DETAILED ACTION
Notice of Pre-AIA or AIA Status and New Examiner
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571) 272-1113.
Election/Restrictions and Status of the Claims
2. Applicant’s election of Group I in the reply filed on 1 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 July 2026.
Claims 1-18 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 3 April 2023 and 7 October 2026 are acknowledged and have been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
4. The use of trade names or marks used in commerce (including but not necessarily limited to Ficoll), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
5. Claims 1 and 7 are objected to because of the following informalities:
A. Claim 1 contains the text “providing…thereon with the test sample and a detection solution to form a rection droplet” and :indicates presence,” each of which appears to be a typographic error.
B. Claim 7 recites a “pilar,” which appears to be a typographical error. Appropriate correction is required.
Claim Interpretation
6. For the purposes of examination, the terms SSC, PBS, and TBS are interpreted as saline sodium citrate, phosphate buffered saline, and tris buffered saline, respectively.
Claim Rejections - 35 USC §112
7. 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.
8. Claim 9 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.
Claim 9 contains the text “the sample droplet,” which lacks antecedent basis because there is no previous recitation of a “sample droplet.”
Claim Rejections - 35 USC §103
9. 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.
10. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claims 1-4, 6-9, and 13-18 are rejected under 35 U.S.C. 103 as obvious over Lo et al. (U.S. Patent Application Publication No. US 2016/0258020 A1, published 8 September 2016).
Regarding claim 1, Lo et al. teach a method of detecting a target nucleic acid (Title) in a test sample comprising providing a substrate having a reaction area, in the form of a micro-island, depositing a test sample and a detection solution having a detection agent with a sequence complementary to a strand of the target nucleic acid, in the form of a hybridization buffer containing DNA oligo probes, on a micro-island to form a droplet thereon, incubating the droplet to evaporate the droplet, and detecting hybridization of the DNA oligo probes to the target nucleic, thereby indicating the presence of the target nucleic acid in the test sample (paragraph 0011).
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
In the instant case, it is believed that the evaporation of the droplet as taught by Lo et al. includes “incubating” in order achieve the evaporation.
Alternatively, it is noted that Lo et al. teach incubation (e.g., paragraph 0120). Thus, all of the steps of the instant claim are taught by Lo et al., and the claim is obvious over Lo et al.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel’s mere arguments cannot take the place of evidence in the record.
Regarding claims 2-3, the method of claim 1 is discussed above. Lo et al. also teach drying sample droplets (i.e., claim 3; paragraph 0014).
With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, any claimed order of steps is an obvious variant of the steps of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 4, the method of claim 1 is discussed above. Lo et al. teach the reaction area is hydrophilic and the surrounding area is hydrophobic (paragraph 0011).
Regarding claim 6, the method of claim 1 is discussed above. Lo et al. teach the substrate comprises silicon (paragraph 0122).
Regarding claim 7, the method of claim 1 is discussed above. Lo et al. teach the reaction area (i.e., micro-island) is a pillar, in the form of a raised area (Figure 8 and paragraphs 0122-0123), and is circular (Figure 22a).
Alternatively, the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Thus, the claimed circular pillars are alternatively obvious variants of the teachings of Lo et al. See MPEP 2144.04 IV B.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 8, the method of claim 7 is discussed above. Lo et al. teach diameters of 125 microns (paragraph 0052).
Regarding claim 9, the method of claim 1 is discussed above. Lo et al. teach the sample droplet is about 5 microliters (paragraph 0178).
In addition, with respect to claims 8-9, it is alternatively noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges alternatively represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 13, the method of claim 1 Is discussed above. Lo et al. teach the conditions include a temperature of 50oC (paragraph 0176).
Alternatively, it is noted that the courts have held that optimization through routine experimentation, and in particular, when related to differences in temperature, do not support patentability (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It is also reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists.
Thus, the claimed temperature range is an obvious variant and/or routine optimization of the range taught by the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 14, the method of claim 1 is discussed above. Lo et al. teach the target nucleic acid is DNA (paragraph 0176).
Regarding claims 15-17, the method of claim 1 is discussed above. Lo et al. teach the target nucleic acid is from HIV (paragraph 0089).
Regarding claim 18, the method of claim 1 is discussed above. Lo et al. teach the sample is a blood sample (paragraph 0099).
12. Claim 5 is rejected under 35 U.S.C. 103 as obvious over Lo et al. (U.S. Patent Application Publication No. US 2016/0258020 A1, published 8 September 2016) as applied to claim 1 above, and further in combination with Chetverin et al. (U.S. Patent No. 6,103,463, issued 15 August 2000)
Regarding claim 5, the method of claim 1 is discussed above in Section 11.
Lo et al. also teach the methods have the added advantage of allowing quantitation of nucleic acids for diagnostic purposes (paragraph 0006). Thus, Lo et al. teach the known techniques discussed above.
Lo et al. do not teach non-permeable boundaries.
However, Chetverin et al. teach methods wherein nuclide acids are hybridized to arrays (Abstract), wherein each area is surrounded by an impermeable wall, which has the added advantage of allowing reactions to be performed simultaneously in individual areas (column 10, lines 15-60). Thus, Chetverin et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantages of allowing quantitation of nucleic acids for diagnostic purposes as explicitly taught by Lo et al. (paragraph 0006) and allowing reactions to be performed simultaneously at individual areas as explicitly taught by Chetverin et al. (column 10, lines 15-60) In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in techniques useful in the detection of nucleic acids.
13. Claims 10-12 are rejected under 35 U.S.C. 103 as obvious over Lo et al. (U.S. Patent Application Publication No. US 2016/0258020 A1, published 8 September 2016) as applied to claim 1 above, and further in combination with Farrell (U.S. Patent Application Publication No. US 2008/0057513 A1, published 6 March 2008) and as applied to claims 11, as evidenced by sigmaaldrich.com ( [retrieved on 2026-10-14]. Retrieved from the Internet: <URL: www.sigmaaldrich.com/US/en/product/sigma/s6639?msockid=2a0d1c5c423c62c43e840b81434e639c>).
Regarding claims 10-12, the method of claim 1 is discussed above in Section 11.
Lo et al. also teach the methods have the added advantage of allowing quantitation of nucleic acids for diagnostic purposes (paragraph 0006). Thus, Lo et al. teach the known techniques discussed above.
Lo et al. do not teach HCR mixtures (i.e., claim 10) or the solution components of claims 11-12.
It is noted that while the claim requires an HCR mixture, it does not actually require performing a hybridization chain reaction.
Farrell teaches methods utilizing hybridization chain reaction mixtures (i.e., of a plurality of nucleic acid molecules (paragraph 0107). Farrel also teaches a detection solution (i.e., hybridization buffer) comprising 2x SSC (i.e., claim 12; paragraph 0208), which includes 300 mM Na ions as evidenced by sigmaaldrich.com (i.e., claim 11). Farrell also teaches the methods have the added advantage of significantly increasing detectable signals from probes (paragraph 0107). Thus, Farrell teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantages of allowing quantitation of nucleic acids for diagnostic purposes as explicitly taught by Lo et al. (paragraph 0006) and significantly increasing the detectable signals from the probes as explicitly taught by Farrell (paragraph 0107) In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in techniques useful in the detection of nucleic acids.
Conclusion
14. No claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
