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 (A system for storing or cultivating an organ or tissue model) in the reply filed on March 20, 2026 is acknowledged. Claims 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (claims 12-16), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 20, 2026. The examiner has rejoined Species a-e in the restriction dated January 21, 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Instant claim 1 recites “means for measuring and adjusting temperature of perfusion fluid placed in the chamber…..means for measuring and adjusting temperature of the perfusion fluid in the container.” This claim limitation satisfies the three prong test because: 1. the limitation recites the term “means for”, 2. the means for term is modified by functional language (measuring and adjusting temperature), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claims 1 recites “means for measuring glucose concentration in the perfusion fluid and for dosing glucose into the perfusion fluid.” This claim limitation satisfies the three prong test because: 1. the limitation recites the term “means for,” 2. the means for term is modified by functional language (measuring glucose concentration in the perfusion fluid and for dosing glucose in the perfusion fluid), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 recites, “means for measuring pH of the perfusion fluid and for dosing substance for adjusting the pH of the perfusion fluid.” This claim limitation satisfies the three prong test because: 1. the limitation recites the term “means for,” 2. the means for term is modified by functional language (measuring pH of the perfusion fluid and for dosing substance for adjusting the pH), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claims 1 and 5 recite, “means for contactless mixing of the perfusion fluid.” The claim limitation satisfies the three prong test because: 1. the limitation recites the term “means for,” 2. the means for term is modified by functional language (measuring and controlling flow parameters of the perfusion fluid), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claims 1, 5,9,10 recite, “means for measuring and controlling one or more parameters.” The claim limitation satisfies the three prong test because: 1. the limitation recites the term “means for,” 2. the means for term is modified by functional language (measuring and controlling one or more parameters), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim 2 recites “system control means, configured and programmed to obtain measurement values for at least one parameter…” This claim limitation satisfies the three prong test because: 1. the limitation recites the term “system control means”, 2. the term “means” is modified by functional language (configured and programmed to obtain measurement values for at least one parameter), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim 3 recites “means for measuring and controlling the oxygenation of perfusion fluid and/or means for air removal of the perfusion fluid.” This claim limitation satisfies the three prog test because 1. the limitation recites the term “means for,” 2. The term “means” is modified by functional language (measuring and controlling the oxygenation of perfusion fluid and/or means for air removal of the perfusion fluid,” and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim 4 recites “means for measuring loss and replenishment of the perfusion fluid.” This claim limitation satisfies the three prog test because: 1. this limitation recites the term “means for”, 2. the term “means for” is modified by functional language (measuring loss and replenishment of the perfusion fluid), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant clam 7 recites, “means for taking samples of the perfusion fluid.” This claim limitation satisfies the three prong test because: 1. this limitation recites the term “means for,” 2. the term “means for” is modified by functional language (taking samples of the perfusion fluid), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim 9 recites, “means for adjusting temperature in the range from 0 to 37°C.” This claim limitation satisfies the three prong test because 1. this limitation recites the term “means for,” 2. the term “means for” is modified by functional language (adjusting temperature in the range from 0 to 37°C), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim 10 recites, “means for dosing medicaments and/or nutrients and/or perfusion fluid components.” This claim limitation satisfies the three prong test because: 1. this limitation recites the term “means for,” 2. the term “means for” is modified by functional language (dosing medicaments and/or nutrients and/or perfusion components), and 3. the limitation is not modified by sufficient structure, material, or acts for performing the claimed function. Therefore, this limitation will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-11 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. The limitations recited in the claims frequently include the term “preferably.” It is unclear if the preferred limitations are required or not. For purposes of examination, the examiner will interpret the preferred limitations as being optional. “Preferably” is present in instant claims 1,3-5,8, and 10-11.
Claim 1 recites “….a perfusion fluid container, equipped with means for measuring and adjusting temperature of the perfusion fluid in the container during operation of the system, preferably a heating-cooling plate.” Claim 1 is stating that the perfusion fluid container has the ability to measure and adjust the temperature of the perfusion fluid, not serve as a mixing device. Claim 5 is indefinite because it contradicts claim 1. Claim 5 recites that perfusion container is swung, apparently to assist with mixing. There is a disconnect because claim 1 states that the perfusion container is used for monitoring/heating whereas claim 5 is reciting that the perfusion container is used for mixing the perfusion fluid.
Claim 6 is also similarly indefinite. Claim 6 recites….”contactless mixing the perfusion fluid are provided in a form of a cylindrical design of the perfusion container.” Claim 6 contradicts claim 1 because claim 6 recites that the perfusion container serves as a mixer while independent claim 1 states that the perfusion container is used for monitoring the perfusion fluid and heating. Claim 6 is indefinite because it assigns a different purpose to the perfusion container.
Claim 6 also discusses that a perfusion container and an oxygenator are connected to one another to form a oxygenator circuit. Claim 6 further recites, “….during operation of the system, the perfusion fluid is mixed by placing inlet and outlet of the oxygenator circuit in the perfusion fluid container on opposite sides of the perfusion fluid container, tangentially to cylindrical walls of the perfusion fluid container.” An oxygenator is a device that provides oxygen to a perfusion fluid and often involves taking away gases such as carbon dioxide. The claim is stating that the oxygenator’s inlet and outlet are connected to the perfusion fluid container, the alleged mixer. In order for the oxygenator to function appropriately, it needs to be connected to a source of oxygen and possibly be connected to a gas removal system, not a perfusion fluid mixing device. Thus, claim 6 is indefinite because the structure and function of the perfusion fluid container and its connection to the oxygenator is not clearly established in the instant set of claims.
