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 .
Restriction/Election
Applicant’s election without traverse of Group I (Claims 1-17) in the reply filed on February 26,2026 is acknowledged. Claims 18-20 (Group II) were subsequently canceled in the claim amendments dated February 26, 2026. Election was made without traverse in the reply filed on February 26, 2026.
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 10-11 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 10 recites “wherein the circuitry is configured to compute a respiratory quotient from the carbon dioxide data and the oxygen data.” There is no reference to either a carbon dioxide data and/or an oxygen data in the claims from which claim 10 depends from; there is insufficient antecedent basis for this limitation in claim 10. Dependent claim 11 fails to provide additional clarification.
Claim Rejections - 35 USC § 102
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 1-2,5-9, and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tempelman (US 20120178150).
Tempelman discloses a perfusate source, a perfusate distributor coupled to the perfusate source and configured to convey oxygen containing perfusate from the perfusate source to tissue and exhaust carbon dioxide generated by the tissue, and a carbon dioxide sensor coupled to sense the carbon dioxide generated by the tissue (Figure 5, Figure 6, and Paragraphs 41,105-122) as in instant Claim 1. Tempelman discloses circuity coupled to receive an indication from the carbon dioxide sensor, the indication representing a concentration of carbon dioxide (Paragraphs 41, 110, and 113) as in instant Claim 2. Tempelman discloses wherein the perfusion distributor comprises a perfusate circulation system having a gas exchanger coupled to oxygenate the perfusate and to remove carbon dioxide from perfusate from the tissue and further comprising an exhaust conduit coupled to the gas exchanger to receive carbon dioxide removed from the carbon dioxide containing perfusate (Figure 5, Figure 6 and Paragraphs 41,105-122) as in instant Claim 5. Tempelman discloses wherein the carbon dioxide sensor is coupled to the exhaust conduit to measure carbon dioxide in the exhaust conduit (Paragraphs 41, 110, and 113 of Tempelman) as in instant Claim 6. Tempelman discloses the carbon dioxide is in gas form (Paragraphs 41 and 110 of Tempelman) as in instant Claim 7. Tempelman discloses an oxygen sensor coupled to the exhaust conduit to measure oxygen in the exhaust conduit (Paragraphs 41, 110, and 113 of Tempelman) as in instant Claim 8. Tempelman discloses circuity coupled to an indication from the carbon dioxide sensor, this indication representing a concentration of carbon dioxide and an indication from the oxygen sensor representative of sensed oxygen concentration (Figure 5, Paragraphs 41,105-111, and 113) as in instant Claim 9. Tempelman discloses a gas flow sensor coupled to measure gas flow between the oxygen source and the gas exchange (Paragraphs 22,41,43,75,110,113 of Tempelman) as in instant Claim 12. Tempelman discloses a pump coupled to move perfusate through the perfusion distributor (Power Sources control the movement/pump the fluid in Figures 5 and 6; Paragraphs 87 and 107 of Tempelman) as in instant Claim 13. Tempelman discloses a tissue canister configured to receive the tissue, the tissue canister comprising ports or coupling to the perfusion distributor (Figure 5-6, Paragraphs 105-122) as in instant Claim 14. Tempelman discloses a perfusion system comprising a gas exchanger coupled to an oxygen source and the perfusion distributor; and a gas flow regulator coupled between the oxygen source and the gas exchanger (Figures 5-6, Paragraphs 43 and105-122 of Tempelman) as in instant Claim 15. Tempelman discloses wherein the gas flow regulator is to regulate the flow of oxygen to the gas exchange (Figures 5-6, Paragraphs 43, 105-122) as in instant Claim 16. Tempelman discloses a gas exchanger to receive oxygen from an oxygen source; a perfusate circulation system coupled to the gas exchanger and configured to convey oxygen containing perfusate from the gas exchanger to tissue and return carbon dioxide containing perfusate from the tissue to the gas exchanger; an exhaust conduit coupled to the gas exchanger to receive gas containing carbon dioxide removed from the returned carbon dioxide containing perfusate; a carbon dioxide sensor coupled to the exhaust conduit to measure carbon dioxide concentration in the carbon dioxide containing gas; a controller coupled to receive carbon dioxide indication from the carbon dioxide sensor to determine a rate of carbon dioxide generation by the tissue based on the carbon dioxide data, and a flow rate of the gas (Figures 5-6, Paragraphs 28-35,41,43,105-122 of Tempelman) as in instant Claim 17.
