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 .
Status of the Claims
Claims 1-20 are pending.
Claims 1, 7, 11, and 17 are amended.
Response to Amendments
Applicant’s amendments filed 22 October 2025 are acknowledged.
Claim Rejections - 35 USC § 103
Applicant’s amendments to claims 1 and 11 is sufficient to overcome the rejection of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Beckett et al. (US20180236373, cited by applicant 02 February 2023, hereinafter Beckett) in view of Kobari (US20110138581, cited by applicants as US8425625 on 02 February 2023). Due to the amendments to claims 1 and 11 the rejection is withdrawn and a new ground(s) of rejection is/are provided below.
Response to Arguments
Applicant’s arguments filed 22 October 2025 have been fully considered but they are not persuasive.
Applicant’s argue that Beckett and Kobari do not disclose the limitations as recited in amended claims 1 and 11. These arguments have been considered but are not persuasive for the reasons set forth in the new grounds of rejection below and the response to arguments below.
In response to applicant’s arguments on pages 8-12 of the remarks filed on 22 October 2025 that “the process in Beckett does not heat the solution to a temperature that is equal to the predetermined temperature”, and the Beckett process does not teach “a current temperature”, “a predetermined temperature”, “a predetermined treatment time period”, “a cooling process” and “a crystallization temperature”.
It is noted, the instant claims to not recite any specific temperature range for “a current temperature” and “a predetermined treatment temperature” and any specific time range for “a predetermined treatment time period”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims, see In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) and MPEP 2111.01. The instant specification does not clearly define a current temperature, a predetermined treatment temperature, or a predetermined treatment time period “with reasonable clarity, deliberateness, and precision”, see MPEP 2111.01 IV.A.
The instant specification Para. [0051] details embodiments with exemplary “treatment temperature ranges” and “treatment time period ranges”; however, these ranges appear to not define a current temperature, a predetermined treatment temperature, or a predetermined treatment time period “with reasonable clarity, deliberateness, and precision”. The instant specification Para. [0077] states “a predetermined treatment temperature (e.g., 270° C.)” and “a predetermined treatment time period (e.g., 30 minutes).” The use of e.g. aka for example is not a specific definition “with reasonable clarity, deliberateness, and precision” for the claim limitations of “a predetermined treatment temperature” and “a predetermined treatment time period”. The instant specification Paras. [0078]-[0080] and Fig. 6, detail “an exemplary graphical presentation 54 of the current temperature”, where “the current temperature of the solution 24 can temporarily exceed the predetermined treatment temperature as shown in FIG. 6”. There is no specific definition “with reasonable clarity, deliberateness, and precision” for the claim limitation of “a current temperature”. Therefore, the instantly claimed current temperature, predetermined treatment temperature, and predetermined treatment time period are interpreted as any temperature or time needed to crystallize “a solution having at least one compound mixed with a dissolving agent” as stated in instant specification Para. [0010], where “the predetermined treatment temperature is higher than a melting temperature of the compound 18 so that the compound 18 can be melted in the dissolving agent 20. After the sludge 23 is heated for the predetermined treatment time period, the sludge 23 becomes the solution 24” as stated in instant application Para. [0050].
As stated on pages 3-6 in the previous office action dated 28 July 2025 (hereinafter POA), Beckett teaches the known prior art of heating a solution to a temperature to melt/dissolve a compound in the solution, see Paras. [0005];[0021], a cooling process, and a crystallization temperature, see Paras. [0005];[0021];[0024]. Therefore, Beckett specifically teaches heating “the solution to a temperature that is equal to the predetermined temperature” to melt the compound in the solution, “a cooling process”, and “a crystallization temperature” where crystalline particles are formed in the solution.
For the reasons indicated above, applicant’s above arguments are not persuasive.
In response to applicant’s arguments on pages 10-11 of the remarks filed on 22 October 2025 that “Kobari does not disclose or suggest setting a cooling speed of the solution to produce crystalline particles having a certain particle size”. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain”, see In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)) and MPEP 2123.
In this case, Kobari specifically teaches the known prior art of controlling the cooling rate of a solution in order to precipitate crystals of the desired particle size distribution from the solution, see Abstract; Paras. [0031]-[0033];[0042];[0138]-[0140]; Figs. 2-4, where a controller is used to control the cooling speed of the crystallization from above 50 ◦C to 30 ◦C over a period of time of about 1 minute to about 82 minutes creating cooling phases along the line (a), see Figs. 2 and 3; Para. [0031]-[0032];[0042];[0079]-[0081];[0098];[0117]. The cooling control is regulated to a preset cooling temperature profile to generate crystal particles having a narrow particle size distribution width and aligned particle size that differ but are maintained around a mean distribution, such as the majority of the particles have a particle size of about 234 μm and the remainder have particle sizes of about 100 μm to about 234 μm, see Fig. 4; Paras. [0026];[0033];[0133];[0138]-[0141]. Therefore, Kobari specifically teaches a cooling speed of the solution to produce crystalline particles having a certain particle size. For the reasons indicated above, applicant’s above arguments are not persuasive.
