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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63/146,779, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. claims of this application requires pillar array, a fiber-bead microstructure, a grating, a convex, a concave, a cave, a wavy structure, and combinations thereof, cell-cell interaction molecule (claim 1), removable inner isolator (claim 2), removable isolators, marking (claim 3), microplate format of 6, 12, 24, 48, 96, 384 or 1536 wells (claim 5), height of microwells, all ECM molecules in claim 6, cell adhesion molecules (claim 10); however, provisional Application No. 63/146,779 does not provide support for said elements of the claimed biochip.
The disclosure of the prior-filed application, Application No. 63/146,270, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. claims of this application requires a convex, a concave, a cave, a wavy structure, and combinations thereof, cell-cell interaction molecule (claim 1), microplate format of 6, 12, 24, 48, 96, 384 or 1536 wells (claim 5), height of microwells, all ECM molecules in claim 6, cell adhesion molecules (claim 10); however, provisional Application No. 63/146,270 does not provide support for said elements of the claimed biochip. Accordingly, this application has been given the effective filing date of February 7, 2022.
Election/Restrictions
Applicant’s election without traverse of Group I, claim 1-6, 10 and 12, in the reply filed on June 30, 2026, is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the structure of biochip as claimed in claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 6 and 12 are objected to because of the following informalities: In claim 1, the limitation “wherein the one or more biofactors are selected from the group consisting of an extracellular matrix (ECM) macromolecule, a cell-cell interaction molecule and/or a soluble factor” should read “wherein the one or more biofactors are selected from the group consisting of an extracellular matrix (ECM) macromolecule, a cell-cell interaction molecule and 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.
Claims 1-3, 5-6, 10 and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the one or more topological factors" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claims 2-3, 5-6, 10 and 12 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 1 recites the limitation "the one or more biofactors" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "microwells" in line 2. However, it is unclear if the microwells are referring to the plurality of microwells associated with the solid support as recited earlier in the claim or are additional microwells.
Regarding claims 5-6 and 10, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 recites the limitation "wherein the top surface of the solid support comprises a plurality of microwells" in lines 1-2. However, it is unclear if the plurality of microwells is referring to the plurality of microwells associated with the solid support as recited earlier in the claims or are additional microwells.
Claim 6 recites the limitation "the removable inner isolator" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the limitation "between about 0.5 to about 10 mm in height" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "between about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Claim 6 recites the limitation "the microwells" in line 3. It is unclear if said limitation refers to the microwells of the inner isolator or the microwell of the solid support.
Regarding claim 10, the limitation "a height between about 1 and 50 μm" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "between about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Claim 10 recites the limitation "one or more soluble factors" in lines 3-4. However, independent claim 1 recites a soluble factor and it is not clear if the previously recited soluble factor is included in the one or more soluble factors recited in the instant claim.
Claim 12 recites the limitation "the soluble protein" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claim 12 is treated as being dependent from claim 10.
Claim 12 recites the limitation "CAM molecule" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, claim 12 is treated as being dependent from claim 10.
Claim 12 recites the limitation "the CAM" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "extracellular matrix" in line 3. However, independent claim 1 recites an extracellular matrix and thus not clear if the limitation is referring to the one recited earlier in the claims or is an additional extracellular matrix.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhatia et al (already of record, US 2006/0160066; hereinafter “Bhatia”).
Regarding claim 1, Bhatia discloses a biochip comprising a first and a second layer (see, e.g., FIG. 1: biologically compatible culture substrate (10) and gel pad (20); [0030]-[0035]), wherein: (i) the first layer is a macrostructure comprising a solid support (FIG. 1: biologically compatible culture substrate (10); [0030]-[0035]), wherein the solid support comprises a flat top surface or a top surface comprising a plurality of microwells (biologically compatible culture substrate (10) comprises a first surface (12) comprising an array of microspot islands or microwells; [0006], [0030], [0032]), and (ii) the second layer comprises one or more microstructures comprising a bioactive factor ([0065]) and/or one or more cell niche factors selected from topological factors and biofactors, wherein the one or more topological factors is selected from the group consisting of a flat micro-matrix, a pillar array, a fiber-bead microstructure, a grating, a convex, a concave, a cave, a wavy structure, and combinations thereof, and wherein the one or more biofactors are selected from the group consisting of an extracellular matrix (ECM) macromolecule, a cell-cell interaction molecule and/or a soluble factor (gel pad (20) includes a surface comprising an array of microspot islands or microwells having extracellular matrix (ECM) macromolecule, biological proteins, nucleic acids and soluble factors on a hydrogel; see [0006], [0026], [0028], [0030]-[0031], [0034]-[0037], [0039], [0047], [0051]-[0053], [0062], [0065]-[0066]).
