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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the vial holder as set forth in claim 1 (to the extent the vial holder is meant to be the mechanical component 110A as described in paragraph [0165] of the pgpub, the language should be consistent), the actuated manipulator as set forth in claim 1, to the extent the actuated manipulator is meant to be the vial manipulator/agitating element 110, the language should be consistent), the gripping the vial by actuation of an actuator of the vial holder as set forth in claims 27-32, one or more arms of the actuator of the vial holder as set forth in claim 27, one or more grippers of the actuator of the vial holder as set forth in claim 28, the robotic mechanism of the actuator as set forth in claim 31, a motor of the actuator as set forth in claim 32 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both manipulator and agitator.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. None of the original claims, disclosure or figures describe “gripping the vial by actuation of an actuator of the vial holder”. Figure 1 and the disclosure that describes figure 1 shows/describes that there is a reference #110 which is made up of a manipulator/agitator that rotates the vial by a motor that is the actuator of the manipulator. There is nothing that describes the actuator being for gripping the vial holder. The only structure shown is figure 110A which holds the vial 115. There is no gripping the vial by actuation of an actuator of the vial holder and there is nothing in the original disclosure that describes the vial holder as having any of these actuator structures. Claims 2-20 and 27-32 are also rejected under 35 USC 112(a) by virtue of their dependency on claim 1.
Similarly claims 27-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 27, there is nothing in the original disclosure that describes the actuator having one or more arms or that it is part of the vial holder. Regarding claim 28, there is nothing in the original disclosure that supports multiple grippers of the actuator. Regarding claim 29, there is nothing in the original disclosure that supports the gripping of the vial by the actuation of the actuator of the vial holder is implemented by the actuated manipulator controllably interacting with the vial. Regarding claim 30, there is nothing in the original disclosure that supports the gripping of the vial by the actuation of the actuator of the vial holder is implemented by the actuated manipulator controllably interacting with and moving the vial. Regarding claim 31, there is nothing in the original disclosure that supports the gripping of the vial by the actuation of the actuator of the vial holder is implemented by a robotic mechanism of the actuator of the vial holder. Regarding claim 32, there is nothing in the original disclosure that supports the gripping of the vial by the actuation of the actuator of the vial holder is implemented by movement of a motor of the actuator of the vial holder.
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 1-20 and 27-34 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.
Claim 1 refers to a vial holder, an actuated manipulator and an agitator as all attempting hold the vial. It is unclear whether these are all different structures or the same structure and how they interact or are connected. For example, reference #110 is used to refer to the manipulator, agitator and gripper so it is unclear which structure is being referred to or how they make up each other. Reference #110A is used to refer to a structure that holds the vial, but it is unclear if this is considered the gripper, vial holder or something else. Furthermore, there is no structure that is described as being the vial holder, but the claims recite that it comprises the actuator and does the gripping so it is unclear what structure this is and if it is different than the gripper. Additionally, the actuator is described as being a motor that operates the agitator to rotate, so it is unclear how this actuator does any kind of gripping of the vial holder or if there is more than one actuator as part of the system/method. As such the claims are indefinite for failing to distinctly claim the invention. Claims 2-20 and 27-32 are also rejected under 35 USC 112(b) by virtue of their dependency on claim 1.
Claims 27-31 refer to a vial holder, an actuator, gripping and an agitator as all attempting hold the vial. It is unclear whether these are all different structures or the same structure and how they interact or are connected. For example, reference #110 is used to refer to the manipulator, agitator and gripper so it is unclear which structure is being referred to or how they make up each other. Reference #110A is used to refer to a structure that holds the vial, but it is unclear if this is considered the gripper, vial holder or something else. Furthermore, there is no structure that is described as being the vial holder, but the claims recite that it comprises the actuator and does the gripping so it is unclear what structure this is and if it is different than the gripper. Additionally, the actuator is described as being a motor that operates the agitator to rotate, so it is unclear how this actuator does any kind of gripping of the vial holder or if there is more than one actuator as part of the system/method. As such the claims are indefinite for failing to distinctly claim the invention.
