DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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
3. Applicant’s election of Group I in the reply filed on 20 August 2025 (which correctly notes that claims 35-37 should have been included in Group I) 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)).
Claims 38-84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 20 August 2025.
Claims 1-37 are under prosecution.
Drawings
4. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by:
I. The appropriate fee set forth in 37 CFR 1.17(h);
II. One set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web; and, unless already present,
III. An amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
5. A statement from Applicant that there is no intention to have color drawings will result in acceptance of the drawings; otherwise, the conditions set forth above must be met in order for the color drawings to be accepted.
Specification
6. The use of trade names or marks used in commerce (including but not necessarily limited to Triton, Tween, Pluronic, etc.), has been noted in this application. The terms 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.
Information Disclosure Statement
7. The Information Disclosure Statements filed 18 September 2023, 8 April 2024, and 13 October 2025 are acknowledged and have been considered.
Claim Interpretation
8. The claims are subject to the following interpretation:
A. The claims are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
B. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., for isolating a nucleic acid, as recited in claim 1) fail to define additional structural elements of the claimed system. Therefore, any prior art that teaches the structural elements of the claim anticipates and/or renders obvious the claimed invention. See MPEP § 2114.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-15, 27, 29, 31-32, 35, and 37 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.
A. Claims 1 (upon which claims 2-15, 27, 29, 31-32, 35, and 37 depend) is indefinite in the recitation “the aqueous phase or the oil phase) in the last two lines of the claim, which lacks antecedent basis in the previous recitation “at least one aqueous phase and at least one oil phase.”
B. Claim 3 (upon which claim 4 depends) is indefinite in the recitation “or a material having a preference…” at the end of the claim. The use of an additional “or” at the beginning of the phrase makes it unclear if it can be one of the “one or more chemical or physical material characteristics.”
Claim Rejections - 35 USC § 102
11. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12. Claims 1-2 and 31-32 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tuteja et al. (U.S. Patent Application Publication No. US 2015/0136606 A1, published 21 May 2015).
Regarding claims 1-2, Tuteja et al. teach systems (paragraph 0124) comprising a container having an aqueous phase and an oil phase stabilized in proximity to one another by inclusion of a porous oleophobic material (i.e., the hydrophilic material of claim 1; Figures 10(a)-(b)), which is in contact with both layers (i.e., claim 2; Figure 10(a)).
Regarding claims 31-32, the system of claim 1 is discussed above. The claims refer to the sample and the target, which are not part of the claimed system, and thus are not further limiting.
13. Claims 1-3, 5-7, 12-15, 27, 31-32, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casavant et al. (Lab Chip, vol. 13, pages 391-396, published 19 November 2012) and, as applied to claim 2, as evidenced by the online catalog from Sterlitech [retrieved on 2026-01-23]. Retrieved from the Internet: <URL: www.sterlitech.com/polyester-membrane-filter-pet8025100.html?queryID=6795f33aa8d6ca734759760a64c4df5d&objectID=1110&indexName=live_default_products>.
Regarding claim 1, Casavant et al. teach a system comprising at least one aqueous phase and at least one oil phase stabilized in proximity to each other within a container, in the form of a VerIFAST device, which further comprises a porous structural material, in the form of a porous membrane, associated with the aqueous phase (Figure 4A.
Regarding claim 2, Casavant et al. teach the system of claim 1, wherein the aqueous layer is associated with a PET8025100 membrane from Sterlitech (“Device preparation”), which is hydrophilic as evidence by the online catalog of Sterlitech.
Regarding claim 3, Casavant et al. teach the system of claim 2, wherein the phases are further stabilized via geometry; i.e., using wells that are deep and narrow to hold the fluids (“Settling Chamber”).
Regarding claims 5-6, Casavant et al. teach the system of claim 1, wherein there are multiple oil and aqueous phases (i.e., claim 5), and the oil phases are not in direct contact with each other, and the aqueous phases are not in contact with each other (i.e., claim 6; Figure 4A).
Regarding claim 7, Casavant et al. teach the system of claim 7, wherein the container comprise a top opening, in the form of the input portion (Figure 4A). It is noted that permitting addition of the sample is an intended use, and does not further limit the structure of the claimed system based on the rationale discussed above.
Regarding claims 12 and 14, Casavant et al. teach the system of claim 1, further comprising paramagnetic particles (i.e., claim 12) functionalized with streptavidin (i.e., claim 14; “Paramagnetic particle preparation”).
Regarding claims 13 and 15, Casavant et al. teach the system of claim 12, wherein the PMPs are housed (i.e., during use) within an aqueous phase (Figure 3A).
Regarding claim 27, Casavant et al. teach the system of claim 1, further comprising a magnet (Figure 3A).
Regarding claims 31-32, the system of claim 1 is discussed above. The claims refer to the sample and the target, which are not part of the claimed system, and thus are not further limiting.
