Prosecution Insights
Last updated: October 04, 2026
Application No. 18/154,230

In-time storage of manufactured cells for medical cellular therapy grown and differentiated in bioreactors

Final Rejection §103
Filed
Jan 13, 2023
Priority
Jan 31, 2022 — provisional 63/304,934
Examiner
NGUYEN, HENRY H
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Sciperio Inc.
OA Round
4 (Final)
64%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
188 granted / 295 resolved
-1.3% vs TC avg
Strong +37% interview lift
Without
With
+37.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
99 currently pending
Career history
377
Total Applications
across all art units

Statute-Specific Performance

§101
3.6%
-36.4% vs TC avg
§103
44.1%
+4.1% vs TC avg
§102
20.4%
-19.6% vs TC avg
§112
28.5%
-11.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 295 resolved cases

Office Action

§103
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 Amendment The Amendment filed 08/26/2026 has been entered. Claims 1-12 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below. 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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “mature cell separation unit” in claim 1; and “temperature-controlled storage unit” in claim 3. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. In this case: “mature cell separation unit” in claim 1 is being interpreted as a filter, microfluidic device, passive separation elements, active separation elements, centrifugation, cyclonic separation (specification, paragraphs [0010],[0020]) and equivalents thereof; and “temperature-controlled storage unit” in claim 3 is being interpreted as including, pH and dissolved oxygen sensors with the ability to cool the container to near 4°C and introduce gaseous nitrogen to create a hypoxic environment and carbon dioxide to control pH levels (paragraph [0021]). Note that claim 4 recites that mature cell separation unit comprises at least one of filters, cyclonic separation, and microfluidics. Therefore, the mature cell separation unit is not interpreted under 35 U.S.C. 112(f) in claim 4. 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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (KR 20190075858 A; cited in the IDS filed 09/14/2023; see machine translation) in view of Smith et al. (US 20100159524 A1) and Sato et al. (JPH05305123A; see machine translation). Regarding claim 1, Baek teaches a system (Fig. 1; abstract) comprising: a bioreactor (Fig. 1, paragraph [0098], “bioreactor”) having an inlet (Fig. 1, left inlet of the bioreactor adjacent to the feeding pump) and an outlet (Fig. 1, bottom outlet of the bioreactor); a cell-media recirculation loop between the outlet of the bioreactor and the inlet of the bioreactor (Fig. 1 and paragraph [0053] teaches transport pipe from the outlet of the bioreactor to the inlet of the bioreactor providing cells to the blood cell separator and for re-introduction of immature cells from the cell separator to the bioreactor, wherein the transport pipe is fluidly between the bioreactor outlet and inlet); a pump (Fig. 1, “feeding pump”) operative to circulate cell media within the cell media re-circulation loop during operation of the bioreactor (interpreted as a functional limitation of the pump, see MPEP 2114; Fig. 1 and paragraphs [0051]-[0053],[0055] teach the feeding pump circulating nucleated cells within the cell media-recirculation loop while simultaneously maintaining a cell culture in the bioreactor) and positioned between the bioreactor outlet and the bioreactor inlet (Fig. 1 teaches the feeding pump fluidly located between the bioreactor outlet and bioreactor inlet); a mature cell storage unit for storing mature cells (Fig. 1 shows a container, i.e. storage unit, for storing enucleated RBCs, i.e. mature cells); a mature cell separation unit (Fig. 1 and paragraph [0057] teaches a blood cell separator including a centrifuge) positioned along the cell-media recirculation loop (Fig. 1 shows the blood cell separator is positioned along the transport pipe that is from the bioreactor outlet to the bioreactor inlet) wherein the mature cell separation unit is for performing separation of mature cells which are enucleated from immature cells during operation of the bioreactor (interpreted as an intended use, see MPEP 2114; Fig. 1 and paragraphs [0034], [0047], [0057],[0070] teach centrifugation in a cell separator to separate red blood cells according to their maturity, such as immature red blood cells and mature red blood cells, i.e. enucleated mature cells, during the continuous culture process of cells, i.e. during operation of the bioreactor) and direction of the immature