In response to applicant’s arguments on pages 8 and 11-12 of the remarks filed on 22 October 2025 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), and MPEP 2143. “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).”, see MPEP 2141.01(a).
In this case, Beckett teaches a method and a system for the desired particle size distribution cooling crystallization of a compound, such as paracetamol, mixed with and dissolved in a solute to form a solution, see Paras. [0005];[0008]-[0009];[0018]-[0024].
As stated above, Kobari is in the known prior art field of controlling the cooling rate of a solution in order to precipitate crystals of the desired particle size distribution from the solution and is applied to teach the problem to be solved of precipitating crystals of the desired particle size distribution from the solution, see Abstract; Paras. [0026];[0031]-[0033];[0042];[0138]-[0141]; Figs. 2-4.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Beckett and Kobari teach controlling the crystallization of a compound from a solution to obtain the desired particle size distribution, a person of ordinary skill in the art has good reason to modify Beckett by relying upon Kobari before the effective filing date of the claimed invention for knowledge generally available within the crystallization art regarding controlling the cooling rate in order to control the particle size distribution of the crystals, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a compound with the desired differing crystalline particle size distribution for the intended use of the crystals, see Kobari, Paras. [0003];[0013];[0142] and MPEP 2141.
New 112(b) claim rejection(s) based on Amendments to the claims
filed 22 October 2025
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Instantly amended claims 1 and 11 state “the cooling process utilizing the cooling process having a plurality of cooling phases to produce a plurality of crystal particles having a first particle size or a plurality of crystal particles having a second particle size, wherein the first particle size and the second particle size are different”. The claim limitation includes the conjunction “or” while also detailing the first particle size is different from the second particle size. The claims lack clarity because the first particle size or the second particle size is not present; as a result, there is no difference in particle sizes. The claims are interpreted to state “to produce a plurality of crystal particles having a first particle size ”.
In addition, “the cooling process utilizing the cooling process having a plurality of cooling phases …” appears to either lack antecedent basis regarding whether the second cooling process is a different cooling process then first mentioned cooling process, whether the second cooling process is the same cooling process as the first mentioned cooling process, or the claim limitation is not grammatically correct. The phrase is interpreted to state “the cooling process utilizes
Claims 2-10 and 12-20 depend from base claims 1 and 11, and are included in this rejection as they do not correct the informalities identified in base claims 1 and 11.
New 35 USC 103 claim rejection(s) based on Amendments to the claims
filed 22 October 2025
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Beckett et al. (US20180236373, published 23 August 2018, hereinafter Beckett) in view of Kobari (US20110138581, published 16 June 2011), and as applied in the 35 USC 103 rejection of claims 1-20 in the previous office action dated 28 July 2025 (hereinafter POA).
