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
Applicant’s election without traverse of Group I, claims 16-27 in the reply filed on 29 July 2026 is acknowledged.
Claims 28 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method and product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 July 2026.
Claim Rejections - 35 USC § 102103
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.
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 16-27 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Huang (US 20160361476).
With respect to claim 16, Huang discloses a system for tissue-derived cell processing comprising a controlling component (Figure 1D:290) and a driving and/or heating component (Figure 1D:211) configured to host a cartridge (Figure 1C:300) and to drive and/or heat the cartridge. This is described in paragraphs [0130]-[0146].
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Figure 1E and paragraph [0144] indicate that the driving and/or heating component 211 includes a heating chamber 204 for regulating temperature. Figure 1E and paragraphs [0156] and [0157] further state that the driving and/or heating component 2011 includes actuators 208, 209 for driving the cartridge 300. A fluid mixing system (Figure 1F:293) is shown in a block diagram in Figure 1F and is described as including a shaker (“the fluid mixing system 293 comprises a shaker that shakes or rocks the sample processing compartment 311”). The disclosed temperature control system 291 and fluid mixing and control systems 292, 293 are understood to reside in the driving and/or heating component 211. Paragraph [0166] further teaches that a computer controller (Figure 1F:294) and user interface (Figure 1E:210) are disposed in the controlling component. Accordingly, it is believed that Huang anticipates the claimed invention. In the alternative, if the Huang components (e.g., heating means, driving means, controlling means) are not assembled in the manner required by the claims, it would have been obvious to make minor changes in design to arrive at the claimed configuration. A mere rearrangement in parts that does not substantially affect device operation is considered to be prima facie obvious. See MPEP 2144.04.
With respect to claim 17, Huang discloses the apparatus as described above. Huang teaches in paragraph [0156] that the cartridge includes a shaker.
With respect to claim 18, Huang discloses the apparatus as described above. Huang teaches that the cartridge 300 is inserted into the driving and/or heating component 211, and therefore is connected to the driving and/or heating component and is driven by and heated by the driving and/or heating component.
With respect to claim 19, Huang discloses the apparatus as described above. Huang further teaches that the controlling component includes a computer processor to control the operation of the driving component and heating component. See, for example, paragraphs [0166]-[0170]. Huang additionally shows in Figs. 1A and 1B that the controlling component and driving and/or heating component are discrete modules that are fluidically connected using a tubes. In the event that the controlling component and driving and/or heating component are not “modular”, it would have been obvious to construct them in this way because this is what Huang depicts in Figs. 1A and 1B and because it is generally understood that it is prima facie obvious to make individual elements selectively separable and interchangeable. See MPEP 2144.04.
With respect to claims 20-24, Huang discloses the apparatus as described above. Huang further shows that the controlling component includes a plurality of slots for the insertion of a plurality of syringes. The syringes include a substance to be expelled into the driving and/or heating component and into the cartridge via a liquid connection. The syringes are operated using a plunger and a mechanical actuator. This is described in paragraphs [0133]-[0137], [0152], [0153] and [0161].
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With respect to claims 25 and 26, Huang discloses the apparatus as described above. Huang further discloses in paragraphs [0131], [0140] and [0152]-[0154] that one or more valves are configured to enable fluid flow between the controlling component and the cartridge through the driving and/or heating component.
With respect to claim 27, Huang discloses the apparatus as described above. As discussed above, Huang states that the controlling component and the driving and/or heating component are electrically and fluidically connected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Smith (US 20080113426), Cimino (US 20150368603), Oram (US 20200208095), Griffin (US 20200392449) and Thakkar (US 20210283606) references disclose the state of the art regarding cell processing systems comprising a controlling, driving and heating components.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 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, 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.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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