Claim 27 recites the limitation "the gripping of the vial by the actuation of the actuator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the gripping of the vial by the actuation of the actuator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the gripping of the vial by the actuation of the actuator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the gripping of the vial by the actuation of the actuator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the gripping of the vial by the actuation of the actuator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 refers to a vial holder, an actuated manipulator and an agitator as all attempting hold the vial. It is unclear whether these are all different structures or the same structure and how they interact or are connected. For example, reference #110 is used to refer to the manipulator, agitator and gripper so it is unclear which structure is being referred to or how they make up each other. Reference #110A is used to refer to a structure that holds the vial, but it is unclear if this is considered the gripper, vial holder or something else. Furthermore, there is no structure that is described as being the vial holder, but the claims recite that it comprises the actuator and does the gripping so it is unclear what structure this is and if it is different than the gripper. Additionally, the actuator is described as being a motor that operates the agitator to rotate, so it is unclear how this actuator does any kind of gripping of the vial holder or if there is more than one actuator as part of the system/method. As such the claims are indefinite for failing to distinctly claim the invention.
Claim 33 refers to a vial holder, an actuated manipulator and an agitator as all attempting hold the vial. It is unclear whether these are all different structures or the same structure and how they interact or are connected. For example, reference #110 is used to refer to the manipulator, agitator and gripper so it is unclear which structure is being referred to or how they make up each other. Reference #110A is used to refer to a structure that holds the vial, but it is unclear if this is considered the gripper, vial holder or something else. Furthermore, there is no structure that is described as being the vial holder, but the claims recite that it comprises the actuator and does the gripping so it is unclear what structure this is and if it is different than the gripper. Additionally, the actuator is described as being a motor that operates the agitator to rotate, so it is unclear how this actuator does any kind of gripping of the vial holder or if there is more than one actuator as part of the system/method. As such the claims are indefinite for failing to distinctly claim the invention.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 27-32 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al. (U.S. Patent Pub. No. 2021/0086153).
Regarding claim 1, Gross et al. discloses a method of controlling dissolution of a solute into a solvent in a vial, the vial being held by a vial holder comprising an actuated manipulator of a pharmaceutical preparation device (figure 1; figure 9; [0003]; [0006]; [0021]-[0025]; [0029]; [0037]), the method comprising:
agitating the vial holder by an agitator operably connected to the vial holder, thereby shaking the solute and the solvent in the vial being held by the vial holder (figure 1, reference #12 and 20; [0003]; [0029]-[0032]; [0038]);
accessing, by processing circuitry, a plurality of images of vial contents captured after the agitation was initiated ([0029] (one or more optical sensors such as cameras (plurality of optical sensors means plurality of images with provided feedback); and [0032] (a feedback loop based on information from one or more sensors)), wherein the images are obtained while the solute and the solvent remain in motion relative to the vial containing them ([0029]; [0032]);
by image processing with the processing circuitry, assessing a characteristic of vial contents using differences among the plurality of images due to motion of the solute and the solvent ([0029] (optical sensor assesses characteristic of status of mixing and compares it to target characteristic of completed mixed material to determine whether mixing is complete); and [0032] (updating motion based on feedback loop based on the information from the one or more optical sensors));
comparing the assessed characteristic to a targeted characteristic of the vial contents using differences among the plurality of images due to motion of the solute and the solvent ([0029] (optical sensor assesses characteristic of status of mixing and compares it to target characteristic of completed mixed material to determine whether mixing is complete); and [0032] (updating motion based on feedback loop based on the information from the one or more optical sensors)); and
adjusting, by the processing circuitry, agitation by the agitator, in accordance with a result of the comparing ([0029] adjustments include halting mixing if comparison shows mixing not complete or [0032] updating mixing by starting, stopping, increasing or decreasing acceleration based on information from optical sensor)).