cells back through the cell media recirculation loop to the inlet of the bioreactor for continued maturation therein (interpreted as an intended use, see MPEP 2114; Fig. 1 and paragraph [0065] teaches the blood cell separator returns non-enucleated immature cells back to the inlet of the bioreactor through a pipe, i.e. cell media recirculation loop, for additional maturation culture) and direction of the mature cells to the mature cell storage unit for storing the mature cells which are enucleated (interpreted as an intended use, see MPEP 2114; Fig. 1 and paragraph [0085] teach the blood cell separator directs enucleated red blood cells to the container for storing the enucleated red blood cells); at least one sensor (paragraphs [0050],[0056] teaches a device for monitoring culture conditions such as temperature and oxygen); a control system, wherein the control system is in communication with the at least one sensor (Fig. 1 paragraphs [0050],[0056] teach a device for controlling and adjusting culture conditions based on the monitoring results, which implies a control system in communication with the at least one sensor). Baek fails to teach: the at least one sensor comprising a pH sensor and a dissolved oxygen sensor positioned within the mature cell storage unit; and wherein the control system is in communication with the at least one sensor, and wherein the control system is operative to introduce gaseous nitrogen into the mature cell storage unit to create a hypoxic environment within the mature cell storage unit and to introduce carbon dioxide into the mature cell storage unit to control pH within the mature cell storage unit. Baek teaches a cell incubator includes a device for monitoring and adjusting culture conditions such as temperature and oxygen (paragraphs [0050],[0056]). Baek teaches sensor probes within the bioreactor (Fig. 1). Smith teaches an apparatus for growth of cells (abstract), including red blood cells (paragraph [0091]). Smith teaches the apparatus includes means for delivery of gasses such as nitrogen and carbon dioxide (paragraph [0008]), and includes means for monitoring and adjusting one or more chemical and physical parameters of the system as a function of one or more monitored parameters, such as pH, temperature, oxygen concentration, and carbon dioxide concentration (paragraph [0008]). Smith teaches adjusting dissolved oxygen concentration by means of addition of oxygen and/or air to a desired level, such as Smith teaches adjusting pH to a desired level by addition carbon dioxide in response to pH measurements (paragraph [0062]). Smith teaches a computer programmed with optimum culture conditions can monitor sensor data and adjust pH by addition of carbon dioxide (paragraph [0096]). Smith teaches nitrogen can be set and adjusted to be optimal for cells (paragraph [0136]). Smith teaches the apparatus allows for maintaining cells at a high level of viability (paragraph [0050]). Sato teaches a method for preserving red blood cell preparations (paragraph [0001]). Sato teaches the main cause of damage is caused by dissolved oxygen in plasma and blood (paragraph [0004]). Sato teaches by actively reducing the concentration of oxygen, during storage using another gas, the product can withstand long-term storage (paragraph [0005]). Sato teaches it is preferable to purge the atmosphere with nitrogen to reduce the oxygen contained in the blood, i.e. hypoxic environment, (paragraph [0006]); wherein the method provides preserving blood by reducing oxygen damage to blood during storage by replacing the air with nitrogen, thereby lowering oxygen concentration in the blood (paragraph [0007]). Sato teaches that by adjusting and controlling the carbon dioxide concentration of the blood in the storage environment, the blood pH index during storage can be maintained in a state favorable for blood metabolism (paragraph [0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one sensor of Baek to incorporate Baek’s teachings of sensors within a bioreactor to monitor and adjust conditions such as oxygen (paragraphs [0050],[0056]), Smith’s the teachings of a system for growth of cells and measuring and adjusting parameters such as pH, oxygen concentration, nitrogen and carbon dioxide by adding carbon dioxide or nitrogen of Smith (paragraphs [0008],[0062],[0096],[0136]), and Sato’s teachings of storing and preserving red blood cells by introducing nitrogen to reduce oxygen in the blood and adjusting carbon dioxide to control pH (paragraphs [0005]-[0007],[0009]) to provide: the at least one sensor comprising a pH sensor and a dissolved oxygen sensor positioned within the mature cell storage unit; and wherein the