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 without traverse of Group I, claims 1-17, in the reply filed on March 30, 2026 is acknowledged.
Claim Objections
Claims 1-17 are objected to because of the following informalities: In claim 1, the limitation “suspension cell” should probable read “cell suspension” for consistency with the Applicant’s disclosure. In claims 2-17, “The device” should read “The platelet production device” for consistency. Appropriate correction is required.
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 1-17 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.
The term “large-scale” in claim 1 is a relative term which renders the claim indefinite. The term “large-scale” 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. It is unclear as to what constitutes “large-scale” platelet production. Claims 2-17 are included in this rejection by virtue of their dependency upon a rejected base claim.
Regarding claims 6, 9 and 14-17, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites the limitation "the head cap" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 8 is treated as being dependent from claim 6.
Claim 14 recites the limitation "the volumes" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "porous material" in line 2. However, it is unclear if said limitation is referring to the porous material recited earlier in the claim or is an additional element.
Claim 16 recites the limitation "porous material" in line 2. However, it is unclear if said limitation is referring to the porous material recited earlier in the claim or is an additional element.
Claim 16 recites the limitation "the density" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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.
Claims 1, 3-8, 10-12 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR 2016-0108844-A; with English machine translation).
Regarding claim 1, Kim discloses a platelet production device for large-scale platelet production from megakaryocytes, comprising: a vessel (see, e.g., FIGS. 8-9: culture tank body (10); [0169]) and a rotatable bed reactor disposed therein (FIG. 8: bed (202) rotatable by bed shaft (811); [0137]-[0138]), wherein the bed reactor is configured to contain a porous material ([0124]) and to be immersed into a suspension cell contained within the vessel (the bed reactor of Kim is structurally the same as the instant bed reactor and thus fully capable “to contain a porous material and to be immersed into a suspension cell contained within the vessel”; see [0150]). Furthermore, it is noted that the recitation of functional language "to contain a porous material and to be immersed into a suspension cell contained within the vessel" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 3, Kim further discloses wherein the bed reactor comprises a through hole disposed at the center of the bed reactor (see FIGS. 8-9: through hole formed in a center of cover hub (245) and lower hub (235) receiving bed shaft (811)).
Furthermore, the limitation “for facilitating a flow of the cell suspension through the bed reactor” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 4, Kim further discloses wherein the bed reactor comprises a hollow body including a peripheral outer wall extending from a base plate to a top plate (FIG. 8: bed (202) includes bed body (230) having bed cover (240) on an upper portion of the bed body and a bottom bed cover having a bottom portion of the bed body, and a peripheral outer wall therebetween; see also [0113]-[0124]), and wherein the peripheral outer wall comprises openings or is made of a mesh, preferably the hollow body has a cylindrical shape (see FIGS. 8 and 9; [0113], [0117]-[0118] and [0121]).
Regarding claim 5, Kim further discloses wherein the bed reactor further comprises inner walls disposed within the hollow body and extending from the base plate to the top plate, wherein the inner walls each include a plurality of openings formed thereon (FIG. 8: support (237); [0125]).
Regarding claims 6 and 8, the vessel of Kim is structurally the same as the instant vessel and thus considered to be fully capable “to be capped with a head cap forming a chamber preferably the chamber is configured to be purged, wherein the head cap comprises an opening for adding the cell suspension into the vessel.”
Regarding claim 7, the bed reactor of Kim is structurally the same as the instant bed reactor and thus considered to be fully capable “to be attached to a rotor shaft via a connector, wherein the connector comprises apertures for facilitating the cell suspension to enter into the bed reactor.”
Regarding claim 10, the vessel of Kim is structurally the same as the instant vessel and thus considered to be fully capable “to be jacketed using a cooling or heating jacket.” See also [0054])
Regarding claim 11, the bed reactor of Kim is structurally the same as the instant bed reactor and thus considered to be fully capable “to be rotated at up to 1000 rpm.”
Regarding claim 12, Kim further discloses wherein the bed reactor further comprises inner walls disposed within the hollow body and extending from the base plate to the top plate, wherein the inner walls each include a plurality of openings formed thereon (FIG. 8: support (237) arranged between layers of porous materials; [0125]).
Regarding claim 16, regarding the limitations “wherein the density of megakaryocytes per cubic millimeter of porous material is in a range of 10-103 MK/mm3 to 100-106 MK/mm3 , preferably in a range of 100 - 103 MK/mm3 to 10-106 MK/mm3,” it should be noted that the megakaryocytes are materials worked on and not elements of the claimed device. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. See also [0116] which discloses megakaryocytes suspension.
Therefore, Kim meets and anticipates the limitations set forth in claims 1, 3-8, 10-12 and 16.
Claims 1-2, 6-8, 10-11 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakano et al (US 2011/0065190; hereinafter “Nakano”).
Regarding claim 1, Nakano discloses a platelet production device for large-scale platelet production from megakaryocytes, comprising: a vessel (FIG. 5: housing 11; [0114]) and a rotatable bed reactor disposed therein (FIG. 5: composite membrane 8; [0114]), wherein the bed reactor is configured to contain a porous material ([0114]) and to be immersed into a suspension cell contained within the vessel (the bed reactor of Nakano is structurally the same as the instant bed reactor and thus fully capable “to contain a porous material and to be immersed into a suspension cell contained within the vessel”; see [0114]). Furthermore, it is noted that the recitation of functional language "to contain a porous material and to be immersed into a suspension cell contained within the vessel" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, the cell suspension is a material worked on and not an element of the claimed device. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. See also [0116] which discloses megakaryocytes suspension. Nakano further discloses wherein the porous material comprises foams, fibers, 3D printed porous structures, woven filters, non-woven filters, microcarriers, gels or hydrogels or packed-beads (see [0095]-[0096]).
