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 .
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.
Election/Restrictions
Claims 8-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/15/2025.
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.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800).
With respect to claim 1, the reference of Horseman discloses:
A cell culture device (Fig. 1) comprising:
a culture vessel (mixing vessel)(1) that accommodates a cell suspension containing cells and a culture medium; and
a stirring device (mixer drive) that is provided at a bottom part (8) of the culture vessel (1) to stir the cell suspension accommodated in the culture vessel,
wherein the stirring device has
a shaft part (stub shaft)(14),
a rotating part ((rotor)(12) and (hub)(13)) that has a hole part (center of hub (13)) into which the shaft part is inserted (Fig. 1), and is provided to have a gap (area between the upper and lower bearings) between an interior wall demarcating the hole part and the shaft part so that the rotation part is rotatable with the shaft part as a rotation axis, and
a closing part (bearing) (page 2, lines 17-26) that closes an end part of the gap in an axial direction of the rotation axis.
While the reference of Horseman discloses a gap (area between the upper and lower bearings) between an interior wall demarcating the hole part and the shaft part so that the rotation part is rotatable with the shaft part as a rotation axis, the reference is silent with respect to the dimension of the gap.
Claim 1 currently specifies the gap as “100 µm or more” which would encompass a gap with dimensions well beyond the micrometer realm. As a result, if the gap of the reference of Horseman does not intrinsically meet this dimensional open ended range limitation, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the gap size through routine experimentation based on design parameters such as the size of the vessel and properties of the fluids employed within the vessel while maintaining the efficiency of the stirring device.
With respect to claims 3 and 4, the reference of Horseman discloses closing parts (bearings) at both ends of the gap (Fig. 1).
With respect to claim 5, the rotating part (rotor)(12) is rotated by a magnetic force.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800) in view of Whitehouse et al. (US 2007/0065312).
The reference of Horseman has been discussed above with respect to claim 1.
Claim 6 differs by reciting that the closing part is a packing made of polymer.
The reference of Whitehouse et al. discloses that it is known in the art to employ a closing part (bearing sleeve)(18) made of a food grade polymer on a mixing device (¶[0023]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a food grade polymer between the shaft and hub of the mixing device of the primary reference of Horesman for the known and expected result of providing an art recognized material while preventing any contamination of the material used within the mixing vessel.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800) in view Stobbe (US 2018/0155667).
The reference of Horseman has been discussed above with respect to claim 1.
While the reference of Horseman discloses that the mixing vessel can be used for microbial or pharmaceutical operations (page 1, lines 21-27), claim 7 differs by reciting that the vessel has the form of a bag.
When mixing within a bioreactor vessel, the reference of Stobbe discloses that many different containers or vessels can be used, including bag vessels (¶[0024] and [0059]).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a vessel in the form of a bag for the known and expected result of providing an alternative vessel recognized in the art to achieve the same result, support and mix culture medium. Use of a bag vessel would eliminate the need for inhouse cleaning and sterilization of the vessel to be employed.
Allowable Subject Matter
Claims 2 and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Claims 2 and 15 would be allowable because the prior art of record fails to teach or fairly suggest a cell culture device, in the claimed environment or scope of claim, wherein the gap formed between the interior wall of the hole part of the rotating part and the shaft part is between 100 µm and 400 µm or alternatively between 150 µm and 400 µm. While the prior art of record suggests a gap of “100 µm or more” as discussed above with respect to claim 1, nothing in the prior art of record suggests the gap ranges required of claims 2 or 15.
Response to Arguments
The rejections of Claims 1-5 under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800) in view of Denoth (WO 2014/180954 and corresponding English language machine translation); Claim 6 under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800) in view of Denoth (WO 2014/180954 and corresponding English language machine translation) taken further in view of Whitehouse et al. (US 2007/0065312); and Claim 7 under 35 U.S.C. 103 as being unpatentable over Horseman (GB 2196800) in view of Denoth (WO 2014/180954 and corresponding English language machine translation) taken further in view of Stobbe (US 2018/0155667) have been withdrawn in view of Applicants remarks on pages 5-6 of the response dated 11/13/2025. Note: New grounds of rejection have been made under 35 USC 103 over the reference of Horseman (GB 2196800) alone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (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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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB