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 .
DETAILED ACTION
Amendments
In the reply filed 06/08/2026, Applicant has amended claims 46-47, 54-55, 58 and 64-66, newly canceled claims 49-53, 56, 60 and 63, and added new claims 67-74.
Claim Status
Claims 46-47, 54-55, 57-59, 61-62 and 64-74 are pending and are considered on the merits.
Withdrawn Specification Objections
The prior objection to the disclosure because of typographic errors is withdrawn in light of Applicant’s amendment to the specification.
Withdrawn Claim Objections
The prior objection to claims 47, 49, 51-53, 58 and 64 because of informalities is withdrawn in light of Applicant’s cancelation of claims 49 and 51-53, and amendment to claims 47, 58 and 64.
New Claim Objections
Claims 58, 64 and 74 are objected to because of the following informalities:
Claim 58 recites the phrase “poly(ethylene glycol) tacrolimus (PEGTAC) PEGTAC”. It seems that the second PEGTAC is mistakenly kept. It is recommended to delete the second “PEGTAC”.
Claim 64 recites a list of components. However, it seems that the term “(3)” is mistakenly deleted. It is recommended to add the numbering “(3)” in front of “NAP”.
Claim 74 is objected to because of the following informalities: Applicant is advised that should claim 72 be found allowable, claim 74 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 46-47 and 49-66 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicant’s cancelation of claims 49-53, 56, 60 and 63, and amendment to claim 46 to delete the phrase “advanced manufactured”.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of claims 46, 47 and 65 under 35 U.S.C. 102 (a)(1) as being anticipated by Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) is withdrawn in light of Applicant’s amendment to claim 46 to recite new limitations of “3D-printing the transwell with a synthetic bioink as a single integrally formed unit”, which is not taught by Maoz.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 50-56 and 66 under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) is withdrawn in light of Applicant’s cancelation of claims 50-53 and 56, and amendment to claim 46 to recite new limitations of “3D-printing the transwell with a synthetic bioink as a single integrally formed unit”, which is not taught by Maoz.
The prior rejection of claim 49 under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Lu et al., (J Biomed Mater Res. 2006; 77A: 396-405) is withdrawn in light of Applicant’s cancelation of claim 49.
The prior rejection of claims 58, 59 and 64 under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Keilsohn et al., (US Patent No: 12,384,935, effectively filed on 07/15/2022 as provisional application 63/389,459) is withdrawn in light of Applicant’s amendment to claim 46 to recite new limitations of “3D-printing the transwell with a synthetic bioink as a single integrally formed unit”, which is not taught by Maoz.
The prior rejection of claim 60 under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Keilsohn et al., (US Patent No: 12,384,935, effectively filed on 07/15/2022 as provisional application 63/389,459), as applied to claims 58 and 46 above, and further in view of Shiwarski et al., (APL Bioeng. 2021; 5: 010904, p. 1-15) is withdrawn in light of Applicant’s cancelation of claim 60.
The prior rejection of claims 57 and 61-63 under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Keilsohn et al., (US Patent No: 12,384,935, effectively filed on 07/15/2022 as provisional application 63/389,459), as applied to claims 58 and 46 above, and further in view of Lutolf et al., (Nat Biotechnol. 2003;21(5):513-518) is withdrawn in light of Applicant’s cancelation of claim 63, and amendment to claim 46 to recite new limitations of “3D-printing the transwell with a synthetic bioink as a single integrally formed unit”, which is not taught by Maoz.
New 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.
Claims 46-47, 54-55 and 65-74 are rejected under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Kalsoom et al., (Anal. Chem. 2018, 90, 12081-12089).
With respect to independent claims 46, 71 and 73, it is noted that all the claims recite the new limitation “3D-printing the transwell … as a single integrally formed unit”. The instant specification recites “AM-Transwell Printing” in [0089] that “bioink was added to printer vat. Printer settings were loaded to digital light projection (DLP) printer and then printed. After printing, the 3D printed AM-transwells were offloaded into 1X PBS Ca+/Mg+” (specification, [0089], p. 16-17, and see Figs 4-5 for a 3D printed AM-transwell including a 3D printed outer wall and a 3D printed membrane). Therefore, based on the broadest reasonable interpretation in light of the specification (see MPEP 2111), this limitation is interpreted and examined as the transwell is 3D printed as a single integrally formed unit wherein (a) an outer wall and (b) a membrane directly coupled to the outer wall are simultaneously printed from one 3D printing process.
