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/Restrictions
Newly submitted claims 46-49 are directed to an invention that would have been grouped with Group II (non-elected invention) and newly submitted claim 50 is directed to an invention that would have been grouped with Group IV (non-elected invention) in the Office Action dated 04/17/2025.
Since applicant previously elected Group I and has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 46-50 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
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 31-34 and 36-41 is 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.
Regarding Claim 31, it is unclear which positively recited portion of the system is capable of generating the cell-relevant data after operation of the AMFAT component and automatically adjust at least one operational parameter of the centrifuge component based on the cell-relevant data. Further clarification and correction is required.
Claims 32-34 and 36-41 are further rejected for the same reasons above as they depend from Claim 31.
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.
Claims 31-34 and 36-41 are rejected under 35 U.S.C. 103 as unpatentable over Fraser et al. (US20040106196A1).
Regarding Claim 31, Fraser teaches the following:
Systems for using cells derived from adipose tissue that are placed directly into a recipient (para 15)(a system for cell processing)
A processing device which measures the amount of tissue/fluid to be moved along a particular pathway using volumetric mechanisms (para 95)(a cell quantifying component configured for quantifying a volume flow in the system)
Alternatively, the volume may be determined by measurement of the weight of material (para 97)(quantifying the weight of the tissue)
An agitation/incubation chamber 102 where mixing is done by agitation rocking (para 99) which creates the micro fragmented tissue, the tissue being adipose tissue (Abstract), and placed back into the recipient (para 68)(autologous)(an Autologous Micro-Fragmented Adipose Tissue component (AMFAT))
A cell collection container 26 which includes a cell concentrator like a centrifuge device (para 77)(a centrifuge component)
The software component includes automated collection of “run data” including … temperature and volume measurements, tissue volume (measurement of the derived tissue by the cell quantifying component) and cell number parameters (para 100)(system configured for generating cell-relevant data)
Fraser further teaches the device could be incorporated into the controller system (para 100) and the steps such as the mixing mechanisms may be automated (para 95). Fraser does not explicitly teach at least one operational parameter of the AMFAT component or the centrifuge component is generated base on cell-relevant data. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate a parameter of the mixing mechanism (part of the AMFAT component) based on the cell-relevant data that is being collected by the software component and incorporated into the controller system. One would have been motivated to make this modification as it would allow further automation of operational parameter adjustment which would result in improved performance of the procedures (para 95).
Further, the system configured (a) to generate at least a portion of the cell-relevant data after operation of the AMFAT component and (b) to automatically adjust at least one operational parameter of the centrifuge component based on the cell-relevant data so generated are directed to the function of the apparatus and/or the manner of operating the apparatus and all of the structural limitations have been disclosed. The system of Fraser is capable of generating at least a portion of the cell-relevant data after operation of the AMFAT component and to automatically adjust at least one operational parameter of the centrifuge component based on the cell-relevant data so generated. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Fraser (see MPEP §2114).
Regarding Claim 32, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches the tissue collection container 12 include a tissue collecting inlet port 14 (para 75) and the tissue collection container is placed into the agitation chamber 102 where the tissue is collected prior to placement or while it is positioned within the device (para 96-97)(the AMFAT component comprises an inlet for feeding tissues into the AMFAT component).
Regarding Claim 33, Fraser teaches all of the limitations of Claim 32 (see above). Fraser further teaches the agitation chamber is agitated by rocking (para 99) requiring there to be a component which rocks or swivels the agitation chamber. As above, Fraser further teaches the steps such as the mixing mechanisms may be automated (para 95). Fraser does not explicitly teach at least one operational parameter of the swivel component is generated base on cell-relevant data. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate a parameter of the mixing mechanism (swivel component) based on the cell-relevant data that is being collected by the software component and incorporated into the controller system. One would have been motivated to make this modification as it would allow further automation of operational parameter adjustment which would result in improved performance of the procedures (para 95).
Regarding Claim 34, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches The software component includes automated collection of “run data” including … temperature and volume measurements, tissue volume and cell number (quality) parameters (para 100)(a portion of the cell relevant data is generated by the cell quantifying component and the cell relevant data comprises at least one of… temperature or quality).
Regarding Claim 36, Fraser teaches all of the limitations of Claim 33 (see above). Fraser further teaches additive line 42 is provided to deliver one or more enzymes to the tissue collection chamber (para 83)(an enzyme component, configured to add at least one enzyme in the volume flow).
Regarding Claim 37, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches a temperature control device to change the temperature of the fluid being deliver to tissue collecting container (para 81)(a temperature controller, configured to maintain an optimized predetermined temperature of the volume flow)
Regarding Claim 38, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches one or more additives may be added to the various containers as needed to enhance the results (para 93)(an additive component , configured to add at least one predetermined additive to an end product of the system).
Regarding Claim 39, Fraser teaches all of the limitations of Claim 36 (see above). Fraser further teaches additive line 42 is provided to deliver one or more enzymes to the tissue collection chamber (which is part of the agitation chamber)(para 83)(configured to feed at least one enzyme from the enzyme component to the swivel component).
Regarding Claim 40, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches the tissue collection chamber includes an aspiration port 18 which is coupled to a suction device 20 which may be a syringe, which should be capable of aspirating tissue from a patient (para 76)(one syringe driver, configured to transfer the volume flow in the system).
Regarding Claim 41, Fraser teaches all of the limitations of Claim 31 (see above). Fraser further teaches a user interface screen 106 (implying user data) and the volume which may be determined by measurement of the weight (cell-relevant data) may displayed on the user interface screen (configured to extract user data and further associate the user data with the cell-relevant data). Alternatively, the user interface configured to extract user data and further associate the user data with the cell-relevant data is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The user interface of Fraser would be capable of associating the cell-relevant data with the user data and therefore meets the claim.
Response to Arguments
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 4 that Fraser’s system cannot satisfy the requirements of Claim 31 because it does not (a) generate at least a portion of the cell-relevant data after operation of the AMFAT component and (b) automatically adjust at least one operational parameter of the centrifuge component based on the cell-relevant data so generated, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus and all of the structural limitations have been disclosed. The system of Fraser is capable of generating at least a portion of the cell-relevant data after operation of the AMFAT component and to automatically adjust at least one operational parameter of the centrifuge component based on the cell-relevant data so generated (Fraser teaches the device could be incorporated into the controller system [para 100] and the steps such as the mixing mechanisms may be automated [para 95] and further automation of operational parameter adjustment would result in improved performance of the procedures [para 95]). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Fraser (see MPEP §2114).
The amendments made to address the 112(b) rejection from the 11/12/2025 Office Action have been accepted and the 112(b) rejection from the 11/12/2025 Office Action has been withdrawn, however, new 112(b) rejections have been made due to amendments.
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 JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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.
/J.E.L./Examiner, Art Unit 1796
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights