DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a DIV of 16/948,442 filed 09/18/2020, now US PAT 11,473,132 which is a DIV of 15/208,215 filed 07/12/2016 now US PAT 10,954,553 which is a DIV of 14/071,444 filed 11/04/2013 now PAT 9,416,405 which claims benefit of 61/740,242 filed 12/20/2012 and claims benefit of 61/721,968 filed 11/02/2012.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/23/2022 and 1/25/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 10/6/2022. These drawings are found acceptable by Examiner.
Claim Rejections - 35 USC § 112
5. 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. Claims 1-18 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 1-12 are indefinite and does not appear to provide a clear nexus between the steps in the claims 1 and 7 because it is unclear after performing the method steps to form an amplification product or extension product results in detecting the ‘absence’ of amplification product or extension product. Clarification is required as to how the method is expected to function in order to achieve the results of the preamble.
(b) Claim 7-12 is indefinite in the claim 7 because the claims lack a final method step which clearly articulates that the goal of the preamble has been achieved and, if so, in what step. Specifically, the preamble recites inhibiting or substantially blocking undesired amplification of a target acid, but the final process step recites “detecting the presence or absence of the extension product”. It is unclear how detection of the presence or absence of the extension product results in inhibiting or substantially blocking undesired amplification of a target nucleic acid.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 11, and 17 are 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.
The claims 5, 11 and 17 recite “The oligonucleotide of claim 4”, “The oligonucleotide of claim 10” and “The oligonucleotide of claim 16”, respectively. However, the claims 4, 10 and 16, respectively are directed to a method of detecting a nucleic acid.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
7. 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.
8. Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8 and 11 of U.S. Patent No. 9416405 {US Patent ‘405 used interchangeably herein}.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims of the instant invention and the claims of US Patent ‘405 comprise of overlapping subject matter that are clearly related to each other. Specifically, the independent claims 1, 7 and 13 of the instant invention recite the following:
Claim 1 is directed to a method of detecting a nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; extending the oligonucleotide to form an extension product; amplifying the extension product to form an amplification product; and detecting the presence or absence of the amplification product, thereby detecting the target nucleic acid.
Claim 7 is directed to a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; extending the oligonucleotide to form an extension product; incubating the extension product with an amplification reaction mixture; and detecting the presence or absence of the extension product.
Claim 13 is directed to a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; and extending the oligonucleotide to form an extension product, wherein the extension product inhibits or substantially reduces undesired amplification of the target nucleic acid. The dependent claims 2-6, 8-12 and 14-18 encompass the limitations of the claims 1, 7 and 13 recited above.
The claims 2-6, 8-12, 14-18 overlap in scope with the limitation of the claims 1, 5-8 and 11 of US patent 9416405. Specifically, the independent claims 1, 5, 6, 7 and 11 of US patent 9415405 recite the following:
Claim 1 of US Patent ‘405 teach a composition comprising a first oligonucleotide primer comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence portion and a target nucleic acid hybridization sequence portion; and a second oligonucleotide primer comprising a target nucleic acid hybridization sequence portion, wherein the STAR tag sequence is the same as all or a portion of the target nucleic acid hybridization sequence of the second oligonucleotide primer and the STAR tag sequence is the same as a sequence in the target nucleic acid 5′ of the first oligonucleotide target nucleic acid hybridization sequence hybridization site.
Claim 5 of US Patent ‘405 teach a method of detecting a nucleic acid comprising: contacting the target nucleic acid with a composition of claim 1; hybridizing the target nucleic acid with the first oligonucleotide primer; extending the oligonucleotide to form an extension product; amplifying the extension product to form an amplification product; and detecting the presence or absence of the amplification product, thereby detecting the target nucleic acid.
Claim 6 of US Patent ‘405 recite a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: contacting the target nucleic acid with a composition of claim 1; hybridizing the target nucleic acid with the first oligonucleotide primer; extending the oligonucleotide to form an extension product; incubating the extension product with an amplification reaction mixture; and detecting the presence or absence of the extension product.
Claim 7 of US Patent ‘405 recite a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: contacting the target nucleic acid with a composition of claim 1; hybridizing the target nucleic acid with the first oligonucleotide primer; and extending the oligonucleotide to form an extension product, wherein the extension product inhibits or substantially reduces undesired amplification of the target nucleic acid.
Claim 11 is of US Patent ‘405 recite composition comprising a first oligonucleotide primer comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence portion and a target nucleic acid hybridization sequence portion; and a second oligonucleotide primer comprising a target nucleic acid hybridization sequence portion, wherein the STAR tag sequence is complementary to all or a portion of the target nucleic acid hybridization sequence of the second oligonucleotide primer and the STAR tag sequence is the same as a sequence in the target nucleic acid 5′ of the first oligonucleotide target nucleic acid hybridization sequence hybridization site.
Thus, the claims of the instant invention and the recited claims of US patent ‘405 comprise of a species/genus relationship. As the court stated in In re Goodman, 29 USPQ2d 2010 (CAFC 1993), “a second application-- "containing a broader claim, more generical in its character than the specific claim in the prior patent"--typically cannot support an independent valid patent. Miller, 151, U.S. at 198; See Stanley, 214 F.2d at 153. Thus, the generic invention, as noted above is "anticipated" by the species of the patented invention. Cf., Titanium metal corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that an earlier species disclosure in the prior art defeats any generic claims). This court's predecessor has held that, without a terminal disclaimer, the species claims preclude issuance of the generical application. "In re Van Ornum, 686 F.2d 937, 944, 214 USPQ 761, 767 (CCPA 1982); Schneller, 397 F.2d at 354".
9. Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7 of U.S. Patent No. 11473132 {US Patent ‘132 used interchangeably herein}.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims of the instant invention and the claims of US Patent ‘405 comprise of overlapping subject matter that are clearly related to each other. Specifically, the independent claims 1, 7 and 13 of the instant invention recite the following:
Claim 1 is directed to a method of detecting a nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; extending the oligonucleotide to form an extension product; amplifying the extension product to form an amplification product; and detecting the presence or absence of the amplification product, thereby detecting the target nucleic acid.
Claim 7 is directed to a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; extending the oligonucleotide to form an extension product; incubating the extension product with an amplification reaction mixture; and detecting the presence or absence of the extension product.
Claim 13 is directed to a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: hybridizing a target nucleic acid with an oligonucleotide comprising a 5′ Sequence-Targeted Amplification Restrictive (STAR) tag sequence and a target nucleic acid hybridization sequence, wherein the STAR tag sequence is capable of forming a stem-loop structure upon extension of the oligonucleotide along the target nucleic acid; and extending the oligonucleotide to form an extension product, wherein the extension product inhibits or substantially reduces undesired amplification of the target nucleic acid. The dependent claims 2-6, 8-12 and 14-18 encompass the limitations of the claims 1, 7 and 13 recited above.
The claims 2-6, 8-12, 14-18 overlap in scope with the limitation of the claims 1, 5, 6 and 7 of US patent 132. Specifically, the independent claims 1, 5, 6 and 7 of US patent 11473132 recite the following:
Claim 1 of US Patent ‘132 teach composition comprising: a first oligonucleotide primer and a second oligonucleotide primer, wherein the first primer comprises a sequence-targeted amplification restrictive (STAR) tag sequence which is the same as all or a portion of a target nucleic acid hybridization sequence of the second primer; and a detectable label attached to the first oligonucleotide primer, the second oligonucleotide primer, or a probe, wherein the STAR tag sequence further comprises a portion of an internal amplicon sequence of a target nucleic acid.
Claim 5 of US Patent ‘132 teach a method of detecting a nucleic acid comprising: providing the composition of claim 1; hybridizing a target nucleic acid with the first oligonucleotide primer; extending the oligonucleotide to form an extension product; amplifying the extension product to form an amplification product; and detecting the presence or absence of the amplification product, thereby detecting the target nucleic acid.
Claim 6 of US Patent ‘132 recite a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: providing the composition of claim 1; hybridizing a target nucleic acid with the first oligonucleotide primer; extending the oligonucleotide to form an extension product; incubating the extension product with an amplification reaction mixture; and detecting the presence or absence of the extension product.
Claim 7 of US Patent ‘132 recite a method of inhibiting or substantially blocking undesired amplification of a target nucleic acid comprising: providing the composition of claim 1; hybridizing a target nucleic acid with the first oligonucleotide primer; extending the oligonucleotide to form an extension product; incubating the extension product with an amplification reaction mixture; and detecting the presence or absence of the extension product.
Thus, the claims of the instant invention and the recited claims of US patent ‘132 comprise of a species/genus relationship. As the court stated in In re Goodman, 29 USPQ2d 2010 (CAFC 1993), “a second application-- "containing a broader claim, more generical in its character than the specific claim in the prior patent"--typically cannot support an independent valid patent. Miller, 151, U.S. at 198; See Stanley, 214 F.2d at 153. Thus, the generic invention, as noted above is "anticipated" by the species of the patented invention. Cf., Titanium metal corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that an earlier species disclosure in the prior art defeats any generic claims). This court's predecessor has held that, without a terminal disclaimer, the species claims preclude issuance of the generical application. "In re Van Ornum, 686 F.2d 937, 944, 214 USPQ 761, 767 (CCPA 1982); Schneller, 397 F.2d at 354".
Claim Rejections - 35 USC § 103
10. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
11. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
12. Claims 1, 7 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hall et al (WO 2008045251, citation made of record in the IDS filed11/23/2022) in view of Oultram et al (US WO 2004013354, citation made of record on IDS filed 11/23/2022).
Regarding claim 1, 7, 13, Hall et al teach a method and snap-back primers and detectable hairpin structures used for detecting whether certain target nuclei acid structures are present or absent in a sample. Hall et al teaches that the snap back primer comprises regions configured to hybridize to the target nucleic acid (Summary of the Invention). Hall teaches that the snap-back primers of DNA comprise a sequence tag sequence having characteristics of STAR and a target sequence that folds back upon extending the target sequence and forms a polynucleotide extension product as disclosed in the present application (see examples and Figures 1 and 3). Hall et al teach composition comprising a first snap back primer comprising the detectable 5’ hairpin structure and a second additional primer (e.g., page 7) that could be used in an amplification-based reaction. Hall teaches that one advantage of the present invention is the ability to avoid certain stretches of a target nucleic acid by making them a part of the loop (page 26, lines 6-8).
Oultram et al provides a general method and composition for amplifying a sequence, the composition comprising a stem loop extension structure which can be amplified by a second primer (Figure, primer number 5). Oultram et al teach wherein the composition has a loop generating primer, a second primer and a third synthetic oligonucleotide (page 23). Oultram et al teach that the primers allow for heighten rate of product generation (page 23).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have been motivated to combine the amplification method and composition tag structure of Hall with the method and composition tag structure of Oultram for the benefit of increasing rate of product generation and detection as suggested by Oultram and for the ability to avoid or reduce undesired amplification of a target nucleic acid as suggested by Hall.
Conclusion
13. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/ Primary Examiner, Art Unit 1681