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 .
Response to Arguments
In response to the amendments filed 11/10/2025, the rejection under 35 USC 112(b) have been withdrawn.
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Applicant argues that the movement of the molds in Li occurs through the movement of the stretching means 11 and therefore does not meet the claim which specifies the moving occurs without moving the base. Examiner disagrees, As cited in the rejection, the base is the ring 23 and cup 24 assembly. The stretching means 11 are the pegs and the mold is the substrate S. As can be seen in Figure 3, the stretching means 11 (pegs) stretch the mold (substrate S) outward without moving the ring 23 (base). Applicant further argues the same for claims 2-3, 6, 18, and 20. Examiner disagrees and notes the apertures are the holes in the centers of the ring 23 and cup 24. As states above, the ring and cup assembly is not being moved by adjusting the stretching means 11.
With respect to the rejection of claim 1 in view of McCoy and Li, Applicant similarly argues that McCoy does not describe the required stretching without moving the base and that Li also does not describe this limitation. Applicant also presents similar arguments regarding claim 16 and the Endoh reference. Examiner notes that the rejection recognizes that McCoy does not meet this limitation, however, as noted above, Li does describe stretching without moving the base.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-7, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 2019/0390152).
Regarding claim 1, Li meets the claimed, A method of moving a mold, said method comprising: clamping the mold between a first base (Li [0093] describes a cell substrate S or mold being attached to the ring 23) a second base of a clamp assembly (Li [0093] describes the hoop 24) wherein each of the first base and the second base comprises at least one aperture interfaced with the mold, (Li [0093] describes a ring 23 having a space in the middle where the substrate S is located) wherein the clamp assembly is operational to stretch and compress the clamped mold without movement of the first base and the second base; (Li [0103] and Figure 3 show the substrate S can be stretched by the clip members 12 without moving the ring 23 or hoop 24) and the at least one aperture interfaced with mold (Li Figure 3 shows the substrate S is interfaced with the aperture) moving the clamped mold, wherein the moving comprises adjustment of the peg, (Li [0094]-[0095] describe stretching means 11, see the stretching means 11 located in the hole of the ring 23 on Figure 3) and wherein the moving occurs without moving the first base, the second base and the at least one aperture interfaced with the mold (Li Figure 3 shows the substrate S being moved without moving the ring 23 or hoop 24, note only the stretching means 11 are moving.)
Regarding claim 2, Li meets the claimed, The method of claim 1, wherein the moving comprises stretching the clamped mold without biaxial movement of the first base, the second base, and the at least one aperture interfaced with the mold (Li [0103] and Figure 3 show the substrate S can be stretched by the clip members 12 without moving the ring 23 or hoop 24).
Regarding claim 3, Li meets the claimed, The method of claim 1, wherein the moving comprises compressing the clamped mold without biaxial movement of the first base the second base, and the at least one aperture interfaced with the mold (Li [0103] and Figure 3 show the substrate S can be stretched by the clip members 12 without moving the ring 23 or hoop 24 or the stretch can be reduced.)
Regarding claim 4, Li meets the claimed, The method of claim 1, wherein the moving comprises uniaxial movement of the clamped mold (Li Figure 3 shows uniaxial stretching in the radial direction.)
Regarding claim 6, Li meets the claimed, wherein each of the first base and the second base comprises a plurality of apertures interfaced with the mold, (Li [0093] describes a ring 23 and a hoop 24 each having a space in the middle where the substrate S is located) wherein each of the plurality of apertures comprises at least one peg associated with the mold, and wherein the moving comprises adjustment of the pegs (Li [0094]-[0095] describe stretching means 11, see the stretching means 11 located in the hole of the ring 23 on Figure 3) wherein the moving occurs without moving the first base, the second base, and the at least one aperture interfaced with the mold (Li Figure 3 shows the substrate S being moved without moving the ring 23 or hoop 24, note only the stretching means 11 are moving.)
Regarding claim 7, Li meets the claimed, The method of claim 6, wherein the moving comprises differential adjustment of the pegs to provide different degrees of stretching, compressing, or combinations thereof (Li [0101] describes how the stretching means 11 can be adjusted via turning a knob to make them tighter or more relaxed.)
Regarding claim 16, Li meets the claimed, A clamp assembly comprising: a first base and a second base; wherein each of the first base and the second base comprises at least one aperture, (Li [0093] describes a ring 23 and a hoop 24 each having a space in the middle where the substrate S is located) wherein the at least one aperture comprises at least one peg (Li [0094]-[0095] describe stretching means 11, see the stretching means 11 located in the hole of the ring 23 on Figure 3) and, and a mold, (Li [0093] describes a cell substrate S or mold being attached to the ring 23 and hoop 24) wherein the mold is operational to be clamped between the first base and the second base of the clamp assembly, interface with the at least one aperture, and associate with the at least one peg, and wherein the clamp assembly is operational to stretch and compress the clamped mold through adjustment of the peg, and without movement of the first base , the second base, and the at least one aperture (Li [0103] and Figure 3 show the substrate S can be stretched by the clip members 12 without moving the ring 23 or hoop 24).
