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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2026 has been entered.
Status of the Claims
Claims 22-25, 27-31, 35-26 and 38 are currently pending.
Claims 22-25, 27- 31, 35-36, and 38 are amended.
Claims 22-25, 27- 31, 35-36, and 38 have been considered on the merits.
Withdrawn Rejections
The objections made onto claim 29 is withdrawn in light of the amendments submitted on 04/02/2026
The 112(b) rejections made onto claims 22, 24, 25, 27, 30-31, 34-35, and 32 are withdrawn in light of the amendments submitted on 04/02/2026.
The 112(a) rejections made onto the claims is withdrawn in light of the amendments submitted on 04/02/2026.
The 35 U.S.C. 103 rejections made onto the claims are withdrawn in light of the amendments made on 04/02/2026.
New and Maintained Rejections Necessitated by Amendment
Claim Interpretation
Claim 22 is directed to a bioassembly device “for use with a bioprinter and a scaffold” which is an intended use limitation. It is only the product, a bioassembly device, which carries patentable weight because the claims are directed to a product and not a method of use (See MPEP 2111.02 II). The claim makes many references to the potential methods of use of the bioassembly device which do not carry patentable weight. Only the limitations regarding the bioassembly device carry patentable weight.
Claim 23 contains the wherein clause “wherein said top portion and said bottom portion has a configuration that secures said bioprinted scaffold while said bioprinted scaffold is transferred to a bioreactor” in lines 1-2. The phrase “while said bioprinted scaffold is transferred to a bioreactor” is an intended use of the bioassembly device and does not carry patentable weight. Additionally, for clarity the phrase “has a configuration that secures” imparts no tangible limitation on the claim besides the need for the ability (in any feasible way) to secure the scaffold between the top and bottom portion of the bioassembly device.
Claim 25 contains the wherein clause “wherein said top portion and said bottom portion have a configuration that secures said bioprinted scaffold in said bioreactor after said scaffold is transferred to a bioreactor, wherein said transferred scaffold is a tissue engineered construct”. The phrase “have a configuration that secures said bioprinted scaffold in said bioreactor after said scaffold is transferred to a bioreactor, wherein said transferred scaffold is a tissue engineered construct” is an intended use of the bioassembly device and does not carry patentable weight. Additionally, for clarity the phrase “have a configuration that secures” imparts no tangible limitation on the claim besides the need for the ability (in any feasible way) to secure the scaffold between the top and bottom portion of the bioassembly device.
Claim 30 contains the wherein clause “wherein said top portion and said bottom portion have a configuration that secures said scaffold there between while cells are deposited onto said first side of said scaffold or both said first side and a second side of said scaffold during said bioprinting”. The phrase “have a configuration that secures said scaffold there between while cells are deposited onto said first side of said scaffold or both said first side and a second side of said scaffold during said bioprinting” is an intended use of the bioassembly device and does not carry patentable weight. Additionally, for clarity the phrase “have a configuration that secures” imparts no tangible limitation on the claim besides the need for the ability (in any feasible way) to secure the scaffold between the top and bottom portion of the bioassembly device.
Claim 31 contains the wherein clause “wherein said top portion and said bottom portion have a configuration that secures said scaffold there between while said cells are encapsulated in a gel during bioprinting”. The phrase “have a configuration that secures said scaffold there between while said cells are encapsulated in a gel during bioprinting” is an intended use of the bioassembly device and does not carry patentable weight. Additionally, for clarity the phrase “have a configuration that secures” imparts no tangible limitation on the claim besides the need for the ability (in any feasible way) to secure the scaffold between the top and bottom portion of the bioassembly device.
Claim 35 contains the wherein clause “wherein said top portion and bottom has a configuration that they secure in place at a designated location in said bioreactor”. The phrase “has a configuration that they secure in place at a designated location in said bioreactor” is an intended use of the bioassembly device and does not carry patentable weight. Additionally, for clarity the phrase “has a configuration that they secure” imparts no tangible limitation on the claim besides the need for the ability (in any feasible way) to secure the scaffold between the top and bottom portion of the bioassembly device.