Maoz teaches an insert chip (i.e., a transwell. See e.g., Fig 1A in the front page) and teaches a method of making such a transwell (see [0058] and Fig 4), thus teaches the preamble a method of making a transwell in independent claims 46, 71 and 73.
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In regard to the transwell comprising (a) an outer wall and (b) a membrane directly coupled to the outer wall, Maoz teaches the insert chip (i.e., transwell) comprises a hollow scaffold body ([0074], Fig 1A (attached) element #10, i.e., an outer wall), and a membrane ([0074], Fig 1A element #2). Maoz teaches a support element 4 (e.g., a ring) is configured to be placed on a top surface of membrane and aid aligning the membranes into its location/position in the hollow scaffold ([0074]), indicating that the membrane is directly coupled to the outer wall (with a ring on the top surface but nothing between the bottom surface of the membrane and the hollow scaffold, thus being directly coupled). Maoz teaches there is a lower space between the well-plate (scaffold legs) and the membrane corresponding to the leg height (see e.g., Fig 9 the space pointed by 210A) and a upper space within the hollow scaffold above the membrane (see e.g., Fig 9 the space pointed by 204). Thus, Maoz teaches the membrane separates an inner volume defined by the outer wall (within the hollow scaffold from the upper surface to the legs) into a first chamber and a second chamber (i.e., the upper space between the upper surface of the scaffold to the membrane, and the lower space between the membrane to the legs of the scaffold).
In regard to the method, Maoz teaches “the advantageous insert chip platform disclosed here utilizes new fabrication tools (3D printing) to develop an easy-to-use, customizable, microfluidic chip that, can be inserted into any standard culture platform” ([0072]), and “the insert chip may be a 3D-printed insert chip” ([0087]), using a dental long-term (LT) clear resin (e.g., [00107]), thus teaches the method comprises 3D-printing the transwell with a synthetic bioink.
However, Maoz only exemplifies 3D printing the hollow scaffold (i.e., the outer wall) and assembling the scaffold with a polycarbonate (PC) membrane (see e.g., [00107]-[00110] and Fig 4), but does not provide a working example of 3D printing the transwell as a single integrally formed unit so that the outer wall and the membrane are simultaneously printed from one 3D printing process without assembling the outer wall and the membrane.
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Kalsoom teaches a method of making a low-cost sampling device with integrated porous membrane produced using multimaterial 3D printing (e.g., title). Kalsoom teaches the main circular housing structure of the sampler was printed with black PLA and Poro-Lay Lay-Felt porous filament was used for the simultaneous printing of the membrane (e.g., p. 12083, the bridging sentence between left column and right column, see figure attached). Kalsoom teaches as the membrane circumference is embedded in the structure of the sampler body (thus the membrane is directly coupled to the supporting structure), it does not require additional O-rings or other assembly parts, therefore providing very simple and quick assembly and teaches the samplers can be produced in-house, in customized formats, by researchers with access to low-cost printer (e.g., p. 12088, left col.).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of making a transwell by 3D printing the outer wall and assembling the outer wall with a membrane and a ring disclosed by Maoz, by substituting with simultaneously 3D printing the supporting structure and the membrane as a single integrally formed unit without the need of additional O-rings or assembling as suggested by Kalsoom with a reasonable expectation of success. Since Maoz teaches “the advantageous insert chip platform disclosed here utilizes new fabrication tools (3D printing) to develop an easy-to-use, customizable, microfluidic chip that, can be inserted into any standard culture platform” ([0072]), and since Kalsoom teaches the simultaneous printing does not require additional O-rings or other assembly parts, thus is very simple and quick, allowing the units be produced in-house, in customized formats, by researchers with access to low-cost printer (e.g., p. 12088, left col.), one of ordinary skill in the art would have had a reason to substitute with simultaneously 3D printing the outer wall and the membrane as a single integrally formed unit without the need of assembling as suggested by Kalsoom in order to take advantage of the simple and quick process for in-house producing the transwell in customized formats without the need of making O-rings or assembling the parts (in claims 46 and 71). One of ordinary skill in the art would have expected that without the need of the O-rings, the simultaneously 3D printed transwell of Maoz in view of Kalsoom would have had only two components, i.e., the outer wall and the membrane directedly coupled to the outer wall, thus the transwell would consist of the outer wall and the membrane in claim 73.
With respect to claim 47, as stated supra, Maoz teaches the 3D printing technique is a stereolithography (SLA) 3D printing technique (e.g., [00107]), and Kalsoom teaches a fused deposition modeling (MM-FDM) 3D printing (e.g., abstract), which is an extrusion 3D printing technique.
