DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 July 2026 has been entered.
Claim Rejections - 35 USC § 102
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 41-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Felder (US 20050054101).
With respect to claim 1, Felder discloses an automated cell culture system comprising a stationary member configured to retain a cell culture medium comprising magnetic beads (“microcarriers”). A magnetic field generator configured as electromagnetic coils or magnets (see Figs. 6-10) is used to move the magnetic beads in the culture medium. Paragraphs [0016]-[0018] specifically describe the magnetic field generator as including a series of coils wrapped around the stationary member (“a series of electromagnetic coils or magnets are used to encircle a culture vessel”). A controller (Figure 4:“Control System”) is configured to generate a variable magnetic field on the magnetic beads. This is described in paragraphs [0030]-[0032] and [0054]-[0058] (“By computer-controlled activation of the magnets and alteration of their polarity, many different microcarrier paths can be effected for stirring, media changing, cell adhesion operations, or cell harvesting”). Figs. 2 and 8 of Felder show magnetic force applied at offset and varying angles. Paragraph [0065] expressly states that the direction of the applied magnetic field may be changed to produce different effects on the cells and magnetic particles (“changes in cellular physiology or biochemistry are measurable in response to an externally applied magnetic field that allows for changes in microcarrier internal or external kinetic energy, for example, in one embodiment, rotation according to a user programmable profile of speed, direction, amplitude, and temporal profile (such as pulsatile, ramping, square wave, and other user definable profiles”). Paragraphs [0021], [0065] and [0091] further teach that cells on the surfaces of the magnetic beads are subjected to shear stress as the beads are moved through the fluid (“A rotating microcarrier will impart shear stresses on the cells on its surface (See FIG. 11). Thus, changes in cellular physiology or biochemistry are measurable in response to an externally applied magnetic field that allows for changes in microcarrier internal or external kinetic energy”).
With respect to claim 7, Felder discloses the apparatus as described above. Felder additionally teaches in paragraph [0056] that the variable magnetic field is a pulsed magnetic field.
With respect to claims 41-46, Felder discloses the apparatus as described above. Felder shows in at least Figs. 5-10 that the stationary member is configured as a linear tubular container, such that the magnetic generator includes a plurality of coils wrapped around the linear tubular container. Felder teaches in paragraphs [0055]-[0058] that the coils are capable of moving beads between first and second ends of the linear tubular container in a reciprocating manner in order to subject the beads to shear stress. Furthermore, it is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
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 47-51 are rejected under 35 U.S.C. 103 as being unpatentable over Felder (US 20050054101) as applied to claim 1, and further in view of Surapaneni (US 20100144022).
Felder discloses the apparatus set forth in claim 1, however does not appear to teach that the stationary member is configured as a toroidal container.
Surapaneni discloses a cell culture system comprising a toroidal chamber (Figure 4D:455) configured to hold cells and a culture medium. See paragraphs [0059] and [0066], for example.
Before the effective filing date of the claimed invention, it would have been obvious to consider a variety of bioreactor shapes when creating Felder’s stationary member, including toroidal shapes. Surapaneni teaches that torus reactors may be fabricating using known bioreactor materials, such as steel, glass and flexible plastics. Surapaneni further teaches that the toroidal shape allows for improved agitation, which facilitates nutrient and gas distribution in the culture medium while also preventing cell settling and clumping.
Response to Arguments
In response to Applicant’s amendment filed 27 July 2026, a new ground of rejection is made in view of the Felder reference under 35 U.S.C. 102.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Selker (US 20080274541), Schwarz (US 5763279), Daly (US 11000780) and Moretti (US 20100297233) references teach the state of the art regarding toroidal reactors.
This is a non-final rejection.
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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