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 .
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DETAILED ACTION
1. Claims 1, 5-15, 17-19, 22, 26 are amended. Claims 2-4, 16 are canceled. Claims 1, 5-15, 17-26 are under consideration.
Claim Objections
2. (previous objection, withdrawn) Claims 1, 5-15, 17-19, 22 were objected to.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the objection is withdrawn.
3. (new objection) Claims 23, 24, 25 are objected to because of the following informalities:
As to claims 23, 24 the claims recite a comma after reciting dependency (“claim 22, wherein”). To be consistent with the other claims, the comma in claims 23, 24 should be deleted, or alternately all of the dependent claims should recite the comma. The punctuation in the instant claims is not consistent.
As to claim 25, for improved language, the claim should recite “analysing” to be consistent with claim 22 on which the claim depends.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. (previous rejection, withdrawn) Claims 22, 25 were rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claims 15, 18 were rejected under 35 U.S.C. 112(d)
or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to
further limit the subject matter of the claim upon which it depends, or for failing to include all
the limitations of the claim upon which it depends.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.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.
6. (new, necessitated by amendment) Claim 25 is 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 claim 25 as submitted 7/31/2026.
Claim 25 recites ”analyzing the sample for the detection of viral RNA”. In view of the amendment to claim 22, it is not clear what the relationship between “analyzing” in claim 25 and “analysing” as recited in claim 22 is. It is not clear if they are intended to read on the same step or not.
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.
7. (previous rejection, maintained) Claims 1, 5-15, 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Laughlin et al. (US20180235206)(cited in applicant's IDS
submitted 3/8/2023). in view of Curry et al. (US20110212002; previously cited).
See claims 1, 5-15, 17-26 as submitted 7/31/2026.
Applicant contends: Neither Laughlin et al. nor Curry et al. discloses or suggests the invention as claimed; the invention provides a safe and stable receptacle; the DNA of Laughlin et al. is more stable; a skilled artisan would not have a reasonable expectation that a matrix precipitated onto a tube could preserve delicate RNA molecules over extended periods without refrigeration; Curry et al. is directed to a sample receiving device having a pierceable barrier and cutting mechanism to release a substance; Curry et al. does not suggest or disclose composition as set forth in claim 1; a skilled motivation would have no motivation to combine the references; routine optimization is unfounded; the specification demonstrates stability, including or a minimum of 2 weeks at room temperature without degradation; further saliva samples maintained a high degree of stability; neither Laughlin et al. nor Curry et al. suggests that precipitating the claimed solid would yield zero degradation of viral RNA under thermal stress; the claims are non-obvious.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action. As to amended claim 22, it is noted that Laughlin et al. also teaches: PCR [00132]. Further, the active step recited in claim 22 ii) is merely a filling step (See MPEP 2111.02: 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)).
Response to Arguments
Turning to applicant’s arguments, first, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is maintained that the instant rejection is in view of the language of the instant claims. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., safety, stability, preservation of RNA at indicated temperatures) are not recited in the rejected claim(s). 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, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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.
Further, as to routine optimization, such a doctrine is already recognized by the MPEP as being in fact routine absent demonstrated unexpected results commensurate in scope with the instant claim language (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). As indicated above, the rejection is in view of the instant claims, which merely recite composition comprising guanidinium salt in receptacle as recited in claim 1. Further, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The rejection is maintained for reasons of record.
Conclusion
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, 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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