As applied in the POA
Beckett teaches the claims 1-3, 5, 6, 10-13, 15, 16, and 20 limitations of a method and a system for the crystallization of a compound, such as paracetamol, mixed with and dissolved in a solute to form a solution, see Paras. [0005];[0021], the solution in reservoir 1 is heated or thermally treated to a temperature of 65 degrees C. using a heater 12 controlled by the controller 20, agitated to mix the solution using agitator 13 controlled by the controller 20, and maintained at a temperature and concentration below a level at which primary nucleation of paracetamol spontaneously forms crystalline particles, see Para. [0021], and Fig. 1, meeting the method and system dissolving, heating and heating assembly, and maintaining in claim 1 and in claim 11;
Reservoir 1 heated to a temperature of 65 degrees C., as depicted in Fig. 1, has an inner volume for storing the solution to be crystallized, an inner surface, and an outer surface, which will inherently define a ratio value of the outer surface area of the thermal treatment vessel divided by the inner volume of the thermal treatment vessel, see Fig. 1, Paras. [0019]-[0021], and MPEP 2112, meeting the thermal treatment vessel in claim 5 and in claim 15, and the ratio value in claim 6 and in claim 16;
Pump 2 delivers the 65 degrees C. heated solution to the treatment chamber 3, which is the first phase, where the solution is cooled to a temperature of 35 degrees C. and treated with acoustic energy, where, exposure to focused acoustic energy while cooling in the treatment chamber 3 causes crystalline particles to be formed, and the crystalline particles exit the treatment chamber 3 and flow to the second reservoir 4, which is the second phase, see Para. [0021] and Figs. 1 and 3, meeting the cooling process and cooling device in claim 1, in claim 3, in claim 11, and in claim 13;
Crystallization treatment chamber 3 is also a thermal treatment chamber at a temperature of 65 to 35 degrees C., see Paras. [0019];[0021], where the internal volume 33 may be sized and shaped as appropriate for the material to be treated and there may be multiple treatment chambers 3 with multiple crystallization phases, i.e., first phase 1, first phase 2, first phase 3, etc., see Paras. [0019];[0023]-[0024] and Fig. 3. The formed crystal particles are sent to second phase reservoir 4 which is a mixed-suspension, mixed-product-removal (MSMPR) vessel and the crystalline particle-containing solution is maintained at 35 degrees C. without crystallization energy, i.e., a termination temperature, where first phase treatment chambers 3 temperature is 65 to 35 degrees C. and second phase reservoir 4 is maintained at 35 degrees C., see Paras. [0019];[0021] and Fig. 1, meeting the causing formation of crystals by a cooling process including a plurality of cooling phases in claim 1, in claim 2, in claim 11, and in claim 12;
A peak incident power (PIP) of the focused acoustic energy during cooling crystallization in the thermal crystallization treatment chamber is adjusted based on the cooling temperature fluctuations, concentration of the crystals, per unit volume of the treatment chamber and/or reaction time in order to maintain control over the size and/or number of crystalline particles, see Paras. [0005]-[0008];[0023], meeting the variation allowance crystallization based on the volume of the treatment vessel in claim 10 and in claim 20;
The controller 20 controls the entire system 100 with one or more sensors or data input devices including controlling the temperature in the crystallization treatment chamber 3 and the temperature inside of reservoir 4, see Paras. [0009];[0020];[0024], Figs. 1 and 3, meeting the controller used for controlling the temperature and crystallization in claim 11 and in claim 13, and the controller controls the entire system including the reaction rate in the treatment vessel in claim 10 and in claim 20; and,
The crystal is crystallized repeatedly in order to vary the particle size distribution and morphology of the crystals as desired, see Paras. [0018]-[0019], meeting varying the particle size of the crystals in claim 1 and claim 11.
Beckett does not teach:
The claim 1 limitations of varying a particle size of each of the plurality of crystal particles based on a cooling speed of the solution during the cooling process;
The claim 11 limitations of a controller configured to vary a particle size of each of the plurality of crystal particles based on a cooling speed of the solution during the cooling process; and,
The limitations of claims 4, 7, 8, 9, 14, 17, 18, and 19.
Kobari relates to a crystallization method based on a cooling temperature profile, see Abstract; Paras. [0081]-[0083], Figs. 1 and 2, where the resultant particle size is determined by a cooling temperature profile which decreases the cooling speed or increases the cooling speed throughout the crystallization method until termination of crystallization in order to produce monodispersed particles, see Para. [0007]. A temperature controller 32 within a temperature control device 14 is used to control the cooling rate of crystallization or the temperature change during crystallization, see Paras. [0081];[0098]-[0100], Figs. 1 and 2. The temperature control device performs control for cooling the solution according to an arbitrary cooling temperature profile selected from a linear cooling profile, a natural cooling profile, and a controlled cooling profile based on a predetermined set value of the desired product particle size of the crystal, see Paras. [0015]-[0019]. After the absolute particle number reaches the set value, the cooling temperature profile can be changed to shorten the crystallization time, see Para. [0121], and cooling is conducted as a function of time, see Fig. 3. Crystallization is conducted according to the selection of a preset cooling temperature profile in order to generate monodispersed crystal particles having a narrow particle size distribution width and aligned particle size, see Paras. [0021];[0023], meeting:
The particle size variation and cooling speed controlled by a controller in claim 1, in claim 7, in claim 11, and in claim 17;
The temperate decrease to the termination temperature controlled by a controller in claim 4 and in claim 14; and,
Selecting the optimal cooling temperate profile for crystallization selected by and controlled by a controller in claim 8, in claim 9, in claim 18, and in claim 19.
New claim rejection(s) based on Amendments to claims 1 and 11 filed 22 October 2025
Regarding amended instant application claims 1 and 11, Beckett teaches a method and a system for the desired particle size distribution cooling crystallization of a compound, such as paracetamol, mixed with and dissolved in a solute to form a solution, see Paras. [0005];[0008]-[0009];[0018]-[0024] and the detailed 35 USC 103 POA rejections above.