With respect to claims 54 and 55 directed to printing at least 3 and 20 transwells, Maoz teaches a plurality of insert chips (e.g., [0023]) that are placed in separate wells of cell culture containers such as 6, 12, and 24 well-plates (e.g., [0023], [0057] and Fig 3A). Accordingly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have printed at least 3, or 20 transwells as suggested by Maoz with a reasonable expectation of success. One of ordinary skill in the art would have had a reason to do so in order to apply the transwells in culturing a plurality of different cell types (e.g., [0006]) and in various high-throughput experiments (e.g., [0007]).
With respect to claim 65, Maoz teaches the hollow scaffold (the outer wall) has a cylindrical shape (see e.g., Fig 1A).
With respect to claim 66 directed to the dimensions of the outer wall, Maoz teaches the transwells are made in different sizes in order to be associated with commercially available cell culture plates (e.g., [0057], [0074]). Maoz teaches exemplary leg heights of the scaffold being 1mm, 2mm and 4mm in Fig 2A, in which one exemplary scaffold (the rightmost one, 50C) (i.e., the outer wall) has a height of about 10 mm to about 16 mm (comparing the scaffold to the scale bar of 2 mm) and a thickness from about 1 mm to about 3 mm (see the inlet and the outlet above the scaffold that have a diameter/thickness about the same as the scale bar of 2 mm).
Accordingly, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen the claimed height and thickness of the outer wall as suggested by Maoz with a reasonable expectation of success. Since Maoz suggests to make the transwells in different sizes in order to be associated with commercially available cell culture plates (e.g., [0057], [0074]) and reduces to practice the claimed height and thickness, one of ordinary skill in the art would have had a reason to choose the claimed height and thickness in order to associate the transwells with different cell culture containers.
With respect to claim 67 directed to the outer wall having a cubic shape, Maoz teaches the hollow scaffold body (i.e., the outer wall) may be fabricated in any desired shape and size to fit in a corresponding culture well (e.g., [0074]). Accordingly, one of ordinary skill in the art would have chosen the outer wall having a cubic shape as suggested by Maoz with a reasonable expectation of success. One of ordinary skill in the art would have had a reason to do so in order to make a transwell to fit in a corresponding culture well.
With respect to claim 68 directed to an edge of the outer wall comprising extensions that are legs of the transwell, Maoz teaches the outer wall of the transwell has one or more extensions being legs (see e.g., Fig 1A attached above, elements 8A and 8B).
With respect to claim 69 directed to an edge of the outer wall comprising recesses wherein portions of the outer wall between the recesses are legs of the transwell, Maoz teaches the outer wall of the transwell has one or more legs (see e.g., Fig 1A attached above, elements 8A and 8B). It is noted that the open spaces between the legs can be viewed as recesses, and thus, the portions of the outer wall between those open spaces are legs of the transwell.
With respect to claims 70, 72 and 74, Maoz teaches the transwell is seeded with cells (see Example 2 “Cell culture” and see Fig 9 for the membrane being seeded with cells on both sides), thus teaches the method further comprising seeding cells on at least one side of the membrane.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 06/08/2026 are acknowledged.
Applicant argues that Maoz's membrane and hollow scaffold are distinct elements, thus the combination of Maoz's membrane with Maoz's hollow scaffold are not "a single integrally formed unit” by 3D printing as recited in the amended claims and new claims (Remarks, p. 9-10 regarding 102 and 103 rejections).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior 102 and 103 rejections have been withdrawn. However, as necessitated by amendments, a new ground of rejection has been made over Maoz in view of Kalsoom as discussed above. Specifically, Kalsoom is cited to make obvious a method of simultaneously 3D printing a supporting structure (e.g., an outer wall) and a membrane as a single integrally formed unit without the need of additional O-rings or assembling (see above).
Applicant further argues that one of ordinary skill in the art would not have any reason or motivation to modify Maoz based on any references to arrive at amended claim 46 because such modification would result in changing the principle of operation of Maoz's insert chip and/or render Maoz's invention unsatisfactory for its intended purpose (Remarks, p. 11).
Applicant’s arguments have been fully considered but they are not persuasive.
