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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Status of Claims
Claims 29-42, 45 and 48 are pending. Claims 29-32 and 37-41 are drawn to the nonelected invention. Claims 33-36, 42, 45 and 48 are under examination.
Withdrawn Rejections
In light of the amendments and arguments, the 35 U.S.C. 103 rejection over Lensen et al. in view of Wilkins is hereby withdrawn.
In light of the amendments and arguments, the 35 U.S.C. 103 rejection over Lensen et al. in view of Wilkins and further in view of Murphy is hereby withdrawn.
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.
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.
Claims 33-35, 42, 45 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins et al. (“Immobilized Particle Arrays: Coalescence of Planar- and Suspension-Array Technologies”, Anal. Chem. vol. 75, pgs. 1141-1146, published 2003, 892 dated 06/14/2022) in view of Hook et al. (“Advanced Substrate Fabrication for Cell Microarrays”, Biomacromolecules, vol. 10, pgs. 573–579, published 01/21/2009), as evidenced by MacBeath et al. (US7063979B2, published 06/20/2006).
Wilkins teaches combining positive attributes to planar arrays and suspension arrays, immobilized particle arrays (IPAs) offer a new format in which immobilized submicrometer particles are arrayed on hydrogel-coated slides, providing 100+ assay replicates within each spot (see abstract, pg. 1141, left col., para. 1, Fig. 1). Wilkins further teaches in the abstract that for protein arrays, potential advantages of this format are improved coating of the capture reagent, an increased number of options for protein presentation, reduced mass transport effects, and higher density multiplexing. Wilkins teaches that IPAs have more than 200-fold advantage over planar arrays (see pg. 1142, left col., bottom of para. 3). Wilkins further teaches options for each protein include attachment to any of a variety of microparticle surfaces via a whole range of covalent or affinity interactions (see pg. 1146, right col., para. 3). Wilkins teaches microparticles were printed on aldehyde- and epoxy- activated hydrogel and the aldehydes on the film to react with the particles (see pg. 1143, left col., Array Printing), which would read on a substrate; a plurality of particles, wherein a biological material is immobilized on each of the plurality of particles; and a first layer comprising a hydrophilic nonspecific adsorption-preventing agent (hydrogel) wherein the first layer forms a coating on the substrate; wherein each of the plurality of particles is directly covalently bonded on the first layer via a crosslinking agent (i.e., active aldehyde and epoxy). Wilkins teaches preparing immobilized protein arrays and how to assay the binding of labeled target molecules to the arrayed capture probes (see pg. 1141, left col., para. 1). Fig 1. depicts the immobilized particle array and this array contains 25 spots of microparticles arrayed on a planar surface and each spot within the array contains microparticles coated with capture reagent (also see Fig. 1 caption). Wilkins teaches the hydrogel thickness of 0.05-0.1 µm on the surface of the slide, a geometrical analysis suggests 90% of an IPA-immobilized particle is available for target capture (see pg. 1143, right col., para. 2), which is within the claimed range from 0.01µm to 10µm.
In this particular case, the phrase “biochip” in the preamble and the recitation of “thereby providing a biochip” (as amended 01/16/2026) do not affect the structure of the claimed body because the claims only recite a generic substrate defining the dimensions of a biochip and such substrate is not confined to any particular feature other than the body of the claimed. The phrase “biochip” is not limiting when the claim describes a structurally complete invention such that deletion of the phrase “biochip” does not affect the structures of the claimed invention, which is the case here. Additionally, there is no special definition to the phrase “biochip”. Meanwhile, the teachings of hydrogel-coated slides and the hydrogel thickness of 0.05-0.1 µm on the surface of the slide (see abstract and pg. 1143, right col., para. 2) as taught by Wilkins read on the structure of the generic substrate. Thus, the hydrogel-coated slide embodied the phrase biochip.
MPEP 2111.02 (II) states "[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.…Without such reliance, however, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." Consequently, "preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant." (See also Catalina Mktg. Int’l, 289 F.3d at 808-09, 62 USPQ2d at 1785). (Emphasis added).
Even though the activated aldehyde and epoxy crosslinking agents are on the hydrogel for covalently attaching to the microparticles, Wilkins does not explicitly teach a crosslinking agent is present as a plurality of spots on the first layer to form a second layer, thereby providing the plurality of particles bound at the plurality of spots.
