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 with traverse of Group III, claims 14-20, in the reply filed on May 22nd, 2026 is acknowledged. The traversal is on the ground(s) that . This is not found persuasive because there would not be an increased search burden as the Groups of claims including overlapping classification in C12M with differentiation only in subclasses or secondary search classes.
Examiner maintains that a serious search and/or examination burden exists as outlined in MPEP 808.02.
-For a serious search burden list one or more of the following:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The claims remain to have different classification regardless of a commonality shown at the higher level of “C12M,” wherein the citation of “A61L” and “C12N” as being listed subsequent thereto the particular C12M [and particular class/sub] does not mean such different and distinct classification are secondary or of less importance/significance. Further, it is seen that the inventions would require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 are withdrawn from consideration.
Claim Objections
Claim 18 is objected to because of the following informalities: The recitation “a nanofibers” is grammatically incorrect and it appears that Applicant intends to recite “a nanofiber” or “nanofibers”. Appropriate correction is required.
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.
Claim 16 is 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 16 recites the limitation "the well surface". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 previously provides a plurality of wells, and does not delineate or specify a surface of one or more of those wells. Appropriate correction is required.
Claim 18 is 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 18 recites the limitation "the hydrogel" in the first instance. There is insufficient antecedent basis for this limitation in the claim. Claim 14 previously recites “a natural hydrogel” wherein it appears that Applicant intends to recite “the natural hydrogel” (as likewise recited in the last recitation of claim 18).
Claim 19 is 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 19 recites the limitation "the nanofiber". There is insufficient antecedent basis for this limitation in the claim. Claim 18 previously recites “a nanofibers…” wherein it appears that Applicant either intends to recite “a nanofiber” in claim 18 or “the nanofibers” in claim 19.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 recites “the nanofiber….” wherein choice of a nanofiber is not necessitated as claim 18 provides a recitation of “nanofibers and/or nanoparticles). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 14, 15, 17, and 20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Park et al. (US 2009/0136583), hereafter Park.
With regard to claim 14, Park discloses a biomimetric composition comprising a natural hydrogel, in agarose as in cl. 15, micropatterned with a plurality of wells (abstract; pars.[0030,0031,0038. Examiner asserts that the recitation “formed using the microfluidic system…of claim 1” is drawn to a process recitation not afforded patentable weight in a device claim, and drawn to an intended use recitation not afforded patentable weight with a prospective element in that of the ‘microfluidic system of claim 1’ that is not positively claimed. With regard to claim 17, Park discloses that the modular, biomimetric composition is thin film (pars.[0010,0040]). With regard to claim 20, a cell well is not a positively claimed element of the composition as it is drawn to a process step to use of the microfluidic system of claim 1 wherien such system and its usage are not positively provided, nor is patentable weight attributed to such a process in the present device claims (and further noting that “cell well” is not necessitated by cl. 1 given the recitation to “…and/or removable window plate”).
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) 16, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Park et al. (“Polydopamine-based interfacial engineering of extracellular matrix hydrogels…” ACS, 2019, 11(27), 273919-23925), hereafter Park-2.
Park has been discussed above.
Park does not specifically disclose wherein the well surface is functionalized with polydopamine.
Park-2 discloses polydopamine functionalization of the surface of the culture substrate or interface to which the hydrogel is attached (Abstract; Introduction pgs. 2-3).
It would have been obvious to one of ordinary skill in the art to modify Park to functionalize the well surface with PDA such as suggested by the analogous art of Park-2 to that of engineered extracellular hydrogels for cell culturing in which it can be seen through Park-2 that functionalization of the well surface so as to provide a microwell hydrogel to Park that is a stable cell-culture platform in which PDA functionalization to the well surface removes hydrogel contraction and loss of surface anchorage.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Zhang et al. (“Hydrogels incorporating Au@Polydopamine Nanoparticles…” Analytical Chemistry 2019, 90, 11423-11430), hereafter Zhang.
Park has been discussed above.
Park does not specifically disclose the hydrogel comprises a nanofibers and/or nanoparticles embedded within the natural hydrogel.
Zhang discloses a natural hydrogel as in agarose in which Au@PDA nanoparticles are embedded therein to provide a stable, functional hydrogel composite that is useful for optical sensing functionality, improved stability, and anti-interference properties (Abstract; pgs. 11423-11424).
It would have been obvious to one of ordinary skill in the art to modify Park to provide the natural hydrogel with nanoparticles embedded within such as suggested by the analogous prior art of Zhang to hydrogels utilized in biological applications and wherein such incorporation of Au@PDA nanoparticles within the hydrogel provides a predictable and beneficial functional benefit in providing a more stable hydrogel.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Saraswat et al. (“CellWell: A micropatterned biphasic nanocomposite…” bioRxiv; Oct. 2019, South Dakota School of Mines and Technology; and likewise seen as through Saraswat et al. “Micropatterned Biphasic Nanocomposite platform…” ACS, March 2020, cited by Applicant in IDS of 08/26/25), hereafter Saraswat.
Park has been discussed above.
Park does not specifically disclose the hydrogel comprises a nanofibers and/or nanoparticles embedded within the natural hydrogel, and wherein the nanofiber comprises a polyvinyl alcohol, collagen, chitin, or a combination thereof.
Saraswat discloses a micropatterned composition cell culture platform with a network of wells embedded with polyvinyl alcohol nanofibers (Abstract, for example).
It would have been obvious to one of ordinary skill in the art to modify Park to provide nanofibers, as in polyvinyl alcohol, embedded within the natural hydrogel such as suggested by the analogous prior art of Saraswat to a micropatterned hydrogel with a plurality of wells in order to reinforce the hydrogel of Park and provide a fibrous, extracellular matrix structure that affords suitable application with biological or cell culture applications with hydrogels being robust to withstand deformation and facture as similarly contemplated by Park (see pars.[0034,0037]).
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.
Claims 14-16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 11 of U.S. Patent No. 12,098,354. Although the claims at issue are not identical, they are not patentably distinct from each other because the designation of the wells being hemispherical in shape amounts to a routine and conventional shape to microwells and represents an obvious design choice afforded to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
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