The reference anticipates the claim limitations.
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 1-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) in view of Brassil (US 20050255442)
Tempelman applies as above 1-2,5-9, and 12-17. A purpose of Templeman’s perfusion process is to maintain an organ/tissue successfully by preserving its viability. Tempelman monitors the perfusion process using gas sensors that monitor carbon dioxide and oxygen (Paragraphs 41, 110 and 113 of Templeman). Templeman teaches that it is able to monitor the carbon dioxide leaving from the exhaust and gather carbon dioxide data (Paragraphs 41 and 110). Templeman teaches that a fluid flow rate can be successfully monitored (Paragraph 43). Templeman does not state that it is able to successfully monitor the perfusion process by obtaining a tissue mass value, a flow rate of the perfusion solution exiting with carbon dioxide, tissue type, metabolic state. Tempelman does not further state that such values can be used to indicate the viability of the tissue/organ. Brassil teaches that the following parameters can be gathered and then analyzed to determine tissue/organ viability: (pressure/flow) (flow rate of the exiting perfusion solution which inherently has carbon dioxide), carbon dioxide data, metabolic states, fluid flow rate (Paragraph 111 of Brassil). Paragraph 198 of Brassil further states that type of organ/tissue and the tissue sample mass can be inputted into a perfusion system in order to assist the perfusion system with determining the proper cell viability. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have considered the parameters taught in Brassil. An artisan would have been motivated to have analyzed such parameters as taught in Paragraphs 111 and 198 of Brassil because they can be used to indicate tissue/organ viability. There would have been a high expectation of success because Brassil teaches that these parameters can be used to successfully determine viability (Paragraphs 111 and 198 of Brassil) as in instant Claims 3-4.
Tempelman discloses a perfusion system with sensors that can monitor the presence of carbon dioxide and oxygen, including sensors in the exhaust of such a system. Templeman does not teach all the monitoring parameters that can be used for determining viability; however, Brassil does teach the parameters recited in the instant set of claims. Furthermore, Brassil teaches that such parameters can indicate the viability/health of the tissue being perfused. Besides collecting and sensing the levels of oxygen and carbon dioxide as taught in Tempelman, an artisan would have also been motivated to have collected the other parameters discussed in Brassil to determine the viability of the organ/tissue to successfully monitor the health status of the organ/tissue. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literate and have the practical experience in molecular biology, cell culture, and perfusion. Therefore, the level of ordinary skill in this art is high.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tempelman (US 20120178150) in view of Brassil (US 20050255442) and Jones (US 20180059126)
Tempelman and Brassil apply as above to teach1-9, and 12-17. Tempelman and Brassil teach various parameters that can be studied to determine cell viability during a perfusion process. Neither of these references teach that a respiratory quotient can be generated from the data sensed by carbon and oxygen sensors and that the respiratory quotient can be used to indicate the viability of organs/tissue. However, at the time of applicants’ invention, it was known that such respiratory quotients could be used to study viability. Jones teaches that a respiratory quotient generated from carbon dioxide and oxygen sensory data can be used to analyze the viability of the cells/tissue (Paragraph 412 of Jones). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used such a respiratory quotient as taught by Jones to monitor the health/viability of the tissue during a perfusion process taught in Tempelman. An artisan would have been motivated to have used such a respiratory quotient because such data can assist with determining the viability of tissues/cells (Paragraph 412 of Jones). Because the respiration quotient taught by Jones can provide information on the viability of cells/tissue, there would have been a high expectation for success using the respiratory quotient generated from data sensed by the carbon and oxygen sensors (Paragraph 412 of Jones).
Tempelman discloses a perfusion system with sensors that can monitor the presence of carbon dioxide and oxygen, including sensors in the exhaust of such a system. Templeman does not teach all the monitoring parameters that can be used for determining viability; however, Brassil does teach the parameters recited in the instant set of claims. Furthermore, Brassil teaches that such parameters can indicate the viability/health of the tissue being perfused. Besides collecting and sensing the levels of oxygen and carbon dioxide as taught in Tempelman, an artisan would have also been motivated to have collected the other parameters discussed in Brassil to determine the viability of the organ/tissue to successfully monitor the health status of the organ/tissue. An artisan would have further been motivated to have used the respiratory quotient involving carbon dioxide and oxygen levels as taught in Jones since it provides information concerning the tissue’s viability. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. V. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literate and have the practical experience in molecular biology, cell culture, and perfusion. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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