Hook teaches the fabrication and characterization of chemical patterns using a technique that can be readily integrated with methods currently used for the formation of microarrays is present wherein a high density of polyethylene glycol coating was deposited on a glass slides as a background exhibiting low cell attachment properties and phenylazide modified polymers were then printed on this background and UV irradiation of these polymer arrays resulted in the crosslinking of the polymer spots and their covalent attachment on the surface (see abstract and Scheme 1). Scheme 1 shows polymer/azide spots (i.e., phenylazide). Hook further teaches this microarray demonstrates only the ability of this platform to limit cell attachment to specific regions, but also the suitability for chip-based functional genomics and high density cell assays (see abstract and Fig. 1). Hook teaches that researchers desire cell attachment to be limited to the array spots, while the area in between the spots prevents cell attachment (see pg. 573, left col., middle of para. 1). Hook teaches that the spots formed from the derivatized polymers are covalently cross-linked to the surface and are able to withstand extensive washing (see pg. 577, right col., bottom of para. 2, Polymer Microarray Characterization). Hook teaches that cell attachment is limited to specific regions (see pg. 578, right col., bottom of para. 2). Hook also teaches green and red fluorescing cells were observed on the spot, demonstrating the absence of cross-contamination (see pg. 578, left col., bottom of para. 2).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the hydrogel-coated slides as taught by Wilkins with polymer spotting on slides as taught by Hook because Wilkins teaches modifying the standard planar array is modified with microparticles to offer the advantages of improving coating on the arrays for detection and Hook teaches spotting of crosslinked polymer has the ability to limit target attachments to the crosslinked polymer spots and areas in between the spots are prevented for attachments (see Figs. 1 and 3 of Hook). Thus, it would have been obvious to the person to limit target attachments within the proximity of microparticle sites on the hydrogel array of Wilkins because the spots will be distinctive to target attachments and areas between the spots will not be cross contaminated with nonspecific binding, as taught by Hook.
The person would have a reasonable expectation of success incorporating polymer spotting onto the hydrogel-coated slides of Wilkins because it has been well understood by Wilkins to modify standard planar array on slides with microparticles for assay improvements and Hook teaches fabricating polymer spotting is added onto a polymer glass slide.
With respect to claim 34, Wilkins teaches polystyrene particles (see pg. 1142, right col., para. 2, Experimental Section), which is an organic microparticle.
With respect to claim 35, Wilkins teaches antibody protein (see abstract).
With respect to claim 42, Wilkins teaches in Fig. 2 the first layer having an area surrounded by a boundary to retain in solution. Fig. 2 teaches spots in the assay grids contain assay particles (see caption). It is noted that the claim is directed to a product and the limitation of “stamped” on the layer is a product by process recitation. However, Hook does teach stamping polymer onto the slides (see Scheme 1). As stated above, it would have been obvious to the person to have limited the target attachments to only the microparticle sites of the hydrogel array of Wilkins because the spots will be distinctive to target attachments and without crossovers or cross contamination between the spots, as taught by Hook.
With respect to claim 45, Wilkins teaches aldehyde and epoxy activated hydrogel slides were purchased from NoAb BioDiscoveries (Mississauga, Canada ) (see pg. 1142, right col., para. 3 of Experimental Section). The evidentiary teachings of Macbeath indicate NoAb Biodiscoveries sold glass slide with hydrogel coating (see col. 14, lines 56-58). Macbeath also indicates that the glass slide has about 1 mm thick (see col. 13, line 3). Thus, the slide subtrate of Wilkins is about 1 mm.
With respect to claim 48, Wilkins teaches in Fig. 2 the first layer having an area surrounded by a boundary to retain in solution. Fig. 2 teaches spots in the assay grids contain assay particles (see caption). As stated above, Wilkins does not teach the crosslinking agent as a plurality of spots on the first layer. However, Hook does teach stamping polymer onto the slides (see Scheme 1). As stated above, it would have been obvious to the person to limit target attachments within the proximity of microparticle sites on the hydrogel array of Wilkins because the spots will be distinctive to target attachments and areas between the spots will not be cross contaminated with nonspecific attachments, as taught by Hook. Note that the claim is directed to a product and recitation of “formed by stamping a solution” is a product-by-process limitation.
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins et al. in view of Hook et al., as applied to claim 33 above, and further in view of Murphy et al. (US2015/0291929A1, published 10/15/2015, 892 dated 10/06/2022).
Wilkins and Hook have been discussed above but the references fail to teach a peptide (claim 35) wherein the peptide is immobilized on each of the plurality of particles at the C-terminus or N-terminus (claim 36).
Murphy teaches that the hydrogel compositions offer the ability to rapidly screen substrate components for influencing cell attachments (see abstract). Murphy teaches depositing hydrogel solution and crosslink in a plurality of spots on the layer (see Fig. 9). Murphy teaches photocrosslinking agent (see para. [0123]). Murphy teaches hydrogel spots modulate cell behavior covalently attached adhesion molecules (see bottom of para. [0032]). Murphy teaches covalently attach the peptide to norbornene groups (see right col., para. [0143]). Murphy teaches that the hydrogel array depends on the dimensions of the patterns substrate and/or the dimension of the surface-modified substrate and the resultant hydrogel array also be patterned to result in individual hydrogel spots having any desired sizes (see para. [0069]). Murphy teaches N-terminus of the peptide with fluorescein (see right col., para. [0149]). Murphy teaches functional group that can form a covalent bond with the polymer of the hydrogel (see paras. [0078] and [0192]).
