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 .
Election/Restrictions
Newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions II (claim 21) and I (claims 1-12) are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because claim 21 does not require the mature cell storage unit comprising pH and dissolved oxygen sensors configured to cool the mature cell storage unit to near 4 degrees Celsius and introduce gaseous nitrogen to create a hypoxic environment and carbon dioxide to control pH levels. The subcombination has separate utility such as controlling pH levels.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The Amendment filed 12/29/2025 has been entered. Claims 1-21 remain pending in the application. Claims 13-21 are withdrawn. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 10/10/2025. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 17, it is suggested to delete “the system of claim 1”. Appropriate correction is required.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites “a pump operative to continuously circulate cell media within the cell media re-circulation loop between the bioreactor outlet and the bioreactor inlet” (emphasis added) in lines 5-6. While the specification discloses a pump suitable for conveying the cell culture media solution through the re-circulation loop (paragraphs [0018]-[0019]), the disclosure is silent on the pump operative to continuously circulate cell media within the cell media re-circulation loop between the bioreactor outlet and the bioreactor inlet. Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-12 are rejected by virtue of their dependency on claim 1.
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 1-12 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.
Regarding claim 1, claim 1 recites “the mature cell storage unit comprises pH and dissolved oxygen sensors” in lines 17-18. It is unclear if the pH and dissolved oxygen sensors are the same or different from “at least one sensor” established in line 14. Claims 2-12 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, the term “near” in line 18 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-12 are rejected by virtue of their dependency on claim 1.
Regarding claim 2, claim 2 recites “the mature cell storage unit comprises a pH sensor and a dissolved oxygen sensor” in lines 17-18. It is unclear if the pH and dissolved oxygen sensors of claim 2 are the same or different from “the pH and dissolved oxygen sensors” established in claim 1. Claim 3 is rejected by virtue of their dependency on claim 2.
Regarding claim 4, claim 4 recites “the mature cell storage unit comprising at least one of filters…”. It is unclear if “comprising at least one of…” is further limiting the “mature cell separation unit” or the “mature cell storage unit”. For examination purposes, the mature cell storage unit is interpreted as comprising at least one of filters, cyclonic separation, and microfluidics.
Regarding claim 6, claim 6 recites “at least one sensor” in lines 1-2. It is unclear if the at least one sensor of claim 6 is the same or different from the “at least one sensor” established in claim 1. Claims 7-12 are rejected by virtue of their dependency on claim 6.
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).
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 between the bioreactor outlet and the bioreactor inlet (Fig. 1 shows the feeding pump circulating nucleated cells within the cell media-recirculation loop 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 (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) and direction of the immature cells back through the cell media recirculation loop to the inlet of the bioreactor (Fig. 1 and paragraphs [0065],[0067] teaches the blood cell separator returns immature cells back to the inlet of the bioreactor through a pipe, i.e. cell media recirculation loop) 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);
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).
Baek fails to teach: the pump operative to continuously circulate cell media within the cell media re-circulation loop between the bioreactor outlet and the bioreactor inlet; the system of claim 1 wherein the mature cell storage unit comprises pH and dissolved oxygen sensors configured to cool the mature cell storage unit to near 4 degrees Celsius and introduce gaseous nitrogen to create a hypoxic environment and carbon dioxide to control pH levels.
Baek teaches a cell incubator includes a device for monitoring culture conditions such as temperature and oxygen (paragraphs [0050],[0056]), and red blood cells can be moved to a storage space that can be stored at refrigerated temperatures (paragraph [0090]).
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 temperature, such as a cooling jacket in relationship with the vessel to a desired level (paragraph [0062]). 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 mature cell storage unit 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 temperature and oxygen of Baek (paragraphs [0050],[0056]), and the teachings of red blood cells can be moved to a storage space that can be stored at refrigerated temperatures of Baek (paragraph [0090]) to provide: the system of claim 1 wherein the mature cell storage unit comprises pH and dissolved oxygen sensors configured to cool the mature cell storage unit to near 4 degrees Celsius and introduce gaseous nitrogen to create a hypoxic environment and carbon dioxide to control pH levels. 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]), such as providing refrigerated temperatures as desired by Baek (paragraph [0090]), therefore improving maintenance of cells at a high level of viability (Smith, paragraph [0050]).
Modified Baek fails to teach: the pump operative to continuously circulate cell media within the cell media re-circulation loop between the bioreactor outlet and the bioreactor inlet.
Smith teaches the apparatus allows for maintaining cells at a high level of viability (paragraph [0050]). Smith teaches cell culture and media may be in circulation via circulation or pumping means (paragraph [0101]). Smith teaches a medium replenishment loop including a pump (paragraph [0117]). Smith teaches circulating flow of cells in a cell circulation loop and flow of regenerating medium in the media circulation loop are advantageously controlled with pumping means, and can be controlled by a computer in response to parameters (paragraph [0149]). Smith teaches continuously pumping cells from a stirred tank bioreactor by means of a pump (paragraph [0154]), wherein optimum rate of flow through the loop is provided (paragraph [0155]).
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 Baek to incorporate the teachings of pumps for circulating cells and media in a loop and continuously pumping cells of Smith (paragraphs [0101],[0117],[0149], [0154],[0155]) to provide: the pump operative to continuously circulate cell media within the cell media re-circulation loop between the bioreactor outlet and the bioreactor inlet. Doing so would have reasonable expectation of successfully improving control of the pump to provide optimum rate of flow of cell media to the bioreactor.
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Fig. 1 of Baek.
Regarding claim 2, modified Baek further teaches the system of claim 1 wherein the mature cell storage unit comprises a pH sensor and a dissolved oxygen sensor (see above claim 1; Baek in combination with Smith provides the mature cell storage unit comprising the pH and dissolved oxygen sensors of claim 1), to cool the mature cell storage unit to 4 degrees Celsius (see above claim 1).
Modified Baek fails to teach explicitly teach: the pH sensor and the 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 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 pH sensor and the dissolved oxygen sensor and control system of modified 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 and adjusting culture conditions such as oxygen of Baek (paragraphs [0050],[0056]) to provide: the pH sensor and the 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).
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 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 system comprises at least one sensor (Fig. 1 and paragraph [0042] teaches the cell culture device, i.e. bioreactor, comprises sensors and sensor probes; paragraphs [0082]-[0083] teaches a sensor) and 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 8 and 10, filed 12/29/2025, with respect to the claim objections and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(b) of 12/29/2025 has been withdrawn.
Applicant’s arguments, see pages 8-10, filed 12/29/2025, with respect to the interpretation of “mature cell storage unit” under 35 U.S.C. 112(f) have been fully considered and are persuasive. Specifically, claim 1 provides sufficient structure to perform the recited function. The interpretation of “mature cell storage unit” under 35 U.S.C. 112(f) has been withdrawn.
Applicant's arguments, see pages 8-10, filed 12/29/2025, with respect to the interpretation of “mature cell separation unit” under 35 U.S.C. 112(f) have been fully considered but they are not persuasive.
Claim 1 recites “a mature cell separation unit”, which includes a generic placeholder of “unit” that is coupled with functional limitations “mature cell separation” and “for performing separation…” without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. The preceding limitation of “mature cell separation” is not a structural modifier. Therefore, “mature cell separation unit” is interpreted under 35 U.S.C. 112(f).
While the disclosure and references provides examples of a mature cell storage unit, due to the claim limitations, the term “mature cell separation unit” is interpreted under 35 U.S.C. 112(f).
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.
Applicant’s arguments, see pages 10-13, filed 12/29/2025, with respect to the rejection(s) of claims 1 and 3-12 under 35 U.S.C. 102(a)(1) and claim 2 under 35 U.S.C. 103, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kotz et al. (US 20190085280 A1) teaches a device and method for treatment of cells, including separating cells (abstract). Kotz teaches a recycle loop may be configured to pump media back to an inlet of the first plate. In some embodiments, the recycle loop may be configured to pump media continuously or in a pulsed flow (paragraph [0129]).
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.
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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