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 .
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.
Claim(s) 1, 4, 5, 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2017/0175063, hereinafter Smith.
Regarding claim 1, Smith teaches a method for the automatic manufacture of tissue (figure 17) comprising: receiving cells in a fluid suspension in at least one vial (paragraph [0199], item 322); pumping the cells in the fluid suspension from the at least one vial to at least one first bioreactor (paragraph [0199], item 300); creating a first pre-selected environment to promote expansion of the cells in the at least one first bioreactor (paragraph [0203]); pumping the expanded cells from the at least one first bioreactor to a concentrator when the expanded cells have reached a pre-selected density (paragraph [0203]); concentrating the expanded cells (paragraphs [0203]-[0204]); pumping the concentrated cells into the at least one first bioreactor when a pre-selected event has occurred (paragraph [0203]); resuspending the concentrated cells (paragraph [0203]); pumping the cells from the at least one first bioreactor to at least one second bioreactor when the concentrated cells are resuspended (paragraph [0204]); and creating a second pre-selected environment promoting maturation of the concentrated cells into the tissue in the at least one second bioreactor (paragraph [0204]).
Regarding claim 4, Smith teaches wherein the first pre-selected environment comprises a first growth media, the first growth media being continuously automatically adjusted based on monitoring sensor data of critical process parameters to maintain first pre-selected levels of growth media characteristics (paragraph [0202]).
Regarding claim 5, Smith teaches wherein the second pre-selected environment comprises second growth media, the second growth media being continuously automatically adjusted based on monitoring of sensor data of critical process parameters to maintain second pre- selected levels of growth media characteristics (paragraph [0204]).
Regarding claim 12, Smith teaches further comprising: agitating the cells to encourage attachment of the cells to a surface (paragraph [0182]); adjusting a temperature of the at least one first bioreactor based on a pre-selected desired temperature (paragraph [0177]); adjusting levels of a gas in media surrounding the cells, the levels of gas based on pre- selected desired values of characteristics of the media (paragraph [0177]); sensing values of the characteristics of the media (paragraph [0180]); and moving the media to and from the at least one first bioreactor (paragraph [0184]).
Regarding claim 13, Smith teaches wherein the characteristics comprise dissolved oxygen and pH (paragraphs [0177] and [0180]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of United States Application Publication No. 2016/0252537, hereinafter Murali.
Regarding claim 2, Smith teaches all limitations of claim 10; however, Smith teaches the concentrating the expanded cells comprise a filtration concentrator (paragraph [0203]) and not a centrifugation device.
Murali teaches the use of filtration or centrifugation to concentrate cells (Murali, paragraph [0042]). Examiner further finds that the prior art contained a device/method/product (i.e., a centrifugation device) which differed from the claimed device by the substitution of component(s) (i.e., a filtration device) with other component(s) (i.e., a centrifugation device), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a filtration device with a centrifugation device), and the results of the substitution (i.e., concentrating the cells) would have been predictable.
Therefore, pursuant to MPEP $2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the filtration device of reference Smith with the centrifugation device of reference Murali, since the result would have been predictable.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of United States Application Publication No. 2011/0020856, hereinafter Poo.
Regarding claim 3, Smith teaches all limitations of claim 1; however, Smith fails to teach the pre-selected event comprises a detection of a desired concentration.
Poo teaches a method in which the controller controls operation of the pumps to obtain a desired final concentration of the substance flowing into the sample container (Poo, paragraph [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have had the pre-selected event comprises a detection of a desired concentration because it would allow for the recovery of the desired final concentration of the substance (Poo, paragraph [0031]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of United States Application Publication No. 2003/0086830, hereinafter Haywood.
Regarding claim 6, Smith teaches all limitations of claim 1; however, Smith fails to teach the step of receiving cells further comprising: receiving frozen cells in at least one vial; and thawing the frozen cells to produce cells in a fluid suspension.
Haywood teaches that samples are frozen to obtain high quality test results (Haywood, paragraph [0009]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have received frozen cells and then thaw the frozen cells to produce a fluid suspension because when the samples are frozen at the start, they provide a high-quality test result (Haywood, paragraph [0009]).
Allowable Subject Matter
Claims 7-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record is Smith which teaches an expansion subsystem with a vial and bioreactor, a concentration subsystem and a maturation subsystem. However, the prior art does not disclose, teach or suggest the claimed combination of the insulated container with a lid and vial holder, removing the insulated container lid using a first gripper; determining a location of the at least one vial within the vial holder; positioning a second gripper at the location of the at least one vial; removing the at least one vial from the insulated container using the second gripper; placing the removed at least one vial into a cell thawing device using the second gripper; determining when the frozen cells are thawed; removing the at least one vial of thawed cells using the second gripper; transferring the at least one vial of thawed cells to a third gripper; and moving the at least one vial of thawed cells to a first pre-selected location.
Response to Arguments
Applicant’s arguments, see page 5, filed 9/2/2026, with respect to the 112(b) rejection have been fully considered and are persuasive. The 112(b) rejection of claim 3 has been withdrawn.
Applicant's arguments, see pages 5-6, filed 9/2/2026, with respect to the 102(a)(1) rejections have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the method returning the concentrated cells to the same chamber when a pre-selected event has occurred) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim states:
“pumping the expanded cells from the at least one first bioreactor to a concentrator when the expanded cells have reached a pre-selected density;
concentrating the expanded cells;
pumping the concentrated cells into the at least one first bioreactor when a pre- selected event has occurred;”
However, even though the claim states “pumping the concentrated cells into the at least one first bioreactor,” this does not necessarily mean it has to be the same chamber. With the claim specifying “at least one bioreactor,” there can be more than one bioreactor which is considered to be the first bioreactor. Therefore, the step of pumping the expanded cells from the at least one first bioreactor can be performed in one bioreactor and the step of pumping the concentrated cells into the at least one first bioreactor can be a different bioreactor with both bioreactors being considered to be the “at least one bioreactor.” Therefore, Smith teaches the specified limitations and the claim is anticipated.
Conclusion
THIS ACTION IS MADE FINAL. 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 MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
