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 . 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 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.
Claim Objections
Claim 1 is objected: “(d) measuring the amount” should be corrected to read as ”(d) measuring an amount”.
Appropriate action is required.
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 2-4,8, and 10 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.
The term "about" is a relative term which renders the claim indefinite. The term "about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-4, 6-7,9-10, 15-19, 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over DEICKE, DE 29911370 U1, in view of Zaman, US 20210018482 A1.
Claim 1
DEICKE1 in figs.1-4 teaches:
A method for evaluating homogeneity of a suspension containing an active agent (active ingredient e.g., ¶0006), comprising:
(a) obtaining a test sample of the suspension (¶0045) in a container (2 fig.2);
(b) subjecting the container 2 to shaking at a shaker speed (using 14,18,10,11,fig.1b) and for a duration of shaking (e.g., ¶0045,0046);
(c) removing (in 8 fig.3) an aliquot (dosing station 3) of the suspension 4 from the container 2 (e.g., ¶0048-0050,0052,0055);
DEICKE does not specifically teach (d) measuring the amount of the active agent in the aliquot; and (e) comparing the amount of the active agent in the aliquot to an acceptance criteria. (though DEICKE specifically identifies this unmet need, i.e., in ¶0055-¶0057 discloses that Several samples can be examined in parallel in this way, meaning they can be stored simultaneously and examined one after the other at certain time intervals, The duration, shaking frequency and amplitude of the shaking motion can be adjusted variably depending on the purpose of the experiment. The active ingredient content of the samples taken in the dosing and tilting station is then determined outside the apparatus. The device according to the invention enables an objective and therapeutically relevant evaluation of drug suspensions with regard to their redispersibility and thus their handling by the patient... is made possible with the use of the new shaking apparatus with subsequent testing - evaluation of the shaking results.)
In the similar field of endeavor, Zaman2 teaches measuring the amount of the active agent in the aliquot (e.g., ¶0007,0045-0050); and comparing the amount of the active agent in the aliquot to an acceptance criteria (e.g., ¶0051-0052,0066). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Zaman‘s measuring and comparing steps for DEICKE‘s method and (d) measuring the amount of the active agent in the aliquot; and (e) comparing the amount of the active agent in the aliquot to an acceptance criteria as taught by Zaman. One of ordinary skill in the art would have been motivated to make this modification in order to yield the predictable results of quantifying active ingredients and comparing it with reference data as suggested by Zaman, and based on MPEP 2143 (A), courts have ruled that Combining prior art elements according to known methods to yield predictable results is within the purview of a skilled artisan. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421,82 USPQ2d 1385, 1395-97 (2007).
Claim 2
DEICKE in view of Zaman teaches the method of claim 1, but does not teach wherein the shaker speed comprises a low speed of about 140 rpm to about 220 rpm, or about 160 rpm to about 200 rpm, or about 170 rpm to about 190 rpm, or about 175 rpm to about 185 rpm, or about 180 rpm, Nonetheless, the skilled artisan would know too that shaking speeds would effect the homogeneity. The specific claimed speed of about 140 rpm to about 220 rpm, or about 160 rpm to about 200 rpm, or about 170 rpm to about 190 rpm, or about 175 rpm to about 185 rpm, or about 180 rpm, absent any criticality, is only considered to be the “optimum” speeds disclosed by the prior art that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired homogeneity, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the claimed speeds is used, as already suggested by DEICKE. Please note that the specification contains no disclosure of either the critical nature of the claimed speeds ,i.e., any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 3
