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 .
Response to Amendment
This Final Rejection is in response to the Amendment dated December 23, 2025 filed in response to the Non-final Rejection dated July 28, 2025.
Cancelation of claims 11-13 is acknowledged.
The 35 U.S.C. 102(a)(1) rejection in the Non-final Rejection is withdrawn in view of the amendments made to claim 1. However, the claims are unpatentable over the prior art under 35 U.S.C. 103 as explained below.
The 35 U.S.C. 103 rejection in the previous Non-final Rejection is maintained as explained below.
Response to Arguments
Starting in the top half of page 6 of the Amendment, Applicant argues McNally et al. (U.S. Patent Application Publication No. US 2003/0146314 A1) does not teach or suggest claim 1 as amended. Examiner agrees in that McNally et al. is silent as to the type of material used to make impeller blade 58 and chopper blade 48. However, Examiner respectfully disagrees paragraph [0025] McNally et al. states chopper blade48 and impeller blade 58 must be sharp.
Then, starting at the bottom of page 7, Applicant argues Moriya clearly fails to teach or suggest claim 1 as amended. Examiner agrees Moriya does not singularly anticipate or render unpatentable claim 1. However, Examiner finds it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the teaching of Moriya to McNally et al. where McNally et al. is silent regarding the material used to make blades 48 and 58. As was previously pointed out in numbered paragraph 21 starting at the bottom of page 7 of the Non-final Rejection, Moriya teaches it was known to construct components of mixing granulators which come into contact with the material to be granulated out of non-contaminating material. Column 4, line 31-53 of Moriya teaches making stirring blades of organic polymeric plastic material. Therefore, claim 1 is unpatentable over McNally et al. in view of Moriya as explained below.
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 1-10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2003/0146314 A1 by McNally et al., hereinafter “McNally”, in view of U.S. Patent No. 4,655,701 to Moriya, hereinafter “Moriya”.
Regarding claim 1, McNally discloses a mixing granulator (mixing granulator 10 in Figs. 1 and 2; ¶[0025]) comprising:
a container to receive a product (container 16 in Fig. 1 and 54 in Figs. 2 and 3; ¶[0025]);
a mixing tool located in the container (mixing tool impeller blade 58 in Fig. 2; ¶[0025]) and seated on a vertically aligned shaft (shaft impeller 50 in Fig. 2; ¶[0025]); and
a comminuting tool located in the container (comminuting tool chopper blade 48 in Fig. 2; ¶[0025]); wherein
at least one of the container, the mixing tool, and the comminuting tool that contact the product is at least partially made of a plastic or a plastic composite material (¶[0038] discloses container 54 in Figs. 2 and 3 may be made of plastic).
But McNally is silent regarding the material used to make impeller blade 58 and chopper blade 48. Thus McNally does not disclose blades 58 and 48 are made of plastic or a plastic composite as claim 1 has been amended to claim.
In the same field of mixing granulators, Moriya teaches it was known before the effective filing date of the claimed invention to construct components of mixing granulators which come into contact with the material to be granulated out of non-contaminating material. Column 4, lines 31-53 teach making stirring blades in mixing granulators of organic polymeric plastic material.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to construct McNally’s blades 58 and 48 out of plastic to prevent contamination in the same way Moriya teaches. A person of ordinary skill would have recognized applying the teaching of Moriya to the apparatus of McNally would achieve the predictable result of making McNally’s blades 58 and 48 of plastic such that all portions of the container, mixing tool and comminuting tool contacting the product are made of plastic.
Regarding claim 2, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses the container (54 in Fig. 2) includes a first region to receive the product (first region upper portion of interior region 88 in Fig. 3; ¶[0038]) and includes a container wall and a base (the wall and base of container 54 as shown in Figs. 2 and 3), including an opening for the shaft (Figs. 2 and 3 show the base of container 54 has an opening through which impeller 50 project into interior 88), and a connecting region adjoining the first region, which surrounds a coupling located between a drive and the shaft (the connecting region of container 54 surrounding sealing flange 106 in Fig. 3; ¶[0038]), the container including in the container wall in the first region a flange for the comminuting tool (Figs. 2 and 3 show container 54 has an opening in the right sidewall creating a flange for receiving chopping tool 48).
Regarding claim 3, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses the container (container 54 in Figs. 2 and 3) has a single unitary structure made of a plastic or a plastic composite material (Fig. 3 shows container 54 is a single unitary structure and ¶[0038] discloses it may be made of plastic).
