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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, 15, and 17-18, drawn to a multi-level port vessel, classified in C12M23/02.
II. Claims 19-27, drawn to a method of accessing the interior volume of a vessel body via one of a plurality of ports, classified in C12M29/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process, such as a process of storing a material within a vessel wherein the interior of the vessel is not accessed by any port.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Michael Furmanek on 06/09/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13, 15, and 17-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-13, 15, and 17-18 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 “substantially” in claim 1 (“substantially horizontal rotation axis…substantially horizontal surface”) is a relative term which renders the claim indefinite. The term “substantially” 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. The specification does not provide a standard for ascertaining the degree to which an element would or would not be considered “substantially horizontal”.
Regarding claim 2, the limitation “wherein the plurality of ports comprises two or more ports” is indefinite because a “plurality” by definition is understood to mean two or more. Therefore, it is unclear how claim 2 would further limit the subject matter of claim 1, from which it depends, and the metes and bounds of the claim are therefore unclear.
Claim 9 recites the limitation "the tube" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 6, from which claim 9 depends, provides antecedent basis for a “tube guide” but not for a tube.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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.
Claims 1-5, 12-13, 15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US Patent Application Publication 2020/10002598) (already of record) in view of Shimoji et al. (US Patent Application Publication 2022/0267710).
Regarding claim 1, Lee et al. discloses a multi-level port vessel (Abstract; the vessel comprises ports at multiple levels as discussed at para. 14-15 and shown in Fig. 1, sheet 1 of 4), comprising:
a vessel body defining an interior volume (20) (para. 14), the vessel body having a front wall (para. 14) (Fig. 1), a rear wall (para. 14) (Fig. 1), two side walls (para. 14) (Fig. 1), a bottom (para. 14) (Fig. 1), and a top (para. 14) (Fig. 1), the top being open and being adapted to be covered by a removable lid (para. 14, claim 24) (Fig. 1);
a vertically oriented mixing wheel (22) disposed within the interior volume (para. 14) (Fig. 1), the vertically oriented mixing wheel having a substantially horizontal rotation axis when the vessel body is disposed on a substantially horizontal surface (para. 14) (Fig. 1);
a plurality of ports including a port for removing fluid from the vessel (para. 14-15).
Lee et al. is silent as to a plurality of ports disposed in one of the rear wall, the front wall, or the side walls, at least one port of the plurality of ports being located at an elevation that is at least partially encompassed by a projection of the perimeter of the vertically oriented mixing wheel.
However, Lee et al. discloses that the vessel is configured to maintain cultured suspended cells and allow a quantity of cells to be removed from the vessel (para. 1, 14-15).
Furthermore, Shimoji et al. discloses a vessel for culturing suspended cells (Abstract, para. 90) comprising a plurality of ports (321, 322, 323) disposed on a side wall thereof (para. 92) (Fig. 11, sheet 11 of 21), wherein each of the ports is configured to allow a cell sample to be removed from the vessel (para. 92, 97-98). The plurality of ports comprises first, second, and third ports each provided at a different elevation along the height of the vessel (para. 92, 97-98) (Fig. 11). Shimoji et al. discloses that suspended cells within a vessel will naturally be distributed throughout the height of the vessel according to cell size (para. 46-47) and that providing ports at multiple elevation levels allows samples to be drawn throughout the height of the vessel, e.g., to capture different target cells (para. 92, 97-98) (Fig. 11).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the vessel disclosed by Lee et al. to comprise a plurality of ports, including first, second, and third ports, disposed in one of the rear wall, the front wall, or the side walls, each port being disposed at a different elevation, based on the teachings of Shimoji et al., to allow cells to be sampled from different elevations within the vessel, e.g., to examine a homogeneity of dispersion and/or to capture different target cells.
As to the limitation of at least one port of the plurality of ports being located at an elevation that is at least partially encompassed by a projection of the perimeter of the vertically oriented mixing wheel, the particular placement or position of a prior art element is a prima facie obvious design choice (MPEP 2144.04). Arranging one port of the plurality of ports taught by Lee et al. in view of Shimoji et al. so as to be located at an elevation that is at least partially encompassed by a projection of the perimeter of the vertically oriented mixing wheel would not modify the operation of the vessel, as such a port would still allow fluid to be removed from the vessel, and therefore such an arrangement would be prima facie obvious to the skilled artisan.
