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 (claims 1-8) and Species A2 (claims 1 (in part) and 3) in the reply filed on April 23, 2026 is acknowledged. As a result, claims 1-3 are pending and claims 4-17 are withdrawn.
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 23/2026.
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 23/2026.
While Applicant elected without traverse species B1, species B is drawn to a nonelected invention (Group III) and will therefore not be examined.
Claim Rejections - 35 USC § 103
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Fisher (US 11124829 B2) in view of Northrop (Northrop BH et al. Journal of the American Chemical Society. 2012 Aug 22;134(33):13804-17).
Fisher teaches a flow cell comprised of a substrate upon which various components may be added. The substrate may take many shapes, be made of a variety of materials, and may be planar [Fisher, C22 L62 – C23 L56, C91 L30]. At desirable locations on the substate, in a uniform or non-uniform manner, protrusions may be defined with substantially flat top surfaces upon which capture sites may be found [Fisher, C60 L35-37, C61 L23-24]. Each capture site is capable of immobilizing functionalized support structures via complementary chemical capture agents present both at the capture sites and on the support structures, such as reagents capable of forming an electrostatic interaction, hydrogen bond, or a covalent bond (i.e. thiol-disulfide exchange, click chemistry, Diels-Alder, etc.) [Fisher, C19 L5-9/L24-39, C60 L13-29]. These support structures further include a primer set attached to their surface and may be in the form of a sphere, oval, microsphere, or other recognized particle shape [Fisher, C20 L49-53]. Fisher further teaches that the flow cell may be part of a kit [Fisher, C64 L39-40].
Fisher does not explicitly teach the use of alkenes or alkynes as the flow cell surface attachment mechanism but indicates that click chemistry can be utilized for this purpose, as previously mentioned. Northrop teaches that both alkenes and alkynes are well known within the art as common participants in click chemistry reactions. Both copper-catalyzed alkyne-azide click chemistry (CuAAC) and photoinitiated thiol-ene click chemistry have been well-known and used in a wide variety of arts, due in part to their fast reaction times, for over 20 years (Northrop, p13804-05).
Therefore, as Fisher explicitly teaches click chemistry reactions as capable of immobilizing support structures, and Northrop teaches that alkenes and alkynes are well known within the art as being participants in click chemistry reactions, one of ordinary skill in the art prior to the effective filling date of the claimed invention would have been motivated to use one of them as the immobilization (aka flow cell attachment) mechanism. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher in view of Northrop as applied to claim 1 above, and further in view of Schnall-Levin (US 2021/0332424 A1).
Fisher described how each capture site is capable of immobilizing functionalized support structures through complementary chemical capture agents. The regions of the substrate where the capture sites are found can be composed of an acrylamide copolymer such as poly(N-(5-azidoacetamidylpentyl) acrylamide-co-acrylamide) (PAZAM), the structure of which is represented below. The highlighted residue “RA” can be an azido or a thiol, which conduct click reactions with alkynes and alkenes, as evidenced by Northrop, respectively [Fisher, C29 L19-46; Northrop, p13804]. Fisher further teaches that the functionalized support structure is made of a rigid or semi-rigid material [Fisher, C20 L49-50].
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Fisher does not teach that the functionalized support structures (aka the plurality of particles) includes a core, a hydrogel attached to the core, or a primer set attached to the hydrogel; or that a alkene or alkyne moiety is a functional group of the hydrogel component of the functionalized support structure.
However, Schnall-Levin teaches that bead arrays can be generated by attaching beads to selective areas of a substrate through the use of a polymer coating on said substrate. These beads may be spherical. They may be porous, non-porous, solid (e.g., metals or silica), semi-solid, or a combination thereof. Additionally, the beads may include a coating of one or more polymers (e.g., PEG-alkyne) to which suitable conditions can be applied so as to cause polymerization or gelling which may result in the formation of a hydrogel [Schnall-Levin, 0414, 0419, 0420, 0429, 0430-0433, 0435 0454-0457]
Schnall-Levin further teaches functionalizing the beads to facilitate attachment to nucleic acids, such as primers, and other analytes through a variety of methods including activation of chemical groups within the polymer, incorporation of functional groups within the polymer structure, or attachment at the pre-polymerization/gelling stage. By functionalizing the beads in such a way as to facilitate the attachment of a plurality of different analytes, an improvement in the multiplexing capabilities of the beads can be achieved [Schnall-Levin, 0453, 0461, 0462]
Using the information provided by Schnall-Levin, a skilled artisan could conceive of an array in which the component beads include a core (i.e., silica) with a hydrogel coating (i.e., PEG-alkyne) to which primers are attached, thereby arriving at the Applicant’s particle.
Fisher requires a functionalized support structure capable of being immobilized by a capture site. Schnall-Levin provides a well-known method of building such functionalized structures on a bead using polymer/hydrogel coatings which can be functionalized to include a desired capture chemistry. Schnall-Levin explicitly discloses PEG-alkyne as an example of a hydrogel coating which would be capable of performing in a click chemistry reaction with the azido residue of the PAZAM polymer located at the capture sites of Fisher. Furthermore, the beads of Schnall-Levin can be functionalized in a variety of ways, allowing for the both the primers and the chemistry required for immobilization to be present on the bead’s surface via the hydrogel at the same time.
Therefore, a person of ordinary skill in the art prior to the effective filling date of the claimed invention would have been motivated to modify Fisher’s functionalized support structure to include the features of Schnall-Levin’s bead (core + hydrogel coating) to improve the multiplexing capabilities of the beads, as suggested by Schnall-Levin, thus allowing the sequencing system as a whole to analyze a wider range of analytes. Furthermore, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kara N Kovach whose telephone number is (571)272-8134. The examiner can normally be reached Monday - Friday, 9am - 3pm.
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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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