Regarding claim 4, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. Moriya further teaches it is known to construct components of mixing granulators which come into contact with the material to be granulated out of non-contaminating material and to use a replaceable lining in the granulator’s container which may be removed and replaced as desired. See at least column 4, lines 31-53 and column 9, lines 48-61. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use food-safe plastic when constructing McNally’s container 54, blade 58 and blade 48 out of plastic according to the teaching of Moriya to prevent contamination of edible material being mixed in the mixing granulator.
Regarding claim 5, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses the mixing tool includes blades (impeller blades 58 in Figs. 2 and 3; ¶[0038]) and the comminuting tool is substantially U-shaped (Figs. 2 and 3 show chopping tool 48 is substantially U-shaped).
Regarding claim 6, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses comprising a base (base support 14 in Fig. 2; ¶[0024]) covering the drive of the mixing tool (mixing motor 40 in Fig. 2 is covered by support 14; ¶[0025]) and a drive of the comminuting tool (chopping motor drive 42 in Fig. 2 is covered by support 14; ¶[0025]).
Regarding claim 7, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses wherein the container is connected to the base via a bayonet connection. Paragraph [0025] though [0030] disclose container 54 is coupled to support 14 by open ended kidney shaped slots engaging bolts 84 where container 54 is rotated to disengage the slots from bolts 84 in order to decouple the container from the support.
Regarding claim 8, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses wherein the first region of the container is sealed off from outside via a seal that seals the mixing tool and the comminuting tool. Interior region 88 in Fig. 3 is sealed off by dynamic seal 110 which seals mixing impeller blade 58 and dynamic seal 134 which seals cutting tool 48. See paragraphs [0039] and [0040].
Regarding claim 9, the prior art reference combination of McNally in view of Moriya discloses a method of using the mixing granulator according to claim 1 for mixing pharmaceutical powder with aggregates. Paragraphs [0005] and [0024] of McNally disclose potent drugs may be granulated in the disclosed mixing granulator.
Regarding claim 10, the prior art reference combination of McNally in view of Moriya renders the method according to claim 9 unpatentable as explained above. McNally further discloses wherein the mixing granulator is used in a high containment application. Paragraph [0024] discloses the mixing granulator may be used to granulate potent drugs where the container may be removed from the granulating machine without removing the container cover in order to maintain a sealed environment and moved to flow hood 12 shown in Fig. 1 when unsealed to prevent excess toxins from being discharged from the container.
Regarding claim 14, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 1 unpatentable as explained above. McNally further discloses a method of mixing substances with the mixing granulator according to claim 1, wherein the method comprises:
placing the substances in the container (¶[0024] discloses container 16 in Fig. 1 may be used to container the substance to be granulated);
mixing the substances in the container using the mixing tool (¶[0025] discloses the substance in the container is mixed using impeller blade 58 in Fig. 2);
rotating the comminuting tool (¶[0025] discloses chopper blade 48 in Fig. 2 rotates to chop the substance within container 54);
removing or discharging the product from the container (¶[0024] discloses the substance contained in container 54 may be removed under flow hood 12 shown in Fig. 1).
But McNally does not expressly disclose “wherein the at least one of the container, the mixing tool, and the comminuting tool that contact the product is discarded and replaced if a cleaning process is necessary to prevent cross-contamination.”
In the same field of mixing granulators, Moriya teaches it is known to construct components of mixing granulators which come into contact with the material to be granulated out of non-contaminating material and to use a replaceable lining in the granulator’s container which may be removed and replaced as desired. See at least column 4, lines 31-53 and column 9, lines 48-61.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use McNally’s plastic container 16/54 as a replaceable container which may be replaced to prevent contamination of the mixing material as Moriya teaches. A person of ordinary skill would have recognized applying the teaching of Moriya to the apparatus disclosed by McNally would achieve the predictable result of using McNally’s plastic container as a replaceable container to prevent cross-contamination in McNally’s disclosed method of mixing substances in a mixing granulator.
Regarding claim 15, the prior art reference combination of McNally in view of Moriya renders the mixing granulator according to claim 14 unpatentable as explained above. McNally further discloses a high containment application (Paragraph [0024] discloses the mixing granulator may be used to granulate potent drugs where the container may be removed from the granulating machine without removing the container cover in order to maintain a sealed environment and moved to flow hood 12 shown in Fig. 1 when unsealed to prevent excess toxins from being discharged from the container) and the at least one of the container, the mixing tool, and the comminuting tool is the container (container 16/54 is disclosed as being made of plastic).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL DEREK PRESSLEY whose telephone number is (313)446-6658. The examiner can normally be reached 7:30am to 3:30pm Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Templeton can be reached at (571) 270-1477. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P DEREK PRESSLEY/Examiner, Art Unit 3725
/Christopher L Templeton/Supervisory Patent Examiner, Art Unit 3725