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 without traverse of group II, claims 7-17 in the reply filed on 11/17/2025 is acknowledged. Applicant has amended claims 2-5 to depend from elected claim 8, therefore, are considered to be part of group II. Applicant has cancelled claims 1 and 6. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
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.
Claim 9 is 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 9, the limitation “material having an average dimension greater than an upper dimension” renders the claim indefinite because claim fails to define what “upper dimension” is.
Regarding claim 10, the limitation “wherein the second filtration module is configured to remove material having an average dimension less than a lower dimension from a suspension of biological material” renders the claim indefinite because claim fails to define what “lower dimension” is.
Regarding claim 10, the limitation “wherein each of the gas control module and the service media control module is independently fluidly coupled to one or more of the modules” renders the claim indefinite because it is unclear whether “one or more of the modules” also include gas control module and/or service media control modules or only include modules recited in claim 7.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
Claim(s) 7-11 and 15-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yamaguchi et al. (US 2010/0190965A1).
Regarding claim 7, Yamaguchi teaches a fractional filtration system (fig. 4) comprising:
a sample preparation module (4);
a first filtration module (8), wherein the first filtration module is fluidly coupled to the sample preparation module (refer fig. 4);
a second filtration module (24), wherein the second filtration module is fluidly coupled to the first filtration module (refer fig. 4); and
a target material processing module (21), wherein the target material processing module is fluidly coupled to the second filtration module (refer fig. 4);
wherein each of the first filtration module and the second filtration module independently comprises a crossflow filter (Refer abstract, [0089]).
Regarding claim 8, Yamaguchi teaches limitations of claim 7 as set forth above. Yamaguchi further teaches that each of the first filtration module and the second filtration module independently a crossflow filter membrane comprising a porous substrate and a coating overlying the porous substrate (refer [0199] disclosing a coating method that immerses the membrane in a solution containing the hydrophilic polymer, and dries the membrane to allow the hydrophilic polymer to remain on the surface of the membrane).
Regarding claim 9, Yamaguchi teaches limitations of claim 7 as set forth above. The limitation “wherein the first filtration module is configured to remove material having an average dimension greater than an upper dimension from a suspension of biological material” is inherent to a semipermeable membrane of Yamaguchi which allows material smaller than the pore size of the semipermeable membrane to permeate and prevent material larger than the pore size of the semipermeable membrane from permeating.
Regarding claim 10, Yamaguchi teaches limitations of claim 7 as set forth above. The limitation “wherein the second filtration module is configured to remove material having an average dimension less than a lower dimension from a suspension of biological material” is inherent to a semipermeable membrane of Yamaguchi which allows material smaller than the pore size of the semipermeable membrane to permeate and prevent material larger than the pore size of the semipermeable membrane from permeating.
Regarding claim 11, Yamaguchi teaches limitations of claim 7 as set forth above. Yamaguchi further teaches a loading/unloading module (1) fluidly coupled to the sample preparation module.
Regarding claim 15, Yamaguchi teaches limitations of claim 7 as set forth above. The limitation “wherein the fractional filtration system is configured to separate a target biological material from a suspension” is reciting a function of the system or manner of operating the system without imparting additional structure. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Yamaguchi teaches separating immunoglobulin monomers (biological material) from a suspension (Refer abstract).
Regarding claims 16-17, Yamaguchi teaches limitations of claim 15 as set forth above. The limitations “wherein the target biological material is viable” (claim 16) and “wherein the target biological material is capable of reproducing” (claim 17) is reciting material being worked upon by apparatus without imparting additional structure. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2, 3, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (US 2010/0190965A1), in view of Halbach (US 20160001237A1).
Regarding claims 2, 3, 4, and 5, Yamaguchi teaches limitations of claim 8 as set forth above. Yamaguchi does not teach that the coating is elastomeric (claim 2), the coating has shear modulus greater than 0.3 MNm-2 (claim 3), the coating comprises silicone (claim 4), and the coating comprises a functionalized coating (claim 5).
Halback teaches a porous membrane comprising thermoplastic silicone elastomers (abstract). Halback discloses that silicone can be applied as coating (refer [0145]). In table 2, Halback discloses breaking stress of 1.52 and 2.84 MPa which is substantially higher than 0.3 MNm-2. Halback also discloses that the coating provides better mechanical properties (refer [0112], [0120]) which indicates higher shear modulus. Halback also teaches functionalizing the coating (refer [0209]).
It would have been obvious to one of ordinary skill in the art to modify the coating of Yamaguchi to include elastomeric silicone, coating having shear modulus greater than 0.3 MNm-2 and coating being functionalized to improve selectivity and better mechanical properties as taught by Halbach (refer [0112], [0120]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (US 2010/0190965A1), in view of Jay (US 2015/0298035A1).
Regarding claim 12, Yamaguchi teaches limitations of claim 7 as set forth above. Yamaguchi does not teach that the system comprises a temperature control module operatively coupled to one or more of the modules.
Jay teaches a crossflow filtration system (abstract, fig. 1). Jay discloses that the system include in-circuit heat exchangers (not shown) in one or more stages to facilitate temperature adjustment during operation, and may also include additional tanks for permeate and retentate collection and for cleaning solution preparation and supply (refer [0050]). [0067] discloses temperature controlled water is filled into the feed tank (1) or supplied from an external tank.
It would have been obvious to one of ordinary skill in the art to modify the system of Yamaguchi to include a temperature control module operatively coupled to one or more of the modules to facilitate temperature adjustment during operation as taught by Jay.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (US 2010/0190965A1), in view of Shimura et al. (US 2021/0163865).
Regarding claim 13, Yamaguchi teaches limitations of claim 7 as set forth above. Yamaguchi does not teach that the system comprises a gas control module; and service media control module fluidly coupled to one or more of the modules.
Shimura teaches a filtration system comprising a sample preparation module (1) connected to a filtration module (2). The system also comprises a gas control module (91) and a service media control module (feedstock tank or neutralizer) fluidly coupled to the sample preparation module (Refer fig. 1).
It would have been obvious to one of ordinary skill in the art to modify the system of Yamaguchi to include a gas control module to control gas produced in the module and to include service media control module to control addition of neutralizer as taught by Shimura.
Regarding claim 14, Yamaguchi teaches limitations of claim 7 as set forth above. Yamaguchi does not teach that the fractional filtration system is sealed from the ambient environment.
Shimura teaches a filtration system comprising a sample preparation module (1) connected to a filtration module (2). Yamaguchi teaches that module 1 is configured, if desired, to allow for sterilization and hermetic sealing (refer [0043]).
Selecting to provide the system in a sterilized environment or sealed from the ambient environment would have been an obvious matter of choice to one of ordinary skill in the art based on the material being worked upon by the system since Shimura discloses that, if desired, the module can be configured to allow for sterilization and hermetic sealing.
Conclusion
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PRANAV PATEL
Examiner
Art Unit 1777
/PRANAV N PATEL/Primary Examiner, Art Unit 1777