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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-11 , drawn to an apparatus, classified in C12M21/08.
Group II. Claims 19-28, drawn to a method for fabricating an apparatus, classified in C12M21/08.
The inventions are independent or distinct, each from the other because:
Inventions Groups I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process such as process that does not require polymer material.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
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;
The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Applicant’s election without traverse of Group I, claims 1-11 and 19-26 in the reply filed on April 1, 2026 is acknowledged.
Applicant’s election without traverse of Group I, claims 1-11 in the response filed on June 23, 2026 is acknowledged.
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
Claim 10 is objected to because of the following informalities: In claim 10, “each of the fractal features” should read “each of the one or more fractal features” for consistency. 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 7 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 7 recites the limitation "the micro-curvatures" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by SUSARREY ARCE ARTURO (CA-3184398-A1; hereinafter “398).
Regarding claim 1, ‘398 discloses an apparatus for cultivation of cells, the apparatus comprising: a first chamber for cultivating cells (cell culture compartments; page 19, ll. 13-23; claim 28); and a surface, supported in the first chamber, for cell cultivation thereon, the surface exhibiting one or more fractal features, each fractal feature comprising out-of-plane fractal patterning providing non-planar microtopology for the surface (page 19, ll. 13-23; claims 27-28).
Therefore, ‘398 meets and anticipates the limitations set forth in claim 1.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gabriele et al (US 2011/0076771; hereinafter “Gabriele”).
Regarding claim 1, Gabriele disclose an apparatus for cultivation of cells, the apparatus comprising: a surface, supported in the first chamber, for cell cultivation thereon, the surface exhibiting one or more fractal features, each fractal feature comprising out-of-plane fractal patterning providing non-planar microtopology for the surface (e.g., see FIG. 7 which illustrate a surface having one or more fractal features; [0033]). Gabriele does not explicitly disclose a first chamber for cultivating cells supporting the surface. However, Gabriele does disclose wherein a tissue can be applied to the surface exhibiting one or more fractal features, and incubating the tissue ([0009], [0045]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed chamber with the surface of the apparatus of Gabriele for the purpose of providing means for introducing medium to the tissue.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 10,876,089; hereinafter “Zhang”) in view of ‘398 (CA-3184398-A1).
Regarding claim 1, Zhang discloses an apparatus for cultivation of cells, the apparatus comprising: a first chamber for cultivating cells (e.g., FIG. 12A); and a surface, supported in the first chamber, for cell cultivation thereon, the surface exhibiting one or more features, each feature comprising out-of-plane patterning providing non-planar microtopology for the surface (surface (1206) for culturing cells; col. 17, ll. 58-61; col. 18, ll. 2-6). Zhang does not explicitly disclose wherein the one or more features are fractal features. However, Zhang does disclose wherein the one or more features includes topography that approximate or mimics the curving glomerular capillary structures found in vivo (col. 8, ll. 41-44). ‘398 discloses the use of fractal features in a culture chamber for better mimicking of the natural conditions of cells (abstract and [0006]). In view of ‘398, 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 one or more features of Zhang with one or more fractal features as disclosed by ‘398. One of ordinary skill in the art would have made said modification for better mimicking the natural conditions of cells in vivo as disclosed by ‘398 ([0006]). Further, one of ordinary skill in the art would have made said modification because Zhang discloses the need for the one or more features to have topography that mimic the natural cell structure (col. 8, ll. 41-44).
Regarding claim 2, modified Zhang discloses wherein each fractal feature includes protruding Gaussian, fractal micro-curvatures. Zhang discloses protruding, out-of-plane hemispherical microcurvatures for mimicking the curved environment experienced by podocytes in the glomerulus (col. 8, ll. 41-51; col. 11, ll. 24-27; col. 17, ll. 58-61; claim 1). Thus, the combination of Zhang and ‘398 meets the limitation set forth in the claim.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over ‘398 as applied to claim 1 above, and further in view of Patel et al (WO 2018-191787-A1; hereinafter “Patel”).
