DETAILED 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 .
Election/Restrictions
Applicant’s election of Group I, six-carbon sugar, bacterial phospholipid, substrate with depressions surrounded by interstitial regions, lid attached to a solid support in the reply filed on 12/1/2025 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Claims 12-24 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/1/2025.
Priority
The instant application was filed 09/27/2023 and claims priority from provisional application 63377690 , filed 09/29/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/28/2023 and 5/10/2024 are being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 1-11 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.
Claim 1 recites, “respectively.” The recitation is vague and unclear how it limits first and second primers. Further, Differences between.com (https://www.differencebetween.com/difference-between-glycolipids-and-phospholipids/?__cf_chl_f_tk=lrVvyHgIaHVCYmZXjDV2V54gaGouGaYqQv5ynbmFpgo-1783429539-1.0.1.1-u4qCkC.XLCSg6LiBgwhUxDs3myalZNqmP0FzoTywzRc, March 24, 2020) teaches glycolipids are lipids containing carbohydrates and phospholipids are lipid residues containing phosphate groups. Thus the metes and bounds are unclear what is required of the independent claim and claim 3 as the independent appears to require glycolipids, but dependent claim 3 appears to allow for the interpretation of a phospholipid which appears to be distinct from glycolipids based on the art of record.
Claim 3 recites, “wherein the first hydrophobic tail and the second hydrophobic tail are independently selected from the group consisting of a bacterial phospholipid and an archaeal lipid.” Abdel-Mawgoud (Synth Syst Biotechnol. 2017 Dec 15;3(1):3–19) teaches, “The term glycolipids (GLs), in general, encompasses a wide diversity of structurally heterogeneous biological compounds that are produced by microbes, plants, animals and humans.” Thus the metes and bounds are unclear what is required by “bacterial phospholipid and an archaeal lipid.” It is unclear how the name of the source name limits the glycolipid. Further it is unclear if glycolipid obtained from fungus or virus with the same composition as from bacteria or archaea is inside or outside the scope of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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.
Claim(s) 1-3, 5-7, 9, 11 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Ishii( US 20040121377 )
With regards to claims 1 and 2, Ishii discloses an array comprising a solid support, a lipid bi-layer attached to at least a portion of the support and at least two different oligonucleotides attached to the bi-layer (claim 1; fig. 6; para. 10, 16, 33, 41 ). Ishii discloses the lipid being phosphatidylglycerol or phosphatidylinositol (para. 33, 70). Glycerol and inositol are well-known sugar alcohols. Therefore, the phosphatidylglycerol or phosphatidylinositol bi-layers are glucolipid bi-layers. The two oligonucleotides attached to the bi-layer in Ishii can be used as primers and the array can be used for nucleic acid sequencing. Thus Ishii anticipates claims 1 and 2.
With regards to claim 3, Ishii teaches glycerol 3 carbon sugar alcohol and inositol a 6 carbon sugar isomer of glucose. (para. 33, 70)
With regards to claim 5, Ishii teaches a glass support (0053)
With regards to claim 6, Ishii teaches depressions surrounded by interstitial regions (fig 6)
The specification does not specifically define lane. Thus the broadest reasonable interpretation is anything which includes a space around it. Thus Ishii teaches depressions surrounded by interstitial regions (fig 6).
With regards to claim 9, Ishii teaches the structures have diameters of nanometers (0055)
With regards to claim 11, Ishii teaches multiple sequencing components (figure 8).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-7, 9- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishii( US 20040121377 ) and Bello (Microchim Acta (2017) 184:1883–1897)
With regards to claims 1 and 2, Ishii discloses an array comprising a solid support, a lipid bi-layer attached to at least a portion of the support and at least two different oligonucleotides attached to the bi-layer (claim 1; fig. 6; para. 10, 16, 33, 41 ). Ishii discloses the lipid being phosphatidylglycerol or phosphatidylinositol (para. 33, 70). Glycerol and inositol are well-known sugar alcohols. Therefore, the phosphatidylglycerol or phosphatidylinositol bi-layers are glucolipid bi-layers. The two oligonucleotides attached to the bi-layer in Ishii can be used as primers and the array can be used for nucleic acid sequencing.
While Ishii teaches a support, with a glycolipid bilayer, and two primers, Ishii does not specifically teach the glycolipid bilayer is attached to a hydrogel.
However, Bello teaches, “hydrogel encapsulation is particularly attractive because it does not interfere with electrical measurement the transport of analytes through channel proteins. Furthermore, hydrogel encapsulation provides efficient physical support to the membrane structure, and thus prolongs the lipid bilayer membrane lifespan and enhances its durability.” (1885l, 2nd column, top_)
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims. The artisan would be motivated as Bello teaches, “hydrogel encapsulation is particularly attractive because it does not interfere with electrical measurement the transport of analytes through channel proteins. Furthermore, hydrogel encapsulation provides efficient physical support to the membrane structure, and thus prolongs the lipid bilayer membrane lifespan and enhances its durability.” The artisan would have a reasonable expectation of success as the artisan is merely using known methods.(claims 4 and 10)
With regards to claim 3, Ishii teaches glycerol 3 carbon sugar alcohol and inositol a 6 carbon sugar isomer of glucose.