Claim 36 contains the wherein clause “wherein: said securing said scaffold while in said bioreactor includes securing said scaffold in a taut position while in said bioreactor”. The phrases “while in said bioprinter”, “for said bioprinting” are an intended use of the bioassembly device and does not carry patentable weight. The claim is being interpreted to impart the limitation that the scaffold is in a taut position.
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.
Claims 22-25, 27- 31, 35-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bharti et al (WO2018089515A1, Published 05/17/2018), in view of Yan et al (3D bioprinting of skin tissue: From pre-processing to final product evaluation, July, 2018).
With regards to claim 22, Bharti teaches a bioassembly device for use with a bioprinter comprising a top portion (see Fig. 1) and a bottom portion (See Fig. 2 and Fig. 3A) which have a configuration that secures a scaffold between the top and bottom portion in a taut position while a bioprinter performs bioprinting onto a first side of said scaffold (See Fig. 3B). Additionally, Bharti teaches that the bioassembly device is used to perform bioprinting on a first side of the scaffold (pg. 3, para 3), and subsequently is bioprinted on a second side of the scaffold (pg. 3, para 5). Bharti teaches that that the top and bottom portions have a configuration that secures said scaffold along all the edges of the scaffold in the taut position (pg. 54, para 3) without the need of repositioning said scaffold on the said bioassembly device while said bioprinter performs bioprinting one a first side of said scaffold (See image of bioprinting of Fig. 3B) or both the first and second side of the scaffold (pg. 3, para 3 and 5). Bharti demonstrates that the top and bottom portion of the bioassembly device is a frame that has a configuration that secures said scaffold (See top portion: Fig. 1 and Fig. 3A/B; See bottom portion: Fig. 3A-G). Bharti teaches that in some embodiments a kit is provided which may include all the necessary reagents for the system and including the three-dimensional engineered ocular tissue model itself which contains the claimed scaffold (pg. 49, last para spanning pg. 50 para 4).
Bharti does not describe the top portion as having a first and second upper end support in those exact terms, however Bharti does demonstrate that there is a support around the perimeter of the top portion which is also a removable top section (See Fig. 1 B-H). Bharti does not describe the bottom portion as comprising a first and second end support in those exact terms, however Bharti does demonstrate that there is a support as part of the bottom portion which extends to either side of the center part of the bottom portion which connects with the top portion (See Fig. 3D-E) and explicitly states that “The holder is inserted into the collar of the insert body and against the scaffold to retain the printing scaffold securely against the frame to restrain it against movement during bioprinting as cellular layers are carefully positioned in three-dimensional space on the surface of the substrate” (pg. 55, last para). This also demonstrates that Bharti teaches securing the bioassembly device on a designated area for bioprinting, as required by the claim limitation “wherein said top portion of said bioassembly device and said bottom portion of said bioassembly device have a configuration that they secure in place on said bioprinter at a designated location on said bioprinter with a recess, wherein said recess is disposed on each of: said first upper end support and said second upper end support of said top portion and said first lower end support and said second lower end support of said bottom portion”. Turning to the instant specification, the “end supports” are not explicitly defined. The “end supports”, both upper and lower, are depicted in the instant Fig. 9A as items 16, 17, 20, and 21, labelled “End Supports for Fixation to Bioreactor”. It appears that the end supports contain snap closures in the form of a cylindrical “stud” and “socket” which snap together; and when the pieces are snapped together, a hole or recess is left on each side, presumably for fixation to the bioreactor (see Fig. 8D).
