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
Status of Claims
Claims 1-14 are pending. Claims 10-14 have been withdrawn as drawn to non-elected inventions. Claims 1-9 have been examined.
Election/Restriction
Applicant’s election of Group I, claims 1-9, in the reply filed on 11/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application, Serial No. 18/027,202 (PGPub: US2023/0357684) was filed 03/20/2023. This application is a 371 of PCT/US2021/051064 filed 09/20/2021 which claims benefit of 63/080,320 filed 09/18/2020.
Information Disclosure Statements
The Information Disclosure Statement filed 03/20/2023 has been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “impeller-based pump” and it is unclear if the structure of the pump actually includes an impeller, has structure similar to an impeller or has different structure than an impeller but functions similarly.
Claim 8 recites “the pump module” and there is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-2 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (US2017/0227525, Pub Date: 08/10/2017) in view of Varma et al. (US 2017/0065976, Pub Date: 03/09/2017).
Regarding claim 1, Griffith teaches throughout the publication a system to model inter-organ communication (abstract) comprising: one or more micro-culture well configured to receive a tissue sample therein (see Figure 3A and paragraphs 0012 and 0091); and a pump in fluid communication with the one or more micro-culture well and configured to generate fluid flow through the one or more micro-culture well (paragraph 0227). While Griffith teaches a variety of pumps that can be utilized for fluid flow, the reference fails to teach that the pump is an impeller-based pump.
Varma teaches cell-culture platforms (paragraph 0008) and more specifically teaches that for flow modulation, an impeller pump can be used (paragraph 0062).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate as the pump in the system of Griffith, an impeller pump as taught by Varma because Griffith is generic regarding the type of pump that can be used to manipulate the fluids and one skilled in the art would have been motivated to choose the appropriate pump based on the desired fluidic control.
Regarding claim 2, Griffith teaches the system wherein the one or more micro-culture well is configured to perfuse the fluid transversely with respect to the tissue sample (paragraphs 0160 and 0243).
Regarding claim 8, Griffith teaches the system wherein each of the one or more micro-culture well is contained within a sample container having a sample container inlet and a sample container outlet; wherein the impeller-based pump comprises a pump inlet and a pump outlet; and wherein each sample container and the pump module are arranged to form a single closed fluid circuit in which fluid is flowed into each respective one of the sample container inlet and the pump inlet and out of each respective one of the sample container outlet and the pump outlet (see Figure 1 and paragraph 0026).
Regarding claim 9, Griffith in view of Varma teaches the system comprising one or more fluid conduit elements arranged to provide fluid connections among and between the impeller-based pump and the one or more sample container (Griffith, see Figure 5 and paragraph 0031; Varma, paragraph 0062, impeller pump).
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (US2017/0227525, Pub Date: 08/10/2017) in view of Varma et al. (US 2017/0065976, Pub Date: 03/09/2017), as applied to claim 1 above (hereinafter “Modified Griffith”), and further in view of Warren et al. (US 2014/0273209 Pub Date: 09/18/2014).
Regarding claim 3 and 5, Modified Griffith teaches the system as described above but fails to teach a mesh base positioned within each of the one or more micro-culture well and configured to structurally support the tissue sample thereon as well as a membrane positioned between the tissue and mesh.
Warren teaches throughout the publication an integrated artificial immune system with in vitro cellular and tissue constructs (abstract). More specifically, Warren teaches that the culture can be grown on a bovine collagen membrane supported by a nylon mesh (paragraph 0217) to provide mechanical strength to synthetically formulated biological membranes (paragraph 0223).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the culture wells of Modified Griffith, a mesh base supporting a membrane as taught by Warren because it would have been desirable to provide mechanical strength during culture which allows for more functional in-vitro modeling (Warren, paragraphs 0018 and 0223).
Regarding claim 4, Modified Griffith in view of Warren teach the system wherein the mesh base comprises one or more vertical posts that extend out of the one or more micro-culture well and are configured to aid in insertion and removal of the mesh base with respect to the one or more micro-culture well (Warren, paragraph 0322, insert supports comprising laminates, crimped rings, adhesives and see Figure 19).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (US2017/0227525, Pub Date: 08/10/2017) in view of Varma et al. (US 2017/0065976, Pub Date: 03/09/2017), as applied to claim 1 above (hereinafter “Modified Griffith”), and further in view of Jaques et al. (US 2017/0349874, Pub Date: 12/07/2017).
Regarding claims 6-7, Modified Griffith teaches the system as described above but fails to teach the system wherein the impeller-based pump comprises: an impeller positioned within a substantially circular chamber; and a magnetic element coupled with the impeller; wherein the impeller is rotatable within the substantially circular chamber upon application of a magnetic field to the magnetic element to generate fluid flow within the system and further comprising a magnetic field generator spaced apart from the impeller-based pump, the magnetic field generator being configured to apply a rotating magnetic field to the magnetic element.
Jaques teaches throughout the publication single-use bioreactors for the cultivation of mammalian cells (paragraph 0021). More specifically, Jaques teaches that the impeller-based pump comprises: an impeller positioned within a substantially circular chamber (paragraph 0116, impeller shaft sleeve); and a magnetic element coupled with the impeller; wherein the impeller is rotatable within the substantially circular chamber upon application of a magnetic field to the magnetic element to generate fluid flow within the system and further comprising a magnetic field generator spaced apart from the impeller-based pump, the magnetic field generator being configured to apply a rotating magnetic field to the magnetic element (paragraphs 0062-0063 and 0157, rotatable shaft comprises a metallic rod and the top of the rod can include a magnetic member for magnetically engaging a motor that provides a rotational force to the impellers).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the system of Modified Griffith, a circular chamber surrounding the impeller and a magnetic element/magnetic field generator in communication with the impeller as taught by Jaques because it would have been desirable to allow greater control of the components of the system for desired fluid control.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677