DEICKE in view of Zaman teaches the method of claim 1, but does not teach wherein the shaker speed comprises a high speed of about 240 rpm to about 320 rpm, or about 260 rpm to about 300 rpm, or about 270 rpm to about 290 rpm, or about 275 rpm to about 285 rpm, or about 280 rpm, Nonetheless, the skilled artisan would know too that shaking speeds would effect the homogeneity. The specific claimed speed of a high speed of about 240 rpm to about 320 rpm, or about 260 rpm to about 300 rpm, or about 270 rpm to about 290 rpm, or about 275 rpm to about 285 rpm, or about 280 rpm, absent any criticality, is only considered to be the “optimum” speeds disclosed by the prior art that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired homogeneity, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the claimed speeds is used, as already suggested by DEICKE. Please note that the specification contains no disclosure of either the critical nature of the claimed speeds ,i.e., any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 4
DEICKE in view of Zaman teaches the method of claim 1, but does not teach wherein the duration of shaking is about 5 seconds to about 45 seconds, or about 5 seconds, or about 10 seconds, or about 15 seconds, or about 30 seconds or about 45 seconds. Nonetheless, the skilled artisan would know too that the duration of shaking would effect the homogeneity. The specific claimed the duration of shaking is about 5 seconds to about 45 seconds, or about 5 seconds, or about 10 seconds, or about 15 seconds, or about 30 seconds or about 45 seconds, absent any criticality, is only considered to be the “optimum” speeds disclosed by the prior art that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired homogeneity, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the claimed speeds is used, as already suggested by DEICKE. Please note that the specification contains no disclosure of either the critical nature of the claimed speeds ,i.e., any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 6
DEICKE in view of Zaman teaches the method of claim 1, wherein step (b) further comprises shaking the container along a horizontal axis (e.g., see 11 in fig.2).
Claim 7
DEICKE in view of Zaman teaches the method of claim 1, DIECKE teaches wherein step (b) further comprises shaking the container at an angle (90) to a vertical axis.
Claim 9
DEICKE in view of Zaman teaches the method of claim 1, DEICKE teaches wherein step (b) is conducted using a fixed speed reciprocal shaker (15 in fig.2: "a guide rail in which the holding device for the bottle containing the suspension is movably mounted and can be moved back and forth by means of the drive", also: driven by "an electric motor 14 and rotates in the direction of the arrow 16," where "the frequency is determined by the rotational speed of the flywheel." A flywheel driven by a motor at a set rotational speed produces a fixed-speed reciprocating motion during a given shake cycle (even though DEICKE allows the operator to adjust frequency/amplitude between tests via the control device). Under BRI, this reads on "fixed speed reciprocal shaker" — the mechanism is reciprocal by structure and runs at a set speed once configured.).
Claim 10
DEICKE in view of Zaman teaches the method of claim 1, DEICKE does not teach wherein the test sample is about 4 or 8 fluid ounces. Nonetheless, the skilled artisan would know too that some amount of sample would effect the homogeneity. The specific claimed about 4 or 8 fluid ounces, absent any criticality, is only considered to be the “optimum” amount of sample disclosed by the prior art that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired testing features, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the claimed speeds is used, as already suggested by DEICKE. Please note that the specification contains no disclosure of either the critical nature of the claimed speeds ,i.e., any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 15
DEICKE in view of Zaman teaches the method of claim 1, Zaman teaches wherein the aliquot of step (c) is removed using a syringe (pump can be a syringe pump), It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Zaman‘s syringe for the modified DEICKE‘s aliquot of step (c). One of ordinary skill in the art knows it and would have been motivated to make this modification in order to do a quick and safe sampling.
Claim 16
DEICKE in view of Zaman teaches the method of claim 15, DEICKS teaches wherein the container must be inverted prior to removal of the aliquot in step (c) (after removing 2 from 5 they are shaken and then turned upside down to remove drop 4 and back in upright position, this is prior removal).
Claim 17
DEICKE in view of Zaman teaches the method of claim 1, DEICKS teaches wherein the aliquot of step (c) is poured or squeezed from the container into a dosing cup 8.
Claim 18
DEICKE in view of Zaman teaches the method of claim 1, DEICKS teaches wherein the active agent is substantially insoluble (e.g., ¶0006).
Claim 19
DEICKE in view of Zaman teaches the method of claim 1, DEICKS teaches wherein the active agent is an active pharmaceutical ingredient (API) (e.g., ¶0004).