Beckett does not teach:
The amended instant application claims 1 and 11 limitations of setting/set a cooling speed of the solution during the cooling process utilizing the cooling process having a plurality of cooling phases to produce a plurality of crystal particles having a first particle size or a plurality of crystal particles having a second particle size, wherein the first particle size and the second particle size are different.
Kobari teaches the known prior art of controlling the cooling rate of a solution in order to precipitate crystals of the desired particle size distribution from the solution, see Abstract; Paras. [0031]-[0033];[0042];[0138]-[0142]; Figs. 2-4.
Regarding amended instant application claims 1 and 11, Kobari teaches a controller is used to control the cooling speed of the crystallization from above 50 ◦C to 30 ◦C over a period of time of about 1 minute to about 82 minutes creating cooling phases along the linear line (a), see Figs. 2 and 3; Para. [0031]-[0032];[0042];[0079]-[0081];[0098];[0117], meeting setting/set a cooling speed of the solution during the cooling process utilizing the cooling process having a plurality of cooling phases in amended instant application claim 1 and in amended instant application claim 11; and,
The cooling control is regulated to a preset cooling temperature profile to generate crystal particles having a narrow particle size distribution width and aligned particle size that differ but are maintained around a mean distribution, such as the majority of the particles have a particle size of about 234 μm and the remainder have particle sizes of about 100 μm to about 234 μm, see Fig. 4; Paras. [0026];[0033];[0133];[0138]-[0141], meeting a plurality of cooling phases to produce a plurality of crystal particles having a first particle size or a plurality of crystal particles having a second particle size, wherein the first particle size and the second particle size are different in amended instant application claim 1 and amended instant application claim 11.
In reference to the above claim rejections as applied in the POA and the above new claim rejections, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Beckett to determine a cooling profile and to control the cooling speed in the crystallization chamber with the controller based upon the cooling profile in order to obtain the desired crystal size distribution having differing particle sizes, as taught by Kobari, with a reasonable predictability of success for the purpose of generating monodispersed particles having differing particle sizes within a narrow particle size distribution width in the cooling crystallization, even if nucleation timing of crystal particles is different for each batch, see Kobari, Paras. [0003];[0013];[0142].
By applying “routine optimization” and “predictable results” to select the optimal control over the crystallization cooling process, one of ordinary skill in the art would have been motivated to make these modifications because Kobari provides a finite number of identified, predictable solutions. A person of ordinary skill in the art has good reason to produce crystals of the desired differing particle sizes by pursuing the known options within their technical grasp for the benefit of generating monodispersed particles having differing particle sizes within a narrow particle size distribution width in the cooling crystallization, even if nucleation timing of crystal particles is different for each batch, see Kobari, Paras. [0003];[0013];[0142] and MPEP 2141.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense”, see MPEP 2143 I.E. Since patents are part of the literature of the prior art relevant for all they contain, see MPEP 2123, and both Beckett and Kobari teach controlling the crystallization of a compound from a solution to obtain the desired particle size distribution, a person of ordinary skill in the art has good reason to modify Beckett by relying upon Kobari before the effective filing date of the claimed invention for knowledge generally available within the crystallization art regarding controlling the cooling rate in order to control the particle size distribution of the crystals, see MPEP 2143 B & G and 2141, for the benefit of efficiently crystallizing a compound with the desired differing crystalline particle size distribution for the intended use of the crystals, see Kobari, Paras. [0003];[0013];[0142] and MPEP 2141.
As stated in Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh’g denied,
426 U.S. 955 (1976), “[w]hen a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill”, see MPEP 2141.
“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree,” such as controlling the cooling speed, method, and temperature to obtain the desired crystalline particle sizes, “or the substitution of equivalents doing the same thing as the original invention, by substantially the same means,” such as using a controller to control the cooling speed, method, and temperature, “is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)”, see MPEP 2144.05.
Changes in configuration, shape, and/or size, such as the differing sizes of the crystalline particles, is a matter of choice which a person of ordinary skill in the art would have found obvious, such as by controlling the cooling speed, method, and temperature, absent persuasive evidence that the particular configuration as claimed was significant, see MPEP 2144.04 IV.
In addition, broadly providing an automatic or mechanical means, such as a crystallization temperature profile controller, to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, see MPEP 2144.04 B.III.
Conclusion
No claims are allowed.
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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/YO/Examiner, Art Unit 1692
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699