DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Preliminary Amendment and Status of the Claims
2. The preliminary amendment filed 4 October 2024, in which claim 7 was cancelled and new claims 14-18 were added, is acknowledged and has been entered.
Claims 1-6 and 8-18 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statement filed 12 November 2024 is acknowledged and has 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.
Claim Objections
4. Claim 13 is objected to because of the following informalities:
Claim 13 contains the text “molecules comprises,” which appears to be a typographical error.
Appropriate correction is required.
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. Claim 14 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.
The term “high” in claim 14 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
7. 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.
8. Claim 16 is 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.
Claim 16 “comprises 6 repeats of a 12 carbon monomer.” However, claim 15, upon which claim 16 depends, “comprises over 5 repeats of a 12 carbon monomer.” Because “comprises over 5” is the same as “comprises 6,” claim 16 fails to further limit claim 15.
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.
Claim Rejections - 35 USC § 103
9. 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, 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 negated by the manner in which the invention was made.
10. 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).
11. Claims 1-6, 8-9, 11-13, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011).
Regarding claim 1, Clark et al. teach a method of concentrating a target nucleic acid molecule for nanopores sensing comprising capturing the target nucleic acid molecule on a surface, wherein the surface comprises a nanopore and a hydrophobic domain of lipid bilayer (Figs. 17D and 21A and paragraphs 0040 and 0044).
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Clarke et al. further teach that the target nucleic acid molecule comprises a target portion (Fig. 20A, dotted region), a hydrophobic anchor capture element (paragraph 0112) and a leader for interaction with the nanopores (paragraph 0044).
Clarke et al. also teach that the hydrophobic capture element is in the bilayer membrane, which is naturally mobile and coupled target molecule move within the hydrophobic domain of the membrane (paragraph 0097) to bring the leader in proximity with the nanopores (paragraph 0044) and sensing at least the target portion upon interaction with the nanopores (paragraph 0217).
Regarding claim 2, the method of claim 1 is discussed above. Clarke et al. teach the step of capturing the target molecule on the surface comprises contacting the surface with the target molecule, wherein the target molecule comprises, prior to the contacting step, the target portion, the hydrophobic capture element and the leader (Fig. 20A and paragraph 0044).
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.
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 claim 3, the method of claim 1 is discussed above. Clarke et al. teach the step of capturing the target molecule on the surface comprises linking the hydrophobic capture element associated with the surface to the target portion and leader, thereby capturing the target molecule on the surface (Fig. 20A and paragraph 0044).
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. 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 claims 4-5, the method of claim 1 is discussed above. Clarke et al. teach the nanopore is a biological nanopore and the surface is a lipid bilayer (Figs. 17D and 21 and paragraphs 0040 and 0044).
Regarding claim 6, the method of claim 1 is discussed above. Clarke et al. teach the surface is a solid-state or synthetic membrane (paragraphs 0040 and 0090).
Regarding claim 8, the method of claim 1 is discussed above. Clarke et al. teach the target portion comprises nucleic acids and is a linear polymer (Fig. 21 and paragraph 0044).
Regarding claim 9, the method of claim 1 is discussed above. Clarke et al. teach the target portion comprises a molecular bar code (paragraph 0046).
Regarding claims 11 and 17, the method of claim 1 is discussed above. Clarke et al. teach leaders that interact with the nanopore, in the form of a linker attached to an analyte (i.e., polynucleotide), wherein the linker is hydrophilic (i.e., claim 11), in the form of a polyethylene glycol linker (i.e., claim 17; paragraphs 0115-0120).
Regarding claim 12, the method of claim 1 is discussed above. Clarke et al. teach the hydrophobic capture element is a long chain aliphatic hydrocarbon (paragraph 0329).
Regarding claim 13, the method of claim 1 is discussed above. Clarke et al. teach the target molecule comprises long chain aliphatic hydrocarbon and a cholesterol unit(paragraph 0329), which meets the limitation of the target molecule comprising two hydrophobic capture elements.
12. Claims 10 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) as applied to claim 1 above, and further in combination with Kokoris et al. (U.S. Patent No. 7,939,259 issued 10 May 2011).
Regarding claims 10 and 14, the method of claim 1 is discussed above in Section 11.
Clark et al. teach the methods have the added advantage of delivering ultralow concentrations of analyte (paragraph 0007). Thus, Clarke et al. teach the known techniques discussed above.
Clarke et al. do not teach that the target portion comprises an Xpandomer.
However, Kokoris et al. teach methods for analyzing a target nucleic acid comprising the transcribing the sequence of target DNA onto a measurable polymer called an Xpandomer (i.e., claim 10; Abstract and column 4, lies 13-37).
With respect to claim 14, paragraph 0007 of the instant specification acknowledges that the Xpandomers of Kokoris et al. are measurable polymers comprising high signal-to-noise reporters that are separated by about 10 nm and are designed for high-signal-to-noise, well-differentiated responses.
Kokoris et al. also teach the Xpandomers have the added advantage of allowing linear separation of the individual nucleotides to increase the accuracy of the target nucleic acid detection by sequencing (Abstract and column 4, lies 13-37). Thus, Kokoris 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 Clark et al. and Kokoris et al. to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantages of delivering ultralow concentrations of analyte as explicitly taught by Clarke et al. (paragraph 0007) and allowing linear separation of the individual nucleotides to increase the accuracy of the target nucleic acid detection by sequencing as explicitly taught by Kokoris et al. (Abstract and column 4, lies 13-37). 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 molecules and techniques useful in nanopore sequencing.
