DETAILED CORRESPONDENCE
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 without traverse of group I in the reply filed on 3/17/26 is acknowledged. Applicants canceled claims 18-19 of group II, but have also presented new claims 21-22 which are withdrawn. Applicants, on page 7 of their remarks filed on 3/17/26, have stated that claims 21-22 are commensurate in scope with previous claims 18-19 and are newly presented in order to correct an inadvertent claim numbering issue. Thus, claims 21-22 are part of non-elected group II and are withdrawn.
Information Disclosure Statement
/The information disclosure statements (IDS) submitted on 1/23/24, 4/5/24, 3/17/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-18 are pending and claims 21-22 are withdrawn.
Remarks
Claim 18 cannot both be canceled and withdrawn. Although there were duplicate claims for claim 18, since one of the claims is canceled then all instances of claim 18 need to be canceled. The examiner notes that applicants can consider rewriting the claim as new claim 23. In order to advance prosecution, the claims are being examined and the examiner requests applicants correct the informality in the response in order to avoid a notice of non-compliant claims.
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 4, 6, 14, 16, 17 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 pre-AIA the applicant regards as the invention.
Regarding claim 4, it is unclear if the plurality of oligonucleotides are pluralities of the oligonucleotides of claim 1. Claim 1 requires that each oligonucleotide includes both an amplification primer binding sequence and a sequencing primer binding sequence. It is unclear if claim 4 is attempting to recite a plurality of the oligonucleotides of claim 1 or just any oligonucleotide.
Regarding claim 6, it is unclear if the plurality of oligonucleotides are pluralities of the oligonucleotides of claim 5. Claim 5 requires that each oligonucleotide includes both an amplification primer binding sequence and a sequencing primer binding sequence. It is unclear if claim 4 is attempting to recite a plurality of the oligonucleotides of claim 5 or just any oligonucleotide.
As to claim 14, it is unclear how each layer can be 1-2 um but the total of the layers is about 1.5 um to about 5 um. These limitations appear to conflict with each other. For example, if each layer was about 1 um, then the smallest the total layers could be would be about 2 um. Further, if each layer is about 2 um, then the largest the two layers could be is 4 um. Therefore, because the totality of the layers is different than the constraints for each individual layer then it is unclear what applicants are intending to define.
Claim 16 recites the plurality of particles which is unclear because plural particles have not been previously discussed. Therefore, the limitation has insufficient antecedent basis and is unclear. What particles are being referred to?
Claim 17 recites the plurality of particles which is unclear because plural particles have not been previously discussed. Therefore, the limitation has insufficient antecedent basis and is unclear. What particles are being referred to?
Appropriate correction and/or clarification is required.
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 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 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.
(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 1-12, 15-18 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Glezer et al (WO 2020163630; already of record; where US 20210040555 is used as the corresponding document; hereinafter “Glezer”).
As to claim 1, Glezer teaches a solid support comprising a multi-layer polymer, wherein said multi-layer polymer comprises: a first layer attached to said solid support, wherein said first layer comprises a first oligonucleotide within a first polymer layer, and a second layer comprising a second oligonucleotide within a second polymer layer, wherein said first polymer layer is attached to said second polymer layer, and wherein said first oligonucleotide comprises a first amplification primer binding sequence and a first sequencing primer binding sequence; and said second oligonucleotide comprises a second amplification primer binding sequence and a second sequencing primer binding sequence, and wherein said first sequencing primer binding sequence is different from said second sequencing primer binding sequence (Glezer teaches a multi-layer structure; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10. The structures of Glezer are formed of polymers; [139, 182]. Glezer teaches that the layers include multiple oligonucleotides as primers for amplification and sequencing that are present in each layer; [7, 42, 134, 149, 158, 167, 169, 172, 174, 176, 177, 184, 748, 753, 754, 764, 770-772]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Glezer teaches the solid support of claim 1, wherein the multi-layer polymer further comprises a third polymer layer attached to the second polymer layer, wherein the third polymer layer comprises a third oligonucleotide within the third polymer layer, wherein the third oligonucleotide comprises a third amplification primer binding sequence and a third sequencing primer binding sequence; and wherein the third sequencing primer binding sequence is different from the first and second sequencing primer binding sequences (Glezer teaches a multi-layer structure which can include at least 3 layers; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10. Each layer having a different primer is discussed in Glezer above).
As to claim 3, Glezer teaches the solid support of claim 2, wherein the multi-layer polymer further comprises a fourth polymer layer attached to the third polymer layer, wherein the fourth polymer layer comprises a fourth oligonucleotide within the fourth polymer layer, wherein the fourth oligonucleotide comprises a fourth amplification primer binding sequence and a fourth sequencing primer binding sequence; and wherein the fourth sequencing primer binding sequence is different from the first, second, and third sequencing primer binding sequences (Glezer teaches a multi-layer structure which can include at least 4 layers; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10. Each layer having a different primer is discussed in Glezer above).
As to claim 4, Glezer teaches the solid support of claim 1, wherein said first layer comprises a plurality of oligonucleotides covalently attached to said polymer layer; and said second layer comprises a plurality of oligonucleotides covalently attached to said second polymer layer (Glezer teaches covalent attachment; [7, 31, 41-43, 118-121, 142]).
As to claim 5, Glezer teaches a solid support comprising a multi-layer polymer, wherein said multi-layer polymer comprises: a first layer attached to said solid support, wherein said first layer comprises a plurality of particles, each particle comprising a first oligonucleotide moiety covalently attached to said particle via a polymeric bioconjugate linker, and a second layer attached to said first polymer layer, wherein said second layer comprises a plurality of particles, each particle comprising a second oligonucleotide moiety covalently attached to said particle via a polymeric bioconjugate linker, wherein said first oligonucleotide comprises a first amplification primer binding sequence and a first sequencing primer binding sequence; and said second oligonucleotide comprises a second amplification primer binding sequence and a second sequencing primer binding sequence, and wherein said first sequencing primer binding sequence is different from said second sequencing primer binding sequence (Glezer teaches a multi-layer structure; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10. The structures of Glezer are formed of polymers; [139, 182]. Glezer teaches that the layers can be particles; [14-18, 748], Fig. 6, 14, and 7-10. Glezer teaches that the layers include multiple oligonucleotides as primers for amplification and sequencing that are present in each layer; [7, 42, 134, 149, 158, 167, 169, 172, 174, 176, 177, 184, 748, 753, 754, 764, 770-772]).
As to claim 6, Glezer teaches the solid support of claim 5, wherein said first layer comprises a plurality of oligonucleotides covalently attached to said first polymer layer; and/or said second layer comprises a plurality of oligonucleotides covalently attached to said second polymer layer (Glezer teaches that the layers include multiple oligonucleotides as primers for amplification and sequencing that are present in each layer; [7, 42, 134, 149, 158, 167, 169, 172, 174, 176, 177, 184, 748, 753, 754, 764, 770-772]. Glezer teaches covalent attachment; [7, 31, 41-43, 118-121, 142]).
As to claim 7, Glezer teaches the solid support of claim 2, wherein the first layer is immediately adjacent to the second layer, wherein the third layer is immediately adjacent to the second layer, and wherein the first layer and third layer are not immediately adjacent (Glezer teaches a multi-layer structure where there would be intermediate layers as arbitrary layers; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10).
As to claim 8, Glezer teaches the solid support of claim 7, wherein the first layer, second layer, and third polymer are in fluidic contact (Glezer teaches a multi-layer structure where these structures are connected to fluid flow; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10).
As to claim 9, Glezer teaches the solid support of claim 7, wherein the first layer, second layer, and third layer form a contiguous layered unit (Glezer teaches a multi-layer structure; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10).
As to claim 10, Glezer teaches the solid support of claim 9, further comprising a fourth layer attached to the contiguous layered unit (Glezer teaches a multi-layer structure which can include at least 4 layers; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10).