With regards to claim 5, Ishii teaches a glass support (0053)
With regards to claim 6, Ishii teaches depressions surrounded by interstitial regions (fig 6)
The specification does not specifically define lane. Thus the broadest reasonable interpretation is anything which includes a space around it. Thus Ishii teaches depressions surrounded by interstitial regions (fig 6).
With regards to claim 9, Ishii teaches the structures have diameters of nanometers (0055)
With regards to claim 11, Ishii teaches multiple sequencing components (figure 8).
Claim(s) 1-3, 5-9, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishii( US 20040121377 ) and Benizri (: Bioconjugate Chem. 2019, 30, 2, 366–383)
With regards to claims 1 and 2, Ishii discloses an array comprising a solid support, a lipid bi-layer attached to at least a portion of the support and at least two different oligonucleotides attached to the bi-layer (claim 1; fig. 6; para. 10, 16, 33, 41 ). Ishii discloses the lipid being phosphatidylglycerol or phosphatidylinositol (para. 33, 70). Glycerol and inositol are well-known sugar alcohols. Therefore, the phosphatidylglycerol or phosphatidylinositol bi-layers are glucolipid bi-layers. The two oligonucleotides attached to the bi-layer in Ishii can be used as primers and the array can be used for nucleic acid sequencing.
While Ishii teaches a support, with a glycolipid bilayer, and two primers, Ishii does not specifically teach oligonucleotides attached to sugars.
However, Benizri teaches, “Oligonucleotide-based agents have the potential to treat or cure almost any disease, and are one of the key therapeutic drug classes of the future. Bioconjugated oligonucleotides, a subset of this class, are emerging from basic research and being successfully translated to the clinic. In this Review, we first briefly describe two approaches for inhibiting specific genes using oligonucleotides antisense DNA (ASO) and RNA interference (RNAi)followed by a discussion on delivery to cells. We then summarize and analyze recent developments in bioconjugate oligonucleotides including those possessing GalNAc, cell penetrating peptides, α-tocopherol, aptamers, antibodies, cholesterol, squalene, fatty acids, or nucleolipids. These novel conjugates provide a means to enhance tissue targeting, cell internalization, endosomal escape, target binding specificity, resistance to nucleases, and more. We next describe those bioconjugate oligonucleotides approved for patient use or in clinical trials. Finally, we summarize the state of the field, describe current limitations, and discuss future prospects. Bioconjugation chemistry is at the centerpiece of this therapeutic oligonucleotide revolution, and significant opportunities exist for development of new modification chemistries, for mechanistic studies at the chemical−biology interface, and for translating such agents to the clinic..” (abstract_) Benzri teaches linkers of nucleic acids to GalNac
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to use linkers to sugars to attach primers. The artisan would be motivated as Ishii does not provide specific guidance and Benzri provides of review of bioconjugation to oligonucleotides to lipids The artisan would have a reasonable expectation of success as the artisan is merely using known methods.(claim 8)
With regards to claim 3, Ishii teaches glycerol 3 carbon sugar alcohol and inositol a 6 carbon sugar isomer of glucose.
With regards to claim 5, Ishii teaches a glass support (0053)
With regards to claim 6, Ishii teaches depressions surrounded by interstitial regions (fig 6)
The specification does not specifically define lane. Thus the broadest reasonable interpretation is anything which includes a space around it. Thus Ishii teaches depressions surrounded by interstitial regions (fig 6).
With regards to claim 9, Ishii teaches the structures have diameters of nanometers (0055)
With regards to claim 11, Ishii teaches multiple sequencing components (figure 8).
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.
Claim 1-11 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 81-100 of copending Application No. 18/533863. Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are drawn to A nucleic acid sequencing component, comprising: a support; a glycolipid bi-layer attached to at least a portion of the support; and first and second primers respectively attached to the glycolipid bi-layer. Dependent claims draw the invention to phospholipid bilayer.
The claims of 863 are drawn to A system for sequencing a target polynucleotide, comprising: a capture polynucleotide comprising a bilayer anchor moiety; a target polynucleotide hybridized to the capture polynucleotide; a helicase; a polypeptide pore inserted into a membrane; a generator adapted to provide a potential difference across the polypeptide pore; a detector adapted to measure an ionic current flowing through the polypeptide pore; Anda processor programmed with instructions to characterize signals from fractional translocation of the target polynucleotide through the polypeptide pore, wherein the instructions are adapted to characterize at least two signals during a full translocation cycle of the helicase. Dependent claims are drawn to lipid bilayer and phosphocholine.
Thus it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims the claims of 863 encompass the instant claims. Thus the instant claims are obvious over the teachings of 863.
Dependent claims are obvious as they are commensurate in scope.
Summary
No claims are allowed.
Conclusion
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
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