13. Claims 15-16 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) as applied to claims 11 and 12 above, and further in combination with Schatz (U.S. Patent No. 8,021,841 issued 20 September 2001).
Regarding claims 15-16, the method of claim 12 is discussed above in Section 12.
Clark et al. teach the methods have the added advantage of delivering ultralow concentrations of analyte (paragraph 0007). Thus, Clarke et al. teach the known techniques discussed above.
Clarke et al. do not teach that the long chain hydrocarbon comprises the claimed repeats.
However, Schatz teaches methods comprising the use of molecules to bind sample DNA fragments to substrates, wherein the molecules include hydrocarbons of 8 to 100 carbons, which encompasses up to eight 12 carbon repeats, and which has the added advantage of allowing temporary binding (column 17, line 60-column 18, line 20).
It is 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 merely 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.
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 Clark et al. and Schatz to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantages of delivering ultralow concentrations of analyte as explicitly taught by Clarke et al. (paragraph 0007) and allowing temporary binding as explicitly taught by Schatz (column 17, line 60-column 18, line 20). 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 molecules and techniques useful in nanopore sequencing.
Regarding claim 18, the method of claim 11 is discussed above.
Clark et al. teach the methods have the added advantage of delivering ultralow concentrations of analyte (paragraph 0007). Thus, Clarke et al. teach the known techniques discussed above.
While Clarke et al. teach leaders that interact with the nanopore, in the form of a linker attached to an analyte (i.e., polynucleotide), wherein the linker is hydrophilic, in the form of a polyethylene glycol linker (paragraphs 0115-0120). Clarke et al. do not teach the claimed size.
However, Schatz teaches methods of DNA sequencing using nanopores (paragraph 0014), as well attaching oligonucleotides to surfaces (e.g., transfer substates; column 2, lines 30-65) utilizing polyethylene glycol having a molecular weight of 6000 (column 19, lines 45-55), which has the added advantage of allowing lamination as a film over a substrate (column 4, lines 25-50). Thus, Schatz teaches the known techniques discussed above.
It is 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, and 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.
Therefore, the claimed ranges merely 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.
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 Clark et al. and Schatz to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantages of delivering ultralow concentrations of analyte as explicitly taught by Clarke et al. (paragraph 0007) and allowing lamination as a film over a substrate as explicitly taught by Schatz (column 4, lines 25-50). 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 molecules and techniques useful in nanopore sequencing.
Double Patenting
14. 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.
15. Claims 1-6, 8-9, and 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,670,526.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of clams are drawn to the same limitations; i.e., a nanopore surface having a hydrophobic domain, a hydrophobic capture element, sensing translocation, barcodes, biological or solid state nanopores, lipid bilayers, etc. Any additional limitations of the ‘526 claims are encompassed aby the open claim language “comprising” found in the instant claims.
16. Claims 10 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,670,526 as applied to claim 1 above, and further in combination with Kokoris et al. (U.S. Patent No. 7,939,259 issued 10 May 2011) based on the citations and rationale provided above.
17. Claims 15-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,670,526 as applied to claims 11 and 12 above, and further in combination with Schatz (U.S. Patent No. 8,021,841 issued 20 September 2001) based on the citations and rationale provided above.
18. Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,670,526 as applied to claim 11 above, and further in combination with Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) based on the citations and rationale provided above.
19. Claims 1-2, 4-6, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,851,405.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of clams are drawn to the same limitations; i.e., a nanopore surface having a hydrophobic domain, a hydrophobic capture element, sensing translocation, biological or solid state nanopores, lipid bilayers, etc. Any additional limitations of the ‘405 claims are encompassed aby the open claim language “comprising” found in the instant claims.
20. Claims 3, 8-9, 11-12, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,851,405 as applied to claim 1 above, and further in combination with Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) based on the citations and rationale provided above.
21. Claims 10 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,851,405 as applied to claim 1 above, and further in combination with Kokoris et al. (U.S. Patent No. 7,939,259 issued 10 May 2011) based on the citations and rationale provided above.
22. Claims 15-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,851,405 and Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) as applied to claims 11-12 above, and further in combination with Schatz (U.S. Patent No. 8,021,841 issued 20 September 2001) based on the citations and rationale provided above.
23. Claims 1-6, 9-10, and 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,920,184.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of clams are drawn to the same limitations; i.e., a nanopore surface having a hydrophobic domain, a hydrophobic capture element, sensing translocation, barcodes, biological or solid state nanopores, lipid bilayers, etc. Any additional limitations of the ‘184 claims are encompassed aby the open claim language “comprising” found in the instant claims.
24. Claims 8, 11 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,920,184 as applied to claim 1 above, and further in combination with Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) based on the citations and rationale provided above.
25. Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,920,184 and Clarke et al. (U.S. Patent Application Publication No. US 2014/0262784 published Sep. 18, 2014, effective filing date May 27, 2011) as applied to claim 11 above, and further in combination with Schatz (U.S. Patent No. 8,021,841 issued 20 September 2001) based on the citations and rationale provided above.
Conclusion
26. No claim is allowed.
27. 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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights