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 II, claims 9-18, in the reply filed on July 16, 2026 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 1-8 have been canceled from consideration.
Drawings
The drawings were received on 12/21/2023. These drawings are acceptable.
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.
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.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al (WO 2021/216447 A1).
With respect to claim 9 Zhao discloses a method of fabricating an array (reaction cartridge 104, See Fig. 1 and Para. 0054) having compartmentalization comprising:
Printing linker molecules (starting molecules 127) on a surface of a substrate (substrate surface 122) in a plurality of distinct regions to form a printed array of linker molecules (See Para. 0054 and Fig. 1 for discussion of how starting molecules are synthesized with a number of reaction solutions to form a synthesis product 138 inside light exposed reaction wells; applicant should note that “printing” is described in Paras. 0047-0050 of applicant’s specification describes printing as depositing a printing solution or ink with molecules of interest onto a substrate);
Adding physical barriers (reaction barriers 115, See Fig. 1 and Para. 0054) to the surface of the substrate to form one or more compartments,
Wherein the physical barriers are added prior to the printing linker molecules to form the array having compartmentalization (See Para. 0054 for discussion of the reaction barriers being formed prior to formation of synthesis product 138).
With respect to claim 16 Zhao discloses that the linker molecules are selected from an aminosilane, a poly-L-lysine, an epoxysilane, an aldehyde silane, a trichloro(alkyl) silane, and streptavidin (See Para. 0057 for discussion of how second linker molecules can include 3-aminopropyltrimethoxysilane; triethoxylsilane is also disclosed as a linker).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pease et al (US 2003/0175409 A1).
With respect to claim 9 Pease discloses a method of fabricating an array (polynucleotide array, See Para. 0061) having compartmentalization comprising:
Printing linker molecules (See Paras. 0064 and 0078) on a surface of a substrate (substrate 12 surface 14, See Para. 0078) in a plurality of distinct regions to form a printed array of linker molecules (See Para. 0080 for discussion of how the linker molecules may be attached in an ordered array on the surface of the substrate);
Adding physical barriers (barrier pattern 18, See Fig. 2 and Para. 0082) to the surface of the substrate to form one or more compartments,
Wherein the physical barriers are added prior to the printing linker molecules to form the array having compartmentalization (See Para. 0082 for discussion of how the barrier pattern is added in a subsequent step to attaching the linker molecules).
With respect to claim 10 Pease discloses adding one or more bioreagents to the one or more distinct regions, wherein the one or more bioreagents are selected from antibodies, proteins, nucleic acids, cells, extracellular vesicles (EVs), and exosomes (See Paras. 0009, 0012, and 0054 for discussion of the attachment of a monomer unit, such as an oligonucleotide, to the linker).
With respect to claim 11 Pease discloses that the one or more bioreagents are bound onto the substrate via the linker molecules by covalent bonds (See Para. 0054 for discussion of covalent attachment of the monomer to a linker).
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.
The factual inquiries 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.
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.
Claim(s) 9, 10, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0128881 A1) in view of Zhao et al (WO 2021/216447 A1).
With respect to claim 9 Zhang discloses a method of fabricating an array (microarray 4400, See Para. 0083) having compartmentalization comprising:
Printing linker molecules (bifunctional linker, See Para. 0085) in a plurality of distinct regions to form a printed array of linker molecules (See Para. 0063 for discussion of how probes are provided in different regions, in a multiplex format.
Zhang fails to disclose adding physical barriers to the surface of the substrate to form one or more compartments,
Wherein the physical barriers are added prior to the printing linker molecules to form the array having compartmentalization.
Zhao teaches methods of forming a plurality of isolated wells on a solid substrate and then carrying out a plurality of chemical reactions in the isolated wells, wherein physical barriers (reaction barriers 115, See Fig. 1 and Para. 0054) are added to the surface of the substrate (substrate surface 122) to form one or more compartments,
Wherein the physical barriers are added prior to the printing linker molecules to form the array having compartmentalization (See Para. 0054 for discussion of the reaction barriers being formed prior to formation of synthesis product 138). The 3-dimensional barriers and/or microfluidic chambers are used to retain the photogenerated reagents in the light illuminated areas long enough to complete the deprotection of propagating DNA or other biopolymer molecules. A physical 3-deminsional barrier on a substrate can completely block the near surface lateral flow or diffusion of the photogenerated active reagents and is desirable for producing high quality sequences especially for off-chip applications. (See Para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the barriers of Zhao onto the substrate of Zhang to better retain reagents on the substrate (See Para. 0008 of Zhao).