Claim 22
DEICKE in view of Zaman teaches the method of claim 1, regarding “ further comprising:
(f) subjecting a remaining test sample of the suspension in the container to additional shaking at the shaker speed and for a second duration of shaking;
(g) removing a second aliquot of the suspension from the container;
(h) measuring the amount of the active agent in the second aliquot; and
(i) comparing the amount of the active agent in the second aliquot to a second acceptance criteria.” DEICKE teaches steps (f)-(g) DEICKE supports repeating (¶0055: two three times a day) and combined with Zaman which teaches steps (h)-(i), for the same reason and motivation as cited above in claim 1. Furthermore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to repeat the steps, since it has been held that mere duplication of the essential limitations involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 (1977).
Claim 23
DEICKE in view of Zaman teaches the method of claim 22, although DEIKE does not expressly discloses wherein the second acceptance criteria is the same as the acceptance criteria as an obvious design choice, but this is a trivial, non-functional distinction (using the identical criterion twice) — is an obvious design choice absent any showing of criticality.
Claim 24
DEICKE in view of Zaman teaches the method of claim 22, Zaman teaches wherein the second acceptance criteria is different from the acceptance criteria (Zaman distinguishes an "endpoint test" (single-sample, quick, different parameters) from the multi-sample "kinetic release" test, implying different test stages can have different evaluation criteria/parameters. Zaman's ¶0050 is citing (endpoint test parameters are chosen differently to minimize total dissolution time — i.e., different testing goals/criteria at different points). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Zaman‘s second acceptance criteria is different from the acceptance criteria of the modified DEICKE‘s acceptance criteria. One of ordinary skill in the art would have been motivated to make this modification in order to use a routine varying acceptance threshold between an initial vs. later timepoint as a routine QC design choice.
Claim 25
DEICKE in view of Zaman teaches the method of claim 1, regarding limitation “ wherein the step of subjecting the container to shaking at the shaker speed and for the duration of shaking corresponds to a user instruction associated with the test sample”: DEICKE discloses steps (a)–(c) of claim 1 and is expressly directed to designing the shaking apparatus's parameters (speed, amplitude, duration) to correspond to real, observed patient/user shaking behavior, rather than to arbitrary or purely mechanical shaking regimes: e.g., ¶0020 "the innovation is also intended to create a shaking apparatus in which the suspension can be shaken at an intensity that is typical for the patient population, as is required for many shaking processes, e.g. for pharmaceutical suspensions."; "a harmonic shaking motion is generated which was empirically determined from the shaking behavior of people of different ages." ¶0025. DEICKE further cites and incorporates the state of the art establishing that patient shaking behavior has historically been characterized and quantified directly in terms of instructed shaking actions and compliance with those instructions, e.g. ¶0013: "Strobel...defined weak shaking as follows: 'The vials were shaken gently before each drop was taken, i.e. only turned over twice' and vigorous shaking as 'The vials were held between the thumb and index finger and moved back and forth with the arm 20 times as quickly as possible'"; "a statistical study on the number of shaking cycles before the application of an eye drop preparation to hospital patients...Patient Compliance with Use of Topical Ophthalmic Corticosteroid Suspensions."
A person of ordinary skill seeking to implement DEICKE's stated goal — deriving realistic, patient-representative shake parameters — would have recognized that the primary real-world determinant of how a patient or user shakes a commercial suspension product is the instruction provided with or on that product (e.g., package labeling, insert, or verbal instruction accompanying the test sample). It would therefore have been obvious to a POSA to set the shaker speed and duration of shaking in DEICKE's method to correspond to claimed “user instructions associated to the test sample, since doing so is simply an application of DEICKE's own express design principle — matching test conditions to actual patient/user shaking behavior — to the recognized real-world source of that behavior. This yields nothing more than the predictable result DEICKE itself already seeks, achieved by an obvious and conventional means (deriving/observing shake parameters from product-associated use instructions) rather than an alternative surrogate (e.g., DEICKE's cited studies' artificial researcher-defined shaking protocols).