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 1-4,7,9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brasile (WO 02/089571)
Brasile teaches a system for storing or cultivating of an organ or tissue model: comprising a chamber (Figure 1, #32 and #40) for an organ or tissue model equipped with means for measuring and adjusting temperature of perfusion fluid placed in the chamber during operation of the system(Page 22, paragraph 56 of Brasile), wherein said means for measuring and adjusting temperature of the perfusion fluid comprises a temperature heat exchanger (Page 23, paragraph 57), a perfusion fluid container, equipped with means for measuring and adjusting temperature of the perfusion fluid in the container during operation of the system (Page 23, paragraph 57), wherein the perfusion fluid container is connected to the organ chamber by at least one first line through which the perfusion fluid can flow from the perfusion fluid container to the organ chamber during operation, and at least one second line through which the perfusion fluid can flow from the organ chamber to the perfusion fluid container during operation (Figure 1), sensor for measuring glucose concentration in the perfusion fluid and for dosing glucose into the perfusion fluid (Page 9, Paragraphs 29 and 32; Page 26, Paragraph 66), means for measuring pH of the perfusion fluid and for dosing substance for adjusting the pH of the perfusion fluid (Figure 1, #22; Page 11, Paragraph 37; Page 26, Paragraph 66), means for contactless mixing of the perfusion fluid (Figure 1, paragraph 15), means for measuring and controlling of flow parameter of the perfusion fluid, including perfusion fluid pressure (Page 16, paragraph 66; Page 9, Paragraph 29; Page 10, Paragraphs 34-35) as in instant Claim 1. Brasile teaches a system control means, configured and programmed to obtain measurement values for the following parameters selected from: temperature of the perfusion fluid in the organ chamber (Page 22, Paragraph 56), concentration of glucose in the perfusion fluid, pH of the perfusion fluid, parameters of the fluid flow, including pressure of the perfusion fluid (Figure 1; Page 5, paragraphs 12 and 14; Page 8, paragraph 29; Page 9, paragraphs 29 and 32; Page 10, paragraphs 34-35; Page 11, paragraphs 35 and 37), wherein the system control means are further configured and programmed for automatic and/or manual adjustment based on predetermined criteria of the at least one parameter (Figure 1; Page 8, paragraph 29; Page 9, paragraphs 29 and 32; Page 10, paragraphs 34-35; Page 11, paragraph 35 and 37; Pages 26-27, paragraphs 66-68; of Brasile) as in instant Claim 2. Brasile teaches means for measuring and controlling the oxygenation of perfusion fluid and means for air removal from the perfusion fluid (removal of carbon dioxide) (Figure 1; Page 8, paragraph 29; Page 9, paragraphs 29 and 32; Page 10, paragraphs 34-35; Page 11, paragraph 35 and 37 of Brasile) as in instant Claim 3. Brasile teaches means for measuring of loss and replenishment of the perfusion fluid (Pages 28-29, Paragraph 74) as in instant Claim 4. Brasile teaches means for taking samples of the perfusion fluid (Paragraphs 61 and 70 of Brasile) as in instant Claim 7.Brasile teaches wherein the organ chamber and/or the perfusion fluid containiner have means for adjusting temperature in the range of 25-37°C (Paragraphs 34 and 102 of Brasile) as in instant Claim 9. Brasile teaches means for dosing nutrients and perfusion fluid components, wherein the system control means are preferably configured and programmed for automatic and/or manual dosing nutrients and perfusion components based on predetermined criteria (Page 9, Paragraph 29; Page 5; Page 10, Paragraph 35; Pages 22-25) as in instant Claim 10. Brasile teaches air is removed from the perfusion fluid by means of an air bubble eliminator mounted on the first line between the perfusion fluid container and the organ chamber, and the movement of the perfusion fluid between the perfusion fluid container and the organ chamber and the way round during operation of the system is performed by means of at least one pump (Figure 1, #12 and #30; Page 6, paragraph 15; Page 29, paragraph 76) as in instant Claim 11.
The reference anticipates the claim limitation.
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 1-4,7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Brasile (WO 02/089571) in view of Kang (CN 110402921)
Brasile applies as above to teach claims 1-4,7,9-11. Brasile does not teach rotating the organ chamber. However, Kang teaches that the organ chamber can be rotated (Summary of the Invention, Paragraph 2 of Kang). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have rotated the organ chamber. An artisan would have been motivated to have made the organ containing chamber rotatable because it helps prevent unwanted clotting in the organ (Summary of the Invention, Paragraph 2 of Kang). An artisan would have been expected to have optimized the type of rotation used by such a device. Because rotating the chamber where the organ is has desirable benefits like preventing unwanted clots, there would have been a high expectation for success.
Brasile teaches a perfusion process with an organ/tissue chamber and a perfusion fluid container. An artisan would have been further motivated to have engineered the organ chamber of Brasile so that it rotates (as taught in Kang) in order to prevent unwanted clotting. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All 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 predicable 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.Ds. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and organ 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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