Regarding claim 3, ‘398 discloses the apparatus according to claim 1. ‘398 discloses the claimed one or more fractal features but does not explicitly disclose wherein complexity of each fractal feature is determined by a fractal dimension (Df), wherein the fractal dimension is defined as: Df= -log N/log ε wherein N is a number of measurement units, and ε is a scaling factor. Patel discloses in paragraphs [108] fractal dimension relationship expressed as δ = log(U)/log(σ), wherein U represent the number of copies of an object, σ represent scaling factor. In view of Patel, 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 apply Patel’s known fractal dimension relationship to the surface having one or more fractal features of ‘398 in order to characterize the fractal dimension of the one or more fractal features. Further, one of ordinary skill in the art would have made said modification because said modification would have constituted the predictable application of a known technique to a known fractal features for its established purpose, with a reasonable expectation of success.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of ‘398 as applied to claim 1 above, and further in view of Patel et al (WO 2018-191787-A1; hereinafter “Patel”).
Regarding claim 3, modified Zhang discloses the apparatus according to claim 1. Zhang discloses the claimed one or more fractal features but does not explicitly disclose wherein complexity of each fractal feature is determined by a fractal dimension (Df), wherein the fractal dimension is defined as: Df= -log N/log ε wherein N is a number of measurement units, and ε is a scaling factor. Patel discloses in paragraphs [108] fractal dimension relationship expressed as δ = log(U)/log(σ), wherein U represent the number of copies of an object, σ represent scaling factor. In view of Patel, 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 apply Patel’s known fractal dimension relationship to the surface having one or more fractal features of modified Zhang in order to characterize the fractal dimension of the one or more fractal features. Further, one of ordinary skill in the art would have made said modification because said modification would have constituted the predictable application of a known technique to a known fractal features for its established purpose, with a reasonable expectation of success.
Claims 4-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of ‘398 and Patel as applied to claim 3 above, and further in view of Baiguera et al ("Information-Driven Design as a Potential Approach for 3D Printing of Skeletal Muscle Biomimetic Scaffolds" Nanomaterials 10.10 (2020): 1986) (hereinafter “Baiguera”).
Regarding claim 4, modified Zhang discloses the apparatus according to claim 3. Modified Zhang does not explicitly disclose wherein the fractal patterning is derived from a histological section of a biological microenvironment exhibiting the fractal patterning. However, Zhang does disclose wherein the one or more features provide topography that approximates or mimics the cell structures found in vivo (col. 8, ll. 41-44; col. 20, ll. 38-41). Baiguera discloses design-oriented process starting from histological images, wherein histological images of tissue are used as the architectural structure to be reproduced by 3D fabrication, and histological observation are used to design scaffold features reproducing the tissue cross-section (see, pages 3 and 5). In view of Baiguera, 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 derived the fractal patterning of the surface of modified Zhang from a histological section, as disclosed by Baiguera, in order to produce the native architecture and physical microenvironment encountered by the cells in vivo. Further, one of ordinary skill in the art would have made said modification to provide such a biomimetic environment because reproducing native tissue architecture is known to provide more physiologically relevant structure cures to cultured cells, thereby promoting improved cell attachment, organization and differentiation of native cellular morphology and function. Accordingly, applying Baiguera’s histology-based biomimetic design technique to the fractal cultivation surface of modified Zhang would have been a predictable use of a known technique to improve the physiological relevance of the cell culture environment, with a reasonable expectation of success.
Regarding claims 5 and 6, modified Zhang does not explicitly disclose wherein the biological microenvironment is a podocyte microenvironment, wherein the fractal patterning mimics glomeruli in the podocyte microenvironment. However, Zhang does disclose a podocyte microenvironment and further discloses configuring the cultivation surface to approximate or mimic the curved glomerular capillary structures encountered by podocytes in vivo (col. 8, ll. 41-44; col. 20, ll. 38-41). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have derived the fractal patterning from the podocytes microenvironment and configure such patterning to mimic the glomerular architecture, as suggested by Zhang, in order to more closely reproduce the native physical environment of podocytes. One of ordinary skill in the art would have made said modification so as to provide physiologically relevant structure for improved podocyte culture, with a reasonable expectation of success.