Alternatively, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, supports a conclusion of obviousness (MPEP 2143). In this case, the skilled artisan would recognize that there are a finite number of ways to position a plurality of ports along the vessel disclosed by Lee et al. such that each port is at a different elevation (see Fig. 1 of Lee et al.) and it would have been “obvious to try” disposing at least one port at an elevation that is at least partially encompassed by a projection of the perimeter of the vertically oriented mixing wheel, with a reasonable expectation of success of drawing a fluid sample from one of multiple elevation locations.
Regarding claim 2, Lee et al. in view of Shimoji et al. teaches wherein the plurality of ports comprises two or more ports, as set forth above.
Regarding claim 3, Lee et al. in view of Shimoji et al. teaches wherein the plurality of ports comprises a port being located at an elevation that is at least partially encompassed by the perimeter of the vertically oriented mixing wheel (reads on the claimed second port), and wherein the plurality of ports comprises further first and third ports wherein each port is provided at a different elevation, as set forth above.
The prior art combination does not expressly teach wherein the first port located is at an elevation at least partially above the perimeter of the vertically oriented mixing wheel and the third port being located at an elevation at least partially below the perimeter of the vertically oriented mixing wheel.
Nonetheless, it has been held that the particular placement or position of a prior art element is a prima facie obvious design choice (MPEP 2144.04). Arranging the first port and the third port of the plurality of ports taught by Lee et al. in view of Shimoji et al. so as to be located at an elevation at least partially above the perimeter of the mixing wheel and at an elevation at least partially below the perimeter of the mixing wheel, respectively, would not modify the operation of the vessel, as such ports would still allow fluid to be removed from the vessel, and therefore such an arrangement would be prima facie obvious to the skilled artisan.
Alternatively, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, supports a conclusion of obviousness (MPEP 2143). In this case, the skilled artisan would recognize that there are a finite number of ways to arrange a plurality of ports along the vessel disclosed by Lee et al. such that each port is at a different elevation (see Fig. 1 of Lee et al.) and it would have been “obvious to try” disposing the first and third ports at the elevations as claimed, with a reasonable expectation of success of drawing a fluid sample from multiple elevation locations.
Regarding claim 4, Lee et al. in view of Shimoji et al. teaches the first port positioned at a first height from a bottom of the vessel body above the second port, as set forth above.
The prior art combination does not expressly teach the first height corresponding to a vertical dimension of a volume of at least 66% of a full usable volume of the interior volume of the vessel body.
Nonetheless, it has been held that the particular placement or position of a prior art element is a prima facie obvious design choice (MPEP 2144.04). Arranging the first port of the plurality of ports taught by Lee et al. in view of Shimoji et al. so as to be located at a first height corresponding to a vertical dimension of a volume of at least 66% of a full usable volume of the interior volume of the vessel body would not modify the operation of the vessel, as such a port would still allow fluid to be removed from the vessel, and therefore such an arrangement would be prima facie obvious to the skilled artisan.
Alternatively, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, supports a conclusion of obviousness (MPEP 2143). In this case, the skilled artisan would recognize that there are a finite number of ways to arrange the first port at a height along the vessel (see Fig. 1 of Lee et al.) and it would have been “obvious to try” disposing the first port at a height as claimed, with a reasonable expectation of success of drawing a fluid sample from one of multiple elevation locations.
Regarding claim 5, Lee et al. in view of Shimoji et al. teaches the second port positioned at a second height from a bottom of the vessel body above the third port, as set forth above.
The prior art combination does not expressly teach the second height corresponding to a vertical dimension of a volume of approximately 12% of a full usable volume of the interior volume of the vessel body.
Nonetheless, it has been held that the particular placement or position of a prior art element is a prima facie obvious design choice (MPEP 2144.04). Arranging the second port of the plurality of ports taught by Lee et al. in view of Shimoji et al. so as to be located at a second height corresponding to a vertical dimension of a volume of approximately 12% of a full usable volume of the interior volume of the vessel body would not modify the operation of the vessel, as such a port would still allow fluid to be removed from the vessel, and therefore such an arrangement would be prima facie obvious to the skilled artisan.