As to claim 11, Glezer teaches the solid support of claim 1, wherein the polymer comprises polyacrylamide (AAm), poly-N-isopropylacrylamide, poly N-isopropylpolyacrylamide, sulfobetaine acrylate (SBA), carboxybetaine acrylate (CBA), phosphorylcholine acrylate (PCA), sulfobetaine methacrylate (SBMA), carboxybetaine methacrylate (CBMA), phosphorylcholine methacrylate (PCMA), polyethylene glycol acrylate, methacrylate, polyethylene glycol (PEG)- thiol/PEG-acrylate, acrylamide/N,N'-bis(acryloyl)cystamine (BACy), PEG/polypropylene oxide (PPO), polyacrylic acid, poly(hydroxyethyl methacrylate) (PHEMA), poly(methyl methacrylate) (PMMA), poly(N-isopropylacrylamide) (PNIPAAm), poly(lactic acid) (PLA), poly(lactic-co- glycolic acid) (PLGA), polycaprolactone (PCL), poly(vinylsulfonic acid) (PVSA), poly(L- aspartic acid), poly(L-glutamic acid), polylysine, glicydyl methacrylate (GMA), glicydyl methacrylate (GMA) azide, hydroxyethylmethacrylate (HEMA), hydroxyethylacrylate (HEA), hydroxypropylmethacrylate (HPMA), polyethylene glycol methacrylate (PEGMA), polyethylene glycol acrylate (PEGA), isocyanatoethyl methacrylate (IEM), or a copolymer thereof (Glezer; [139, 182]).
As to claim 12, Glezer teaches the solid support of claim 1, wherein each layer is substantially planar (Glezer teaches a multi-layer structure that is substantially planar; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10).
As to claim 15, Glezer teaches the solid support of claim 7, wherein the first layer, the third layer, or both the first layer and the third layer are attached to a solid support (Glezer teaches a multi-layer structure which can include at least 3 layers; [14-18, 127, 130, 741, 749, 754], Figs. 6, 14, and Figs. 7-10. Each layer having a different primer is discussed in Glezer above).
As to claim 16, Glezer teaches the solid support of claim 1, wherein the polymer, the plurality of particles, or both, comprise water (As best understood, Glezer teaches a hydrogel; [139, 182]).
As to claim 17, Glezer teaches the solid support of claim 1, wherein the polymer, the plurality of particles, or both, comprise a refractive index of about 1.3 when hydrated (As best understood, Glezer teaches a hydrogel; [139, 182]. Glezer teaches that the hydrogels used have a refractive index close to water of about 1.33; [749]. Glezer also teaches many of the same materials in the instant application; [139, 182]. The instant application states that gels/hydrogels have a refractive index close to water and then give various examples of polymers; see [72, 103, 135, 136, 148, 252, 285] of the instant application. Because Glezer teaches the same polymer gels as disclosed in the instant application, then those materials would be expected to have the same refractive index. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
As to claim 18, Glezer teaches the solid support of claim 1, wherein the first amplification primer binding sequence, first sequencing primer binding sequence, second amplification primer binding sequence and second sequencing primer binding sequence are each about 10 to about 45 nucleotides in length (Glezer teaches 10-40 nucleotides in length; [38]).
Claims 1-12, 15, 16, 17 are rejected under 35 U.S.C. 102a2 as being anticipated by Ghorbani et al (US 20240200133; already of record; hereinafter “Ghorbani”).