Regarding claim 17, Li meets the claimed, The clamp assembly of claim 16, wherein the at least one peg is operational for stretching and compressing the mold through adjustment of the peg (Li [0094]-[0095] describe stretching means 11, see the stretching means 11 located in the hole of the ring 23 on Figure 3.)
Regarding claim 18, Li meets the claimed, The clamp assembly of claim 16, wherein each of the first base and the second base comprises a plurality of apertures interfaced with the mold, (Li [0093] describes a ring 23 and a hoop 24 each having a space in the middle where the substrate S is located) wherein each of the plurality of apertures comprises at least one peg associated with the mold, and wherein the pegs are operational for stretching and compressing the mold through adjustment of the pegs and without movement of the plurality of apertures (Li [0094]-[0095] describe stretching means 11, see the stretching means 11 located in the hole of the ring 23 on Figure 3.)
Regarding claim 19, Li meets the claimed, The clamp assembly of claim 18, wherein the pegs are operational for providing different degrees of stretching and compressing through the differential adjustment of the pegs (Li [0101] describes how the stretching means 11 can be adjusted via turning a knob to make them tighter or more relaxed.)
Regarding claim 20, Li meets the claimed, The clamp assembly of claim 16, wherein the clamp assembly is operational to stretch and compress the clamped mold without biaxial movement of the first base and the second base (Li [0103] and Figure 3 show the substrate S can be stretched and released by the clip members 12 without moving the ring 23 or hoop 24.)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over McCoy (“Collagen Fiber Orientation Regulates 3D Vascular Network Formation and Alignment” see NPL copy provided with the IDS filed 11/3/2023) modified by Li (US 2019/0390152.)
Regarding claim 1, McCoy meets the claimed, A method of moving a mold, said method comprising: clamping the mold between a first base and a second base of a clamp assembly (McCoy Figure 1 shows the microwell mold is clamped between the base areas).
McCoy moves the base portions and does not meet the claimed, wherein the clamp assembly is operational to stretch and compress the clamped mold without movement of the first base and the second base and moving the clamped mold, wherein the moving occurs without moving the first base and the second base of the mold.
Analogous in the field of cell or tissue culture stretching, Li also describes a stretching apparatus and meets the claimed, wherein the clamp assembly is operational to stretch and compress the clamped mold without movement of the first base and the second base; (Li [0103] and Figure 3 show the substrate S can be stretched by the clip members 12 without moving the ring 23 or hoop 24) and moving the clamped mold, wherein the moving occurs without moving the first base and the second base of the mold (Li Figure 3 shows the substrate S being moved without moving the ring 23 or hoop 24.)
It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the clamp of McCoy with the clamp of Li that does not move the ring or hoop portions when stretching in order to allow for adjustability of the mold to a maximum value, see Li [0023].
Regarding claim 8, McCoy meets the claimed, The method of claim 1, wherein the method comprises: stretching the clamped mold; placing a precursor solution on the clamped and stretched mold; curing the precursor solution on the clamped and stretched mold; and compressing the clamped mold after the curing (Mccoy page 2968 Section 2 describes placing a cell solution on a strained microwell mold, forming the hydrogel, and relaxing the microwell mold.)
Regarding claim 9, McCoy further meets the claimed, The method of claim 8, wherein the curing comprises incubating the precursor solution with the clamped and stretched mold (McCoy page 2968 section 2 describes incubation at 4°C.)
Regarding claim 10, McCoy meets the claimed, The method of claim 8, wherein the incubating occurs at a temperature below room temperature (McCoy page 2968 section 2 describes incubation at 4°C.)
Regarding claim 11, McCoy meets the claimed, The method of claim 8, wherein the incubating occurs at about 4°C (McCoy page 2968 section 2 describes incubation at 4°C.)
Regarding claim 12, McCoy meets the claimed, The method of claim 8, wherein the compressing comprises removing the clamped and stretched mold from the first base and the second base (Mccoy page 2968 Section 2 describes relaxing the microwell mold.)
Regarding claim 13, McCoy meets the claimed, The method of claim 8, wherein the precursor solution comprises an extracellular matrix precursor solution (McCoy page 2968 Section 2 describes a solution prepared.)
Regarding claim 14, McCoy meets the claimed, The method of claim 8, wherein the precursor solution further comprises cells (McCoy page 2968 describes cells are added to the solution.)
Regarding claim 15, McCoy meets the claimed, The method of claim 8, wherein the method is used to form aligned extracellular matrix fibers on the mold (Mccoy page 2968 describes forming cell solutions with particular alignments, see “Collagen Alignment Analysis”.)
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Li modified by Endoh (US 2018/0257270.)
Regarding claim 21, Li does not describe the mold substrate being made of hydrogel and does not meet the claimed, The clamp assembly of claim 16, wherein the mold comprises a hydrogel.
Analogous in the field of molds, Endoh meets the claimed, The clamp assembly of claim 16, wherein the mold comprises a hydrogel (Endoh [0007] describes a mold made of a hydrogel or sol-gel material.)
It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the material of the mold as described in Li with the hydrogel material disclosed in Endoh in order to avoid having to apply a mechanical load to remove, see Endoh [0007].
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 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.
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744