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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Amendment
The Amendment filed 04/27/2026 has been entered. Claims 1-12 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(a) and 112(b) rejections previously set forth in the Final Office Action mailed 02/26/2026.
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.
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.
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.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baek et al. (KR 20190075858 A; cited in the IDS filed 09/14/2023; 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 (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).
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 Baek is identical to the presently claimed structure. Baek discloses the claimed bioreactor, cell-media recirculation loop, pump, and mature cell separation unit as claimed and therefore, would have the ability to perform the uses and functions recited in the claim. See MPEP 2112.01 (I).
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Fig. 1 of Baek.
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).
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Baek as applied to claim 1 above, and further in view of Smith et al. (US 20100159524 A1).
Regarding claim 2, Baek fails to teach: wherein the at least one sensor comprises a pH sensor and a dissolved oxygen sensor positioned within the mature cell storage unit, the pH sensor and dissolved oxygen sensor in communication with the control system, wherein the control system is operative to control a hypoxic environment and 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]).
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 pH, oxygen concentration, and temperature (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 adjusting pH to a desired level by addition carbon dioxide in response to pH measurements (paragraph [0062]). Smith teaches nitrogen can be set and adjusted to be optical for cells (paragraph [0136]). Smith teaches the apparatus allows for maintaining cells at a high level of viability (paragraph [0050]).
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 the teachings of a system for growth of cells and measuring and adjusting parameters such as pH, oxygen concentration, nitrogen and carbon dioxide of Smith (paragraphs [0008],[0062],[0136]) and the teachings of a device for monitoring culture conditions such as oxygen of Baek (paragraphs [0050],[0056]) to provide: wherein the at least one sensor comprises a pH sensor and a dissolved oxygen sensor positioned within the mature cell storage unit, the pH sensor and dissolved oxygen sensor in communication with the control system, wherein the control system is operative to control a hypoxic environment and 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]).
Regarding claim 3, Baek further teaches wherein the storage unit is a temperature-controlled storage unit (note that “temperature-controlled” is interpreted as a functional limitation of the storage unit, see MPEP 2114; Fig. 1 shows a container, i.e. storage unit, for storing enucleated RBCs, i.e. mature cells; paragraph [0090] teaches storing the red blood cells in refrigerated temperatures; therefore, the container of Fig. 1 is structurally capable of being stored in a refrigerator and thus is capable of being temperature-controlled).
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 04/27/2026, with respect to the claim objections and rejections under 35 U.S.C. 112(a) and 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(a) and 112(b) of 02/26/2026 have been withdrawn.
Applicant's arguments, see pages 10-12, filed 04/27/2026, with respect to the rejections under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive. 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 response to applicant’s arguments that Baek fails to disclose “discloses a mature cell separation unit that separates enucleated mature cells from immature cells during operation of the bioreactor, with the immature cells returned through the recirculation loop for continued maturation in the bioreactor” and “a separation unit operative to perform the claimed separation concurrently with ongoing maturation of additional cells in the bioreactor” since Baek’s centrifuge “is not a structure operative to separate cells within a recirculation loop during active operation of a bioreactor with continued maturation of immature cells therein” (Remarks, pages 11-12), the examiner disagrees.
Baek teaches: 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 (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 (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 (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). Therefore, Baek teaches the mature cell separation unit as claimed. Additionally, Baek teaches the system maintains continuous culture process of cells simultaneously while separating mature red blood cells with the centrifugal separator (paragraph [0057],[0051]), and the blood cell separator returns immature cells back to the inlet of the bioreactor through a pipe, i.e. cell media recirculation loop, for additional maturation culture via a feeding pump (Fig. 1 and paragraphs [0051]-[0053], [0055], [0065]) therefore, the claimed mature cell separation unit is capable of performing intended uses and functional limitations as claimed.
Additionally, the argued limitations of the 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 Baek is identical to the presently claimed structure. Baek discloses the claimed bioreactor, cell-media recirculation loop, pump, and mature cell separation unit as claimed and therefore, would have the ability to perform the uses and functions recited in the claim. See MPEP 2112.01 (I).
In response to applicant’s arguments regarding Smith (Remarks, pages 11-12), the arguments regarding Smith have been considered but are moot because the new grounds of rejection of claim 1 does not rely on Smith for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ikeda et al. (US 20210087512 A1) teaches a cell culture system (abstract; Fig. 1) including a culturing tank housing a liquid culture medium containing cells to be cultured, a hydrodynamic separation device, and a filtration separator for removing cells (abstract). Ikeda teaches known cell culture methods including continuous culture methods, wherein a predetermined amount of liquid medium and cells are put into a culture tank to proliferate the cells, and at the same time, a part of the liquid medium is extracted and a new liquid medium is put into the replacement; thus, the cell culture is continued using the supplemented nutrients. Since the extracted liquid medium contains useful substances produced by cells, the useful substances are recovered by appropriately performing purification treatment after removing the cells from the liquid medium (paragraph [0004]). Ikeda teaches cells contained in the cell-rich fraction can be returned to the culture tank to continue culturing (paragraph [0034]). Ikeda teaches by returning the concentrated and separated cells into the culture tank, proliferation efficiency can be maintained (paragraph [0048]).
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.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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