As to claim 1, Ghorbani teaches a solid support comprising a multi-layer polymer, wherein said multi-layer polymer comprises: a first layer attached to said solid support, wherein said first layer comprises a first oligonucleotide within a first polymer layer, and a second layer comprising a second oligonucleotide within a second polymer layer, wherein said first polymer layer is attached to said second polymer layer, and wherein said first oligonucleotide comprises a first amplification primer binding sequence and a first sequencing primer binding sequence; and said second oligonucleotide comprises a second amplification primer binding sequence and a second sequencing primer binding sequence, and wherein said first sequencing primer binding sequence is different from said second sequencing primer binding sequence (Ghorbani teaches a multi-layer structure; [91, 159, 179, 444, 445, 452], Figs. 1a, 1b, 37a, 44a, 44b, 49a. The structures of Ghorbani are formed of polymers; [12, 208, 444, 445, 446, 452]. Ghorbani teaches that the layers include multiple oligonucleotides as primers for amplification and sequencing that are present in each layer; [132-157]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Ghorbani teaches the solid support of claim 1, wherein the multi-layer polymer further comprises a third polymer layer attached to the second polymer layer, wherein the third polymer layer comprises a third oligonucleotide within the third polymer layer, wherein the third oligonucleotide comprises a third amplification primer binding sequence and a third sequencing primer binding sequence; and wherein the third sequencing primer binding sequence is different from the first and second sequencing primer binding sequences (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers; Fig. 37A. Ghorbani teaches above how each layer includes the primers; see claim 1).
As to claim 3, Ghorbani teaches the solid support of claim 2, wherein the multi-layer polymer further comprises a fourth polymer layer attached to the third polymer layer, wherein the fourth polymer layer comprises a fourth oligonucleotide within the fourth polymer layer, wherein the fourth oligonucleotide comprises a fourth amplification primer binding sequence and a fourth sequencing primer binding sequence; and wherein the fourth sequencing primer binding sequence is different from the first, second, and third sequencing primer binding sequences (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers; Fig. 37A. Ghorbani teaches above how each layer includes the primers; see claim 1).
As to claim 4, Ghorbani teaches the solid support of claim 1, wherein said first layer comprises a plurality of oligonucleotides covalently attached to said polymer layer; and said second layer comprises a plurality of oligonucleotides covalently attached to said second polymer layer (Ghorbani teaches covalent attachment; [203, 208]).
As to claim 5, Ghorbani teaches a solid support comprising a multi-layer polymer, wherein said multi-layer polymer comprises: a first layer attached to said solid support, wherein said first layer comprises a plurality of particles, each particle comprising a first oligonucleotide moiety covalently attached to said particle via a polymeric bioconjugate linker, and a second layer attached to said first polymer layer, wherein said second layer comprises a plurality of particles, each particle comprising a second oligonucleotide moiety covalently attached to said particle via a polymeric bioconjugate linker, wherein said first oligonucleotide comprises a first amplification primer binding sequence and a first sequencing primer binding sequence; and said second oligonucleotide comprises a second amplification primer binding sequence and a second sequencing primer binding sequence, and wherein said first sequencing primer binding sequence is different from said second sequencing primer binding sequence (Ghorbani teaches a multi-layer structure; [91, 159, 179, 444, 445, 452], Figs. 1a, 1b, 37a, 44a, 44b, 49a. The structures of Ghorbani are formed of polymers; [12, 208, 444, 445, 446, 452]. Ghorbani teaches that the layers can include particles; [84, 93, 204, 208]. Ghorbani teaches that the layers include multiple oligonucleotides as primers for amplification and sequencing that are present in each layer; [132-157]).
As to claim 6, Ghorbani teaches the solid support of claim 5, wherein said first layer comprises a plurality of oligonucleotides covalently attached to said first polymer layer; and/or said second layer comprises a plurality of oligonucleotides covalently attached to said second polymer layer (Ghorbani teaches covalent attachment; [203, 208]).
As to claim 7, Ghorbani teaches the solid support of claim 2, wherein the first layer is immediately adjacent to the second layer, wherein the third layer is immediately adjacent to the second layer, and wherein the first layer and third layer are not immediately adjacent (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers; Fig. 37A).
As to claim 8, Ghorbani teaches the solid support of claim 7, wherein the first layer, second layer, and third polymer are in fluidic contact (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers; Fig. 37A. The structures of Ghorbani are fluidically connected).