Regarding claims 35 and 37, Casavant et al. teach the system of claim 1,further comprising reagents for detecting the target, in the form of a well comprising staining reagents (“In-line staining”). Because claims 35 and 37 refer to reagents that “may” comprise LAMP or RT-LAMP reagents, The staining reagents anticipate the embodiments where the LAMP or RT-LAMP reagents are not required.
Claim Rejections - 35 USC § 102/103
14. 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.
15. 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.
16. Claims 3, 7, and 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tuteja et al. (U.S. Patent Application Publication No. US 2015/0136606 A1, published 21 May 2015) as applied to claim 1 above.
Regarding claim 3, the system of claim 1 is discussed above in Section 12.
Tuteja et al. teach the system uses surface chemistry, in the form of a low surface energy porous substrate (paragraph 0034). Alternatively, Tuteja et al. teach a plurality of a porous oleophobic materials (paragraph 0030); thus, there is an additional layer having a prefers for a phase in the system, and Tuteja et al. either anticipate, or render obvious the instant claim.
It is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
Regarding claim 7, the system of claim 1 is discussed above.
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, Tuteja et al. teach the fluids are added to an upper tube (paragraph 0049); thus, either the container has a top opening, or it would be obvious to include one.
Regarding claim 9, the system of claim 7 is discussed above. Tuteja et al. teach the oil phase (e.g., hexadecane) is in the upper tube (paragraph 0050).
17. Claim 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Casavant et al. (Lab Chip, vol. 13, pages 391-396, published 19 November 2012) as applied to claim 1 above.
Regarding claim 29, the system of 1 is discussed above in Section 13.
A review of the specification yields no limiting definition of a “multi-well plate.” Thus, the multi-well device formed from polystyrene (“Device preparation” and Figure 1A) is interpreted as a multi-well plate, and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a multi-well “plate” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
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 plate is and obvious variant of shape of Casavant et al. See MPEP 2144.04 IV B.
Claim Rejections - 35 USC § 103
18. Claim 11 is rejected under 35 U.S.C. 103 as obvious over Casavant et al. (Lab Chip, vol. 13, pages 391-396, published 19 November 2012) as applied to claim 1 above.
Regarding claim 11, the system of 1 is discussed above in Section 13.
Casavant et al. teach washing in the container (“Staining protocols”), as well as washing with aqueous buffers (e.g., PBS; “Cell culture”). Thus, it would have been obvious to use a wash buffer in the container.
Double Patenting
19. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
20. Claims 1-3, 7, 9, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 22 of copending Application No. 18/387,625 in view of Tuteja et al. (U.S. Patent Application Publication No. US 2015/0136606 A1, published 21 May 2015).
Both sets of claims are drawn to systems (i.e., devices) comprising at least one aqueous phase and at least one oil phase with a structural material, etc. Any additional limitations of the ‘625 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘625 claims do not comprise the claimed functionally equivalent porous material.
However, Tuteja et al. teach the claimed porous material, as well as the other limitation of the claims as discussed above. Tuteja et al. also teach the system has the added advantage of allowing on-demand separation of liquid-liquid mixtures (Abstract). Thus, Tuteja 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 modified the ‘625 claims with the teachings of Tuteja et al. to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a system having the added advantage of allowing on-demand separate of liquid-liquid mixtures as explicitly taught by Tuteja et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Tuteja et al. could have been applied to the ‘6325 claims with predictable results because the known techniques of Tuteja et al. predictably result in useful functionally equivalent barriers
This is a provisional nonstatutory double patenting rejection.
21. Claims 1-3, 5-7, 11-15, 27, 29, 31-32, 35, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 22 of copending Application No. 18/387,625 in view of Casavant et al. (Lab Chip, vol. 13, pages 391-396, published 19 November 2012).
Both sets of claims are drawn to systems (i.e., devices) comprising at least one aqueous phase and at least one oil phase with a structural material, etc. Any additional limitations of the ‘625 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘625 claims do not comprise the claimed functionally equivalent porous material.
However, Casavant et al. teach the claimed porous material, as well as the other limitation of the claims as discussed above. Casavant et al. also teach the system has the added advantage of performing complex multi-step washing procedures without centrifugation or transfer steps (Abstract). Thus, Casavant 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 modified the ‘625 claims with the teachings of Casavant et al. to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the modification because said modification would have resulted in a system having the added advantage of allowing performance of complex multi-step washing procedures without centrifugation or transfer steps as explicitly taught by Casavant et al. (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of Casavant et al. could have been applied to the ‘6325 claims with predictable results because the known techniques of Casavant et al. predictably result in useful functionally equivalent barriers
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter and Conclusion
22. Claims 16-26, 28, 30, 33-34, and 36 are allowed. Claims 1-15, 27, 29, 31-32, 35, and 37 are rejected.
23. 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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683