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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/28/2026 has been entered.
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.
Claim(s) 1-7, 9-13, 17, 20, 34, 35 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. (U.S. Patent No. 8,708,548) in view of Fontanez et al. (U.S. Patent Pub. No. 2021/0215591).
Regarding claim 1, Engelhardt et al. discloses a method of controlling dissolution of a solute into a solvent in a vial as vial contents (abstract; figure 1, container 150, solid substance 153, liquid phase 154), the vial being held by a vial holder of a pharmaceutical device (figure 1, apparatus 100, holder socket 111; column 7, lines 24-26), the method comprising:
agitating the solute and the solvent in the vial by shaking the vial with the vial holder, said agitating imparting vortical motion to the vial contents relative to the vial (figure 1, agitator device 110, rotary movement 172; figure 5, step 511; column 7, lines 30-59);
after initiating the agitating, imaging the vail contents through a surface of the vial to obtain a plurality of images of the vial contents as the vial contents are in said vortical motion (abstract; figure 1, camera 140; figure 2, images 211 and 212; columns 2-4, lines 64-17; column 8, lines 34-51); and
processing circuitry (figure 1, processor unit 130)
accessing the plurality of images of the vial contents (figure 2, images 211 and 212; column 8, lines 34-36);
determining a motion signal based on differences among the plurality of images due to said vortical motion of the solute and solvent (figure 2, analytical representation 220, moving particles 253A, 253B, liquid 254; column 3, lines 32-38; columns 7-8, lines 66-3; columns 8-9, lines 65-2);
assessing a characteristic of the vial contents using said motion signal (figure 2, evaluation zone 290; column 6, lines 12-16; columns 7-8, lines 66-3; column 8, lines 34-37; columns 9-10, lines 3-6)
comparing the assessed characteristic to a target characteristic of the vial contents (figures 3 and 4; column 6, lines 17-34; column 8, lines 34-37; column 10, lines 20-30; column 11, lines 40-64); and
adjusting the agitating of the vial with the vial holder based on a result of the comparing (column 8, lines 34-44; column 10, lines 31-42).
While Engelhardt et al. discloses the camera may be located at different positions, with preference for a location that can image the entire container, as long as it generates data and/or images of the mixture (columns 2-4, lines 64-17), Engelhardt et al. does not explicitly disclose imaging from a direction parallel to a longitudinal axis. Fontanez et al. teaches another apparatus for agitating material in a vial with photodetection (abstract), wherein the photodetector (camera) may be placed in a variety of spatial arrangements relative to the vessel, holder, and liquid sample, including imaging the vial contents through a surface of the vial from a direction parallel to a longitudinal axis of the vial (figure 14, photodetector 1432; [0079]; [0082]). 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 imaging at a position for imaging the vial contents through a surface of the vial from a direction parallel to a longitudinal axis of the vial as taught by Fontanez et al. in order to take a complete image of the entire contents of the vessel, 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.
Regarding claim 2, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the adjusting comprises halting the agitating of the vial with the vial holder (column 10, lines 36-42 (predicting the remaining time required means the adjusting will halt the agitation at the end of that time)).
Regarding claim 3, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the adjusting comprises restarting the agitating of the vial with the vial holder (column 8, lines 37-39 (reactivate the drive mechanism); columns 10-11, lines 43-10 (step 510 is agitating, then step 511 stops agitating, then after the observations and evaluations, the process repeats to step 510 to restart agitating of the vial with the vial holder)).
Regarding claim 4, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the adjusting comprises modifying at least one parameter of the agitating of the vail with the vial holder (column 6, lines 32-34; column 8, lines 37-41).
Regarding claim 5, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the solute is a solid (figure 1, solid substance 153).
Regarding claim 6, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the solvent is a fluid (figure 1, liquid phase 154).
Regarding claim 7, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the assessed characteristic assesses dissolution of the solute into the solvent, the targeted characteristic of the vial contents comprises a dissolution appearance criterion, and the adjusting comprises halting or extending a period of the agitating of the vial with the vial holder (abstract; column 6, lines 17-46; columns 7-8, lines 60-3; column 8, lines 24-44; column 10, lines 20-43; column 11, lines 1-10; column 11, lines 34-64).