control system is in communication with the at least one sensor, and wherein the control system is operative to introduce gaseous nitrogen into the mature cell storage unit to create a hypoxic environment within the mature cell storage unit and to introduce carbon dioxide into the mature cell storage unit to control pH within the mature cell storage unit. Doing so would have a reasonable expectation of successfully improving monitoring and adjustment of conditions of chemical and physical parameters of the mature cell storage unit as discussed by Smith (paragraphs [0008],[0062],[0136]), therefore improving maintenance of cells at a high level of viability (Smith, paragraph [0050]), and optimizing storage conditions for long-term preservation and storage of mature cells in the mature cell storage unit as taught by Sato (paragraphs [0004]-[0007],[0009]). Note that the limitations of the pump, mature cell storage unit, and mature cell separation unit are interpreted as intended uses and functional limitations of the claimed mature cell separation unit. An intended use or functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended uses or functional limitations, then it meets the claim. See MPEP 2114. The apparatus of modified Baek is identical to the presently claimed structure. modified Baek discloses the claimed bioreactor, cell-media recirculation loop, pump, mature cell separation unit, at least one sensor, and control system as claimed and therefore, would have the ability to perform the uses and functions recited in the claim. See MPEP 2112.01 (I). PNG media_image1.png 609 851 media_image1.png Greyscale Fig. 1 of Baek. Regarding claim 2, Baek fails to teach: wherein the control system is further operative to cool the mature cell storage unit. Baek teaches a cell incubator includes a device for monitoring and adjusting culture conditions such as temperature and oxygen (paragraphs [0050],[0056]). Smith teaches an apparatus for growth of cells (abstract), including red blood cells (paragraph [0091]). Smith teaches the apparatus includes means for monitoring and adjusting one or more chemical and physical parameters of the system as a function of one or more monitored parameters, such as pH, temperature, oxygen concentration, and carbon dioxide concentration (paragraph [0008]). Smith teaches the apparatus includes means for adjusting one or more chemical and physical parameters of the system as a function of one or more monitored parameters (paragraph [0008]). Smith teaches the apparatus allows for maintaining cells at a high level of viability (paragraph [0050]). Sato teaches a method for preserving red blood cell preparations (paragraph [0001]). Sato teaches storage temperature for stored blood is in the range of -2 to 6 C (paragraph [0009]). Sato teaches the present invention makes it possible to suppress the increase in free hemoglobin due to hemolysis during storage, enabling blood storage at lower temperatures than conventional methods, and maintaining improved blood quality for a longer period than current storage methods; therefore, reducing waste of stored blood; and extending blood storage period (paragraph [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system of modified Baek to incorporate Baek’s teachings of monitoring and adjusting temperature (paragraphs [0050],[0056]), Smith’s teachings of measuring and adjusting parameters such as temperature (paragraph [0008]), and Sato’s teachings of storing and preserving red blood cells at low temperatures (paragraphs [0009],[0013]) to provide: wherein the control system is further operative to cool the mature cell storage unit. Doing so would have a reasonable expectation of successfully improving monitoring and adjustment of conditions of chemical and physical parameters of the mature cell storage unit as discussed by Smith (paragraphs [0008],[0062],[0136]), therefore improving maintenance of cells at a high level of viability (Smith, paragraph [0050]), and optimizing storage conditions for long-term preservation and storage of mature cells in the mature cell storage unit as taught by Sato (paragraphs [0009], [0013]). Regarding claim 3, modified Baek fails to teaches wherein the storage unit is a temperature-controlled storage unit operative to maintain the mature cells at a temperature of about 4 degrees Celsius (as interpreted under 35 U.S.C. 112(f)). Smith teaches an apparatus for growth of cells (abstract), including red blood cells (paragraph [0091]). Smith teaches the apparatus includes means for delivery of gasses such as nitrogen and carbon dioxide (paragraph [0008]), and includes means for monitoring and adjusting one or more chemical and physical