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
The cancelation of previously restricted claims 36-47 is acknowledged.
Claim Rejections - 35 USC § 112
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 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, and 48 are rejected under 35 U.S.C. 112 (b).
Claim 23 is rejected under 35 U.S.C. 112 (b) for being indefinite since the claim requires a bladeless planetary mixer while the container requires a bladed mixer and the bladed mixer is in the bladeless planetary mixer. Correction/clarification is required.
Claims 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, and 48 depend on claim 23 and do not overcome the 35 U.S.C. 112 (b) rejection of claim 23. Therefore, claims 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, and 48 are rejected under 35 U.S.C. 112 (b) for being indefinite.
Claim Rejections - 35 USC § 103
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.
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 23, 24, 25, 26, 27, 30, 31, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano (U.S. Publication 2016/0038376) in view of Sand (U.S. Publication 2012/0088455) in further view of Flackett (U.S. Publication 2003/0198126).
Regarding claim 23, Alfano teaches a method for preparing a de-aerated pharmaceutical composition (paragraph 4, paragraph 46 teaches mixing which inherently de-aerates the subsequent mixture) by mixing two or more ingredients, at least one of which comprises an active pharmaceutical ingredient (paragraph 46 teaches pharmaceutical materials including powder and solvent, the pharmaceutical component inherently requires an active ingredient), the method comprising: providing a mixing container (paragraph 18 cartridges shown in figure 3 item 303) comprising: a container body including the ingredients (each of item 303 walls enclosing the container are considered the body, the ingredients are housed in the cartridge); a cover configured to engage the container body (top surface of item 403 is considered reading on a cover), and subjecting the mixing container to rotational movement in a bladeless mixer (paragraph 17 teaches using a motor to rotate the holder for the cartridges, and blades are not used by the rotor). Regarding claim 23, Alfano is silent to the mixing containers comprising a nozzle, shaft, blade shaft, and the planetary mixer providing superimposed rotations and revolution movements. Regarding claim 23, Sand teaches a container body including ingredients (receptacle 5) a cover configured to engage the container body (cap item 30), the cover including a nozzle defining an aperture configured to receive a blade shaft of a bladed mixer (opening 25 through which item 25 extends, item 15 is considered comprises blades, item 120), the blade shaft being connected to a motor (paragraph 55 teaches electric drills which would inherently require a motor). Regarding claim 23, Flackett teaches a bladeless planetary mixer (see figure 1), providing superimposed rotations (see arrow showing item 20 rotation direction) and revolution movements (see item 18 with arrow showing revolution movements). Regarding claim 23, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration of Flackett in order to obtain the desired degree of agitation.
Regarding claim 24, Alfano is silent to a cap on a nozzle. Regarding claim 24, Flackett teaches a cap for a holder (item 22 which covers the top opening of item 24). Regarding claim 24, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and cover of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container.
Regarding claim 25, Alfano is silent to the threaded configuration. Regarding claim 25, Flackett teaches a cap for a holder (item 22 which covers the top opening of item 24) including a threaded configuration (paragraph 20 first and second threaded portions). Regarding claim 25, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and cover of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container.
Alfano is silent to the language of claim 26. Regarding claim 26, Flackett teaches a nozzle (opening through which 20 extends). Regarding claim 26, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and cover of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container. Regarding claim 26, absent any unexpected results, it would have been obvious to one of ordinary skill in the art to modify the opening shape in order to accommodate the shape of a shaft since it is well settled that it is an obvious matter of design choice to change the general shape or size of a known element in the absence of a disclosed non-obvious advantage associated with the change. Gardner vs. TEC Systems Inc., 725 F.2d 1338, 1349-50 (Fed. Cir. 1984); In re Kuhle, 526 F.2d 553, 555 (CCPA 1975); In re Dailey, 357 F.2d 669, 672 (CCPA 1966).
Alfano is silent to the language of claim 27. Regarding claim 27, Flackett teaches a nozzle (opening through which 20 extends) that is generally centrally located on the cover (item 25 is centrally located on item 30). Regarding claim 27, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and cover of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container.
Alfano is silent to the language of claim 30. Regarding claim 30, Flackett teaches wherein the bladeless planetary mixer comprises a receiving basket (item 20), the method comprising providing an adapter, wherein the mixing container is configured to be fitted with the adapter to fit the mixing container into the receiving basket of the bladeless planetary mixer (item 14), such that ingredients in the mixing container can be subjected to a bladeless pattern of motion throughout space including superimposed revolution and rotation movements (see figure 1 revolutions and rotations proximate items 18 and 20). Regarding claim 30, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and backet and adapter of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container.
Alfano is silent to the language of claim 31. Regarding claim 31, Flackett teaches wherein the adapter has a generally circular configuration (item 14 has a circular cross section and considered reading on a generally circular configuration). Regarding claim 31, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the rotor with containers of Alfano with the blade configuration of Sand and the superimposed rotation/revolution configuration and backet and adapter of Flackett in order to obtain the desired degree of agitation and to better secure the mixing container.
Alfano is silent to the language of claim 48. Regarding claim 48, Sand teaches dispersing the ingredients within the container body (figure 1, ingredients are mixed in item 5) including: inserting the blade shaft from underneath the cover through the aperture (figure 1 item 20 extend from underneath the opening 25) such that the mixing blade is positioned within the container body to disperse the ingredients (item 15 is placed inside item 5), and securing the cover onto the container body during mixing to obtain the dispersed ingredients (item 30 is secured to item 5 during mixing to obtain the mixed product).
Allowable Subject Matter
Claims 28, 29, 32, 33, 34, and 35 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.
Regarding claim 28, the prior art does not teach or fairly suggest the method of preparing a deaerated pharmaceutical composition with the combination of the mixing container configuration including a bladed mixer connected to a motor, a planetary mixer, the nozzle configuration and the piston configuration.
Regarding claim 32, the prior art does not teach or fairly suggest the method of preparing a deaerated pharmaceutical composition with the combination of the mixing container configuration including a bladed mixer connected to a motor, a planetary mixer, the basket, the adapter wherein the adapter includes a resilient component.
Regarding claim 34, the prior art does not teach or fairly suggest the method of preparing a deaerated pharmaceutical composition with the combination of the mixing container configuration including a bladed mixer connected to a motor, a planetary mixer, the basket, the adapter wherein the adapter comprises a plurality of prongs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 p.m..
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/ANSHU BHATIA/Primary Examiner, Art Unit 1774