Regarding claim 9, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the adjusting comprises extending the agitating of the vail with the vial holder while the targeted dissolution appearance criterion remains unsatisfied (column 11, lines 1-10).
Regarding claim 10, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the dissolution appearance criterion comprises a measure of at least one of: transparency of the solvent, color of the solvent, and clarity of the solvent (figure 2; columns 5-6, lines 56-46; columns 7-8, lines 66-16; columns 8-9, lines 45-54).
Regarding claim 11, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the dissolution criterion comprises the measure of color of the solvent, selected in accordance with a type of the solute (column 5, lines 20-29; column 8, lines 3-16).
Regarding claim 12, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the assessed characteristic assesses caking of the solute, the targeted characteristic of the solvent in the vial comprises a caking appearance criterion, and the adjusting comprises modifying a parameter governing a movement pattern of the vial holder (column 8, lines 4-64; column 9, lines 34-46; column 11, lines 40-64).
Regarding claim 13, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. 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 (figure 1, oscillatory movements 171 and rotary movements 172; column 7, lines 30-59).
Regarding claim 17, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses 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 (column 2, lines 55-63; column 3, lines 45-57; column 9, lines 34-46; column 10, lines 36-42).
Regarding claim 20, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the plurality of images of vial contents is imaged from a position below the vial (Fontanez et al. figure 14, photodetector 1432).
Regarding claim 34, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the result of the comparing distinguishes at least between at least two incompletely dissolved states of vial contents (figure 2, image 210 and 221; column 8, lines 45-64); and wherein the adjusting comprises changing a pattern of motion of the agitating (column 7, lines 42-44; column 8, lines 34-44).
Regarding claim 35, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the identifying comprises comparing the plurality of images to identify difference in magnitudes due to motion of the solute within the solvent during said agitating (figures 2-4; column 3, lines 25-57; columns 7-8, lines 60-3).
Regarding claim 37, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein said imaging the vial contents includes imaging the vial contents through a bottom surface of the vial (Fontanez et al. figure 14, photodetector 1432).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claims 1 and 7 above, and further in view of Gross et al. (U.S. Patent Pub. No. 2021/0086153).
Regarding claim 8, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the adjusting comprises halting the agitating of the vial with the vial holder while the targeted dissolution appearance criterion remains unsatisfied (figures 5 and 6, first step 512 before the steps are repeated; column 10, lines 53-58); however, fails to explicitly disclose raising an alert. Gross teaches another method of controlling dissolution of a solute in a solvent by agitation and imaging (figure 1; [0003]; [0029]) wherein the adjusting comprises halting the agitating of the vial with the vial holder while the targeted dissolution appearance criterion remains unsatisfied ([0029]; [0032]) and raising an alert ([0028]). It would have been obvious to one having ordinary skill in the art before the time of filing to raise an alert as taught by Gross as part of the method of Engelhardt et al. in order to better communicate and provide safety and/or operation controls such as lockouts, warnings and/or shutdowns to protect the mixer and system (Gross [0028]).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Gross et al. and Khan et al. (U.S. Patent Pub. No. 2005/0252572).
Regarding claims 14 and 15, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses the adjusting comprises halting the agitating of the vial with the vial holder (figures 5 and 6, first step 512 before the steps are repeated; column 10, lines 53-58); however, fails to 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; and also in accordance with the result of comparing, the processing circuitry raises an alert.
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 Engelhardt 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]).
Gross teaches another method of controlling dissolution of a solute in a solvent by agitation and imaging (figure 1; [0003]; [0029]) wherein the adjusting comprises halting the agitating of the vial with the vial holder while the targeted dissolution appearance criterion remains unsatisfied ([0029]; [0032]) and raising an alert ([0028]). It would have been obvious to one having ordinary skill in the art before the time of filing to raise an alert as taught by Gross as part of the method of Engelhardt et al. in order to better communicate and provide safety and/or operation controls such as lockouts, warnings and/or shutdowns to protect the mixer and system (Gross [0028]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Gross et al. and Herzog et al. (U.S. Patent Pub. No. 2022/0134295).
