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 1, 3-5, 7, 8, 10-14, 16-18, 20 and 21 in the reply filed on 26 November 2025 is acknowledged.
Claims 22, 23, 25 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 November 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 14, 16-18, 20 and 21 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Independent claim 1 requires “a rotating member…configured to rotate within the stationary member”. However, dependent claims 14, 16-18, 20 and 21 relate to embodiments described in paragraphs [0060] and [0061] and shown in Figs. 8 and 9 where there is no rotating member. Indeed, paragraph [0060] directly states that the toroidal container “does not include a rotating member disposed within stationary member 110”. There does not appear to be support in the specification for embodiments where the stationary member is both characterized by a linear or toroidal tubular container while also having a rotating member. Rather, the rotating member is only found in embodiments where the stationary member is configured as a more traditional upright reactor (see Figs. 1 and 2 and paragraphs [0049]-[0056]).
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.
Claims 14, 16-18, 20 and 21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 14, 16-18, 20 and 21 are drawn to embodiments in which the stationary member is configured as a toroidal or linear tube, such that the toroidal or linear tube is surrounded by a coiled magnetic field generator. This is shown in Figs. 8 and 9 and described in paragraphs [0060] and [0061] of the specification. These embodiments are said to not operate using a rotating member (“but does not include a rotating member disposed within stationary member 110”). Accordingly, it is unclear if the rotating member set forth in independent claim 1 is a required feature of the invention set forth in dependent claims 14, 16-18, 20 and 21. Due to this contradiction between the claim language and Applicant’s disclosure, the metes and bounds of the invention of claims 14, 16-18, 20 and 21 is unclear.
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 1, 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rakoczy (EP 3088509) in view of Chang (US 7662615) and/or Felder (US 20050054101).
With respect to claim 1, Rakoczy discloses an apparatus comprising a stationary member (Figure 6:3), a magnetic field generator (Figure 1:7), and a rotating member (Figure 6:19). The rotating member is configured to rotate within the stationary member, and the magnetic generator is configured to generate a magnetic field on magnetic particles disposed within a cell culture medium. This is described in paragraphs [0041]-[0044]. Rakoczy, however, does not appear to teach that the magnetic generator is controlled by a controller configured to generate a variable magnetic field on the magnetic beads.
Chang discloses a system for cultivating cells in a culture medium supported by a stationary member. A magnetic field generator configured as an electromagnetic coil (Figure 1A:16) surrounds the stationary member and produces a magnetic field that is applied on the cells. Column 2, line 52 to column 3, line 35 teach that a controller (Figure 1A:18) is configured to control the magnetic field generator to generate a variable magnetic field (“Additionally, the electromagnetic stimulator 18 is able to adjust the waveform, frequency, and amplitude of the first signals 17, so as to change the pulse pattern, frequency, and intensity of the induced electromagnetic field”).
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. 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”).
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Rakoczy system includes a controller configured to regulate the generation of a variable magnetic field on magnetic beads in the culture medium. Chang and Felder each teach that different cell types respond differently to variable stimulation during culture, and that it is important to adjust the applied electromagnetic field to respond to detected cell growth and activity. Those of ordinary skill would have further understood that a variable pulsed electromagnetic field would enhance mixing of the magnetic beads suspended in the culture medium and enable additional operations, such as product separation and cell harvesting.
With respect to claim 3, Rakoczy, Chang and Felder disclose the combination as described above. Rakoczy further shows that the cell culture medium is located between the stationary member and the rotating member.
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With respect to claims 4, 5 and 7, Rakoczy, Chang and Felder disclose the combination as described above. Rakoczy, Chang and Felder each teach the generation of magnetic fields that may be applied in different directions with different forces and as pulses. 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.
Claims 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rakoczy (EP 3088509) in view of Chang (US 7662615) and/or Felder (US 20050054101) as applied to claim 1, and further in view of Traelnes (US 3604690) and Shkidchenko (US 4379846).
With respect to claims 8 and 10, Rakoczy, Chang and Felder disclose the combination as described above, however do not appear to teach that the rotating member comprises discs that are interdigitated with a plurality of annular surfaces extending from the stationary member.
Traelnes discloses an agitation system for cell culture comprising a stationary member having a plurality of baffle surfaces (Figure 1:4). The baffle surfaces are interdigitated with a plurality of rotating discs (Figure 1:3).
Shkidchenko discloses a cell culture system comprising a stationary member having a plurality of annular surfaces (Figure 1:8). The annular surfaces are interdigitated with a plurality of rotating discs (Figure 1:7).
Before the effective filing date of the claimed invention, it would have been obvious to modify Rakoczy to include essentially any rotating member configuration suitable for agitating a cell culture solution. Traelnes and Shkidchenko show how rotating discs that interact with annular baffles surfaces may improve mixing and aeration (“at a high-power input and high aeration rate a much greater rate of oxygen absorption is obtained”) while providing a uniform distribution of cells and nutrients.
With respect to claims 11 and 12, Rakoczy, Chang, Felder, Traelnes and Shkidchenko disclose the combination as described above. Traelnes further shows that the plurality of discs 3 include a plurality of apertures (Figure 2:11) through which cells and magnetic beads may travel. Shkidchenko additionally states that the discs are fabricated from a capillary porous material and therefore include a plurality of apertures.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Rakoczy (EP 3088509) in view of Chang (US 7662615) and/or Felder (US 20050054101) as applied to claim 1, and further in view of Jones (US 20120045834).
Rakoczy, Chang and Felder disclose the combination as described above, however do not appear to teach that the rotating member comprises a plurality of randomly oriented fibers.
Jones discloses a rotating member (Figure 1:10) for mixing cell culture fluid within a bioreactor defined by a stationary member. See Fig. 8. Paragraphs [0057] and [0058] state that the rotating member may be made from a variety of different materials, including carbon fiber and fiberglass.
Before the effective filing date of the claimed invention, it would have been obvious to fabricate the Rakoczy rotating member from essentially any material recognized in the art as being biocompatible and suitable for use as a mixing element. Jones teaches that carbon fiber and fiberglass impellers (which include randomly oriented fibers) are an inexpensive and durable option and may be manufactured by standard techniques.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Yazdan (US 20210261897), Patel (US 20180187139) and Gebauer (US 20150367302) references teach the state of the art regarding cell culture devices comprising magnetic field generators.
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.
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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