Alternatively, it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, supports a conclusion of obviousness (MPEP 2143). In this case, the skilled artisan would recognize that there are a finite number of ways to arrange the second port at a height along the vessel (see Fig. 1 of Lee et al.) and it would have been “obvious to try” disposing the second port at a height as claimed, with a reasonable expectation of success of drawing a fluid sample from one of multiple elevation locations.
Regarding claim 12, Lee et al. discloses a removable lid covering the top of the vessel (para. 14, claim 24) (Fig. 1).
Regarding claim 13, Lee et al. discloses wherein the removable lid comprises at least one inlet opening (para. 14, claim 24) (Fig. 1).
Regarding claim 15, Lee et al. discloses wherein the vertically oriented mixing wheel comprises a plurality of mixing paddles (para. 16) and a plurality of magnets (para. 16).
Regarding claim 17, Lee et al. in view of Shimoji et al. teaches providing the at least one port of the plurality of ports disposed in one of the rear wall, the front wall, or the side walls, to allow cells to be sampled from different elevations within the vessel, as set forth above.
Although the prior art combination does not expressly teach the at least one port being located in the rear wall of the vessel, it is clear from the disclosure of Lee et al. that providing the at least one port so as to be located in any of the front wall, rear wall, or side walls of the vessel would allow multi-elevation sampling (see Fig. 1 of Lee et al), and therefore it would have been obvious to one of ordinary skill in the art to locate the at least one port in the rear wall of the vessel.
Regarding claim 18, Lee et al. in view of Shimoji et al. teaches providing the plurality of ports disposed in one of the rear wall, the front wall, or the side walls, to allow cells to be sampled from different elevations within the vessel, as set forth above.
Although the prior art combination does not expressly teach wherein another port is located in the front wall or in one of the side walls, it is clear from the disclosure of Lee et al. that providing another port of the plurality of ports so as to be located in any of the front wall, rear wall, or side walls of the vessel would allow multi-elevation sampling (see Fig. 1 of Lee et al), and therefore it would have been obvious to one of ordinary skill in the art to locate another port in the front wall or in one of the side walls of the vessel.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US Patent Application Publication 2020/10002598) (already of record) in view of Shimoji et al. (US Patent Application Publication 2022/0267710), as applied to claim 1, above, and in in further view of Stankowski et al. (US Patent Application Publication 2020/0108242).
Regarding claim 6, Lee et al. in view of Shimoji et al. teaches the at least one port for removing fluid, as set forth above. Lee et al. further discloses connecting a tube to a port for removing fluid (para. 15).
The prior art combination is silent as to a tube guide proximate the at least one port.
Stankowski et al. discloses a clamping device for securing a tube to a port of a bioprocessing vessel (para. 15) (Figs. 4-5, sheets 5-6 of 15) (thus the clamping device reads on a tube guide proximate to a port), the clamping device comprising a pair of outwardly extending ribs that are configured to receive a tube that is connected to a port (para. 48) (Fig. 5). The clamping device improves sealing between the tube and the port (para. 9).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the vessel taught by Lee et al. in view of Shimoji et al. to comprise a tube guide comprising a pair of outwardly extending ribs that are configured to receive a tube that is connected to the at least one port, based on the teachings of Stankowski et al., to improve sealing between the at least one port and a tube for removing fluid from the vessel.
Regarding claim 7, the prior art combination teaches a pair of outwardly extending ribs that are configured to receive a tube that is connected to the at least one port for providing access to the interior volume via the at least one port, as set forth above.
Regarding claim 8, the prior art combination teaches a tube guide for improving sealing between the at least one port and a tube, and the prior art combination teaches the plurality of ports, as set forth above.
The prior art combination does not expressly teach a plurality tube guides, each tube guide of the plurality being located proximate to a different port in the plurality of ports.