Regarding claim 2, Gross et al. discloses wherein the adjusting comprises halting agitation ([0029]; [0032]).
Regarding claim 3, Gross et al. discloses wherein the adjusting comprises restarting agitation ([0032]).
Regarding claim 4, Gross et al. discloses wherein the adjusting comprises modifying at least one parameter of agitation motion ([0032]).
Regarding claim 5, Gross et al. discloses wherein the solute is a solid ([0003] (powders)).
Regarding claim 6, Gross et al. discloses wherein the solvent is a fluid ([0003 (flowable materials such as creams...or viscous materials)).
Regarding claim 7, Gross et al. discloses wherein the assessed characteristic assesses the dissolution of the solute into the solvent ([0029], the targeted characteristic of the vial contents comprises a dissolution appearance criterion ([0029], and the adjusting comprises halting or extending a period of operation of the agitator ([0029] (stop the servo motor); [0032] (stopping)).
Regarding claim 8, Gross et al. discloses wherein the adjusting comprises halting operation of the agitator while the targeted dissolution appearance remains unsatisfied ([0029]; [0032]) and raising an alert ([0028]).
Regarding claim 9, Gross et al. discloses wherein the adjusting comprises extending operation of the agitator while the targeted dissolution appearance criterion remains unsatisfied ([0032]).
Regarding claim 27, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented using one or more arms of the actuator of the vial holder (figure 9, reference #38 and 48; [0021]; [0023]-[0025]; [0037]).
Regarding claim 28, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented using one or more grippers of the actuator of the vial holder (figures 1 and 2, reference #18; figure 9, reference #38 and 48; [0021]; [0023]-[0025]; [0037]).
Regarding claim 29, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented by the actuated manipulator controllably interacting with the vial (figures 1 and 2, reference #18; figure 9, reference #38 and 48; [0021]; [0023]-[0025]; [0037]).
Regarding claim 30, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented by the actuated manipulator controllably interacting with and moving the vial (figures 1 and 2, reference #18; figure 9, reference #38 and 48; [0021]; [0023]-[0025]; [0037]).
Regarding claim 31, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented by a robotic mechanism of the actuator of the vial holder (figure 9, reference #38 and 48; [0023]; [0037])
Regarding claim 32, Gross et al. discloses wherein the gripping of the vial by the actuation of the actuator of the vial holder is implemented by movement of a motor of the actuator of the vial holder (figures 1 and 2, reference #18; figure 3, reference #18 and 22; figure 9, reference #38 and 48; [0021]; [0023]-[0025]; [0037]).
Regarding claim 33, Gross et al. discloses a method of controlling dissolution of a solute into a solvent in a vial, the vial being held by a vial holder comprising an actuated manipulator of a pharmaceutical preparation device (figure 1; figure 9; [0003]; [0006]; [0021]-[0025]; [0029]; [0037]), the method comprising:
agitating the vial holder by an agitator operably connected to the vial holder, thereby shaking the solute and the solvent in the vial being held by the vial holder (figure 1, reference #12 and 20; [0003]; [0029]-[0032]; [0038]);
accessing, by processing circuitry, a plurality of images of vial contents captured after the agitation was initiated ([0029] (one or more optical sensors such as cameras (plurality of optical sensors means plurality of images with provided feedback); and [0032] (a feedback loop based on information from one or more sensors));
by image processing with the processing circuitry, assessing a characteristic of vial contents ([0029] (optical sensor assesses characteristic of status of mixing);
comparing the assessed characteristic to a targeted characteristic of the vial contents ([0029] (optical sensor assesses characteristic of status of mixing and compares it to target characteristic of completed mixed material to determine whether mixing is complete); and
adjusting, by the processing circuitry, agitation by the agitator, in accordance with a result of the comparing ([0029] adjustments include halting mixing if comparison shows mixing not complete or [0032] updating mixing by starting, stopping, increasing or decreasing acceleration based on information from optical sensor));
wherein the result of the comparing distinguishes at least between at least two incompletely dissolved states of the vial contents ([0029]); and
wherein the adjusting comprises changing a pattern of motion of the agitator ([0029]-[0032]).