As to claim 9, Ghorbani teaches the solid support of claim 7, wherein the first layer, second layer, and third layer form a contiguous layered unit (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers in a continuous layered fashion; Fig. 37A).
As to claim 10, Ghorbani teaches the solid support of claim 9, further comprising a fourth layer attached to the contiguous layered unit (Ghorbani teaches in Fig 37A that there are two channels, with each channel having an upper and lower layer, thereby being 4 total layers in a continuous layered fashion; Fig. 37A).
As to claim 11, Ghorbani teaches the solid support of claim 1, wherein the polymer comprises polyacrylamide (AAm), poly-N-isopropylacrylamide, poly N-isopropylpolyacrylamide, sulfobetaine acrylate (SBA), carboxybetaine acrylate (CBA), phosphorylcholine acrylate (PCA), sulfobetaine methacrylate (SBMA), carboxybetaine methacrylate (CBMA), phosphorylcholine methacrylate (PCMA), polyethylene glycol acrylate, methacrylate, polyethylene glycol (PEG)- thiol/PEG-acrylate, acrylamide/N,N'-bis(acryloyl)cystamine (BACy), PEG/polypropylene oxide (PPO), polyacrylic acid, poly(hydroxyethyl methacrylate) (PHEMA), poly(methyl methacrylate) (PMMA), poly(N-isopropylacrylamide) (PNIPAAm), poly(lactic acid) (PLA), poly(lactic-co- glycolic acid) (PLGA), polycaprolactone (PCL), poly(vinylsulfonic acid) (PVSA), poly(L- aspartic acid), poly(L-glutamic acid), polylysine, glicydyl methacrylate (GMA), glicydyl methacrylate (GMA) azide, hydroxyethylmethacrylate (HEMA), hydroxyethylacrylate (HEA), hydroxypropylmethacrylate (HPMA), polyethylene glycol methacrylate (PEGMA), polyethylene glycol acrylate (PEGA), isocyanatoethyl methacrylate (IEM), or a copolymer thereof (Ghorbani; [12, 208, 444, 445, 446, 452]).
As to claim 12, Ghorbani teaches the solid support of claim 1, wherein each layer is substantially planar (Ghorbani teaches a multi-layer structure that are planar; [91, 159, 179, 444, 445, 452], Figs. 1a, 1b, 37a, 44a, 44b, 49a.).
As to claim 15, Ghorbani teaches the solid support of claim 7, wherein the first layer, the third layer, or both the first layer and the third layer are attached to a solid support (Ghorbani teaches a multi-layer structure which are attached to a support; [91, 159, 179, 444, 445, 452], Figs. 1a, 1b, 37a, 44a, 44b, 49a).
As to claim 16, Ghorbani teaches the solid support of claim 1, wherein the polymer, the plurality of particles, or both, comprise water (As best understood, Ghorbani teaches gels; [208] see also [12, 208, 444, 445, 446, 452]).
As to claim 17, Ghorbani teaches the solid support of claim 1, wherein the polymer, the plurality of particles, or both, comprise a refractive index of about 1.3 when hydrated (As best understood, Ghorbani teaches a hydrogel; [208]. Ghorbani also teaches many of the same materials in the instant application; [12, 208, 444, 445, 446, 452]. The instant application states that gels/hydrogels have a refractive index close to water and then give various examples of polymers; see [72, 103, 135, 136, 148, 252, 285] of the instant application. Because Ghorbani teaches the same polymer gels as disclosed in the instant application, then those materials would be expected to have the same refractive index. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
Claim Rejections - 35 USC § 103
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 as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al (WO 2020163630; already of record; where US 20210040555 is used as the corresponding document; hereinafter “Glezer”).