Therefore, it would have been obvious to have used the microparticle array of Wilkins to immobilize peptides at the N-terminus of Murphy because Wilkins teaches attaching proteins to the microparticles and Murphy teaches functional reactive groups of peptides at the N-terminus react and form covalent attachments. The person would have a reasonable expectation of success in attaching at the N-terminus of peptides because it has been well understood in the art to form covalent attachments of peptides at N-terminus for assays, as taught by Murphy.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 33-36, 42, 45 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-28, 34, 38-39, 41-44 of copending Application No. 16/645312 (‘312) (892 dated 06/25/2021) in view of Wilkins et al. (“Immobilized Particle Arrays: Coalescence of Planar- and Suspension-Array Technologies”, Anal. Chem. vol. 75, pgs. 1141-1146, published 2003, 892 dated 06/14/2022) and Hook et al. (“Advanced Substrate Fabrication for Cell Microarrays”, Biomacromolecules, vol. 10, pgs. 573–579, published 01/21/2009).
With respect to claims 33-34, copending Application No. ‘312 recites in claim 23 a biochip, comprising: a biochip substrate comprising a resin-made surface and at least one reaction area on the resin-made surface; and a material which is immobilized on each of the at least one reaction area and comprises a biological material, wherein each of the at least one reaction area is hydrophilic and comprises at least more than one spot comprising a thickener and a surfactant, and wherein the at least one reaction area is optionally surrounded by a boundary to retain a liquid in the at least one reaction area, and wherein the at least one reaction area is optionally covered with functional groups having polarity, which are generated by cleaving bonds associated with carbon of a resin of the resin-made surface and binding sites cleaved with oxygen, wherein the biological material is a peptide, and wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip, and wherein the material, the thickness, and the surfactant are absent on the reaction area between the spots.
Copending claim 24 recites that the reaction area is hydrophilic and is surrounded by a boundary to retain a liquid therein, which reads on a layer comprising a non-specific adsorption-preventing agent, wherein the biological material is a peptide, and wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip, and wherein the material, the thickness, and the surfactant are absent on the reaction area between the spots. Copending claim 26 recites the coating layer consists of a water-soluble polymer. Copending claim 27 recites the water-soluble polymer is polyethylene glycol methacrylate. Copending claim 28 recites the material is immobilized on the reaction area by a photocrosslinking agent having at least two photoreactive groups in a single molecule, wherein the material is immobilized on an immobilization carrier, and the immobilization carrier is immobilized on the reaction area; wherein the biochip substrate is made of a polystyrene resin, a polypropylene resin, a polycarbonate resin, or an acrylic resin.
Even though copending Application No. ‘312 recites a reaction area being hydrophilic and comprises at least one spot, the copending Application does not recite a plurality of particles and a second layer that comprises the crosslinking agent wherein the coating formed by the first layer has a thickness of from 0.01 µm to 10 µm.
Wilkins and Hooks have been discussed in the above rejection. It would have been obvious to the person of ordinary skill at the time of filing to have made the biochip substrate as recited in the copending Application No. ‘312 with a plurality of particles and polymer spotting as taught by Wilkins and Hooks because Wilkins teaches the potential advantages of immobilized particle arrays are the improvement in coating the capture reagent and an increased number of options for protein presentation in multiplexing and Hook teaches that spotting of crosslinking polymer has the ability to limit target attachments to the array spots and areas in between the spots are prevented for attachments (see Figs. 1 and 3 of Hook). Thus, it would have been obvious to the person to have limited the target attachments to only the spot sites as recited in the copending Application because the spots will be distinctive to target attachments and areas between the spots will not be cross contaminated with nonspecific binding, as taught by Hook.
With respect to claims 35-36, the copending claim 44 recites polypeptide.
With respect to claim 42, the copending claim 24 recites the spots further comprise a thickener and a surfactant.
With respect to claim 45, the copending claims 23-24 recite a biochip substrate. Although the copending claims do not recite a thickness of the substrate is from 0.3 mm to 3.0 mm, it has been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum thickness of a biochip substrate holding the hydrogel in a particular assay. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation" Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Absent of unexpected results, it would have been obvious to the person of ordinary skill to discover the optimum substrate thickness for a particular assay because the copending Application recites a biochip substrate for peptides.
With respect to claim 48, the copending claim 28 recites the material is immobilized on the at least one reaction area by a photocrosslinking agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed 01/16/2026 have been considered but are moot because the current amendments necessitated a new ground of rejection. Although Wilkins and Murphy were used in the previous obviousness rejection, Applicant’s arguments are only directed to Lensen. The arguments to Lensen are moot as it no longer applies to the current obviousness rejection.
With respect to the nonstatutory double patenting rejection, Applicant argues that the rejection should be reconsidered and withdrawn for the reasons stated in the rejection under 103. As discussed above, the arguments to Lensen are moot as it no longer applies to the current nonstatutory double patenting rejection. Meanwhile, the nonstatutory double patenting rejection over copending Application No. 16/645312 is still pending in view of Wilkins and Hook (see above).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAM P NGUYEN whose telephone number is (571)270-0287. The examiner can normally be reached Monday-Friday (8-4).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.P.N/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
Prosecution Insights