Detailed Office Action
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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 14 April, 2026. Claims 42-81 are pending in the instant application. Applicants’ election of Group I (claims 42-66) without traverse is noted. Claims 67-81 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
35 U.S.C. § 119
Acknowledgment is hereby made of Applicant’s claim for foreign priority based on EP 20214412.7, filed 16 December, 2020, EP 20200426.3, filed 06 October, 2020, and EP 20200425.5, filed 06 October, 2020. It is noted, however, that applicant has NOT filed a certified copy and English translation (if required) of the first application (EP 20214412.7) as required by 35 U.S.C. § 119(b)(3). Accordingly, the foreign priority claim has NOT been entered.
37 C.F.R. § 1.98
The information disclosure statements filed 30 March, 2023, 31 March, 2023, 19 September, 2024 (2), 29 October, 2025, 12 March, 2026, and 02 August, 2026, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 30 March, 2023, have been reviewed and are acceptable.
37 C.F.R. § 1.57(d)
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., see pages 2 and 74). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See M.P.E.P. § 608.01.
Claim Objections
Claims 46, 48, and 51 are objected to because of the following informalities:
-claim 46, after embodiment (iv), item (c), the claim should recite “(c) Tris(carboxyethyl)phosphine (TCEP); and (v) active ingredients…”
-claim 48, after embodiment (ee), the claim should recite “nucleic acid is derived from a coronavirus; or (ff) the target nucleic acid…”
-claim 51, after embodiment (ff), the claim should recite “optionally a PBS buffer; and/or the medium…”
Appropriate correction is required.
35 U.S.C. § 112(b)
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.
Claims 46 and 51-53 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Claim 46 references an “extraction solution that is selected from the following embodiments (i) to (v)”. However, it is not readily manifest if the claims encompass a singular embodiment or multiple embodiments. Amendment of the claim language to recite an extraction solution comprising one or more of the recited embodiments would be acceptable.
Claim 51 references a medium with a series of “characteristics” selected from one or more of (aa)-(gg). This recitation is confusing because it is not readily manifest what constitutes the characteristics of any of the recited items. Amendment of the claim language to reference a medium that comprises one or more of the recited items would be acceptable (e.g., wherein the medium comprises (aa) HBSS).
Claim 52 recites the limitation “medium” with respect to claim 42. However, there is insufficient antecedent basis for this limitation in the claim.
Claim 53 references a reaction that comprises the “characteristics” of embodiments (i)-(vii). This recitation is confusing because it is not readily manifest what constitutes the characteristics of any of the recited items. Amendment of the claim language to reference the actual amplification reaction employed would be acceptable (e.g., wherein the amplification reaction is selected from one of the following methods: (i) reverse transcription (RT) amplification…).
Appropriate clarification and correction are required.
35 U.S.C. § 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)(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.
Claims 42-46, 48-61, and 64-66 are rejected under 35 U.S.C. § 102 (a)(2) as being clearly anticipated by Golz et al. (WO 2021/204701 A1, published 14 October, 2021, and claiming priority to Prov. Appl. No. 63/007,255, filed 08 April, 2020). This teaching discloses a method for the direct amplification of a target nucleic acid in a biological sample without prior nucleic acid purification, wherein the method comprises utilizing an extraction buffer comprising a surfactant, nuclease inhibitor, and/or reducing agent (see Materials and Methods, p. 28; Examples 1-3, pp. 30-35; and claims). In particular nasal swabs were collected and transferred to a sample buffer comprising a surfactant (Triton X-100), nuclease inhibitor (RNase inhibitor), and reducing agent (DTT). An aliquot was removed and the sample subjected to direct PCR. In particular, RT-PCR was performed to detect viral RNA (SARS-CoV-2). Primers specific for the E gene and RdRP were employed (see pp. 29-30). This teaching meets all of the claimed limitations.
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 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 of this title, 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.
Claims 47, 62, and 63 are rejected under 35 U.S.C. § 103 as being unpatentable over Golz et al. (WO 2021/204701 A1, published 14 October, 2021, and claiming priority to Prov. Appl. No. 63/007,255, filed 08 April, 2020) in view of Nazareth et al. (WO 2020/025947 A1, published 06 February, 2020). The claims further require a heat-inactivation step involving the sample prior to amplification. Golz et al. (2021) disclose a method for the direct amplification of a target nucleic acid in a biological sample without prior nucleic acid purification, wherein the method comprises utilizing an extraction buffer comprising a surfactant, nuclease inhibitor, and/or reducing agent (see Materials and Methods, p. 28; Examples 1-3, pp. 30-35; and claims). However, this teaching does not provide a heat-inactivation step. The ‘947 publication discloses PCR amplification methods utilizing heat-inactivation in the presence of an extraction buffer comprising a detergent, solvent, and polymerase. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Golz et al. (2021), to incorporate a heat-inactivation sample step, as provided by Nazareth et al. (2020). One of ordinary skill in the art would have been motivated to employ such a step to reduce the infectivity of the biological sample thereby facilitating the performance of direct-PCR reactions.
Nonstatutory 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 obviousness-type 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 U.S.P.Q.2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 U.S.P.Q.2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 U.S.P.Q. 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 U.S.P.Q. 761 (C.C.P.A. 1982); In re Vogel, 422 F.2d 438, 164 U.S.P.Q. 619 (C.C.P.A. 1970); and In re Thorington, 418 F.2d 528, 163 U.S.P.Q. 644 (C.C.P.A. 1969).
A timely filed terminal disclaimer in compliance with 37 C.F.R. § 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 M.P.E.P. § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in M.P.E.P. § 2159. See M.P.E.P. §§ 706.02(l)(1)-706.02(l)(3) 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 C.F.R. § 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 42, 46, 51, 62, and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 26, and 31-33 of copending Application No. 18/029,408. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application are directed toward methods for amplifying biological samples without prior nucleic acid purification utilizing an extraction solution that comprises a surfactant, nuclease inhibitor, and reducing agent. The samples may also be heat-inactivated. The claims of the ‘408 application are also directed toward a method for amplifying a target in a biological sample without subjecting the sample to nucleic acid purification. The method also employs a surfactant, nuclease inhibitor, and reducing agent. Heat inactivation of the sample is also contemplated. Accordingly, the claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
Information regarding the status of an application may be obtained from the Patent Center. Status information for published applications may be obtained from the Patent Center. Status information for unpublished applications is available through the Patent Center for authorized users only. Should you have questions about access to Patent Center, 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.
Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 08 August, 2026
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