As to claim 13, Glezer teaches the solid support of claim 1, wherein each layer has a width of about 1-20 mm, a length of about 1-20 cm, and a depth of about 0.5-15 um (Glezer teaches 5-10 cm in length, 3-5 mm in width, and a depth of 10 um; [133, 157]. Glezer also teaches a depth of the total layers being 1-15 um, where each layer would need to be less than the 15 um; Fig. 9. However, if it is deemed than Glezer does not teach each layer has a depth of about .5-15 um, then it would have been obvious to one of ordinary skill in the art to have modified depth of each layer of Glezer to be a depth of about 0.5-15 um in order to provide the advantage of a compact device that did not take up too much space but also provided enough separation to enable clear imaging of each layer. Further, in the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
As to claim 14, Glezer teaches the solid support of claim 1, wherein the combined thickness of the first polymer layer and second polymer layer is about 1.5 um to about 5 um, and the thickness of each polymer layer is about 1 um to about 2 um (Glezer teaches a depth of greater than 10 um; [133, 157]. Glezer also teaches a depth of the total layers being 1-15 um, where each layer would need to be less than the 15 um; Fig. 9. In Figure 9 of Glezer, if the total of the 3 layers were in the range of 1-15 um such as 3 um, then each layer would be about 1 um and read on the claims. However, if it is deemed than Glezer does not teach each layer has a depth of about 1-2 um, then it would have been obvious to one of ordinary skill in the art to have modified depth of each layer of Glezer to be a depth of about 1-2 um in order to provide the advantage of a compact device that did not take up too much space but also provided enough separation to enable clear imaging of each layer. Further, in the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
Claims 13-14, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ghorbani et al (US 20240200133; already of record; hereinafter “Ghorbani”).
As to claim 18, Ghorbani teaches the solid support of claim 1, wherein the first amplification primer binding sequence, first sequencing primer binding sequence, second amplification primer binding sequence and second sequencing primer binding sequence are each about 10 to about 45 nucleotides in length (Ghorbani teaches .01 kb which is a length of 10 base pair (10 nucleotides) and also .05 kb which is a length of 50 base pair (50 nucleotides). In the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05)).
As to claims 13 and 14, Ghorbani teaches the solid support of claim 1, wherein each layer has a width of about 1-20 mm, a length of about 1-20 cm, and a depth of about 0.5-15 um; and wherein the combined thickness of the first polymer layer and second polymer layer is about 1.5 um to about 5 um, and the thickness of each polymer layer is about 1 um to about 2 um. However, the size of the channels and each layer is a result effective variable that depends on the size of the channels and flow cell. It would have been obvious to one of ordinary skill in the art to adjust the overall size of each layer such that each layer has a width of about 1-20 mm, a length of about 1-20 cm, and a depth of about 0.5-15 um; and wherein the combined thickness of the first polymer layer and second polymer layer is about 1.5 um to about 5 um, and the thickness of each polymer layer is about 1 um to about 2 um in order to provide a flow cell that was large enough to run samples through without being too large to waste samples and reagents such that it was compact and efficient while also providing a large enough structure to handle and image.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Church et al (US 20030124594; hereinafter “Church”; already of record) teaches amplification and binding primers; [301-306].
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18303464 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a solid support comprising a multi-layer polymer (Claim 1 of ‘464 teaches a solid support with multi player polymer), wherein said multi-layer polymer comprises: a first layer attached to said solid support, wherein said first layer comprises a first oligonucleotide within a first polymer layer (Claim 1 of ‘464 teaches a first layer with amplification and sequencing primers), and a second layer comprising a second oligonucleotide within a second polymer layer, wherein said first polymer layer is attached to said second polymer layer (Claim 1 of ‘464 teaches the third layer with amplification and sequencing primers), and wherein said first oligonucleotide comprises a first amplification primer binding sequence and a first sequencing primer binding sequence (Claim 1 of ‘464 teaches a first layer with amplification and sequencing primers); and said second oligonucleotide comprises a second amplification primer binding sequence and a second sequencing primer binding sequence (Claim 1 of ‘464 teaches the third layer with amplification and sequencing primers). Although the claims do not recites that said first sequencing primer binding sequence is different from said second sequencing primer binding sequence, it would have been obvious to one of ordinary skill in the art to have used different sequences if different detection targets were desired. Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of reference application ‘464.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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