Nonetheless, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04). It would have been obvious to the skilled artisan to duplicate the tube guide disclosed by Stankowski et al. and apply a tube guide so as to be proximate to each of the plurality of ports, as such a modification would yield the predictable results of improving sealing between tubing and each of the respective ports.
Regarding claim 9, Lee et al. in view of Shimoji et al. teaches the at least one port, as set forth above. Lee et al. further discloses wherein at least one port is fluidly connected to a connector that allows fluid to be removed from the port into a tube, the connector having an inlet and an outlet secured to the tube (para. 15) (Fig. 2, sheet 2 of 4).
The prior art combination is silent as to wherein the at least one port is fluidly connected to a molded elbow, the molded elbow having an inlet and an outlet, the outlet secured to the tube.
However, Stankowski et al. discloses a clamping device for securing a tube to a port of a bioprocessing vessel, as discussed above, and further discloses attaching a tube by means of an elbow connector (see connector 11 which has the form of an elbow as shown in Fig. 1B, sheet 1 of 15; see also para. 46), the elbow having an inlet and an outlet wherein the outlet is secured to the tube (para. 46, 62) (Figs. 1B and 7).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the at least one port taught by Lee et al. in view of Shimoji et al. to be fluidly connected to an elbow, the elbow having an inlet and an outlet secured to a tube, as Lee et al. discloses that it was known in the art to use a connector to allow fluid removal from a port to a tube, and Stankowski et al. discloses that elbow tube connectors were known in the art; thus using an elbow connector represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143). As to the limitation of the elbow being a molded elbow, it is noted that the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113). In this case, the limitation of the elbow being molded is merely a recitation of how the elbow is produced, and the limitation does not introduce a patentable distinction over the prior art.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US Patent Application Publication 2020/10002598) (already of record) in view of Shimoji et al. (US Patent Application Publication 2022/0267710) and Stankowski et al. (US Patent Application Publication 2020/0108242), as applied to claim 9, and in further view of Brown et al. (US Patent 5,350,080).
Regarding claim 10, Lee et al. in view of Shimoji et al. and Stankowski et al. teaches wherein the at least one port is fluidly connected to a molded elbow, as set forth above.
The prior art combination is silent as to an o-ring between the molded elbow and the port.
Brown et al. discloses connecting a port of a cell culture vessel to tubing by means of a connector wherein an O-ring is provided between the connector and the port (Abstract, col. 10 lines 16-26) (Fig. 7, sheet 7 of 7), wherein the O-ring prevents introduction of contaminants (col. 10 lines 38-44).
It would have been obvious to one of ordinary skill in the art to further modify the port taught by the prior art combination such that an o-ring is provided between the molded elbow and the port, based on the teachings of Brown et al., in order to prevent ingress of contaminants.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US Patent Application Publication 2020/10002598) (already of record) in view of Shimoji et al. (US Patent Application Publication 2022/0267710) and Stankowski et al. (US Patent Application Publication 2020/0108242), as applied to claim 9, and in further view of Lyons et al. (US Patent Application Publication 2017/0276666).
Regarding claim 11, Lee et al. in view of Shimoji et al. and Stankowski et al. teaches wherein the at least one port is fluidly connected to a molded elbow having an inlet, as set forth above, wherein the inlet comprises a cylindrical shape so that a portion of the cylindrical shape is not perpendicular to the port (e.g., see Fig. 2 of Lee et al. and Fig. 7 of Stankowski et al.).
The prior art combination is silent as to wherein the inlet of the molded elbow comprises an angled cone so that a portion of the angled cone is not perpendicular to the port.
Nonetheless, it has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP §2144.04). Lyons et al. discloses a port opening into a vessel body (para. 31) wherein the port may have a “tapered or expanded end or opening, thereby altering the inner diameter and thus the flow rate of fluid therethrough” (i.e., an angled cone).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the inlet of the molded elbow to have the shape of an angled cone so that a portion of the angled cone is not perpendicular to the port, as is known in the art, as such a modification represents a prima facie obvious change in shape.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zarur et al. (US Patent Application Publication 2005/0019904) is directed to a cell culture apparatus comprising a vessel and a vertically oriented mixing wheel within the vessel, a port being provided on a side wall of the vessel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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