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.
4. Claims 2-10, 24, 25 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 2-10, 24, 25 as submitted 3/8/2023.
As to claim 2-8, the claim recites “coronavirus deactivating composition”. Claim 1 recites “anti-coronavirus deactivating composition”. Thus for reciting “coronavirus deactivating composition”, there is insufficient antecedent basis for this limitation in the claim. It is not clear if the claims “further” have a coronavirus deactivating composition or not.
As to claims 9, 10, the claim recites “the guanidinium salt”. There is insufficient antecedent basis for this limitation in the claim.
As to claims 24, 25, the claims recite a method but no apparent steps. It is not clear what the steps are.
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.
5. Claims 1, 3, 4, 11-15, 17-26 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, 3, 4, 11-15, 17-26 as submitted 3/8/2023.
See also the 35 U.S.C. 112(b) rejection above.
The claims have been described above. Each of the claims is drawn, inherently or explicitly, to an “anti-coronavirus deactivating composition”. Thus, the claims are drawn to compositions comprising or methods of using a genus of “anti-coronavirus deactivating compositions”.
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 teaches: guanidinium salt (p. 6); including guanidinium thiocyanate; guanidinium hydrochloride, guanidinium iso-thiocyanate; Tris, EDTA (p 7); urea (p. 5).
However, the application does not teach a representative set of species within the breadth of the claimed genus. There is no apparent common structure to the different anti-coronavirus deactivating compositions that distinguishes those compositions that have anti-coronavirus deactivating effect from those that do not. There is therefore a high level of uncertainty as to which compositions fall within the scope of the indicated genus.
In view of the fact that the examples provided do not demonstrate possession of anti-coronavirus deactivating compositions, and that the application has not identified structure correlating with anti-coronavirus deactivating composition, there is insufficient written description support for the indicated genus of anti-coronavirus deactivating compositions.
In the present case, the applicant has identified compositions useful in the claimed methods only by function: the ability to show anti-coronavirus deactivating effect. However, while the application identifies select buffers and guanidinium salts, it does not identify a representative sample of species clearly within the claimed genus.
Nor does the application provide a specific structure of the anti-coronavirus deactivating compositions within the genus that correlates with the required function. While all of the compositions are required to have anti-coronavirus deactivating effect, this is not alone sufficient structure to correlate with the function.
For the reasons above, and in view of the uncertainty as to which compositions would be able to show anti-coronavirus deactivating effect, the application has not provided sufficient written description support for anti-coronavirus deactivating compositions.
Claim Rejections - 35 USC § 102/103
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.
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.
6. Claims 1-5, 9-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Laughlin et al. (US20180235206)(cited in applicant’s IDS submitted 3/8/2023).
See claims 1-5, 9-14 as submitted 3/8/2023.
Laughlin et al. teaches: stabilizing saliva samples (title); apparatus [00127](as recited in claim 1); guanidinium thiocyanate [0056](as recited in claims 1, 9, 10); solid form [0057](as recited in claims 1, 2); edta [0062](as recited in claim 5); tris [0097](as recited in claim 5); solid buffer [0060](as recited in claim 4); tube [00105](as recited in claim 11); dispenser for sealing [00105](as recited in claim 12); cap [00105](as recited in claim 13); saliva sample [00129](as recited in claim 14).
As to claim 3, such a recitation is interpreted as a product by process reading on composition on an inner surface of the receptable (for example, Laughlin et al. teaches use of a tube [00105])(See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) ... II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE: "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983)).
Thus, Laughlin et al. anticipates or renders obvious the instant claims.
Claim Rejections - 35 USC § 103
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.
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.
7. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Laughlin et al. as applied to claims 1-5, 9-14 above.
See claims 6-8 as submitted 3/8/2023.
See the teachings of Laughlin et al. above.
As to claims 6-8, such recitations are considered to be those determine by routine optimization to one of ordinary skill in the art in view of the teachings or suggestions of Laughlin et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 15, 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Laughlin et al. as applied to claims 1-5, 9-14 above, and further in view of Curry et al. (US20110212002)(See PTO-892: Notice of References Cited).
See claims 15, 17-26 as submitted 3/8/2023.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Laughlin et al. It is noted Laughlin et al. also teaches: PCR [00132](as recited in claim 26).
Laughlin et al. does not teach: polystyrene; polyolefin; gargling composition; tube; saline.
Curry et al. teaches: detection and analysis of nucleic acid [0152](as recited in claims 21, 22); preserving samples such as nucleic acid containing saliva samples [0067]; sample receiving device; for storing substance (abstract); including polystyrene, polyolefin [0113](as recited in claims 15, 18); as well as funnel made of polyethylene [0088](as recited in claim 18); including gargling composition [0151](as recited in claims 17, 20, 22, 23); receptacle [0014](as recited in claim 17); use of multiple tubes/vials [0131](as recited in claims 17, 19, 22); saline [0151](as recited in claim 20); RNA [0145]; RNA found in viruses [0144]; using nucleic acid preservative with saliva sample (as recited in claim 21).
One of ordinary skill in the art would have been motivated to use components as taught by Curry et al. with the composition as taught by Laughlin et al. Laughlin et al. teaches using saliva samples, and Curry et al., which also teaches saliva samples, teaches the advantage of using components known and used in the art for using, storing, and analyzing saliva samples.
As to claims 24, 25, such recitations are interpreted as statements of intended use (See MPEP 2112: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
One of ordinary skill in the art would have had a reasonable expectation of success for
using components as taught by Curry et al. with the composition as taught by Laughlin et al. There would have been a reasonable expectation of success given the underlying materials (saliva samples as taught by Laughlin et al. and Curry et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
9. 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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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1671