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) 10, 11, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. in view of Khan et al. (U.S. Patent Pub. No. 2005/0252572).
Regarding claims 10 and 11, Gross et al. discloses all the limitations as set forth above. While the reference discloses an optical sensor such as a camera to determine the optical properties of the mixing material [0029], the reference does not explicitly disclose wherein the dissolution appearance criterion comprises a measure of color.
Khan et al. teaches another mixer system (abstract). The reference teaches many different types of sensors may be used to measure the characteristics of the mixed materials, including measuring the color of the solvent ([0072]). Since the instant specification is silent to unexpected result, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the optical sensor of Gross et al. to measure the color of the solvent to determine the dissolution criterion, as taught by Khan et al., because selecting one of known optical sensors for determining the dissolution criterion would have been considered obvious to one of ordinary skill in the art at the time the invention was filed and because said optical sensor for determining the dissolution criterion based on measuring color of the solvent mouthpiece would operate equally well as the one disclosed by Gross et al.
Regarding claims 14 and 15, Gross et al. discloses all the limitations as set forth above. The reference further discloses the adjusting comprises halting agitation ([0029]; [0032]); and also in accordance with the result of the comparing, the processing circuitry raises an alert ([0028]). However, the reference does not explicitly disclose wherein the assessed characteristic assesses presence of foreign particles in the solvent, the targeted characteristic of the vial contents comprises a foreign particle presence criterion.
Khan et al. teaches another mixer system (abstract). The reference teaches wherein the assessed characteristic assesses presence of foreign particles in the solvent ([0015]), the targeted characteristic of the vial contents comprises a foreign particle presence criterion ([0015]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the assessed characteristic of Gross et al. to include the presence of foreign particles in the solvent as taught by Khan et al. One of ordinary skill in the art would reasonably expect such a combination to be suitable given that both references teach mixer systems. One of ordinary skill in the art would be motivated to include the foreign particle assessment because the presence of foreign particles is unwanted in the final mixture since it can pose a safety risk or be a sign of contamination that requires the mixture to be discarded (Khan et al. [0010]).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. in view of Merrill et al. (U.S. Patent Pub. No. 2007/0188753).
Regarding claim 12, Gross et al. discloses all the limitations as set forth above. The reference further discloses the adjusting comprises modifying a parameter governing a movement pattern of the agitator ([0032]). However, the reference does not explicitly disclose wherein the assessed characteristic assesses caking of the solute, the targeted characteristic of the solvent in the vial comprises a caking appearance criterion.
Merrill et al. teaches another mixing system (title). The reference teaches wherein the assessed characteristic assesses caking of the solute ([0004]; [0025]), the targeted characteristic of the solvent in the vial comprises a caking appearance criterion ([0004]; [0025]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the assessed characteristic of Gross et al. to include caking as taught by Merrill et al. One of ordinary skill in the art would reasonably expect such a combination to be suitable given that both references teach mixer systems. One of ordinary skill in the art would be motivated to include the caking assessment and criterion because it is a way to monitor the status of the mixing and the completeness of the mixing so that the mixing schemes can be optimized (Merrill et al. [0025]).
Regarding claim 13, Gross et al. in view of Merrill et al. discloses all the limitations as set forth above. The reference as modified further discloses wherein the movement pattern is adjusted in at least one of: an amplitude, an acceleration, a rotation of the vial, and a geometry of a path along which the vial is moved (Gross et al. [0032]; Merrill [0025]).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. in view of Herzog et al. (U.S. Patent Pub. No. 2022/0134295).
Regarding claim 16, Gross et al. discloses all the limitations as set forth above. The reference further discloses the adjusting comprises halting agitation ([0029]; [0032]); and also in accordance with the result of the comparing, the processing circuitry raises an alert ([0028]). However, the reference does not explicitly disclose wherein the assessed characteristic assesses a volume of the vial contents, the targeted characteristic of the solvent in the vial comprises an expected amount of the vial contents.