As a first matter, as stated supra, Kalsoom is cited to make obvious a method of simultaneously 3D printing a supporting structure (e.g., an outer wall) and a membrane as a single integrally formed unit without the need of additional O-rings or assembling (see above). Since Maoz teaches “the advantageous insert chip platform disclosed here utilizes new fabrication tools (3D printing) to develop an easy-to-use, customizable, microfluidic chip that, can be inserted into any standard culture platform” ([0072]), and since Kalsoom teaches the simultaneous printing does not require additional O-rings or other assembly parts, thus is very simple and quick, allowing the units be produced in-house, in customized formats, by researchers with access to low-cost printer (e.g., p. 12088, left col.), one of ordinary skill in the art would have had a reason to substitute with simultaneously 3D printing the outer wall and the membrane as a single integrally formed unit without the need of assembling as suggested by Kalsoom in order to take advantage of the simple and quick process for in-house producing the transwell in customized formats without the need of making O-rings or assembling the parts.
In regard to the principle of operation of Maoz's insert chip and/or its intended purpose (Remarks, p. 11), Maoz teaches the insert chip is provided for culturing a plurality of different cell types (see e.g., Maoz, [0006] and see Fig 9 for culturing at least 3 types of cells on both sides of the membrane and on the bottom of culture well). Therefore, one of ordinary skill in the art would have immediately expected that the simultaneously 3D printed outer wall and membrane as a single integrally formed unit of insert chip (i.e., transwell) would be similarly capable of culturing a plurality of different cell types, as the assembled insert chip does. In other words, one of ordinary skill in the art would have immediately expected that the insert chip produced by the modified method of Maoz in view of Kalsoom would have had the same principle of operation and the same intended purpose as Maoz's insert chip.
Claims 58, 59 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Kalsoom et al., (Anal. Chem. 2018, 90, 12081-12089), as applied to claim 46 above, and further in view of Keilsohn et al., (US Patent No: 12,384,935, effectively filed on 07/15/2022 as provisional application 63/389,459. Prior art of record).
Claims 58, 59 and 64 are directed to the compositions of the synthetic bioink.
However, Maoz and Kalsoom are silent on the synthetic bioink comprising compositions recited in claims 58, 59 or 64.
Keilsohn, in provisional application 63/389,459 filed on 07/15/2022, teaches bioink compositions for production of biocompatible hydrogel articles having high resolution features (see e.g., [0001]). Keilsohn teaches the ink comprises a polyethylene glycol diacrylate (PEGDA) component, sulfonated quinoline yellow, a photoinitiator component, and water (e.g., [0004], related to claims 58 and 59), and further comprises an acrylate component (e.g., [0017]) and one or more UV-absorbers/light stabilizers (e.g., [0028]). Keilsohn teaches the PEGDA component has an average molecular weight of 0.1 kDa to 20 kDa ([0014] and Table 1, encompassing claimed PEGDA 3400, PEGDA 6000, PEGDA 575 and PEGDA 700), and is present in an amount of 1-20% or 5-20% ([0015]), related to claim 58 and claim 64 (2). Keilsohn teaches the acrylate component is in addition to the PEGDA component, including hydroxypropylacrylate (HPA) being present in an amount of 1-40 wt.% ([0017]-[0018]), related to claim 58 and claim 64 (1). Keilsohn teaches photoinitiators such as anthraquinone ([0022], it is noted that anthraquinone is a similar quinone compound as the claimed NAP naphthoquinone, thus they are art-recognized obvious equivalents to each other. See MPEP 2144.06) being present in an amount of 0.1% to 5%, related to claim 58 and claim 64 (3). Keilsohn teaches UV-absorbers/light stabilizers including UV386 in an amount of 0.1-2% ([0028]), related to claim 58 and claim 64 (4).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the synthetic bioink of Maoz in view of Kalsoom with the ink comprising the claimed components in the claimed amounts as taught by Keilsohn with a reasonable expectation of success. Since Keilsohn reduces to practice the claimed synthetic bioink comprising the claimed components in the claimed amounts (see above and Table II), and teaches the ink compositions can be used to print biocompatible hydrogel articles having high resolution features ([0001]), one of ordinary skill in the art would have had a reason to substitute with the synthetic bioink taught by Keilsohn in the method of Maoz in view of Kalsoom in order to make a biocompatible transwell having high resolution features.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 06/08/2026 are acknowledged and have been discussed above.
Claims 57 and 61-62 are rejected under 35 U.S.C. 103 as being unpatentable over Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024) in view of Kalsoom et al., (Anal. Chem. 2018, 90, 12081-12089) and Keilsohn et al., (US Patent No: 12,384,935, effectively filed on 07/15/2022 as provisional application 63/389,459. Prior art of record), as applied to claims 58 and 46 above, and further in view of Lutolf et al., (Nat Biotechnol. 2003;21(5):513-518. Prior art of record).