Bharti meets the limitations of the end supports because Bharti teaches a device which contains a top and bottom portion. Bharti does demonstrate that there is a support around the perimeter of the top portion which is also a removable top section (See Fig. 1 B-H). Bharti does demonstrate that there is a support as part of the bottom portion which extends to either side of the center part of the bottom portion which connects with the top portion (See Fig. 3D-E) and explicitly states that “The holder is inserted into the collar of the insert body and against the scaffold to retain the printing scaffold securely against the frame to restrain it against movement during bioprinting as cellular layers are carefully positioned in three-dimensional space on the surface of the substrate” (pg. 55, last para). It appears that the device of Bharti renders obvious all aspects of the “end supports” and the MPEP states in reference to changes in shape that “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.)”. Therefore, one or ordinary skill in the art would have found obvious to adjust the shape of the design taught by Bharti for attachment with or to any machinery already in use for cell culture and related activities in the prior art.
Regarding claim 23, Bharti teaches that the top portion and said bottom portion has a configuration that secures said bioprinter scaffold while said bioprinted scaffold is transferred to a bioreactor (See Fig. 3B).
Regarding claim 24, Bharti teaches that the top and bottom portion slid together and are pressed firmly together to connect the bioassembly top and bottom portion which meets the limitations of a “slidably connected with one another or snap-fit connected with one another” ( pg. 57 last para spanning pg. 58 and Fig. 3H).
Regarding claim 25, Bharti teaches the bioassembly device wherein the top portion and the bottom portion have a configuration that secures the bioprinted scaffold in a culture environment after the scaffold is transferred to the culture environment (See Fig. 3A-B and pg. 4 Description of Fig. 1A-H). The limitation of “after the scaffold is transferred to the bioreactor” is being interpreted to be an intended use of the bioassembly device met by any device of the art which has a top and bottom portion having a configuration that secures the bioprinted scaffold for further culturing. Additionally, Bharti teaches that the transferred scaffold is a engineered tissue construct (pg. 2, para 1/ pg. 4 Description of Fig. 1A-H).
Regarding claim 27, Bharti teaches that the scaffold which is a tissue engineered construct (pg. 2, para 1/pg. 4 Description of Fig. 1A-H) which is described as an implantable tissue engineered construct (pg. 49, para 4), a three-dimensional structure tissue engineered construct (abstract), an engineered organ construct (pg. 34, para 3), an engineered spherical tissue construct which reads on an organoid (pg. 33, para 3), a sheet like construct (pg. 14, para 2), a tissue engineered construct with varying geometrical shapes such as rectangular, square, oval, ellipsoid, circular, trapezoidal, spherical, cuboidal, ect. (pg. 33, para 3), a tissue engineered construct with distinct consistency on a first side relative to a second side of the tissue engineered construct which is met by Bharti because Example 1 details a design structure with fibroblasts on one side of the construct and RPE cells seeded on the other side of the scaffold as a monolayer (pg. 60, para 3).
Regarding claims 28-29, Bharti does not explicitly teach that the kit provides a scaffold in a folded configuration construct, however, Bharti does teach the scaffold itself in detail at pg. 18 para 2 spanning pg. 22 para 2. The MPEP teaches that changes in shape (i.e. folding) are “a matter of choice which a person of ordinary skill in the art would have found obvious” (MPEP 2144.04 IV, B). Similarly, Bharti does not explicitly teach that the kit provides two or more scaffolds that are stacked however, Bharti does teach the scaffold itself in detail at pg. 18 para 2 spanning pg. 22 para 2. The MPEP teaches that “duplication of parts has no patentable significance unless a new and unexpected result is produced” (MPEP 2144.04 VI, B).
Regarding claim 30, Bharti teaches that the top and bottom portion have a configuration that secures said scaffold there between while cells are deposited onto said first side of said scaffold or both said first side and a second side of said scaffold during said bioprinting (See Fig. 3B and Example 1, pg. 60, para 3).
Regarding claim 31, Bharti teaches that the top and bottom portion have a configuration that secures said scaffold therebetween while said cells are encapsulated in a gel during bioprinting (See Example 1 pg. 60 para 4-5).
