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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “carrier portion comprising a cam” and “a cam follower” in claims 9, 10 and “a lock arranged to prevent the membrane from being moved from the second position to the first position” in claim 12, the container comprising “a plurality of outlet valves” in claim 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The instant apparatus type claims contain a large amount of functional/process/intended use language. However, functional/process/intended use language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. Therefore, if the prior art structure is capable of performing the function or intended use, then the prior art meets the limitation in the claims. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. Also note that it has been held that recitations in which an element is "adapted to/for", “configured to/for”, “positionable”, etc., only requires the ability to so perform (i.e., functional/process/intended use). (see MPEP § 2114 & § 2173.05(g)).
In addition, the instant apparatus claims contain a large number of elements that are not positively recited. The claimed invention is defined by the only positively recited claimed elements. Thus,"[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”, see MPEP 2115 (Material or Article Worked Upon by Apparatus). It is improper to construe elements that are not positively recited in a way that would make infringement or validity turn on their presence in the invention. Also, recitations in the preamble of the claim(s) are not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02.
In the patentability analysis of apparatus claims 1-23, aspects or limitations the examiner interprets as functional/process/intended use and/or not positively recited as part the claimed apparatus have been generally italicized whereas aspects interpreted as positively recited structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional/process/intended use and not positively recited structures.
Please note these recitations have not been ignored by the examiner. All of the claimed recitations in applicant’s claims 1-23 have been considered by the examiner and afforded the appropriate amount of patentable weight. In certain instances during prosecution, the examiner’s current interpretations regarding the patentable weight of these limitation might change based on the facts of the case.
The examiner's patentability analysis provides one or more interpretations and claim mappings of the claimed structures and steps although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification and specific limitations from the specification have not been read into the claims. See MPEP at least §2111.02, 2173.01 I 2114, and 2173.05(g).
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.
Claims 1-23 are rejected under 35 U.S.C. 112(b), 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 is directed to an outlet valve for a container. That is, the container is not positively recited and thus not required for the reasons delineated above. However elements of the outlet valve in claims 2-12 are defined relative to a container which is confusing and indefinite. Essentially, claim 1 recites a membrane attachable to a wall of the container and an actuator operable to move the membrane between a first position and second position. An actuator is merely a means for transmitting an arbitrary driving force that thus, under BRI there is no difference from the displaceable membrane itself than the outlet valve.
Independent claims 1 and 13 both recite “in the second position the membrane includes a frustum-shape”. It is not clear what membrane shape applicant considers frustum. Looking to the specification for clarification, it appears that the membrane 22 can be considered frustum shaped in both the first and second positions shown in Fig. 13(a) and 13(b). Also, frustum shape is not considered typical term of art that would suggest specific dimensions such that one of skill in the art would be able to recognize at what point the membrane has reached the claimed frustum-shape at a given position through actuation. This is confusing and indefinite.
The problem addressed in the application states cell therapy manufacturing often involves many manual transfers between devices, which increases cost, contamination risk, and operator error. It notes that harvesting cells from culture container is especially problematic because opening the container or using pipettes can expose the cell suspension to contaminants and can damage the cells. The disclosure also points to a need for compact, closed, and sterile systems that can perform harvesting and related unit operations more reliably. In short, the problem is how to remove cell suspension from a container without exposing it or the cells to unnecessary handling. It is not clear how a membrane and an actuator absent a container provides the improvement described in the specification. See MPEP 2106.04(a) which details that the claims must reflect the disclosed improvement. Note specifically, MPEP 2106.05(a), 4th paragraph that states the claims must include the components or steps of the invention that provide the described improvement. Claim 1 does not include any specific elements to solve the problem stated. It other words, it is not clear how a membrane and actuator that moves the membrane from a flat first position to a frustum-shaped second position provides sterile handling make a specific contribution to allow for sterile handling.
Claim 9 recites one of the actuator and the carrier portion comprises a cam, and the other of the actuator and the carrier portion comprises a cam follower arranged to engage the cam, wherein rotation of the actuator moves the carrier portion causing the membrane to move from the first position to the second position. It is not clear if the cam and cam follower are part of the valve. Nor This is confusing and indefinite.
Claim 12 recites the outlet valve comprises a lock arrangement. It is not clear what applicant means by a “lock arranged to prevent the membrane from being moved from the second position to the first position”. This limitation is not shown or disclosed but for “the housing 30 may include a locking arrangement (not shown) to lock the membrane 22 and/or the carrier portion 26 in the second position. This will prevent movement of the membrane 22 to the first position during harvesting of the contents of the bioreactor 10. For example, the locking arrangement may be a leaf spring in the housing 30 (e.g., in the cam ring 42), which engages a corresponding opening in the carrier portion 26 to lock the carrier portion 26 in the second position, see para [0092] of applicant’s corresponding US publication 2024/0351042. It is worth noting that the housing is not claimed as part of the outlet valve.
