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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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.
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 1-4, 6-10 and 19-25 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.
Claim 1 recites the limitation "at least one smart tank" in line 13. It is unclear whether the at least one smart tank is referring to the modular smart tank recited earlier in the claim or is an additional smart tank. Claims 2-4, 6-10 and 25 are included in this rejection by virtue of their dependency upon a rejected base claim.
Regarding claim 10, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18 recites the limitation "the at least one sidewall elements" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. Further, the claim recites the limitation “at least one sidewall element” in line 4, and then recites the limitation “one or more of the at least one sidewall elements.” It is unclear how many sidewall elements are required by the claim. Claims 19-24 are included in this rejection by virtue of their dependency upon a rejected base 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)(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.
Claims 1-4 and 9-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gabusi (already of record, WO 2020/225838-A1).
Regarding claim 1, Gabusi discloses an assembly system for assembling a modular smart tank for a biopharma process under clean room conditions, the system comprising: at least one mobile storage means (see FIG. 1 of Gabusi, annotated and reproduced below; transport container (20); page 10, ll. 8-11) for storing components of the modular smart tank (interpreted as a simple container);
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the at least one mobile storage means of Gabusi is structurally the same as the instant at least one mobile storage means, and thus fully capable of “storing components of the modular smart tank, the components including a top plate element, at least one sidewall element, and a bottom plate element. wherein the top plate element, the at least one sidewall element and the bottom plate element can be assembled to form a reservoir of the smart tank for receiving at least one biochemical medium, wherein at least one of the top plate element, the at least one sidewall element and the bottom plate element comprises at least one channel for guiding the at least one biochemical medium and/or an operating medium”); an assembly room (see annotated FIG. 1: processing chamber (12); p. 9, line 30 to p. 10, line 3), wherein the assembly room is adapted to provide clean room conditions and wherein the assembly room is configured to allow assembly of at least one smart tank within the assembly room from the components stored in the mobile storage means (FIG. 1: processing chamber (12) of Gabusi is structurally the same as the instant assembly room and thus considered to be fully capable of meeting the claimed functions; p. 9, line 30 to p. 10, line 3), and a manipulator, being adapted to automatically assemble the smart tank within the assembly room (FIG. 1: robotic arm (13) structurally the same as the instant manipulator and thus considered to be fully capable of meeting the claimed functions; see also p. 12, ll. 23-29),
Furthermore, it is noted that the phrase “can be” renders the limitations that follow the phrase optional.
Furthermore, it is noted that the recitation of functional language "e.g., for assembling a modular smart tank" 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 assembly system and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, Gabusi further discloses wherein the mobile storage means includes a sealable opening that is configured for allowing removal of components of the at least one smart tank from the mobile storage means, and wherein the assembly room comprises at least one corresponding sealable opening that is configured for receiving components from a mobile storage means (FIG. 1: transport container 20 comprises closing means (20’) that is coupled to closing means (19’); p. 10, ll. 17-24), whereinthe sealable opening of the mobile storage means and the corresponding seal able opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the mobile storage means (FIG. 1: transport container 20 comprises closing means (20’) to be coupled with a mating closing means (19’); p. 10, line 17 to p. 11, line 5). Furthermore, 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.
Regarding claim 3, regarding the limitation “wherein the mobile storage means is provided as a single use device. wherein optionally the mobile storage means is a plastic-based device that can be discarded after use,” it is noted that the mobile storage means of the system of Gabusi is structurally the same as the instant mobile storage means and thus considered to meet the limitation “provided as a single use device.”
Regarding claim 4, Gabusi further discloses wherein the manipulator is adapted to remove components from the mobile storage means and to assemble a smart tank within the assembly room from the removed components to form an assembled smart tank (p. 7, ll. 7-12; col. 17, line 3 to p. 18. Line 13). Furthermore, it is noted that the recitations of functional language "to remove components from the mobile storage means and to assemble a smart tank within the assembly room from the removed components to form an assembled smart tank" are 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 9, Gabusi further discloses wherein the mobile storage means is adapted to allow sterilization of smart tank components being stored within the mobile storage means (the mobile storage means of the system of Gabusi is structurally the same as the instant mobile storage means and thus considered to meet the limitation “allow sterilization of smart tank components being stored within the mobile storage means.”
Regarding claim 10, regarding the limitation “wherein the manipulator is adapted to
disassemble smart tanks and optionally to remove assembled smart tanks from a clean room bag, and wherein the system optionally, further comprises at least one recycling means, adapted for receiving disassembled components of a smart tank and preferably for shredding said components, wherein the recycling means maybe adapted to sealingly couple to the assembly room, the recycling means optionally comprises
at least one sealable opening that is configured for receiving disassembled components from the assembly room, wherein the at least one sealable opening of the recycling means and the corresponding sealable opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the recycling means, and wherein the
sealable opening of the recycling means is further optionally covered by at least one cover element,
wherein the at least one cover element of the recycling means and the at least one corresponding cover element of the assembly room are configured to couple with each other to open jointly,” it is noted that the manipulator of the system of Gabusi is structurally the same as the instant manipulator and thus considered to meet the limitation “disassemble smart tanks.” Furthermore, the limitation “to disassemble smart tanks” 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).
Therefore, Gabusi meets and anticipates the limitations set forth in claim(s) 1-4 and 9-10.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gabusi as applied to claim 1 above, and further in view of Okabe (already of record, US 8,171,964).
Regarding claim 6, Gabusi discloses the assembly system according to claim 1. Gabusi discloses wherein the assembly system includes delivery means for delivering the at least one mobile storage means to the assembly room (see FIG. 1 of Gabusi). Gabusi does not explicitly disclose at least one mobile delivery means the mobile delivery means being adapted to transport the at least one mobile storage means to the assembly room, and wherein optionally the at least one mobile delivery means is adapted to transport mobile storage means to the assembly room in a predefined order. Okabe discloses a mobile storage means (FIG. 1: pod main body 2) coupled to a mobile delivery means (pod table 22) adapted to transport the at least one mobile storage means (see col. 7, ll. 11-20). In view of Okabe, 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 employed the mobile delivery means of Okabe with the assembly system of Gabusi for the purpose of automating the process of delivering the at least one mobile storage means to the assembly room. Further, one of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known delivery means for another for the predictable result of moving components within a system.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gabusi as applied to claim 1 above, and further in view of Mossig (already of record, WO 2019/053186-A1; US 2020/0261901 is used as English translation).
Regarding claim 7, Gabusi discloses the assembly system according to claim 1. Gabusi does not explicitly disclose wherein the assembly room is an assembly bag, comprising flexible wall elements, the assembly bag being optionally a sterile bag, that is further optionally a single-use bag. Mossig discloses that assembly rooms can be formed of flexible or rigid materials ([0002]). In view of Mossig, 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 assembly room of Gabusi with flexible material, because Mossig discloses that it is well known in the art to construct the assembly rooms with flexible or rigid materials ([0002]). 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).
Regarding claim 8, Gabusi does not explicitly disclose wherein the manipulator is provided outside the assembly room, and wherein optionally the manipulator is at least partially covered by a manipulator bag, further optionally the manipulator bag being integrally formed with an assembly bag. Mossig discloses a system comprising an assembly room (shell 3; [0055]) and a manipulator that is provided outside the assembly room (external actuating device (25); [0057]). In view of Mossig, 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 assembly system of Gabusi with the system of Mossig to arrive at the claimed invention. One of ordinary skill in the art would have made said modification since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see also MPEP § 2144.04 VI. C.). One would have been motivated to rearrange the manipulator outside the assembly room for the purpose of maximizing working space within the assembly room.
Claim(s) 18-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niazi (already of record, US 2011/0217690) in view of Bisconte (already of record, US 4,696,902).
Regarding claims 18 and 23, Niazi discloses a modular smart tank system for use in a bio-pharmaceutical process, the system comprising a first smart tank (see FIGS. 3-4 which disclose a system comprising a plurality of tanks; [0034]-[0036]). Niazi does not explicitly disclose wherein tank comprises a top plate element, at least one sidewall element, and/or a bottom plate element, wherein the top plate element, the at least one sidewall element and/or the bottom plate element comprises at least one assembly-connecting means and at least one corresponding assembly-connecting means, the assembly-connecting means and the corresponding assembly-connecting means being configured to engage with each other so as to secure an assembly of at least two adjacent elements selected from the group of top plate element, one or more sidewall elements, and bottom plate element. Bisconte discloses a system comprising a storage container having a top plate element, at least one sidewall element, and/or a bottom plate element, wherein the top plate element, the at least one sidewall element and/or the bottom plate element comprises at least one assembly-connecting means and at least one corresponding assembly-connecting means (see FIG. 3: assembly-connecting means (27,28); col. 8, ll. 29-37). In view of Bisconte, 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 tank of Niazi with the tank Bisconte to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have resulted in tank having the added advantage of ease of assembly as suggested by Bisconte (see FIG. 3: assembly-connecting means (27,28); col. 8, ll. 29-37). Modified Niazi further discloses wherein at least one of the top plate element, the at least one sidewall element and/or the bottom plate element comprises at least one first channel portion and at least one channel-connecting means associated with the respective first channel portion the channel-connecting means and the corresponding channel-connecting means being configured to engage with each other so as to form a fluidically sealed channel connection between the first channel portion and a second channel portion, so as to form at least one channel (see Niazi FIGS. 3-4 which discloses at least two tanks fluidically connected via a channel connected to the tanks by connecting means), at least one bypass channel is provided, for guiding a biochemical medium and/or an operating medium (channel connecting end tanks), and wherein the system comprises a second smart tank, wherein a tank-interconnecting port serves for coupling a channel of the first smart tank fluidically to a corresponding channel of a second smart tank (see Niazi FIGS. 3-4 which discloses at least two tanks fluidically connected via a channel connected to the tanks by connecting means).
Regarding claims 19-20, modified Niazi further discloses wherein a height compensation means is provided, and wherein the height compensation means is adapted so that the top plate element of the first smart tank can be installed at substantially the same height as a top plate element of the second smart tank (as shown in FIGS. 3-4, the height compensation means is adapted to move the tanks up and down as desired elevation). Furthermore, it is noted that the phrase “can be” renders the limitations that follow the phrase optional.
Regarding claim 21, modified Niazi does not explicitly disclose wherein coupling of the height compensation means to the first smart tank is carried out automatically, using a manipulator. However, 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 automated the coupling of the height compensation means to the first smart tank for the purpose of increasing the throughput of the system.
Regarding claim 22, modified Niazi further discloses wherein multiple smart tanks are assembled and directly interconnected with each other, such that at least one channel of the first smart tank is fluidically connected to a corresponding channel of the second smart tank (see Niazi FIGS. 3-4 which discloses at least two tanks fluidically connected via a channel connected to the tanks by connecting means).
Regarding claim 24, modified Niazi further discloses wherein the height compensation means is provided and is being adapted to be coupled to the first smart tank (see Niazi at FIGS. 3-4).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Gabusi in view of Okabe as applied to claim 6 above, and further in view of Tokunaga (US 2004/0152322).
Regarding claim 25, modified Gabusi discloses the assembly system according to claim 6. Modified Gabusi does not explicitly disclose wherein the at least one mobile delivery means is an automated guided vehicle. Tokunaga discloses wherein various types of mobile delivery means can be employed for delivering components into a manufacturing room including automated guided vehicle ([0114]). In view of Tokunaga, 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 mobile delivery means of modified Gabusi with an automated guided vehicle 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 substitution of one known mobile delivery means for another for the predictable result of guiding components into an enclosure, as disclosed by Tokunaga ([0114]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-10, 16 and 18-24 have been considered but are moot in view of the new ground of rejection.
With respect to the Applicant’s argument regarding the rejection of claim 1 (Remarks at page 10), Applicant’s argument is not persuasive. It is noted that the components of the modular smart tank are not positively recited in the claims. The claims merely requires at least one mobile storage means that can be used for storing articles included the claimed articles. As discussed in the rejection, Gabusi discloses at least one mobile storage means that is structurally the same as the instant at least one mobile storage means, and thus fully capable of storing components including the claimed components.
With respect to the Applicant’s argument regarding the rejection of claim 18 (Remarks at pages 11-12), Applicant’s argument is not persuasive. It is noted that independent claim 18 does not require a reservoir defined/integrated by a top plate element, sidewall element and bottom plate element. Claim 18 requires a system comprising one of a top plate element, at least one sidewall element and a bottom plate element comprises assembly-connecting means and channel-connecting means. As discussed in the rejection, Niazi in view of Bisconte discloses a tank comprising assembly-connecting means and channel-connecting means (see Niazi FIGS. 3-4, which discloses at least two tanks fluidically connected via a channel connected to the tanks by connecting means).
Conclusion
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 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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