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 .
Claims Status
Claims 1,22, and 30 are amended.
Claims 1-2,11-12,16, 22, and 25-26, and 55-57 are under examination.
Response to Amendment
Applicant’s arguments have been carefully considered but they are not found persuasive. Response to the argument below addresses the deficiencies raised by Applicant with respect to the amended claims. It should be noted that the submitted amendments fail to overcome the rejection on record, therefore, the rejection is maintained.
Maintained Rejections
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-2,11-12, 16,22, 25-26, and 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Tewary et al (PLOS Biology, 2019), in view of Bosch-Fortea et al (Biomaterials, 2019), hereafter Fortea et al, Sodunke et al ( Biomaterials, 2007), and Hoehnel et al (WO 2018/050862 A1), as evidenced by Bench data sheet.
Regarding claims 1, 12, and 55-57, Tewary et al disclose a method for culturing hPSCs on an anchorage dependent device to study peri-gastrulation-like fate patterning. Tewary et al teach that the anchorage dependent device comprises a plurality of microspots created with PLL-g-PEG-based micropatterning on a glass substrate that is assembled to form a 96-well culture plate. Tewary et al used the photopatterning technology to create platforms with desired patterns of microspots ( i.e. circular, square, triangle, or rectangle). The method involves depositing the microspots to the surface of PEG-coated side of a coverslip by photo-oxidizing selected regions of the substrate using Deep UV exposure for 12 minutes through a Quartz photomask. According to Tewary et al, the disposal of microspots using Deep UV light and photomask (i.e. photopatterning technique) generates microspots with modified chemical attributes (i.e. carboxyl groups) that differ from the chemical attributes of the surrounding interstitial surface, with the microspots and not the interstitial surface being able to support the tethering of biological materials. Tewary et al also teach using carbodiimide and succinimide chemistry (EDC and NHS) to activate the carboxyl groups formed by the photomasking, allowing for covalent binding of ECM proteins, such as Geltrex basement membrane preparation, to the microspots. In one embodiment, Tewary et al demonstrate how to design microspots that are 200 microns in diameter with 500-microns separation. The separation distance reads on “plurality of microspots separated by a pitch”. Tewary et al further disclose utilizing the device to assay hPSCs differentiation outcomes. ( See Fig.1-2, Materials and methods sections “ Preparation of PEG plates”, and “ Comparison between PEG plates with µCP plates”). In addition, the anchorage dependent device of Tewary et al comprises of micropatterned slide that are glued to a bottomless 96-well plates to produce microtiter plates with patterned cell-culture surfaces. It should be noted that the micropatterned slide reads on the first planar surface, whereas the bottomless 96-well plate reads on a leak-proof physical barrier attached to the first planar face. ( See Fig 1.B, and section “Preparation of PEG plates” on page 28). It is submitted that Tewary et al do not specify the number of the respective sets of the plurality of microspots that the leak-proof physical barrier encompasses per each well. However, it is understood that the number of sets in this case would depend on the micro-contact stamps used to generate the plurality of microspots, and thus it would have been prima facie obvious for one with ordinary skill in the art to rely on routine experimentation when determining the appropriate number of the respective sets of the plurality of microspots per well. Because the number of the respective sets/ plurality of microspots may vary depending on the type of the tissue specific organoids being generated. When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges through routine experimentation. See MPEP 2144.05. In other words, Tewary et al render obvious the anchorage dependent device of claim 1.
