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
This application is a national stage application of PCT/EP2022/082644, filed November 21, 2022, which claims benefit of foreign application DE102021130283.8, filed November 19, 2021. Claims 1 and 7-11 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted August 26, 2024, is acknowledged wherein claim 1 is amended, claims 2-6 are canceled, and new claims 7-11 are introduced.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wee et al. (PCT international publication WO2019/018889, Reference included with PTO-892)
Independent claim 1 is directed to a method for extraction and isolation of a nucleic acid, comprising adding a binding buffer, binding to a solid phase, washing, and eluting the nucleic acid. The solid phase is further defined as a reaction vessel which contains grooves or a thread on the inner side of the reaction vessel. Independent claim 10 claims a kit comprising the aforementioned reaction vessel, a binding buffer, a wash buffer, and an elution buffer. In particular, it is noted that claims 1 and 10 do not define the components present in the binding, wash, and elution buffers. Therefore any solution used to carry out the respective function is considered to be a lysis, binding, wash, or elution buffer.
Wee et al. discloses a process for isolating a nucleic acid from a sample comprising exposing a nucleic acid to a thermoplastic polymer substrate, washing the nucleic acid bound to the substrate, and then eluting the nucleic acid from the substrate, as well as a kit comprising the thermoplastic polymer substrate, and an elution buffer. (p. 2 paragraphs 5 and 7) In one particular embodiment the thermoplastic polymer substrate comprises one or more vessels for carrying a solution, such as a 96-well plate. (pp. 11-12, paragraph 37) Vessels as described therein are seen to be substantially the same as “reaction vessels” as recited in the present claims. Furthermore the solution used to bind the nucleic acid to the substrate preferably contains a specific concentration of salt, which is reasonably considered to be a binding buffer. (p. 13 paragraph 41) Washing and elution buffers are also described. (p. 14 paragraph 43 – p. 16 paragraph 50) Furthermore with respect to the limitation that there exist grooves on the inside of the reaction vessel, Wee specifically describes using a 3d printed substrate. (p. 3 paragraph 9, p. 7 paragraph 25, p. 8 paragraph 27, p. 26 paragraph 83) The grooves formed between layers by the 3d printing process were found to be important to the ability of these materials to bind DNA. (p. 31 paragraph 97 – p. 32 paragraph 100) Therefore it is reasonably considered that the 3d printed thermoplastic substrate described by Wee meets the limitations of a reaction vessel having grooves on the inner surface recited in the present claims. Furthermore the limitation “cut into an inner side” recited in claims 1 and 10 is not seen to provide a meaningful structural difference between a “cut” groove and one formed as a result of a layer-by-layer 3d printing process.
Regarding claims 7 and 11, Wee discloses a lysis buffer (paragraph 7) and a step of lysing the biological sample. (p. 12 paragraph 39) Regarding claim 8, the thermoplastic materials described by Wee are plastics. Regarding claim 9, since the reaction vessels described by Wee are produced by 3d printing, it is reasonable to expect that the entire surface of the vessel would contain grooves, including the lower part.
For these reasons Wee anticipates the present claims.
Double Patenting
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.
Claims 1 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, and 11 of U.S. Patent No. 11702648. (Cited in PTO-1449, herein referred to as ‘648) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘648 anticipate the present claims.
In particular, claim 1 of ‘648 claims a process for isolating biological cells to a solid phase having a rough or structured surface. Furthermore claims 4-5 of ‘648 describe the surface as a plastic surface produced by 3d printing. Claim 7 of ‘648 specifies that the surface is a roughened pipette tip. A pipette tip is reasonably considered to be a “reaction vessel” in the broadest reasonable interpretation of the phrase as it can hold a sample within the inside of the pipette tip. Furthermore as discussed previously under 35 USC 102, 3d printed materials are considered to inherently comprise grooves over their entire surface as described by Wee et al.
Furthermore claim 11 of ‘648 describes a further process wherein the cells are lysed, and released nucleic acids are subsequently bound to the surface, then washed, and eluted. Such a process would necessarily anticipate present claims 1 and 7-9.
Regarding claims 10 and 11, while the claims of ‘648 do not specifically disclose a kit comprising the recited pipette tip and relevant buffers, one of ordinary skill in the art would have seen the process recited in claim 11 as necessitating lysis, binding, wash, and elution buffers, and therefore have found it to be obvious to provide a kit comprising the pipette tip and all of the necessary buffers to carry out this claimed process.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 8/28/2026
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