Claims 57 and 61-62 are directed to the bioink comprising a degradable peptide, a mono-cysteine peptide comprising RGDS and a dicysteine peptide.
However, Maoz, Kalsoom and Keilsohn are silent on the synthetic bioink comprising a degradable peptide in claim 57, nor teach the bioink further comprising mono-cysteine peptide comprising RGDS and dicysteine peptide in claims 61 and 62.
Lutolf teaches engineering synthetic poly(ethylene glycol) (PEG)–based hydrogels (comprising the base material PEG taught in Keilsohn) as cell-ingrowth matrices (e.g., abstract). Lutolf teaches the PEG-based hydrogel contains a combination of pendant oligopeptide ligands for cell adhesion (C-RGDSP, i.e., a mono-cysteine peptide comprising RGDS, related to claim 61 and claim 62) and substrates for matrix metalloproteinase (MMP) as linkers between PEG chains (Ac-GCRD-GPQGIWGQ-DRCG-NH2, see p. 517, left col, para 1 and Fig 1, i.e., a degradable peptide and a dicysteine peptide, related to claim 57 and claim 61). Lutolf teaches 10 μl of 1 mM RGD is added to 20 μl triethanolamine buffer and 10 μl dicysteine peptide (i.e., about 0.25 mM RGD) (p. 517, para 1). Lutolf teaches cells are shown to migrate within the matrices by integrin- and MMP-dependent mechanisms, and thus demonstrates cell-mediated proteolytic invasiveness of the gels (e.g., abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the synthetic bioink suggested by Maoz in view of Kalsoom and Keilsohn, by combining a mono-cysteine peptide comprising RGDS and a degradable dicysteine peptide as taught by Lutolf with a reasonable expectation of success. Since Maoz aims to use the transwell to study cell-cell interactions (e.g., [0007]), such as co-culturing three different cell types/populations on both sides of the membrane and on the bottom of the well (shown in Fig 9 and [0063]), and since Lutolf teaches a combination of a mono-cysteine peptide for cell adhesion (C-RGDSP) and a MMP-degradable dicysteine peptide enables cells to migrate within the matrices by integrin- and MMP-dependent mechanisms, and demonstrates cell-mediated proteolytic invasiveness (e.g., abstract), one of ordinary skill in the art would have had a reason to combine a mono-cysteine peptide comprising RGDS and a MMP-degradable dicysteine peptide as suggested by Lutolf in the bioink of Maoz in view of Kalsoom and Keilsohn in order to enhance cell adhesion and to enable cell-mediated proteolytic migration to study cell-cell interactions.
Furthermore, regarding the differences in concentration from Lutolf (about 0.25 mM RGD) and the instant invention (from 0.5 mM to 20 mM of mono- and di-cysteine peptides), MPEP states “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” and “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. See MPEP 2144.05(II)(A). In the instant case, Lutolf teaches a mono- and a di-cysteine peptides are added to the hydrogel (i.e., bioink) to enable cell migration via integrin- and MMP-dependent mechanisms (thus being a results effective variable), and exemplifies an amount of about 0.25 mM RGD. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the claimed working concentrations because they are the results of “routine optimization”.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 06/08/2026 are acknowledged and have been discussed above.
Withdrawn Provisional Double Patenting Rejections
The prior provisional rejection of claims 46-47 and 49-66 on the ground of nonstatutory double patenting as being unpatentable over copending claims 1-3 and 22 of copending Application No. 18/226,635 in view of Maoz et al., (WO 2022/097150, published 05/12/2022, cited in IDS 01/16/2024), Lu et al., (J Biomed Mater Res. 2006; 77A: 396-405), Shiwarski et al., (APL Bioeng. 2021; 5: 010904, p. 1-15) and Lutolf et al., (Nat Biotechnol. 2003;21(5):513-518) is withdrawn in light of Applicant’s cancelation of claims 49-53, 56, 60 and 63, and amendment to claim 46 to recite new limitation of “3D-printing the transwell with a synthetic bioink as a single integrally formed unit”, as the copending application recites a method of making an assembled interpenetrating polymer network, but not a single integrally formed transwell.
Response to Traversal:
Applicant’s arguments filed on 06/08/2026 are acknowledged.
Applicant argues the revised claim set obviates the rejection (Remarks, p. 11).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior provisional nonstatutory double patenting rejection has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
No claims are allowed.
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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