Herzog et al. teaches another mixer system (abstract; figure 4). The reference teaches wherein the assessed characteristic assesses a volume of the vial contents ([0019]; [0028]; [0033]; [0039]; [0066]; [0067]; [0071]), the targeted characteristic of the solvent in the vial comprises an expected amount of the vial contents ([0019]; [0028]; [0033]; [0039]; [0066]; [0067]; [0071]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the assessed characteristic of Gross et al. to include the volume of the vial contents and expected amount of the vial contents as taught by Khan et al. One of ordinary skill in the art would reasonably expect such a combination to be suitable given that both references teach mixer systems. One of ordinary skill in the art would be motivated to include the volume assessment because the volume and expected amount of vial contents affects the shaking movement and thus the complete mixing of the vial contents, and the balance and stability of the shaker (Herzog et al. [0033]; [0039]; [0053]-[0054]).
Regarding claim 17, Gross et al. discloses all the limitations as set forth above. However, the reference does not explicitly disclose wherein at least one of the assessing the characteristic and the comparing comprises classifying the at least one image in accordance with a pre-trained machine learning model.
Herzog et al. teaches another mixer system (abstract; figure 4). The reference teaches wherein at least one of the assessing the characteristic and the comparing comprises classifying the at least one image in accordance with a pre-trained machine learning model ([0057]-[0059]).
While Gross et al. discloses the assessing the characteristic and the comparing, it is not done in accordance with a pre-trained machine learning model. It is well known in the art to use a pre-trained machine learning model for computer assessments and comparisons, as evidenced by Herzog et al. ([0057]-[0059]), and it would have been obvious to one having ordinary skill in the art before the time of filing to use a pre-trained machine learning model to avoid human error.
Regarding claims 18 and 19, Gross et al. discloses all the limitations as set forth above. However, the reference does not explicitly disclose the adjusting comprises adjusting agitation of an at least second vial.
Herzog et al. teaches another mixer system (abstract; figure 4). The reference teaches wherein the adjusting comprises adjusting agitation of an at least second vial, according to the result of the comparing (figure 4, two vials shown; [0061]; [0066]; [[069]; [0071]; [0074]); and wherein the adjusting is according to a plurality of said results of a respective plurality of said comparing (figure 4, two vials shown; [0061]; [0066]; [0069]; [0071]; [0074]).
While Gross et al. only discloses a single vial and adjusting of the single vial, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the system of Gross et al. to have a second vial with adjustment of that second vial according to a plurality of said results of a respective plurality of said comparings so that the system operates faster and more efficiently because two vials with adjustment comparisons ensures no unbalanced forces ensures more precise information on the load distribution of multiple vials an increased amount of accurately mixed end product vials, less wasted time adjusting new vials and better optimization (Herzog et al. [0061]; [0066]; [0069]; [0071]; [0074]), and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. in view of Fontanez et al. (U.S. Patent Pub. No. 2021/0215591).
Regarding claim 20, Gross et al. discloses all the limitations as set forth above. While, the reference does not explicitly disclose wherein the at least one image of vial contents is imaged from a position below the vial, it would have been obvious to one having ordinary skill in the art before the time of filing to obtain an accurate, clear and close image, by placing the at least one image at a position below the vial as taught by Fontanez et al. (figure 8, reference #832; figure 18, reference #1832; [0086])), since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed position would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. in view of Merrill et al. and Khan et al.
