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 with traverse of Group IV, claims 22, 24-28 and newly added claims 36-42 in the reply filed on 01/21/2026 is acknowledged. The traversal is on the ground(s) that the groups are allowed combination of categories and that they are related based on the inventive concepts of Group I. This is not found persuasive because ‘833 discloses the array of wells (modular active surface device 100; wells 105; Fig. 23B; [0053]) with microposts formed on an active surface material ([0011]) that extend into the reaction chambers (chamber/well 105; [0064]). Therefore, ‘833 teaches the common technical feature between the inventions and the inventions lack unity of invention and fail to make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/06/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 30 and 36-42 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims 30 and 36-42 depend upon a rejected claim and should be amended to depend upon claim 22. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Appropriate corrective action is required.
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 28 and 30 are 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.
For claims 28 and 30, it is unclear what mixing action is being claimed as the mixing action is defined within claim 22. As the claim currently reads, it appears two different mixing actions are being claimed where one is an actuation force (claim 22) and the other is a different type of mixing action. Also, if these mixing steps are different, it is unclear when these mixing steps occur and in what order with the mixing step of claim 22. It is recommended to amend the claims such that it is clear that these are the same mixing steps as claim 22.
Appropriate corrective action is required.
Allowable Subject Matter
Claims 22 and 24-27 allowed.
The following is an examiner’s statement of reasons for allowance: For claim 22, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a method of maintaining cell culture growth conditions within a small-volume bioreactor that includes the steps of placing cell culture media in wells, placing the cell culture media in contact with an active surface having an array of actuable surface-attached microposts, actuating the movement of the surface-attached microposts to create a mixing action and measuring an oxygen transfer coefficient (kLa) of the cell culture media to quantify a mixing efficiency of the surface-attached microposts.
Claims 24-28 would be allowable for the same reasons as claim 22.
The closest prior art is Spero et al. (WO 2018/236833 A1) which discloses a modular active surface for microfluidic systems (Abstract) that includes an array of wells (modular active surface device 100; wells 105; Fig. 23B; [0053]) with microposts formed on an active surface material ([0011]) that extend into the reaction chambers (chamber/well 105; [0064]). However, Spero does not teach or fairly suggest the step of measuring an oxygen transfer coefficient (kLa) of the cell culture media to quantify a mixing efficiency of the surface-attached microposts.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim 28 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: claim 28 would be allowable for the same reasons as claim 22.
The closest prior art is Spero et al. (WO 2018/236833 A1) which discloses a modular active surface for microfluidic systems (Abstract) that includes an array of wells (modular active surface device 100; wells 105; Fig. 23B; [0053]) with microposts formed on an active surface material ([0011]) that extend into the reaction chambers (chamber/well 105; [0064]). However, Spero does not teach or fairly suggest the step of measuring an oxygen transfer coefficient (kLa) of the cell culture media to quantify a mixing efficiency of the surface-attached microposts.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Superfine et al. (US 9,238,869 B2) discloses a system for using actuated surface-attached posts for assessing biofluid rheology. However, Superfine does not teach or disclose the step of measuring an oxygen transfer coefficient (kLa) of the cell culture media to quantify a mixing efficiency of the surface-attached microposts.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799