DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/12/2025 is acknowledged. The traversal is on the ground(s) that the International Searching Authority concluded that there is unity of invention. This is not found persuasive because an examiner may make a lack of unity requirement even if no such requirement was made by the ISA. See MPEP 1893.03(d). The reasons for lack of unity are outlined in the Office Action dated 09/11/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-29 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/12/2025.
Claim Objections
Claims 15 and 16 are objected to because of the following informalities:
Claim 15, line 3, and Claim 16, lines 4 and 5 states “first and second buffer channels”. Examiner believe this is a typographical error and should read “first and second buffer channel”.
Claim 18, line 1-2, states “one sensor is positioned, on each fiber, between the flow..”. Examiner believes this is a typographical error and should read “one sensor is positioned on each fiber between the flow..”.
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: pumping unit in claim 15.
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.
Applicant’s specification, page 12, states the pumping unit may be of the syringe type pump or a servo type pump.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-22 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 15, lines 8-12 states “a pumping unit and a control unit configured to: move the multicomponent fluid… through the collector.” It is unclear whether the pumping unit, control unit or both are configured to move the multicomponent fluid as described. Further clarification is requested.
Claims 16-22 are further rejected as they depend from Claim 15.
Regarding Claim 16, lines 1-6 states “the pumping unit and the control unit are configured to: distribute the multicomponent fluid… through the collector.” Again, it is unclear whether the pumping unit, control unit or both are configured to distribute the multicomponent fluid as described. Further clarification is requested.
Regarding Claim 17, it is unclear how the pumping unit contains a sensor that is located inside one of the channels, the main conduct, the fibers, or collector. For examination purposes, it is interpreted as the device contains the sensor.
Claim 22 is further rejected as it depends from Claim 17.
Claim 19 recites the limitation "each sensor" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is interpreted as being dependent from Claim 18.
Claim 20 recites the limitation "each sensor" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is interpreted as being dependent from Claim 18.
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 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Floeser (DE20209547U1) in view of Dadgar et al. (WO2019126212A1).
Regarding Claim 15, Floeser teaches the following:
A device for cell homogenization (para 3) with a main channel, first and second buffer channel, a collector connected to the main channel by means of a main conduct, and connected to the first buffer channel by means of a first fiber and to the second buffer channel by means of a second fiber, and a flow separation point (Fig. 1, below)
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Two syringe connections (pumping unit) provided so a cell suspension can be moved back and forth by alternating actuation of connected syringes (para 3)(a pumping unit to move the multicomponent fluid)
Floeser does not explicitly teach a control unit. Dadgar teaches a system which delivers a payload to a cell and which can homogenize a cell suspension (para 209). Dadgar further teaches one or more computing devices (control module)(para 59). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Floeser with a control module as taught by Dadgar. One would have been motivated to make this addition as it would allow full or partial automated control of one or more components of the system (para 59).
The pumping unit and control unit configured to move the multicomponent fluid from the main channel to the first channel or the second channel through the collector and move the multicomponent fluid from the first or second buffer channel to the main channel through the collector is an intended use of the device. A recitation of the intended use 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 use, then it meets the claim (see MPEP 2114). The pumping unit would be capable of moving the liquid through the system in that manner and therefore meets the claim.
Regarding Claim 16, Floeser in view of Dadgar teaches all of the limitations of Claim 15 (see above). The pumping unit and control unit configured to distribute the multicomponent fluid from the main channel successively to the first then to then to the second buffer channel through the collector and move the multicomponent fluid from the first and the second buffer channels simultaneously to the main channel through the collector is an intended use of the device. A recitation of the intended use 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 use, then it meets the claim (see MPEP 2114). The pumping unit would be capable of moving the multicomponent fluid in that manner and therefore meets the claim.
Regarding Claim 17, Floeser in view of Dadgar teaches all of the limitations of Claim 15 (see above). Floeser does not teach a sensor allowing the detection of fluid inside one of the channels, the main conduct, the fibers or the collector.
Dadgar teaches sensors which sense properties of cells or of cell suspension (the detection of fluid) and which may be connected to components of the system such as inside the flow path of the system (channels)(para 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Floeser with the sensors as taught by Dadgar. One would have been motivated to make this modification as it would allow detection of when fluid flow has been stopped (para 330).
Regarding Claim 18, Floeser in view of Dadgar teaches all of the limitations of 15 (see above). Floeser does not teach one sensor positioned on each fiber between the flow separation point and each buffer channel.
Dadgar teaches the system to comprise multiple flow sensors located within the system (para 330). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Floeser with the sensors as taught by Dadgar. One would have been motivated to make this modification as it would allow detection of when fluid flow has been stopped (para 330).
While Dadgar does not explicitly teach the flow sensors to be located on each fiber, a mere rearrangement of parts is prima facie obvious to one of ordinary skill in the art. See MPEP 2144.04(VI)(C).
Regarding Claim 19, Floeser in view of Dadgar teaches all of the limitations of 15 (see above). Dadgar further teaches the sensors of the system may be configured to come into direct contact with fluid flowing through the system (para 65). This means they also are configured to not come into direct contact with the fluid flowing through the system (sensor able to detect the presence of a fluid without direct contact to the fluid).
Regarding Claim 20, Floeser in view of Dadgar teach all of the limitations of Claim 15 (see above). While Dadgar does not explicitly teach the sensors to be on each fiber situated at a distance inferior to 20 cm from the flow separation point, it would have been obvious to place sensors where needed to determine the flow characteristic’s and a mere rearrangement of parts is prima facie obvious to one of ordinary skill in the art. See MPEP 2144.04(VI)(C).
Regarding Claim 21, Floeser in view of Dadgar teach all of the limitations of Claim 15 (see above). Floeser further teaches the pumping unit to be two syringe connections so cell suspension is moved back and forth (pumping unit comprises at least one volumetric pump).
The limitation of moving the multicomponent fluid volume from the first or second buffer channels to the main channel or from the main channel to the first or second buffer channel is an intended use of the device. A recitation of the intended use 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 use, then it meets the claim (see MPEP 2114). The pumping unit would be capable of moving the fluid in the claimed manner and therefore meets the claim.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Floeser (DE20209547U1) in view of Dadgar et al. (WO2019126212A1) and further in view of Gilboa-Geffen et al. (CN110325841A).
Floeser in view of Dadgar teaches all of the limitations of Claim 17. Floeser in view of Dadgar further teaches a control module to be components of the system, such as sensors and pumps, that work together to control one or more characteristics of the system or fluid controlled by the system (feedback loop activated by at least one sensor). Floeser in view of Dadgar does not teach the pumping unit to be a servo pump.
Gilboa-Geffen teaches a means for driving liquid flow and controlling flow rate (para 19). Gilboa-Geffen further teaches the means may be a gas pump or air pump (servo pump). Note: Applicant’s specification, page 12, states the servo pumps may be gas pumps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Floeser in view of Dadgar with the gas pump as taught by Gilboa-Geffen. One would have been motivated to make this modification as it would have provided an effective pump for the movement of fluid and it would have been obvious to select it base on its suitability for its intended use. See MPEP 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796