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 .
Claim Interpretation
The term “embeds” recited in claim 1 not defined in the applicant’s disclosure. The term is interpreted to mean “encloses”.
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: “a mononuclear cell separating unit” in claim 1; “a blood storing unit” in claim 2; “a separating agent storing unit” in claim 3; “a driving unit” in claim 5; “a slave unit” in claim 6; “a second driving unit” in claim 12; “a second slave unit” in claim 13.
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.
Claim(s) 1-5, 7-12 and 14-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tanabe et al. (already of record, US 2018/0245041; hereinafter “Tanabe”).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Tanabe discloses a method for processing cells, comprising: providing a cell processing apparatus comprising a mononuclear cell separating unit (FIG. 34: vessel (203); [0339]), a housing that embeds the mononuclear cell separating unit such that the mononuclear cell separating unit is entirely disposed inside the housing (a cassette-like casing (259) enclosing the mononuclear cell separating unit (203); FIG. 34; [0353] to [0354]), a waste liquid storage, which is disposed outside the housing and is configured to store
waste liquid (FIG. 34: waste liquid storage section (228) disposed outside the casing (259); [0345] and [0353]-[0354]), and a waste liquid solution-feeding channel connecting the mononuclear cell separating unit and the waste liquid storage (FIG. 34; effluent from mononuclear cell separating unit (203) is transferred to waste liquid storage section (228) via channel (226) communicating with the waste liquid storage section (228) disposed outside the casing (259); [0345]); separating, in the mononuclear cell separating unit, a mononuclear cell from blood or a
blood cell (mononuclear cell is separated from blood or a blood cell using separating agent; [0340]); and transferring waste liquid from the mononuclear cell separating unit to the waste liquid storage through the waste liquid solution-feeding channel (effluent from mononuclear cell separating unit (203) is transferred to waste liquid storage section (228); [0345]).
Regarding claim 2, Tanabe further discloses wherein the cell processing apparatus further comprises a blood storing unit, which stores the blood or the blood cell and is disposed inside the housing (FIG. 34: blood storing unit (201) disposed within the casing (259); [0354]), and a blood solution-feeding channel connecting the mononuclear cell separating unit and
the blood storing unit (FIG. 1: channel 202; [0339]), and wherein the method further comprises transferring the blood or the blood cell from the blood storing unit to the mononuclear cell separating unit through the blood solution-feeding channel ([0339]).
Regarding claim 3, Tanabe further discloses wherein the cell processing apparatus further comprises a separating agent storing unit, which stores a separating agent suitable for separating
the mononuclear cell from the blood or the blood cell and is disposed outside the housing (FIG. 34: separating agent storing device (205) disposed outside the casing (259); [0340]), and a separating agent solution-feeding channel connecting the mononuclear cell separating
unit and the separating agent storing unit (FIG. 34: channel 206), and wherein the method further comprises transferring the separating agent from the separating agent storing unit to the mononuclear cell separating unit through the separating agent solution-feeding channel ([0340]).
Regarding claim 4, Tanabe further discloses wherein the cell processing apparatus further comprises a filter, which is disposed inside the housing (FIG. 34: mononuclear cell purifying filter (210) disposed within the casing (259); [0340]), and a mononuclear cell solution-feeding channel connecting the mononuclear cell
separating unit and the filter (FIG. 34: channel (208); [0340]), and wherein the method further comprises transferring a supernatant containing the mononuclear cell from the mononuclear cell separating unit to the filter through the mononuclear cell solution-feeding channel, and filtering the supernatant to remove components other than the mononuclear cell (mononuclear cell-containing supernatant in the mononuclear cell separating unit (203) is sent to a mononuclear cell purifying filter through a mononuclear cell solution-feeding channel (208); [0340]).
Regarding claim 5, Tanabe further discloses wherein the cell processing apparatus further comprises a driving unit, which is disposed outside the housing and is configured to flow a liquid in the mononuclear cell solution-feeding channel (FIG. 34: pump (209) disposed outside the casing (259); [0340]), and wherein the method further comprises operating the driving unit to transfer the supernatant from the mononuclear cell separating unit to the filter through the mononuclear cell solution-feeding channel ([0340]).
Regarding claim 7, Tanabe further discloses wherein the driving unit is attached to an outer wall of the housing (pump (209) is coupled to an outer surface of casing (259) and coupled to the mononuclear cell solution-feeding channel (208)).
Regarding claim 8, Tanabe further discloses wherein the housing comprises at least one selected from the group consisting of a resin, glass, and a metal (casing made of a resin; [0353]).