parameters of the system as a function of one or more monitored parameters, such as pH, temperature, oxygen concentration, and carbon dioxide concentration (paragraph [0008]). Smith teaches adjusting dissolved oxygen concentration by means of addition of oxygen and/or air to a desired level, such as Smith teaches adjusting pH to a desired level by addition carbon dioxide in response to pH measurements (paragraph [0062]). Smith teaches a computer programmed with optimum culture conditions can monitor sensor data and adjust pH by addition of carbon dioxide (paragraph [0096]). Smith teaches nitrogen can be set and adjusted to be optimal for cells (paragraph [0136]). Smith teaches the apparatus allows for maintaining cells at a high level of viability (paragraph [0050]). Sato teaches a method for preserving red blood cell preparations (paragraph [0001]). Sato teaches the main cause of damage is caused by dissolved oxygen in plasma and blood (paragraph [0004]). Sato teaches by actively reducing the concentration of oxygen, during storage using another gas, the product can withstand long-term storage (paragraph [0005]). Sato teaches it is preferable to purge the atmosphere with nitrogen to reduce the oxygen contained in the blood, i.e. hypoxic environment, (paragraph [0006]); wherein the method provides preserving blood by reducing oxygen damage to blood during storage by replacing the air with nitrogen, thereby lowering oxygen concentration in the blood (paragraph [0007]). Sato teaches that by adjusting and controlling the carbon dioxide concentration of the blood in the storage environment, the blood pH index during storage can be maintained in a state favorable for blood metabolism (paragraph [0009]). Sato teaches storage temperature for stored blood is in the range of -2 to 6 C (paragraph [0009]). Sato teaches the present invention makes it possible to suppress the increase in free hemoglobin due to hemolysis during storage, enabling blood storage at lower temperatures than conventional methods, and maintaining improved blood quality for a longer period than current storage methods; therefore, reducing waste of stored blood; and extending blood storage period (paragraph [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mature cell storage unit of modified Baek to incorporate Smith’s the teachings of a system for growth of cells and measuring and adjusting parameters such as temperature, pH, oxygen concentration, nitrogen and carbon dioxide (paragraphs [0008],[0062],[0096],[0136]), and Sato’s teachings of storing and preserving red blood cells by introducing nitrogen to reduce oxygen in the blood and adjusting carbon dioxide to control pH (paragraphs [0005]-[0007],[0009]) and storing and preserving red blood cells at low temperatures (paragraphs [0009],[0013]) to provide: wherein the storage unit is a temperature-controlled storage unit operative to maintain the mature cells at a temperature of about 4 degrees Celsius (as interpreted under 35 U.S.C. 112(f)). Doing so would have a reasonable expectation of successfully improving monitoring and adjustment of conditions of chemical and physical parameters of the mature cell storage unit as discussed by Smith (paragraphs [0008],[0062],[0136]), therefore improving maintenance of cells at a high level of viability (Smith, paragraph [0050]), and optimizing storage conditions for long-term preservation and storage of mature cells in the mature cell storage unit as taught by Sato (paragraphs [0004]-[0007],[0009],[0013]). Regarding claim 4, Baek further teaches wherein the mature cell separation unit is further operative to direct the mature cells to the mature cell storage unit, the mature cell separation unit comprising at least one of filters, cyclonic separation, and microfluidics (Fig. 1 and paragraph [0085] teach the blood cell separator directs enucleated red blood cells to the container for storing the enucleated red blood cells using centrifugation, i.e. cyclonic separation). Regarding claim 5, Baek further teaches wherein the mature cells are mature red blood cells (Fig. 1 teaches harvesting mature RBCs). Regarding claim 6, Baek further teaches wherein the control system comprises at least one intelligent control operatively connected to the at least one sensor (paragraph [0042] teaches a culture condition control device, i.e. intelligent control, that controls inflow and outflow of cells as needed by a sensor, and therefore is operatively connected to the sensor; paragraphs [0082]-[0083] teaches a sensor sending information to the control unit, i.e. intelligent control). Regarding claim 7, Baek further teaches wherein the mature cells are mature red blood cells (Fig. 1 teaches harvesting mature RBCs). Regarding claim 8, Baek further teaches wherein the at least one intelligent control provides for controlling the separation of the mature cells from the immature cells (paragraphs [0082]-[0085] teach the cell separator includes the control unit, i.e. intelligent control, for implementing techniques of cell separation of mature RBCs and immature RBCs; therefore, the control unit is capable of performing the intended use of controlling separation of mature cells from immune cells). Regarding claim 9, Baek further teaches wherein the at least one intelligent control provides for controlling the direction of the mature cells from the immature cells (Fig. 1 and paragraphs [0082]-[0085] teach the cell separator includes the control unit, i.e. intelligent control, for implementing techniques of cell separation of mature RBCs and immature RBCs to discharge the selected cells to desired transport pipes via connection of proper transport pipes or controlling valves; therefore, the control unit is capable of performing the intended use of controlling the direction of the mature cells from the immature cells in order to direct the mature cells and immature cells to respective locations as shown in Fig. 1). Regarding claim 10, Baek further teaches wherein the at least one intelligent control provides for controlling direction of the mature cells to the mature cell storage unit (Fig. 1 and paragraphs [0082]-[0085] teach the cell separator includes the control unit, i.e. intelligent control, for implementing techniques of cell separation of mature RBCs and immature RBCs to discharge the selected cells to desired transport pipes via connection of proper transport pipes or controlling valves; therefore, the control unit is capable of performing the intended use of controlling direction of the mature cells to the mature cell storage unit in order to direct the mature cells to storage unit as shown in Fig. 1). Regarding claim 11, Baek further teaches wherein the mature cells are mature human cells (Fig. 1 teaches harvesting mature RBCs; paragraph [0061] teaches whole blood from human blood vessels). Regarding claim 12, Baek further teaches wherein the mature cells are mature red blood cells (Fig. 1 teaches harvesting mature RBCs). Response to Arguments Applicant’s arguments, see pages 6-8, filed 08/26/2026, with respect to the rejection(s) of claims 1 and 4-12 under 35 U.S.C. 102(a)(1) and claims 2-3 under 35 U.S.C. 103, specifically regarding amended claim 1, 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 Baek et al. (KR 20190075858 A; cited in the IDS filed 09/14/2023; see machine translation) in view of Smith et al. (US 20100159524 A1) and Sato et al. (JPH05305123A; see machine translation). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Taber et al. (US 20240159672 A1; effectively filed 03/14/2021) teaches a system and process for measuring fluorescence in a sample (abstract). Taber teaches delivery of gas to the head space may allow manipulation of the environment around the test sample to create conditions simulating hypoxia, anoxia, or normoxia and/or low pH; and in some embodiments, a biologically inert gas such as nitrogen may be injected into the media (paragraph [0132]). Taber teaches by perfusing nitrogen into the head space, the available O2 in the medium is displaced and a more hypoxic condition is created around the sample (paragraph [0133]). Yang et al. (CN 1333296 A; see machine translation) teaches a method for preparing hemoglobin for use as a red blood cell substitute (paragraph [0002]). Yang teaches collected hemoglobin is processed under low temperature conditions of 0-4C and deoxygenated by introducing nitrogen or carbon dioxide (paragraph [0021]). Yang teaches cooling to 0-4C and maintained within the temperature range (paragraph [0021]; page 18, second paragraph). Yang teaches adjusting the pH of the solution (paragraph [0009]). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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Prosecution Timeline

Show 1 earlier event
Oct 10, 2025
Non-Final Rejection mailed — §103
Dec 29, 2025
Response Filed
Feb 26, 2026
Final Rejection mailed — §103
Apr 27, 2026
Request for Continued Examination
Apr 29, 2026
Response after Non-Final Action
Jun 25, 2026
Non-Final Rejection mailed — §103
Aug 26, 2026
Response Filed
Sep 23, 2026
Final Rejection mailed — §103 (current)

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5-6
Expected OA Rounds
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99%
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3y 3m (~0m remaining)
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