Regarding claims 6 and 8, the vessel of Nakano is structurally the same as the instant vessel and thus considered to be fully capable “to be capped with a head cap forming a chamber preferably the chamber is configured to be purged, wherein the head cap comprises an opening for adding the cell suspension into the vessel.”
Regarding claim 7, the bed reactor of Nakano is structurally the same as the instant bed reactor and thus considered to be fully capable “to be attached to a rotor shaft via a connector, wherein the connector comprises apertures for facilitating the cell suspension to enter into the bed reactor.”
Regarding claim 10, the vessel of Nakano is structurally the same as the instant vessel and thus considered to be fully capable “to be jacketed using a cooling or heating jacket.” See also [0054]).
Regarding claim 11, the bed reactor of Nakano is structurally the same as the instant bed reactor and thus considered to be fully capable “to be rotated at up to 1000 rpm.”
Regarding claim 16, regarding the limitations “wherein the density of megakaryocytes per cubic millimeter of porous material is in a range of 10-103 MK/mm3 to 100-106 MK/mm3 , preferably in a range of 100-103 MK/mm3 to 10-106 MK/mm3,” it should be noted that the megakaryocytes are materials worked on and not elements of the claimed device. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115. See also [0116] which discloses megakaryocytes suspension.
Regarding claim 17, Nakano further discloses wherein the porous material is coated with a ligand having affinity for megakaryocytes, preferably the ligand comprises von Willebrand factor or its functional variants, polypeptides comprising fragments of Willebrand factor, fibrinogen, fibronectin, laminin, type IV collagen, type III collagen, type I collagen, or vitronectin ([0098]-[0099]).
Therefore, Nakano meets and anticipates the limitations set forth in claims 1-2, 6-8, 10-11 and 16-17.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above.
Regarding claim 2, Kim disclose the platelet production device according to claim 1 as set forth above. Kim does not explicitly disclose wherein the porous material comprises foams, fibers, 3D printed porous structures, woven filters, non-woven filters, microcarriers, gels or hydrogels or packed-beads. However, Kim does suggest that other materials can be used for form the bed reactor ([0044]). 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 substituted the material of the bed reactor with the claimed material because doing so would have been the simple substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Furthermore, the cell suspension is a material worked on and not an element of the claimed device. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 8 above.
Regarding claim 9, Kim disclose the platelet production device according to claim 8 as set forth above. Kim does not explicitly disclose a pump for pumping the cell suspension into the vessel, preferably the pump includes a peristaltic pump. However, Kim does disclose in another embodiment a pump for introducing materials into the vessel (e.g., supply pump (64); [0054])). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a pump with the device of Kim for the purpose of providing means for introducing materials within the vessel as discussed by Kim ([0054]). Furthermore, the limitation “for pumping the cell suspension into the vessel,” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of Cheng et al. (US 2010/0035343; hereinafter “Cheng”).
Regarding claim 13, Kim disclose the platelet production device according to claim 1 as set forth above. Kim does not explicitly disclose wherein the vessel comprises a baffle disposed therein. However, Kim discloses wherein the vessel is coupled to a gas supply means (FIG. 9: air supply device (53)). Cheng discloses a vessel comprising a stirring element and baffles adapted to enhance gas exchange in the vessel ([0038]-[0039]). In view of Cheng, 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 incorporated the baffles of Cheng within the vessel of Kim to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing gas exchange within the vessel as disclosed by Cheng ([0038]-[0039]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kim as applied to claim 1 above, and further in view of Reed (US 4,855,045).
Regarding claim 14, Kim disclose the platelet production device according to claim 1 as set forth above. Kim does not literally define wherein the ratio between the volumes of the bed reactor and the vessel varies from 1: 1 up to 1: 100, preferably from 1:2 to 1:20. Reed discloses wherein a ratio between the volumes of the bed reactor (beads) in a vessel and the vessel varies from 1: 1 up to 1: 100 (col. 1, line 63 to col. 2, line 10). In view of Reed, 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 ratio of the volumes of the bed reactor and the vessel of Kim with the ratio of Reed to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of increasing the throughput of the device as suggested by Reed (see col. 1, ll. 59-61 and col. 2, ll. 2-10).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nakano as applied to claim 1 above.
Regarding claim 15, Nakano disclose the platelet production device according to claim 1 as set forth above. Nakano does not explicitly disclose wherein the bed reactor comprises up to 28 cm3 of porous material and preferably, is configured to fit in a 500 mL vessel. However, Nakano does disclose wherein the volume of the porous material in the vessel should selected to achieve desired process ([0107]). It would therefore 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 volume of the porous material in the vessel of Nakano to a desired volume including the claimed volume, because Nakano discloses that the volume of the porous material in the vessel should selected to achieve desired process ([0107]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hagihara et al (WO 2019-146733) disclose a vessel and a bed reactor within the vessel. 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
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