Claim 26
DEICKE in view of Zaman teaches the method of claim 25, limitation“ wherein the user instruction is provided on a commercial package of the test sample.” adds only that the user instruction is "provided on a commercial package of the test sample" and is obvious for same reason as cited above.
Claim 27
DEICKE in view of Zaman teaches the method of claim 26, limitation “ wherein the user instruction is to “shake well.” further specify that the instruction is the text "shake well." Placing use instructions on a commercial pharmaceutical package is a standard, universal industry and regulatory practice and would have been an obvious location for the "user instruction" to reside; no inventive contribution arises from this placement.
Claim 28
DEICKE in view of Zaman teaches the method of claim 1, regarding limitation “ wherein the step of subjecting the container to shaking at the shaker speed and for the duration of shaking corresponds to an observation of a user based on the user's interaction with a user instruction associated with the test sample.” DEICKE discloses steps (a)–(c) of claim 1 and is expressly directed to designing the shaking apparatus's parameters (speed, amplitude, duration) to correspond to real, observed patient/user shaking behavior, rather than to arbitrary or purely mechanical shaking regimes: "the innovation is also intended to create a shaking apparatus in which the suspension can be shaken at an intensity that is typical for the patient population, as is required for many shaking processes, e.g. for pharmaceutical suspensions."; "a harmonic shaking motion is generated which was empirically determined from the shaking behavior of people of different ages."
DEICKE further cites and incorporates the state of the art establishing that patient shaking behavior has historically been characterized and quantified directly in terms of instructed shaking actions and compliance with those instructions, e.g.: "Strobel...defined weak shaking as follows: 'The vials were shaken gently before each drop was taken, i.e. only turned over twice' and vigorous shaking as 'The vials were held between the thumb and index finger and moved back and forth with the arm 20 times as quickly as possible'"; "a statistical study on the number of shaking cycles before the application of an eye drop preparation to hospital patients...Patient Compliance with Use of Topical Ophthalmic Corticosteroid Suspensions."
A person of ordinary skill seeking to implement DEICKE's stated goal — deriving realistic, patient-representative shake parameters — would have recognized that the primary real-world determinant of how a patient or user shakes a commercial suspension product is the instruction provided with or on that product (e.g., package labeling, insert, or verbal instruction accompanying the test sample). It would therefore have been obvious to a POSA to set the shaker speed and duration of shaking in DEICKE's method to correspond to (to a user instruction associated with the test sample) or to be derived from an observation of a user's actual shaking behavior when following (to claimed an observation of a user based on the user’s interaction with a user instruction associated with the test sample) i.e., the instruction associated with the product, since doing so is simply an application of Deicke's own express design principle — matching test conditions to actual patient/user shaking behavior — to the recognized real-world source of that behavior. This yields nothing more than the predictable result DEICKE itself already seeks, achieved by an obvious and conventional means (deriving/observing shake parameters from product-associated use instructions) rather than an alternative surrogate (e.g., DEICKE's cited studies' artificial researcher-defined shaking protocols).
Claim 29
DEICKE in view of Zaman teaches the method of claim 28, limitation “wherein the user instruction is provided on a commercial package of the test sample.” adds only that the user instruction is "provided on a commercial package of the test sample", Placing use instructions on a commercial pharmaceutical package is standard, universal industry and regulatory practice and would have been an obvious location for the "user instruction" to reside; no inventive contribution arises from this placement.
Claim 30
DEICKE in view of Zaman teaches the method of claim 29, regarding “ wherein the user instruction is to “shake well.” further specify that the instruction is the text "shake well." Placing use instructions on a commercial pharmaceutical package is standard, universal industry and regulatory practice and would have been an obvious location for the "user instruction" to reside; no inventive contribution arises from this placement.
