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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-12, drawn to a cell culture vessel.
Group II, claims 13-21, drawn to a method of manufacturing one or more cell therapies.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of the inner container with a pocket and the outer shell arranged to receive and support the inner container where the outer container has a shell top and bottom, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2019/0048302 A1 – hereafter ‘302. ‘302 discloses a cell culture vessel ([0039]; Fig. 1; vessel 1; [0079]) that has an inner volume or pocket that can hold a cell culture and is supported by a second plate (plate 25; Fig. 6) and a first plate (plate 24; Fig. 6; [0092]) that receives and supports the cell culture vessel and forms a chamber where the vessel is disposed.
During a telephone conversation with Applicant’s representative on 06/29/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The amendment to the specification has been considered and entered for the record.
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.
Claims 1-7 and 10-12 are rejected under 35 U.S.C. 102a1 as being anticipated by Suzuki et al. (US 2019/0048302 A1 – hereafter ‘302).
‘302 discloses a cell culture vessel (Abstract) that includes the following limitations for claim 1:
“A cell culture vessel”: ‘302 discloses a culture vessel (Fig. 1; 0039]).
“an inner container having a pocket defining a volume within which a cell culture is maintained during manufacture of a cell therapy”: ‘302 discloses a culture vessel (vessel 1; Fig. 5; [0090]) that includes an interior volume or pocket that defines a volume that can be used for manufacturing a cell therapy.
“an outer shell arranged to receive and support the inner container, wherein the outer shell includes a shell top and a shell bottom that cooperate with one another to form a chamber within which the inner container is disposed, optionally, encapsulated.”: ‘302 discloses a jig (jig 20) that includes a first plate (plate 24, i.e. top shell) and a second plate (plate 25, i.e. bottom shell) that receives the culture vessel and forms a chamber for the culture vessel (Fig. 6; [0091]; [0092]; [0093]).
For claim 2, the culture vessel, i.e. the inner container, of ‘302 is fully capable of being disposable and the jig is fully capable of being reusable.
For claim 3, the inner container, i.e. the culture vessel, aligns with the jig, i.e. the outer container (Fig. 6; [0091]-[0093]).
For claim 4, the plates of the jig of ‘302 are rigid and have a rigid interior surface that aligns with the inner container or culture vessel (vessel 1) of ‘302 when the vessel is placed within the jig.
For claim 5, the jig of ‘302 has an opening (Fig. 6) that aligns with the inner container. It should be noted that for claim 5 that the prior art only needs to teach one element in order to meet the limitations of the claim.
For claim 6, the volume of the culture vessel (vessel 1; Fig. 6; [0090]) is fully capable of having the volume adjusted.
For claim 7, the pocket of ‘302 is a toroidal shape and would inherently have three subsections (Fig. 6). Furthermore, the jig would interact with the vessel in order to form these sections (i.e. form the shape of the sections by deforming the culture vessel) and therefore form the three subsections. Finally, the clamps are an optional limitation that is not required in order for the prior art to meet the claim limitation. Finally the “or” between elements (i) and (ii) means that the prior art only has to meet one of the limitations in order to render the claim obvious or to anticipate the claim.
For claim 10, ‘302 discloses a conduit that allows for the transfer of fluid into the culture vessel (Fig. 6; [0090]-[0092]).
For claim 11, ‘302 discloses that the conduit is received in a channel of the outer shell where the opening of the jig that the conduit is inserted is being interpreted as the channel of the instant application (Fig. 6; [0090]-[0092]). It should be noted that the “and/or” between elements (iii) and (iv) means that the prior art only has to meet one of the limitations in order to render the claim obvious or to anticipate the claim. In this case, the prior art meets the limitations of element (iv).
For claim 12, ‘302 discloses that the top of the jig, i.e. the shell, is removable form the bottom (Fig. 6; first plate 24, second plate 25; [0090]-[0092]). It should be noted that the “and/or” between elements (v) and (vi) means that the prior art only has to meet one of the limitations in order to render the claim obvious or to anticipate the claim. In this case, the prior art meets the limitations of element (i).
Therefore, ‘302 meets the limitations of claims 1-7 and 10-12.
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US 2019/0048302 A1 – hereafter ‘302).
For claim 8, ‘302 discloses that the culture vessel can have an oblong shape([0011]), but does not explicitly disclose that the shape of the container decreases as it moves away from the inlet. However, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to have the width of the container decrease from the inlet to the back of the container in order to concentrate the cultured cells for collection. Furthermore, this is a change in shape based on relative dimensions of the claimed device and these dimensions would not change the performance of the culture vessel of ‘302 or make it perform differently. Therefore, this limitation does not provide a patentable distinction over the prior art. See MPEP §2144.04 IV A.
For claim 9, ‘302 discloses that the device is symmetrical along a longitudinal axis (Fig. 6). It should be noted that the “or” between elements (i) and (ii) means that the prior art only has to meet one of the limitations in order to render the claim obvious or to anticipate the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dijkhuzen Borgart et al. (US 2013/0157353 A1) discloses a cell culture bag.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
Examiner interviews are available via telephone, in-person, 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
Prosecution Insights