Tewary et al also teach coating the microspots with soluble extracellular matrix proteins (ECM), such as Geltrex. ( See Tewary et al Material and methods sections “ Preparation of PEG plates”, page 28). Tewary et al also describe utilizing the device to assay hPSCs differentiation outcomes, wherein the cells are human (i.e. primate). The method of Tewary involves culturing single cell suspension of hPSCs cells into the micropattern platform, this reads on claim 56. ( See abstract, and Fig.1D). In particular, Tewary’s method for culturing PSCs involves suspending PSCs in SR medium supplemented with ROCK inhibitor and bFGF and then culturing the suspension onto the micropatterned platform for a period of 2 to 3 h till robust cell attachment is observed. When robust cell attachment is observed, ROCK inhibitor is removed from the media and then the cells are left overnight to make colonies. ( See section “ Comparison between PEG plates with μCP plates” on page 29). Tewary et al show that the micropatterned platform allows for the robust geometrical confinement of a variety of cell types in colonies of a variety of shapes and sizes. ( See Fig 1D).
Taken together, Tewary et al teach utilizing the micropatterned platform to assay the human PSCs differentiation outcome and render obvious the anchorage dependent platform of instant claim 1. Tewary et al teach coating the platform with a coating supplement (i.e. Geltrex), and the step of contacting the microspots with a single cell suspension, but they do not teach the step of supplementing the culturing medium with sub-gelation dilution of the coating agent, and thus do not teach inducing the PSCs into specific organoid.
Fortea et al supplement the method of Tewary et al by showing how to produce three-dimensional cellular structures composed of renal epithelial tubules (i.e. a polarized kidney-like tubule structure) using an anchorage dependent device comprising a plurality of microspots. (See Fig.1). Fortea et al are cited to supplement the method of Tewary et al by adding the step of supplementing cultured cells on micropatterned platform with supportive media comprising sub-gelation dilution of the fluid coating supplement to generate three-dimensional aggregate of cells. Fortea et al teach that the generated tubules can be used in nephrotoxicity assay, and suggest that the anchorage dependent device is a powerful tool for studying the molecular mechanisms involved in organogenesis as well as conducting drug development assays. ( See Fortea abstract). The method of Fortea et al involves coating microspots with extracellular matrix protein, such as laminin, and then culturing cells in a supportive medium containing a sub-gelation concentration of Matrigel to produce polarized kidney-like tubules. According to Fortea et al, the growth of 3D structures relies on coating microspots with ECM proteins and supplementation of culture media with Matrigel. (See the 2nd column, 1st paragraph, on page 2, and section 2.4.).
In addition, Sodunke et al supplement Tewary et al by teaching a method for making 3D epithelial cell cultures that can be used in a wide variety of applications in epithelial and cancer biology, tissue engineering, as well as gene/drug screening technology. The method involves suspending human immortalized mammary epithelial (MCF-10A) cells and human breast adenocarcinoma (MDA-MB-231) in growth medium containing 2% Matrigel and culturing them on micropatterned substrate coated with Matrigel. (See section 2.3. and Fig.2). Sodunke et al, demonstrate that MCF-10A and MDA-MB-231 cultured in 3D conditions using a micropatterned template formed normal acini structures with similar properties to standard 3D method including normal acini size, formation of hollow lumen, and proper organization of an outer layer of epithelial cells. ( See Fig.8). It should be noted that acini formation represent some aspects of the human breast mammary glands. In other words, acini formation reads on producing mammary gland organoids. Thus, Sodunke et al teach micropatterned Matrigel for three-dimensional epithelial culture and further teaches culturing the cells in medium containing Matrigel. Sodunke et al report use of 2% Matrigel-containing assay medium during the culture of 3D epithelial structure. The Applicants own specification defines the relevant sub-gelation concentrations as approximately 0-10%. Accordingly, the 2% Matrigel concentration disclosed by Sodunke et al falls within the Applicant’s disclosed sub-gelation range. Thus, Sodunke et al provide ECM-functionalized micropatterned culture surfaces, and the use of a culturing medium containing sub-gelation of ECM during 3D epithelial culturing.
Therefore, it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to modify the method of Tewary et to include the step of culturing PSCs in a supportive media containing a sub-gelation dilution of the coating agent (i.e. Matrigel), as taught by Fortea and Sodunke et al, to produce lumenized three-dimensional aggregates . Because Fortea et al clearly teach that the growth of 3D structures relies on coating microspots with ECM proteins and the supplementation of the culturing media with Matrigel. Sodunke et al, demonstrate that culturing MCF-10A/MDA-231 on micropattern platform coated with Matrigel and supplemented with culturing medium containing Matrigel produce lumenized structure of mammary gland acini. Thus, providing an ordinary skill in the art with the motivation to modify the method of Tewary et al to include the step of supplementing the cells with a medium containing a sub-gelation of the coating agent in order to form 3D aggregates of cells. There would be a reasonable expectation of success because doing so would promote the formation of 3D aggregates of cells.
To summarize, Tewary in view of Fortea et al and Sodunke render obvious the step of utilizing micropatterned substrate to produce polarized kidney-like tubules and mammary gland organoids (i.e. acini). However, neither Tewary, Fortea, or Sodunke teach how to use the micropatterned platform to culture primary or PSC-derived cells to produce tissue specific organoids.
Hoehnel et al supplement the cited prior arts by teaching methods for producing organoid arrays on a micropatterned platform (referred to it as microwell platform). Hoehnel et al are specifically cited to supplement the cited prior arts for the use of human colon progenitor cells (i.e. primary cells that are tissue derived) to produce colon organoid arrays. The method involves seeding single cell suspension of colon-derived progenitor cells in microwells coated with surface hydrogel (i.e. Matrigel), allowing the cells to form cell aggregates by supplementing the cells with media containing a sub-gelation of the coating agent (i.e.2% of Matrigel), and then inducing the formation of organoids using a specific differentiation medium. ( See claims 1-3, page 19 lines 19-22, page 20 lines 1-16, section 6.2.). Hoehnel et al also demonstrate that the platform can be used to generate a variety of tissue specific organoids, including mammary gland organoids, retinal organoids, small intestine organoids, etc. According to Hoehnel et al, the generated organoids array are suitable for high-throughput analysis. Hoehnel et al also state that “ The extremely precise repeatability of the device geometries of the organoid arrays of the present invention finally ensures the compatibility of these arrays of organoids for high throughput drug screening. Using this technology, all organoids are in one focal plane. This solves one of the major current limitations of 3D cell culture where image analysis is significantly slowed down due to the distribution of cellular structures over many different foci, eliminating thus the need for performing z-stacks based analysis . Additionally, all organoids are located within localized regions (regions of interest, ROls), represented by the microwells. This particularity ensures that each organoid can be tracked and analyzed separately and overtime. This gives the opportunity to assess variation on organoid populations and statistical understanding of the overall behaviors. Also, the highly reproducible pattern enables the automation of analysis and thus the compatibility of these cultures with high throughput screening”.( See section 1.3. on page 20 ).
Taken together, claims 1,12, and 55-57 would have been obvious to one of ordinary skill in the art, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Tewary et al utilize micropatterned platform to assay the human PSCs differentiation outcome, and clearly suggest that the platform enables robust geometrical confinement of a variety of cell types in colonies of varying shapes and sizes, but fail to suggest utilizing the platform to induce primary cells derived from tissue to form a polarized organoids. Fortea et al and Sodunke et al supplement Tewary’s method by utilizing micropatterned platform to produce polarized kidney-like tubules and mammary gland organoids (i.e. acini), but fail to teach utilizing the platform to culture primary or PSC-derived cells to produce tissue-specific organoids. Hoehnel et al supplement the cited prior arts by teaching the utilization of human colon progenitor cells (i.e. primary cells that are tissue derived) to produce colon organoid arrays, and clearly suggest that micropatterned platform can be used to generate organoids array useful for high-throughput analysis, such as drug screening. Therefore, an ordinary skill in the art at the time the invention was filed who had reviewed Tewary et al could have come across Fortea, Sodunke, and Hoehnl and immediately noticed the benefit of modifying the teachings of Tewary et al to use the platform of Tewary et al to produce polarized organoids array with precise dimensions and uniform quality. On would be motivated to use the primary cells of Hoehnl et al, culture them on the platform of Tewary et al , and then induce them to produce organoids array that can be used in a high throughput screening system ,such as to conduct drug discovery assays. See MPEP 2143 (I)(G).
Regarding claim 2, the method of Tewary et al involves coating the micropatterned plates with Geltrex (diluted 1:150) for 4 h at room temperature on an orbital shaker. After incubation, the plate is washed with Phosphate Buffered Saline (PBS) at least 3 times to get rid of any passively adsorbed extracellular matrix (ECM). ( See section “ Preparation of PEG plates on page 28).
Regarding claim 11, the combined teachings of Tewary, Fortea, Sodunke, and Hoehnl render obvious claim 1. The instant claim recites a functional outcome “i.e. reduced off target cell differentiation between first and adjacent second three-dimensional aggregates grown using the anchorage surface”. This functional outcome is considered inherent, because the active steps of the claim (i.e. culturing the cell suspensions on an anchorage dependent device comprising a plurality of microspots, and supplementing the cells with a supportive medium comprising a sub-gelation of the coating agent ) is taught by Tewary in view of Fortea, Sodunke, and Hoehnl; and there is nothing in applicants' disclosure that show that these functional results comes from something other than the claimed method steps.
Regarding claim 16, Tewary et al teach utilizing the micropattern platform to expose the cell aggregates to different culturing conditions. For example, Tewary et al demonstrate that exposing undifferentiated hPSCs to different culturing conditions can drive their differentiation into a peri-gastrulation or preneurulation fate. Specifically, Tewary et al teach hPSCs can be induced into peri-gastrulation fate by culturing them in an SR medium supplemented with 100 ng/ml of bFGF and 50 ng/ml of BMP4 , and into preneurulation–like fate using an SR medium supplemented with 100 ng/ml of bFGF with 25 ng/ml of BMP4 and 10 μMSB431542. ( See Materials and methods section “Peri-gastrulation–like and preneurulation-like fate patterning induction”, 2nd paragraph, page 29).
Regarding claim 22, Tewary et al also teach coating the microspots with soluble extracellular matrix proteins (ECM), such as Geltrex, which comprises of laminin, collagen IV, entactin, and heparin sulfate proteoglycan, as evidenced by Gibco data sheet. ( See Tewary et al Material and methods sections “ Preparation of PEG plates”, page 28) and (Gibco product sheet , 1st paragraph).
Regarding claim 25-26, Tewary et al demonstrate that photo-oxidizing organic polymers like PEG with Deep UV light for 12 minutes through a quartz photomask generates micropattern, carboxyl-rich regions. The presence of carboxylic group specifically on the microspots surface and not on the interstitial space generates microspots with a chemical attribute (i.e. carboxyl groups) that are more hydrophilic than the second chemical attribute of the interstitial space, which lacks such group due to the action of the photomasking. (See Fig.1).
Response to Arguments
Applicant's arguments filed 07/13/2026 have been fully considered but they are not
persuasive.