Regarding claim 16, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses the adjusting comprises halting the agitating of the vial with the vial holder (figures 5 and 6, first step 512 before the steps are repeated; column 10, lines 53-58); however, fails to 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; and also in accordance with the result of comparing, the processing circuitry raises an alert.
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 Engelhardt et al. to include the volume of the vial contents as taught by Herzog et al. 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]).
Gross teaches another method of controlling dissolution of a solute in a solvent by agitation and imaging (figure 1; [0003]; [0029]) wherein the adjusting comprises halting the agitating of the vial with the vial holder while the targeted dissolution appearance criterion remains unsatisfied ([0029]; [0032]) and raising an alert ([0028]). It would have been obvious to one having ordinary skill in the art before the time of filing to raise an alert as taught by Gross as part of the method of Engelhardt et al. in order to better communicate and provide safety and/or operation controls such as lockouts, warnings and/or shutdowns to protect the mixer and system (Gross [0028]).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Herzog et al.
Regarding claims 18 and 19, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above; however 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); 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 Engelhardt 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 Engelhardt 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) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Khan et al.
Regarding claim 33, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein the result of the comparing distinguishes at least between caked solid contents (column 8, lines 4-64; column 9, lines 34-46; column 11, lines 40-64); however does not explicitly disclose wherein the result of the comparing distinguishes between foreign particle contents of the vial.
Khan et al. teaches another mixer system (abstract); wherein the result of the comparing distinguishes between foreign particle contents of the vial ([0015]). It would have been obvious to one of ordinary skill in the art before the time of filing to modify the result of comparing of Engelhardt et al. to distinguish foreign particle contents of the vial 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 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]).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Milne et al. (U.S. Patent Pub. No. 2014/0177932).
Regarding claim 36, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. While Engelhardt et al. as modified discloses wherein the imaging comprising illuminating the vial using an illuminations source surrounding the vial, and the quality of the images depends on providing the right illumination, and discloses multiple lights and with multiple angles (column 8, lines 4-23), Englehardt et al. does not explicitly disclose the illumination source is a ring. It is well known in the art that an illumination source can have a variety of shapes of configurations, including ring (as evidenced by Milne et al. figure 6B, ring LED 1120, figures 8 and 9D, light source 122a; [0182]). The change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). It would have been obvious to one having ordinary skill in the art before the time of filing to modify the illumination source of Engelhardt et al. to include a variety of illumination shapes, as taught by Milne et al. An ordinary skilled artisan before the time of filing would have been motivated to do the foregoing in order to maximize the amount of light the particle reflect or refract towards the detector while keeping the background dark to maximize the contrast between images of the particles and background (Milne et al. [0176]).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhardt et al. in view of Fontanez et al. as applied to claim 1 above, and further in view of Danopoulos (U.S. Patent Pub. No. 2022/0008878).
Regarding claim 38, Engelhardt et al. in view of Fontanez et al. discloses all the limitations as set forth above. Engelhardt et al. as modified by Fontanez et al. further discloses wherein said imaging the vial contents includes imaging the vial contents through a surface of the vial that avoids occlusion by occluding matter on the side of the vial (column 4, lines 8-17); however does not explicitly disclose wherein the vial is labeled with a label on a side of the vial that extends parallel to the longitudinal axis of the vial.
Danopoulos teaches another mixer (abstract); wherein the vial is labeled with a label on a side of the vial that extends parallel to the longitudinal axis of the vial (figure 13, bar code 1003). It would have been obvious to one of ordinary skill in the art before the time of filing to provide the label/bar code of Danopoulos on a side of the vial of Engelhardt so that the system can identify what type of material is being mixed in order to ensure the proper mixing of ingredients in certain proportions and process steps (Danopoulos [0156]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 and 33-38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/ELIZABETH INSLER/Primary Examiner, Art Unit 1774
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