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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
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.
Claim(s) 1-2 and 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunas et al. (US 2005/0239199) as applied to claims above and further in view of Lei et al. (CN 107308860 from IDS) and Novikov et al. (SU 688210).
Regarding claim 1 Kunas discloses a device comprising:
a base connector having an opening;(See Kunas Figs. 3A-3B wherein a base connector 382 is provided with an opening into which hub 322 extends.)
an impeller connector coupled to the base connector, wherein the impeller connector has a through-passage aligned with the opening of the base connector;( See Kunas Figs. 3A-3B wherein impeller connector 321 is coupled to the base connector and has a through passage aligned with the opening of the base connector.)
a flexible tube having a first end and a second end, wherein the first end of the flexible tube is coupled to the impeller connector; a seal component coupled to the second end of the flexible tube; (See Kunas [0107] and Fig. 3B wherein flexible tube 390 has a first end coupled to impeller connector at 321 and a second end sealed to the impeller 340,i.e. a seal is formed by some form to seal component coupled to the second end of the flexible tube.
an impeller coupled to the second end of the flexible tube;(See Kunas Fig. 3B and [107] where an impeller 340 is coupled to the second end of the flexible tube.)
and an enclosure disposed enclosing the impeller, the flexible tube, the impeller connector, and the base connector. (See Kunas Figs. 3A-3B wherein an enclosure, i.e. flexible bag, 302 encloses impeller 340, flexible tube 390, impeller connector 321, and base connector 382)
Lei et al. discloses a device comprising an enclosure with a flexible tube therein with a first end of the tube bent relative to the second end and said second end having an impeller coupled thereto provided in order to mix materials within the device. The impeller as provided at an angle relative to a vertical axis of the device in order to provide secondary mixing movement and allow more complete mixing. (See Lei Fig. 1 wherein tube 72 has a second end having an impeller 6 bent relative to the first end.)
Additionally Novikov et al. also discloses providing a second end of a flexible tube being bent relative to a first and such that an impeller attached thereto is provided at an angle relative to a vertical axis of the container and provides for movement along multiple planes such that mixing may occur throughout a vessel. (See Novikov Fig. wherein an impeller 8 is connected to a bent flexible tube 6 in order to allow movement of impeller along multiple planes/axis within a device to perform mixing.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a first end of a flexible tube bent relative to a second end thereof in a mixing device as described by Lei et al. and/or Novikov in the device of Kunos because such a bent shape is known and allows for more efficient and effective mixing of different layers and areas of materials within an enclosure as would be desirable in the device of Kunos.
Regarding claim 2 Kunas discloses all the claim limitations as set forth above as well as the device wherein the impeller connector is a tube barb. (See Kunas Fig. 3A and [0106] wherein the impeller connector is a tube barb 321)
Regarding claim 4 Kunas discloses all the claim limitations as set forth above as well as the device wherein the impeller comprises one or more rotatable vanes. (See Kunas Fig. 3B wherein the impeller 340 comprises vanes which are rotatable.)
Regarding claim 5 Kunas discloses all the claim limitations as set forth above as well as the device, wherein the enclosure is a pre- sterilized bag. (See Kunas [0007]-[0010] wherein the enclosure is flexible bag which is pre-sterilized, i.e. it is pre-sterile.)
Regarding claims 6 and 7 Kunas discloses all the claim limitations as set forth above as well as the device wherein the base connector and impeller connector must either be integrated as a single molded component and/or detachably coupled.
In regards to the parts being integrated such modification would have involved making elements integral in order to enhance strength. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Also One of ordinary skill in the art at the time the invention was made would have been led by the applied references to forgo use of separate modules, along with their function and benefit, where doing so is technically feasible and would reduce cost. See In re Thompson, 545 F.2d 1290, 1229, 188 USPQ 365, 367 (CCPA 1976).
In regards to the parts being detachably coupled it is noted that it would have been obvious to one of ordinary skill in the art to make the elements separable in order to allow removal, cleaning, and repair and because it has been held that making items separable is within the level of ordinary skill in the art In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.")
Additionally, there are only two ways items can be connected, i.e. integrally or detachably, and as such one would have been motivated to connect the base connector and impeller connector integrally or detachably as these represent all possible methods of connection and “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunas et al. (US 2005/0239199) in view of Lei et al. (CN 107308860 from IDS) and Novikov et al. (SU 688210) and as applied to claims above, and further in view of Liu (EP 3623039).
Regarding claim 3 Kunas discloses all the claim limitations as set forth above but does not specifically disclose a friction reduction component.
Liu discloses a device for providing an impeller in an enclosure wherein an impeller drive is inserted into a flexible tube within the enclosure and a grease, i.e. friction reduction component, is provided on an inner peripheral surface of the flexible tube to ease insertion of the drive. (See Liu Abstract and [0014])
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a grease on an inner peripheral surface of an flexible tube a described by Liu in the device Kunas because doing so makes insertion of a drive shaft easier as would be desirable in the device of Kunas which requires insertion of such a drive shaft and one would have a reasonable expectation of success in utilizing such a grease.
Response to Arguments
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
Neither of Kunas or Lei disclose or suggest a device having a flexible tube having a first end and a second end, the second end being bent relative to the first end so that the impeller is provided at an angle relative to a vertical axis of the device to increase the contact area of the impeller to enhance agitation, as recited in Applicant's amended claims. In alleging that it would have been obvious to combine the teachings of Kunas and Lei, the Office Action states that "a bent shape is know and allows for more efficient and effective mixing of different layers of materials within an enclosure," however, no such advantage is disclosed or suggested in either of Kunas or Lei. One of ordinary skill in the art therefore would not have had any reason to combine the teachings of Kunas and Lei, nor do Kunas and Lei disclose or suggest bending one end of a flexible tube in an impeller assembly specifically so that the impeller is provided at an angle to increase the impeller contact area and enhance agitation as claimed.”
The examiner notes that Lei does in fact disclose that providing such a bent tube allows contact both primary and secondary mixing movements such that the device generates two levels of deep stirring and enhanced mixing of layers. Thus applicant’s arguments are not persuasive.
Additionally another reference, Novikov et al., has been provided which shows such bending and also discusses the advantage that such bending allows mixing along multiple movement planes thus enhancing mixing.
In regards to applicant’s argument that the cited art does not recognize the same advantage of providing such a bent flexible tube it is noted that the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799