Applicants argue that Tewary is directed to two-dimensional culturing of PSCs colonies and do not teach or suggest growing 3D aggregate tethered to a microspots.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. This is because while the office agrees with Applicants that Tewary et al utilized the micropatterned platform to produce 2D colonies and not 3D level of cells aggregate, however, Tewary et al was relied upon for teaching the micropatterned anchorage platform, including the chemically differentiated micropatterned regions (i.e. (i) and (iii)), selective extracellular matrix functionalization of the micropatterned microspots, and the localized attachment (i.e. tethered) and growth of cells at those microspots. It should be emphasized that Tewary et al further teach coating the microspots with Geltrex prior to cell seeding, which is composed of more than one extracellular matrix proteins ( as discussed in the rejection above), and hence the newly added limitation is also taught by Tewary et al. The fact that Tewary et al used the anchorage dependent device for culturing and growing cell in 2D environment does not negate the teachings of Tewary concerning the underlaying micropatterned anchorage platform. Moreover, Fortea et al expressly supplements this aspect of Tewary. As such, Fortea et al teach employing a micropatterned-based platform for generating 3D epithelial tubes and report that epithelial tubulogensis is affected by cell confinement and extracellular-matrix composition.( See abstract). In other words, the rejection does not rely on Tewary et al alone for producing 3D dimensional structure. Rather, Tewary et al provide the micropatterned anchorage platform, while Fortea et al demonstrate that micropatterned-based device can be used to grow 3D aggregate of cells. Therefore, a person of ordinary skill in the art would have had a reasonable expectation of success to apply the 3D culture teachings of Fortea et al to the micropatterned platform of Tewary et al because Fortea et al provide an actual demonstration of three-dimensional epithelial morphogenesis using a micropattern-based platform. Therefore, instant claim is merely amounts to combining prior art elements according to known methods to yield predictable results. See MPEP 2143 (I)(A).
Applicants argue that Tewary does not teach or suggest a physical leak proof barrier attached to a substrate that circumscribe sets of microspots respectively within wells, and further state that the reliance of the Office on MPEP 2144.05 is inapplicable because the claimed sets of microspots constitute a structural feature rather than a result-effective variable. (See Applicants Remarks on page 8).
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. Because Tewary et al, as discussed above, disclose a micropatterned substrate assembled with a bottomless 96-well culture plate. In this set up, the wells of the bottomless 96-well plate provide physically separated culture regions over the micropatterned substrate. Thus, when the micropatterned substrate is assembled with the multi-well plate, the walls of the wells define respective enclosed regions containing corresponding micropatterned areas (i.e. microspots). Thus, Tewary et al provide a plurality of physically separated culture microspots associated with corresponding portions of the micropatterned substrate. It should also be noted that the claim does not require a particular number of microspots per set, nor does it require a particular number of sets beyond the claimed respective sets. Accordingly, the argument that Tewary does not expressly specify a particular number of micropatterns per well does not distinguish the claim. To the extent Applicants argue that the claimed “ respective sets” require a particular grouping of microspots within each physically separated region, such grouping represent a result-effective design variable. Tewary et al teach a micropatterned substrate assembled with a bottomless multi-well, thereby providing physically separated culture regions containing micropatterned microspots. Instant specification does not identify a particular critical number or arrangement of microspots per barrier-defined region. Rather, it describes the barrier as being usable to circumscribe a plurality of microspots or respective sets thereof. Thus, an ordinary skill in the art would have recognized that the number and arrangement of micropatterns assigned to each culture region can be varied according to the desired number of cellular structure, culture density, and assay throughput. Selecting the appropriate grouping would have been a routine optimization of a known culture configuration.
Applicants further argue that Fortea discloses kidney tubules and not organoids, and does not teach or suggest growing/differentiating the recited types of tethered 3D lumenized organoids under the recited culture conditions.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. This is because it appears that Applicants are arguing references individually. As discussed in the rejection above, Fortea et al was relied upon for the specific teaching of using a micropatterned- based platform to produce three-dimensional epithelial structures and that ECM composition and cell confinement influence such three-dimensional morphogenesis. It should also be emphasized that the office relied upon the combination of references for the claimed subject matter. Thus, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Tewary et al supply the micropatterned-anchorage platform, Fortea supplies the demonstrated three-dimensional micropatterned-based morphogenesis, and Sodunke supplies additional teachings concerning 3D epithelial culture using micropatterned ECM martials. Accordingly, Applicants argument does not overcome the prima facie case of obviousness.
In addition, Applicants argue that Fortea teach coating the micropatterned platform with laminin while supplementing the cultured cells with supportive medium comprising of Matrigel, which is not the same as the fluid coating supplement used to coat the microspots (i.e. laminin), to grow 3D aggregates of cells.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. First, Tewary et al expressly teach coating its micropatterned region with Geltrex before cell seeding. As noted in the rejection above, Geltrex is an extracellular-matrix composition containing multiple ECM components. Thus, Tewary et al provide the claimed type of multi-ECM fluid coating composition. Second, Sodunke et al teach micropatterned Matrigel for three-dimensional epithelial culture and further teach culturing the cells in medium containing Matrigel. Sodunke et al report use of 2% Matrigel-containing assay medium during the culture of 3D epithelial structure. On the other hand, the Applicants own specification defines the relevant sub-gelation concentrations as approximately 0-10%. [00117]. Accordingly, the 2% Matrigel concentration disclosed by Sodunke et al falls within the Applicant’s disclosed sub-gelation range. Thus, the combined teachings of the cited prior arts when taken together, provide ECM-functionalized micropatterned culture surfaces, and the use of a culturing medium containg sub-gelation of ECM during 3D epithelial culturing. The fact that individual references may employ somewhat different ECM compositions does not establish nonobviousness where the skilled artisan would have been motivated to select among known ECM materials and culture conditions to achieve the demonstrated three-dimensional culture results.
Applicant further argue that Sodunke et al’s cells are embedded within Matrigel islands rather than tethered to a micropattern.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. Because Applicants appear to argue references individually, as Sodunke et al was relied upon to teach that micropatterned ECM material, particularly Matrigel, can support three-dimensional epithelial culture and that Matrigel can be maintained in the culture medium at a sub-gelation concentration during such culture to further support organoid formation. Tewary et al supply the micropatterned platform, while Fortea et al supply the 3D based morphogenesis using a micropatterned-based platform. Sodunke et al supplement these teachings by demonstrating the use of Matrigel in a micropattern three-dimensional epithelial culture and in the culture medium. Accordingly, Applicants appear to attach Sodunke et al individually, rather than the combined teachings relied upon in the rejection. It should be emphasized that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants further argue that none of the cited references teach the coating the microspots with multi-ECM fluid coating supplement and subsequently culturing the cell in a sub-gelation dilution of that same fluid coating supplement.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. This is because Tewary et al teach Geltrex coating of the micropatterned microspots. Sodunke et al teach Matrigel as the micropatterned ECM and further teach Matrigel-containg culture medium at 2%. Fortea et al teach that ECM composition is an important variable in 3D epithelial morphogenesis. Thus, the combined teachings of the prior art provided an ordinary skill in the art with the experimental basis and desirability of selecting an appropriate ECM composition for the coating of the microspots and for the three-dimensional culture environment.
Applicants further argue that Hoehnel does not teach the claimed arrangement because Example 2.4.2 employs a TG-PEG hydrogel sandwich rather than tethering cells to a fluid coating supplement.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. This is because Hoehnel et al is not relied upon for the claimed tethering architecture. Rather, Hoehnl et al is relied upon for teaching the use of array-based culture with primary pluripotent stem-cell derived cells to produce tissue-specific organoids. In particular, Example 6 describes iPSC-derived intestinal and adult colon stem cells cultures in microwell using medium supplemented with 2% Matrigel, resulting in intestinal and colon organoid structures. It should be noted that the 2% Matrigel concentration is also within applicant’s disclosed 0-10% sub gelation range. Thus, Applicants argument concerning the TG-PEG sandwich does not negate Hoehnel’s separate teachings of the claimed cell source, organoid application, and low concentration of Matrigel culture conditions.
Applicants further argue that Hoehnel teach away from the claimed invention because certain hard substrates were unsuccessful for the generation of mouse intestinal organoids.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered, but are not found persuasive. This is because the disclosure concerns particular substrate and organoid combinations and does not teach away from micropatterned-based platform. Accordingly, Applicants arguments are not persuasive.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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