With respect to claim 10 the combination of Zhang and Zhao teaches adding one or more bioreagents to the one or more distinct regions, wherein the one or more bioreagents are selected from antibodies, proteins, nucleic acids, cells, extracellular vesicles (EVs), and exosomes (See Para. 0087 of Zhang for discussion of providing a sample containing at least one glycan-binding protein to the multivalent glycan microarray).
With respect to claim 15 the combination of Zhang and Zhao teaches that the printer of the linker molecules comprises non-contact based printing (See Para. 0083 of Zhang).
With respect to claim 16 the combination of Zhang and Zhao teaches that the linker molecules are selected from an aminosilane, a poly-L-lysine, an epoxysilane, an aldehyde silane, a trichloro(alkyl) silane, and streptavidin (See Para. 0004 of Zhang for discussion of the use of streptavidin as the branched polymer and macromolecule use to functionalize the surface chemistry of the microarray).
With respect to claim 17 the combination of Zhang and Zhao teaches that the linker molecules are printed on the surface of the substrate using a printer solution (See Para. 0083 for discussion of print buffer with additives).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pease et al (US 2003/0175409 A1) in view of Zhang (US 2019/0128881 A1).
Refer above for the disclosure of Pease.
With respect to claim 12 Pease fails to disclose adding a blocking solution to the array having compartmentalization.
Zhang teaches a method of fabricating an array (microarray 4400, See Para. 0083) having compartmentalization , wherein the multivalent glycan microarray of the invention also includes a bifunctional linker, which tethers the branched polymer to a glycan through independent functional groups of the bifunctional linker. The invention generally relates attaching glycans (saccharides) to the branched polymer through a linker and associated coupling chemistries for coupling branched polymers to make functionalized substrates (See Para. 0052). The microarray further comprises additional component(s) which act to reduce the background of the assay during operation. Such component(s) may be called blocking reagents or reagent, for example. Components to reduce background include those known in the art. In an embodiment, the blocking reagents or reagent include an azide-functionalized trialkoxysilane crosslinking reagent for stabilizing the surface coating layer and also includes a PEG such as poly(ethylene glycol) sorbitol hexaoleate for reducing background signal and reducing non-specific binding (See Para. 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a blocking reagent, as taught by Zhang, into the method of array fabrication of Pease, in order to reduce background signal and non-specific binding (See Para. 0068 of Zhang).
With respect to claim 13 the combination of Pease and Zhang teaches that the blocking solution comprises a non-specific protein blocker (PEG; See Paras. 0069 and 0085) and a buffer (See Para. 0089 of Zhang for discussion of the blocking buffer being 1% BSA in PBST; also See Paras. 0076-0079).
With respect to claim 14 the combination of Pease and Zhang teaches that the non-specific protein blocker is bovine serum albumin (BSA) present in the blocking solution in an amount of about 0.2% w/v to about 20% w/v (See Para. 0089 of Zhang for discussion of the blocking buffer being 1% BSA in PBST).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2019/0128881 A1) and Zhao et al (WO 2021/216447 A1) in view of Frey et al (US 2012/0178844 A1).
Refer above for the combined teachings of Zhang and Zhao.
With respect to claim 18 Zhang and Zhao fail teach that the printing solution comprises glycerol present in an amount of about 5% w/v to about 30% w/v (Zhang teaches glycerol in the amount of 0.1%).
Frey teaches the use of photopolymerizable printing ink compositions that may contain components having a water-retaining action (humectant) (See Para. 0329) that make compositions especially suitable for ink-jet printing. Humectants that come into consideration include, for example, urea or a mixture of sodium lactate (advantageously in the form of a 50 to 60% aqueous solution) and glycerol and/or propylene glycol in amounts of e.g. from 0.1 to 30% by weight, especially from 2 to 30% by weight, in the printing inks (See Para. 0336).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate glycerol in the amounts disclosed by Frey into the printing solution of combined Zhang and Zhao such that the composition can be suitable for ink-jet printing (See Para. 0329 of Frey).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796
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