Claim 31
DEICKE in view of Zaman teaches the method of claim 28, DEICKE teaches wherein the observation comprises the user's shaker speed and duration of shaking. Based on obviousness as having derived shake parameters from an observation of the user's interaction with the instruction, it is a matter of routine, conventional data recording — requiring no inventive contribution — to specify that the "observation" includes recording the two parameters already central to DEICKE's own disclosed apparatus and control scheme (shaker speed and duration of shaking), both of which DEICKE's control device already measures, sets, and records for every shake cycle: ¶0054"The shaking and dosing cycle including the shaking profile is controlled by a control device and operated via a PC".
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over DEICKE, DE 29911370 U1, in view of Zaman, US 20210018482 A1 and Carlson, US 20040168529 A1.
Claim 5
DEICKE in view of Zaman teaches the method of claim 1, although DEICKE teaches wherein step (b) further comprises shaking the container along a horizontal axis (15) not vertical axis, however based on MPEP 2144.04 mere changing orientation/arrangement absent an unexpected result held to be obvious design choice. In the similar field of endeavor, Carlson teaches shaking in a vertical axis (¶0152), and as claimed vertical axis enable redispersibility testing. Therefore, POSITA find it obvious to shaking the container along a vertical axis as taught by Carlson as a routine engineering choice, especially that DEICKE is not limited to a horizontal axis.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over DEICKE, DE 29911370 U1, in view of Zaman, US 20210018482 A1 and Eisele, US 20260243635 A1.
Claim 8
DEICKE in view of Zaman teaches the method of claim 7, but does not teach wherein the angle is about 10 degrees to about 80 degrees from the vertical axis. But first: In the similar field of endeavor, Eisele teaches shaking the container at an angle (5-40 degree: ¶0034) to a vertical axis, secondly, the skilled artisan would know too that shaking would effect the homogeneity. The specific claimed 10 degrees to about 80 degrees angle of the container from the vertical axis, absent any criticality, is only considered to be the “optimum” angle disclosed by the prior art that a person having ordinary skill in the art would have been able to determine using routine experimentation (see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)) based, among other things, on the desired homogeneity, manufacturing costs, etc. (see In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and neither non-obvious nor unexpected results, i.e. results which are different in kind and not in degree from the results of the prior art, will be obtained as long as the claimed angles is used, as already suggested by Eisele. Please note that the specification contains no disclosure of either the critical nature of the claimed speeds ,i.e., any unexpected results arising therefrom. Where patentability is said to be based upon particular chosen dimensions or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 11-14 rejected under 35 U.S.C. 103 as being unpatentable over DEICKE, DE 29911370 U1, in view of Zaman, US 20210018482 A1 and Kenley, US 20250325517 A1.
Claim 11
DEICKE in view of Zaman teaches the method of claim 1, but does not teach wherein the aliquot of step (c) is removed using a pipette.
In the similar field of endeavor, Kenley teaches wherein the aliquot of step (c) is removed using a pipette (e.g.,¶0646). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Kenley‘s Pipette for removing the modified DEICKE‘s step. One of ordinary skill in the art knows sampling using pipette from multiple vertical positions (top/middle/bottom) is a known technique for assessing homogeneity or stratification within a liquid or suspension would have been motivated to make this modification in order to measure and transfer even tiny samples with a reasonable expectation of success, since both references involve withdrawing a defined-volume liquid aliquot from a container for downstream compositional analysis.
Claim 12
DEICKE in view of Zaman teaches the method of claim 1, but does not teach wherein the aliquot of step (c) is removed from a top portion of the container. Kenley teaches wherein the aliquot of step (c) is removed from a top portion of the container (e.g., ¶0646). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Kenley‘s Pipette for removing the modified DEICKE‘s step wherein the aliquot of step (c) is removed from a top portion of the container. One of ordinary skill in the art knows sampling using pipette from multiple vertical positions (top/middle/bottom) is a known technique for assessing homogeneity or stratification within a liquid or suspension would have been motivated to make this modification in order to measure and transfer even tiny samples with a reasonable expectation of success, since both references involve withdrawing a defined-volume liquid aliquot from a container for downstream compositional analysis.