Regarding claim 9, Tanabe further discloses wherein the cell processing apparatus further comprises a vessel, which is disposed inside the housing (FIG. 34: factor introducing device (213) disposed within the casing (259); [0342]), and a preintroduction cell solution-feeding channel connecting the mononuclear cell
separating unit and the vessel (FIG. 34: channels (211); [0342]), and wherein the method further comprises transferring a supernatant containing the mononuclear cell from the mononuclear cell separating unit to the vessel through the preintroduction cell solution-feeding channel, and introducing an inducing factor into the mononuclear cell in the vessel ([0342]).
Regarding claim 10, Tanabe further discloses wherein the cell processing apparatus further comprises a vessel, which is disposed inside the housing (FIG. 34: factor introducing device (213) disposed within the casing (259); [0342]), and a preintroduction cell solution-feeding channel connecting the filter and the vessel (mononuclear purifying filter (210) coupled to factor introducing device (213) via channel (211); [0342]), and wherein the method further comprises transferring the supernatant filtered by the filter to the vessel through the preintroduction cell solution-feeding channel, and introducing an inducing factor into the mononuclear cell in the vessel ([0340], [0342]).
Regarding claim 11, Tanabe further discloses wherein the cell processing apparatus further comprises a factor storage, which is disposed outside the housing and stores the inducing factor (FIG. 34: factor storing device (214) disposed outside the casing (259);), and a factor solution-feeding channel connecting the vessel and the factor storage (FIG. 34: channel (215); [0342]), and wherein the method further comprises transferring the inducing factor from the factor storage to the vessel by the factor solution-feeding channel ([0342]).
Regarding claim 12, Tanabe further discloses wherein the cell processing apparatus further comprises a second driving unit, which is disposed outside the housing and is configured to flow a liquid in the preintroduction cell solution-feeding channel (FIG. 34: channel 211 is coupled to a pump (212) that is disposed outside the casing (259); [0342]), and wherein the method further comprises operating the second driving unit to transfer the
supernatant from the mononuclear cell separating unit to the vessel through the preintroduction cell solution-feeding channel ([0342]).
Regarding claim 14, Tanabe further discloses wherein the second driving unit is attached to an outer wall of the housing (pump (212) is coupled to an outer surface of casing (259) and coupled to the mononuclear cell solution-feeding channel (211)).
Regarding claim 15, Tanabe further discloses wherein the vessel comprises a tube ([0342]).
Regarding claim 16, Tanabe further discloses wherein the vessel comprises a tube ([0342]).
Regarding claim 17, Tanabe further discloses wherein the driving unit comprises a tubing pump ([0339]).
Regarding claim 18, Tanabe further discloses wherein the second driving unit comprises a tubing pump ([0339]).
Regarding claim 19, Tanabe further discloses wherein the inducing factor is introduced into the mononuclear cell by RNA lipofection ([0342]).
Regarding claim 20, Tanabe further discloses wherein the inducing factor is included in a vector ([0342]).
Therefore, Tanabe meets and anticipates the limitations set forth in claim(s) 1-5, 7-12 and 14-20.
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.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe as applied to claims 5 and 12 above, and further in view of Arai et al (JPH-04254748-A; with English machine translation; hereinafter “Arai”).
Regarding claim 6, Tanabe discloses the method according to claim 6. Tanabe does not explicitly disclose a slave unit, which is disposed inside the housing and is connected to the mononuclear cell solution-feeding channel, and wherein the driving unit and the slave unit are configured such that driving force from the driving unit is transmitted to the slave unit. Arai discloses a cassette (FIGS. 1-4: cassette mount (11)) comprising an interior having a solution-feeding channel (52) coupled to a pump head (4). A rotating shaft (12) is arranged exterior of the cassette and coupled to the pump head (FIGS. 1-4). In view of Arai, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump of Tanabe with the pump of Arai to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known pumping means for another for the predictable result of conveying fluid through the device.
Regarding claim 13, Tanabe discloses the method according to claim 12. Tanabe does not explicitly disclose a second driving unit, which is disposed outside the housing and is configured to flow a liquid in the preintroduction cell solution-feeding channel, and wherein the method further comprises operating the second driving unit to transfer the
supernatant from the mononuclear cell separating unit to the vessel through the preintroduction cell solution-feeding channel. Arai discloses a cassette (FIGS. 1-4: cassette mount (11)) comprising an interior having a solution-feeding channel (52) coupled to a pump head (4). A rotating shaft (12) is arranged exterior of the cassette and coupled to the pump head (FIGS. 1-4). In view of Arai, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second pump of Tanabe with the pump of Arai to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known pumping means for another for the predictable result of conveying fluid through the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tanaami (JP 2004-212361) discloses a substrate comprising a plurality of chambers. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799