Regarding claim 33, Gross et al. discloses a method of controlling dissolution of a solute into a solvent in a vial, the vial being held by a vial holder comprising an actuated manipulator of a pharmaceutical preparation device (figure 1; figure 9; [0003]; [0006]; [0021]-[0025]; [0029]; [0037]), the method comprising:
agitating the vial holder by an agitator operably connected to the vial holder, thereby shaking the solute and the solvent in the vial being held by the vial holder (figure 1, reference #12 and 20; [0003]; [0029]-[0032]; [0038]);
accessing, by processing circuitry, a plurality of images of vial contents captured after the agitation was initiated ([0029] (one or more optical sensors such as cameras (plurality of optical sensors means plurality of images with provided feedback); and [0032] (a feedback loop based on information from one or more sensors));
by image processing with the processing circuitry, assessing a characteristic of vial contents ([0029] (optical sensor assesses characteristic of status of mixing);
comparing the assessed characteristic to a targeted characteristic of the vial contents ([0029] (optical sensor assesses characteristic of status of mixing and compares it to target characteristic of completed mixed material to determine whether mixing is complete); and
adjusting, by the processing circuitry, agitation by the agitator, in accordance with a result of the comparing ([0029] adjustments include halting mixing if comparison shows mixing not complete or [0032] updating mixing by starting, stopping, increasing or decreasing acceleration based on information from optical sensor)).
However, the reference does not explicitly disclose wherein the result of the comparing distinguishes at least between caked solid contents and foreign particle contents of the vial.
Khan et al. teaches another mixer system (abstract). The reference teaches wherein the result of the comparing distinguishes the presence of foreign particles in the solvent ([0015]).
Merrill et al. teaches another mixing system (title). The reference teaches wherein the result of the comparing distinguishes the caking of the solute ([0004]; [0025])
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the result of the comparing of Gross et al. to distinguish at least between caked solid contents and foreign particle contents of the vial as taught by Khan et al. and Merrill et al. One of ordinary skill in the art would reasonably expect such a combination to be suitable given that all references teach mixer systems. One of ordinary skill in the art would be motivated to include the caking solid and foreign particle contents distinguishing comparison because the presence of foreign particles is unwanted in the final mixture since it can pose a safety risk or be a sign of contamination that requires the mixture to be discarded (Khan et al. [0010]), and the caking assessment is a way to monitor the status of the mixing and the completeness of the mixing so that the mixing schemes can be optimized (Merrill et al. [0025]).
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive.
Regarding the drawing objections, Applicant has failed to address all the objections as set forth above.
Regarding the 112(a) rejections, Applicant has failed to address all the rejections as set forth above.
Regarding the 112(b) rejections, Applicant has failed to address all the rejections as set forth above.
Applicant argues Gross fails to disclose the limitations of claim 1, wherein the images are obtained while the solute and the solvent remain in motion relative to the vial containing them and using differences among the plurality of images due to motion of the solute and the solvent. Examiner finds this argument unpersuasive. Applicant's arguments amount to a general allegation without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant merely points to paragraph [0029] of Gross as reciting optical sensors such as cameras for determining whether mixing is complete, but does not explain why Gross does not disclose the limitations. Rather, as explained in the rejection above, Gross explains in paragraphs [0029] and [0032] “regarding whether mixing is complete” means the optical sensors provide the feedback to the HMI for display of images of the mixing status during the actual mixing/motion and “thereby may stop motor” means feedback is given before the mixing is stopped, and for the user to customize the mixing by updating to stop, increase or decrease acceleration means the images are being obtained during the motion/mixing of the solute and solvent. Furthermore, as explained in paragraph [0032] the HMI displays the multiple images from the optical sensors for the user to update the mixing based on the feedback loop. A feedback loop as described in paragraph [0032] means there is a continuous adjustment of mixing based on the information/each of the plurality of images from the optical sensors with the assessed characteristic being the mixing completion based on those optical sensors.
Regarding claims 33 and 34, Applicant argues Gross fails to disclose those limitations for similar reasons to those above. Examiner finds this argument unpersuasive. The limitations, Applicant argues Gross fails to disclose in claim 1 do not appear in claims 33 or 34. Therefore, Applicant has not pointed out how the limitations of claims 33 or 34 patentably distinguish them from the references.
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.
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/ELIZABETH INSLER/Primary Examiner, Art Unit 1774