Claim 13
DEICKE in view of Zaman teaches the method of claim 1, Kenley teaches wherein the aliquot of step (c) is removed from a bottom portion of the container (e.g., ¶0646). ). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Kenley‘s Pipette for removing the modified DEICKE‘s step wherein the aliquot of step (c) is removed from a bottom portion of the container. One of ordinary skill in the art knows sampling using pipette from multiple vertical positions (top/middle/bottom) is a known technique for assessing homogeneity or stratification within a liquid or suspension would have been motivated to make this modification in order to measure and transfer even tiny samples with a reasonable expectation of success, since both references involve withdrawing a defined-volume liquid aliquot from a container for downstream compositional analysis.
Claim 14
DEICKE in view of Zaman teaches the method of claim 1, Kenley teaches wherein the aliquot of step (c) is removed from a middle portion of the container (e.g., ¶0646). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Kenley‘s Pipette for removing the modified DEICKE‘s step wherein the aliquot of step (c) is removed from a middle portion of the container. One of ordinary skill in the art knows sampling using pipette from multiple vertical positions (top/middle/bottom) is a known technique for assessing homogeneity or stratification within a liquid or suspension would have been motivated to make this modification in order to measure and transfer even tiny samples with a reasonable expectation of success, since both references involve withdrawing a defined-volume liquid aliquot from a container for downstream compositional analysis.
Claims 20-21 rejected under 35 U.S.C. 103 as being unpatentable over DEICKE, DE 29911370 U1, in view of Zaman, US 20210018482 A1 and Latino , US 9976171 B2.
Claim 20
DEICKE in view of Zaman teaches the method claim 19, but does not teach wherein the amount of the active agent in the aliquot is measured in step (d) using an assay analysis of a USP monograph related to the API.
In the similar field of endeavor, Latino teaches wherein the amount of the active agent in the aliquot is measured in step (d) using an assay analysis of a USP monograph related to the API (col.1 lines 60-63:The test contained in the pancrelipase Delayed Release Capsule, USP Monograph for the determination of digestive enzymes release from pharmaceutical oral dosage forms, such as pancrelipase delayed released capsules is based on the specific measurement of lipase activity." And further col.12 after line 45: "The measurement of lipolytic activity is carried out with a method based on the compendia procedure of lipase assay described in the pancrelipase USP monograph..."). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Latino‘s a USP monograph related to the API for the modified DEICKE‘s API. One of ordinary skill in the art would have been motivated to make this modification in order to use the well-established USP monograph assay methodology for the specific API class at issue, since USP monograph compliance is standard practice for pharmaceutical quality control (as Latino itself states: "these tests can also be required as a USP quality parameter, to assess batch-to-batch quality").
Claim 21
DEICKE in view of Zaman teaches the method of claim 19, Latino teaches wherein the acceptance criteria (Q value of Latino) in step (e) corresponds to an approved dose of the API (col.10 L.8-11 :"These Q values are correlated to the labeled potencies and the current acceptance criteria are fixed as 75% of the lipase labeled activity." the Q-value formula explicitly divides by "labeled lipase Activity" — i.e., the FDA-approved labeled dose/potency of the API — to determine whether a batch passes. Further, the gastroresistance acceptance criteria are also explicitly tied to labeled content: col.22 L.62-65, col.23 last para: "UL is labeled content of lipase in the individual dosage unit (USP units/capsule)" the Level 1/2/3 acceptance criteria (90% average, no individual unit below 75%) under "USP, <711> dissolution—Delayed Release forms" are all measured against this labeled (i.e., approved) potency.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Latino‘s approved dose of the modified DEICKE‘s API. One of ordinary skill in the art would have applied this same well-known practice to any redispersibility/content-uniformity test of a pharmaceutical suspension, and use a known, standardized regulatory assay/criteria is generic to ensures that results are clinically relevant, legally compliant, and directly comparable to established standards.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Fatemeh E. Nia whose telephone number is (469)295-9187. The examiner can normally be reached 9:00 am to 4:00 pm.
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/FATEMEH ESFANDIARI NIA/Examiner, Art Unit 2855
1 Prior art of record
2 Prior art of record
Prosecution Insights