Claim 13, line 3 recites “a wall of the container”. It is not clear if applicant is referring to one of “a plurality of walls” defining an internal volume on line 2, or a wall of a different container. The examiner assumes that “a wall” corresponds to one of the plurality of wall. Clarification is requested.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
(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 1-8, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al., (CN 202822123; hereinafter “Li”-already of record).
Regarding claim 1, Li teaches an outlet valve for a container, the outlet valve comprising:
a membrane 3 arranged to face an internal volume of the container, the outlet valve attachable to a wall of the container, and
an actuator 4 operable to move the membrane:
from a first position in which the membrane is substantially in a plane of the wall of the container;
to a second position in which a part of the membrane is displaced from the plane of the wall of the container, the membrane includes a frustum-shape in the second position.
Regarding claim 2, Li teaches an outlet conduit 2 wherein the membrane seals the outlet conduit from the container in the first position and opens a fluid path is formed between the container and the outlet conduit when the membrane is in the second position.
Claim 3 is directed to functional/process/intending use language that does not limit the claim.
Regarding claim 4, Li teaches the outlet conduit is disposed central to the membrane (see Fig. 1).
Regarding claim 5, Li teaches comprising at least part of a needle 2 at least arranged to pierce the membrane as the membrane is moved from the first position to the second position to open the fluid path.
Regarding claim 6, Li teaches a housing 1 that is attachable to the wall of the container, the housing comprising the actuator.
Regarding claim 7, Li teaches a carrier portion 1 connected to the part of the membrane that is displaced in the second position, wherein the actuator is arranged to engage the carrier portion and move the carrier portion causing the membrane to move from the first position to the second position.
Regarding claim 8, Li teaches the actuator 4 is rotatable.
Claims 1-8, 11-15, 17, 18 and 21-23, as best understood, are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ramstad et al., (US 2016/0089668; hereinafter “Ramstad”).
Regarding claim 1, Ramstad teaches an outlet valve for a container 200 the outlet valve comprising:
a membrane 272 arranged to face an internal volume of the container 320, the outlet valve attachable to a wall of the container (Ramstad teaches the seal membrane 272 is configured to directly engage and be pierced by the transfer tube 242 ( see para [0083] et seq. and FIG. 4). , and
an actuator 244 that moves the operable to move the membrane from a first position (see Fig. 9) in which the membrane is substantially in a plane of the wall of the container to a second position (Fig. 10, 11) in which a part of the membrane is displaced from the plane of the wall of the container, the membrane includes a frustum-shape in the second position (see Ramstad teaches once the fluidic cartridge 200 is sufficiently aligned with respect to the system base 320, the fluidic cartridge 200 may be moved toward the system base 320 in a loading direction 330 (actuation direction) along a loading axis 332. In particular embodiments, the loading axis 332 extends parallel to a gravitational force axis. Accordingly, the mating side 202 of the fluidic cartridge 200 may face in a downward direction that is parallel to the gravitational force axis. The mating side 202 may be pushed down onto the control side 322. In such embodiments, the control side 322 of the system base 320 may represent a top side of the system base 320. The system base 320 may effectively support the fluidic cartridge 200 after the mating operation (see para [0091] et seq.)
Regarding claim 2, Ramstad teaches an outlet conduit 284 wherein the membrane seals the outlet conduit 284 from the container in the first position and opens a fluid path is formed between the container and the outlet conduit when the membrane is in the second position (see para [0088] et seq., and Fig. 8).
Claim 3 is directed to functional/process/intending use language that does not limit claim for the reasons delineated above.
Regarding claim 4, Ramstad teaches the outlet conduit is disposed central to the membrane (see Fig. 8).
Regarding claim 5, Ramstad teaches the outlet valve comprising at least part of a needle (reads on piercing segment 290; see Fig. 8) at least arranged to pierce the membrane as the membrane is moved from the first position to the second position to open the fluid path (see para [0080] et seq.)
Regarding claim 6, Ramstad teaches a housing 240 that is attachable to the wall of the container, the housing comprising the actuator (see Fig. 9-11).
Regarding claim 7, Ramstad teaches a carrier portion 270 connected to the part of the membrane that is displaced in the second position, wherein the actuator is arranged to engage the carrier portion and move the carrier portion causing the membrane to move from the first position to the second position (see para [0078] et seq.)