Regarding claim 35, Bharti teaches that the device has a top and bottom portion which has a configuration that they secure in place at a designated location in a culture apparatus (Fig. 3A). Bharti does not explicitly teach a recess disposed on each of the first and second upper and lower end supports of the top and bottom portions, however Bharti explicitly states that “The holder is inserted into the collar of the insert body and against the scaffold to retain the printing scaffold securely against the frame to restrain it against movement during bioprinting as cellular layers are carefully positioned in three-dimensional space on the surface of the substrate” (pg. 55, last para). Further, Bharti demonstrates that the bottom portion is secured into a culture apparatus in the form of a well for further culture after the bioprinting (Fig. 3A and pg. 5, para 2). This also demonstrates that Bharti teaches securing the bioassembly device on a designated area for bioprinting and for further culturing, as required by the claim limitation “wherein said top portion and said bottom portion has a configuration that they secure in place at a designated location in said bioprinter with a recess after said bioprinted scaffold has been transferred to said bioreactor, wherein said recess is disposed on each of: said first upper end support and said second upper end support of said top portion and said first lower end support and said second lower end support of said bottom portion”. The limitation of “after the scaffold is transferred to the bioreactor” is being interpreted to be an intended use of the bioassembly device met by any device of the art which has a top and bottom portion having a configuration that secures the bioprinted scaffold for further culturing. The “end supports”, both upper and lower, are depicted in the instant Fig. 9A as items 16, 17, 20, and 21, labelled “End Supports for Fixation to Bioreactor”. It appears that the end supports contain snap closures in the form of a cylindrical “stud” and “socket” which snap together; and when the pieces are snapped together, a hole or recess is left on each side, presumably for fixation to the bioreactor (see Fig. 8D). ]). It appears that the device of Bharti renders obvious all aspects of the “recess” and the MPEP states in reference to changes in shape that “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.)”. Therefore, one or ordinary skill in the art would have found obvious to adjust the shape of the design taught by Bharti for attachment with or to any machinery already in use for cell culture and related activities in the prior art.
Regarding claim 36, Bharti teaches securing said scaffold while in culture after having been bioprinted in a taut position (See Fig. 3B). Bharti meets the limitations of the intended use of the claimed bioassembly device for placement in a bioreactor because Bharti demonstrates additional culturing of the device in a taut position after having been bioprinted on and the device itself is not changed in any appreciable way by moving the bioassembly device from a bioprinter to a bioreactor/ further culture.
Bharti does not explicitly teach that the scaffold prior to bioprinting is included in a kit including the bioassembly device as required by claim 22. Bharti does not teach that the bioassembly device is provided in a kit that includes a bioprinter as required by claim 22. Bharti does not teach that the kit includes a bioreactor as required by claim 38.
However, Yan teaches about 3D bioprinting of human skin tissue including a bioassembly device which contains a top and bottom plate that is used in the bioprinting process (abstract and Fig. 2). Additionally, a bioreactor can be seen in fig. 2 which integrates with the scaffold holder, the scaffold, and the bioprinting process (Fig. 2). Therefore, the integrated system of Yan would lead one of ordinary skill in the art to create a kit containing the system which is comprised by a scaffold holder, bioprinter, and bioreactor as required by claims 22 and 38.
One of ordinary skill in the art prior to the effective filling date of the instant application would find it obvious to combine the bioprinting scaffold holder and scaffold taught by Bharti with the holder, bioprinter, and bioreactor components taught by Yan to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Yan teaches the “printing of skin faces challenges broadly associated with general 3D bioprinting, including the selection of cell types and biomaterials, and additionally requires in vitro culture formats that allow for growth at an air-liquid interface” (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Bharti with Yan because Bharti teaches a scaffold holder, bioprinter, and scaffold and Yan teaches a bioprinter system with a bioreactor, integrated scaffold holder, and scaffold as a complete system.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments, see Remarks, pg. 13-28, filed 04/02/2026, with respect to the rejection(s) of the claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bharti et al (WO2018089515A1).
Conclusion
No claims are allowed.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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