Regarding claim 2, Bhatia discloses wherein the flat top surface of the solid support is compartmentalized into microwells using a removable inner isolator (solid support (10) includes a first surface (12) delineated by hydrophobic ink, silicone well dividers, 3D surface topography, or a combination thereof ([0032]); a removable hydrogel having a plurality of microwells arranged on the flat surface (12); see [0006], [0030], [0032], [0035]-[0037], [0039], [0047]).
Regarding claim 5, Bhatia discloses wherein the top surface of the solid support comprises a plurality of microwells, in a microplate format, wherein the microwells comprise the one or more microstructures, wherein the microplate format is selected from preferably, in a 6, 12, 24, 48, 96, 384 or 1536 wells (see FIG. 1; [0052], [0058], [0082]).
Regarding claim 6, Bhatia discloses wherein: (a) the removable inner isolator comprises microwells between about 0.5 to about 10 mm in height, or biochip of claim 1, wherein the microwells are between about 0.5 to about 10 mm in height; (b) wherein the second layer has a height of about 0.2 μm to about 100 μm, preferably 20 μm; (c) wherein the ECM molecule is selected from the group consisting of collagen 1, 2, 4 or 6, vitronectin, fibrinogen, laminin 411, 511, or 521, Thrombospondin, tenacin, mucin, byglycan, aggrecan, and decorin ([0059], [0065]-[0066], [0083]); or (d) the soluble factor is selected from the group consisting of BMP2, Wnt3a, EGF, bFGF, TGF-β, BMP4, WNt5A, IL-2 and IL-18.
Therefore, Bhatia meets and anticipates the limitations set forth in claims 1-2 and 5-6.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (already of record, WANG, et al., Multiphoton microfabrication and micropatterning (MMM) - An all-in-one platform for engineering biomimetic soluble cell niches, Biomaterials, Vol. 269, No. 120644, February 2021, 16 pages) (hereinafter “Wang”).
Regarding claim 1, Wang discloses a biochip comprising a first and a second layer, wherein: (i) the first layer is a macrostructure comprising a solid support, wherein the solid support comprises a flat top surface or a top surface comprising a plurality of microwells (see pages 1 to 3), and (ii) the second layer comprises one or more microstructures comprising a bioactive factor and/or one or more cell niche factors selected from topological factors and biofactors, wherein the one or more topological factors is selected from the group consisting of a flat micro-matrix, a pillar array, a fiber-bead microstructure, a grating, a convex, a concave, a cave, a wavy structure, and combinations thereof, and wherein the one or more biofactors are selected from the group consisting of an extracellular matrix (ECM) macromolecule, a cell-cell interaction molecule and/or a soluble factor (see pages 1 to 3).
Regarding claim 6, Wang discloses wherein: (a) the removable inner isolator comprises microwells between about 0.5 to about 10 mm in height, or biochip of claim 1, wherein the microwells are between about 0.5 to about 10 mm in height; (b) wherein the second layer has a height of about 0.2 μm to about 100 μm, preferably 20 μm; (c) wherein the ECM molecule is selected from the group consisting of collagen 1, 2, 4 or 6, vitronectin, fibrinogen, laminin 411, 511, or 521, Thrombospondin, tenacin, mucin, byglycan, aggrecan, and decorin; or (d) the soluble factor is selected from the group consisting of BMP2, Wnt3a, EGF, bFGF, TGF-β, BMP4, WNt5A, IL-2 and IL-18 (see pages 1 to 3).
Therefore, Wang meets and anticipates the limitations set forth in claims 1 and 6.
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bhatia as applied to claim 2 above, and further in view of Goodwin et al (WO 2015/181367-A1; hereinafter “Goodwin”).
Regarding claim 3, Bhatia discloses the biochip according to claim 2. Bhatia does not explicitly disclose wherein the flat top surface of the solid support comprises a marking. However, Bhatia does disclose the use of microscope for assessing cell array of the biochip (see, e.g., [0087]). Goodwin discloses a cell culture slide comprising markings (FIG. 1: indicia (48)) adapted to allow correct orientation of slide with respect to a microscope ([0022]). In view of Goodwin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biochip of Bhatia to comprise marking as disclosed by Goodwin. One of ordinary skill in the art would have made said modification in order to facilitate correct orientation of cell culture slide with respect to a microscope as disclosed by Goodwin ([0022]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatia as applied to claim 1 above.
Regarding claims 10-11, Bhatia discloses the biochip according to claim 1. Bhatia discloses a biomaterial substrate comprising bovine serum albumin, human serum albumin, or collagens (e.g., collagens; see [0059], [0065]-[0066], [0083]). Bhatia discloses wherein the biomaterial substrate has a height but does not explicitly disclose wherein the height is between about 1 and 50 μm, preferably, about 5 μm. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the height of the biomaterial substrate of Bhatia to have any height including the claimed height, since such a modification would involve only a mere change in size of a component. Scaling up or down of an element which merely requires a change in size is generally considered as being within the ordinary skill in the art (see MPEP 2144.04 IV. A.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Raimondi et al (US 2020/0046881).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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