Claim 8 is considered a “functional/process/intended use and does not limit the outlet valve in any way.
Regard claim 11, Ramstad teaches the actuator comprises one or more gripping portions (gripping portions are the sidewalls of the valve 244).
Regarding claim 12, Ramstad teaches a lock arranged to prevent the membrane from being moved from the second position to the first position Ramstad teaches at Fig. 18 and para [0120] “the inner housing surface 484 defines a seal-receiving space 490. The seal-receiving space 490 may be sized and shaped relative to the movable seal 462 so that the positioning tool 460 may hold the movable seal 462 therein. For example, in the illustrated embodiment, the seal-receiving space 490 is sized and shaped relative to the elastic wall 470 and the seal membrane 472. In some embodiments, an interference fit may be formed between the inner housing surface 484 and at least one of the elastic wall 470 or the seal membrane 472. Frictional forces generated by the interference fit may be sufficient for temporarily holding the movable seal 462 while positioning the movable seal 462 within the socket chamber 464, but may also allow the movable seal 462 to be released from the positioning tool 460 when the positioning tool 460 is withdrawn from the socket chamber 464 after the loading process”. That is positioning tool can be used to hold “lock” the membrane 472 until it is removed.
Regarding claim 13, Ramstad teaches
a container 200 comprising;
a plurality of walls 244, defining an internal volume 212; and
an outlet valve for a container 102, 330, the outlet valve comprising:
a membrane 272 arranged to face an internal volume of the container, the outlet valve attachable to a wall of the container (Ramstad teaches the seal membrane 272 is configured to directly engage and be pierced by the transfer tube 242 ( see para [0083] et seq. and FIG. 4). , and
an actuator 244/270 that moves the operable to move the membrane from a first position (see Fig. 9) in which the membrane is substantially in a plane of the wall of the container to a second position (Fig. 10, 11) in which a part of the membrane is displaced from the plane of the wall of the container, the membrane includes a frustum-shape in the second position (see Ramstad teaches once the fluidic cartridge 200 is sufficiently aligned with respect to the system base 320, the fluidic cartridge 200 may be moved toward the system base 320 in a loading direction 330 (actuation direction) along a loading axis 332. In particular embodiments, the loading axis 332 extends parallel to a gravitational force axis. Accordingly, the mating side 202 of the fluidic cartridge 200 may face in a downward direction that is parallel to the gravitational force axis. The mating side 202 may be pushed down onto the control side 322. In such embodiments, the control side 322 of the system base 320 may represent a top side of the system base 320. The system base 320 may effectively support the fluidic cartridge 200 after the mating operation (see para [0091] et seq.).
Regarding claim 14, Ramstad teaches the plurality of walls comprises a bottom wall and at least one side wall, and wherein the outlet valve is mounted to the bottom wall of the container (this is shown in Fig. 4-8).
Regarding claim 15, Ramstad teaches the bottom wall is substantially circular and substantially planar (see Figs. 4-8).
Regarding claim 17, Ramstad teaches a plurality of outlet valves (see Fig. 3).
Regarding claim 18, Ramstad teaches a transfer conduit 326 arranged to be in fluid communication with the container when the membrane is in the second position to transfer fluid out of the internal volume of the container (see Fig. 9-11).
Regarding claim 21, Ramstad teaches a further container (assumed to be a different container 378) arranged to receive fluid from the container via the transfer conduit (see Figs 13-14).
Claims 22 and 23 are considered an intended use claim, which does structurally define over the prior art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16, 19 and 20, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Ramstad.
Regarding claims 16 and 19, Ramstad does not explicitly teach the outlet valve is offset from a center of the bottom wall or that the transfer conduit is a flexible tube.
However, it would have been obvious to one of ordinary skill in the art at the invention was effectively claimed to determine the optimum materials of construction and locations of claimed elements based on considerations such as cost, ease of manufacture, etc. The applicant is advised that the Supreme Court has clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82, USPQ2d 1385, 1397 (2007), see MPEP 2143).
Regarding claim 20, Ramstad teaches wherein the membrane is in the first position the tube is attached to the container for storage as shown in Fig. 9.
Allowable Subject Matter
Claims 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten into independent claim 13 including all of the limitations of the base claim 13 and any intervening claims. The known prior art does not teach or fairly suggest including the limitations of claim7-9 into the container of claim 13, specifically, where one of the actuators and the carrier portions comprises a cam, and the other of the actuator and the carrier portion comprises a cam follower arranged to engage the cams such that wherein rotation of the actuator moves the carrier portion to the membrane to move from the first position to the second position. Again, depending on applicant’s response (arguments and/or amendments), the examiner’s current interpretations may change.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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