Regarding claim 7, modified Zhang does not explicitly disclose one or more fractal features including micro-curvatures that are in convoluted capillary shapes. However, Zhang discloses that the native podocytes niche is characterized by spherically looping capillaries around which podocytes are intimately wrapped (col. 6, ll. 65-67). The instant specification similarly describes the podocytes microenvironment and associated micro-curvature as being patterned after the convoluted capillary shapes of the native microenvironment ([0144]). Thus, Zhang discloses the native convoluted/looping capillary geometry upon which the claimed micro-curvatures are patterned. Accordingly, 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 employ the spherically looping and convoluted capillary geometry of the native podocyte microenvironment as discussed by Zhang to drive fractal patterning of the cultivation surface, thereby more closely reproducing the native glomerular architecture encountered by podocytes in vivo.
Regarding claim 11, modified Zhang does not explicitly disclose wherein the biological microenvironment is a bronchial epithelial, a blood vessel, a lung, or a bone marrow microenvironment. However, Zhang does disclose a podocyte microenvironment and further discloses configuring the cultivation surface to approximate or mimic the curved glomerular capillary structures, i.e., blood vessels, encountered by podocytes in vivo (col. 8, ll. 41-44; col. 20, ll. 38-41). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have derived the fractal patterning from the podocytes microenvironment and configure such patterning to mimic the glomerular architecture, as suggested by Zhang, in order to more closely reproduce the native physical environment of podocytes. One of ordinary skill in the art would have made said modification so as to provide physiologically relevant structure for improved podocyte culture, with a reasonable expectation of success.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of ‘398, Patel and Baiguera as applied to claim 7 above, and further in view of Gentile et al. ("Selective modulation of cell response on engineered fractal silicon substrates" Scientific Reports 3.1 (2013): 1461) (hereinafter “Gentile”).
Regarding claim 8, modified Zhang discloses the apparatus according to claim 7. Modified Zhang does not explicitly disclose wherein Df of each fractal feature is at least 2.2. Gentile discloses engineered fractal cell culture substrate having fractal dimensions ranging from approximately 2.2 to 2.6, and further disclose that cellular response in influenced by the selected fractal dimension (abstract; paragraph bridging pages 5 and 6). In view of Gentile, 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 select a fractal dimensions of at least 2.2 for the one or more fractal features of modified Zhang, because Gentile demonstrates that cellular response varies with fractal dimension and that different Df values can be selected to favor different biological responses (abstract; paragraph bridging pages 5 and 6). Thus, one of ordinary skill in the art would have recognized the fractal dimension as a result-effective variable that can be selected by one of ordinary skill in the art. Such optimization would have involved no more than routine selection of a known parameter from a known range, with a reasonable expectation of achieving the desired cell culture response.
Regarding claims 9-10, modified Zhang does not explicitly disclose wherein an average diameter of the fractal patterning of the one or more fractal features is between 140 to 160 μm, wherein peaks in the fractal patterning of each of the fractal features is between 5 to 15 μm. However, modified Zhang does disclose wherein microtopographical features having diameters and height within or overlapping the claimed ranges, Modified Zhang further discloses that such dimensions are selected to mimic the curved glomerular capillary environment encountered by podocytes in vivo (col. 4, ll. 53-55; col. 11, ll. 24-50; col. 8, ll. 41-47). Accordingly, 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 dimensions of the one or more fractal features of modified Zhang to have the diameter and height as disclosed by Zhang, including the claimed diameter and height, in order to more closely reproduce the native podocytes microenvironment.
Conclusion
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.
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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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