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 .
Election/Restrictions
Claim 30 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/11/2024.
Allowable Subject Matter
Claims 26-27 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Champ (US 20100137629) in view of Orban (US 4683326) as discussed below. Champ teaches heating until a liquid melt is obtained and feeding the liquid melt into the mixing vessel (Examples 5-9). Champ teaches a temperature of 60C is applied and wherein the temperature in the mixing is 35C ([0056]). The prior art does not teach a method as claimed including feeding the melt into a scraped surface heat exchanger with a scraper and applying a shear rate of less than 800/s to the melt wherein the melt is stirred by the scraper.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16, 18-19, 21-25, 28-29, 31-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Champ (US 20100137629) in view of Orban (US 4683326).
Regarding Claims 16, 19, and 31-32, Champ teaches a process for the solidification of hexyl 2-[4-(diethylamino)-2- hydroxybenzoyl]benzoate (INCI diethylamino hydroxybenzoyl hexyl benzoate, DHHB), wherein the process comprises the step of (a) applying a shear rate to liquid hexyl 2-[4-(diethylamino)-2- hydroxybenzoyl]benzoate (stirring, [0018-0020]). Champ teaches the liquid is provided as a melt ([0016]).
Champ teaches a preferred stirring speed of 100-600 rpm ([0020]) and does not explicitly teach speeds of 5 to less than 100 rpm; however, Champ teaches embodiments of stirring speeds below the preferred range (80 rpm, Example 5) and teaches crystallization also occurs under embodiments of no stirring (Comparative Examples). Champ teaches time is dependent on the speed of the stirrer ([0020]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize the stirring speed of the combined references to achieve a desired crystallization time, as suggested by Champ, and in such an optimization one of ordinary skill in the art would have arrived at applicant’s claimed stirring speeds.
Champ teaches an alternative embodiment including adding seed crystals of hexyl 2- [4-(diethylamino)-2-hydroxybenzoyl]benzoate (Comparative Examples 2 and 4). Champ does not explicitly teach an embodiment of stirring with adding seed crystals; however, Orban teaches a continuous method for solvent-free crystallization of a melt wherein seed crystals are added while stirring (Example 2). It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify the method of Champ to include a continuous method of mixing with seeding, as taught in Orban, in order to achieve a continuous crystallization process which is rapid and economical.
Champ teaches time can be reduced if the speed of the stirrer is increased ([0020]). The combined references are silent as to the time required for crystallization to begin or end in an embodiment with seed crystals and stirring; however, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05 II A. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize the time of the combined references by adjusting the speed of the stirrer, as suggested by Champ, in order to achieve production in a time saving manner, and in such an optimization one of ordinary skill in the art would have arrived at applicant’s claimed times.
Champ is silent as to the shear rate; however, Champ teaches stirring the same material, at the same temperature, and at the same stirring speed as the claimed method. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established, In re Best, 195 USPQ 430, 433 (CCPA 1977). With regard to the shear rate limitation, when the structure recited in the prior art is substantially identical to that of the claims, the claimed properties or function are presumed inherent. MPEP 2112. In this situation, the prior art exemplifies the applicant's claimed process, so the claimed shear rate relating to the process are present in the prior art. Absent an objective evidentiary showing to the contrary, the addition of the physical properties to the claim language fail to provide patentable distinction over the prior art of record.
Regarding Claim 18, Champ teaches the melt at a temperature of 59-62C ([0016]).
Regarding Claim 21, Champ teaches the seed crystals added at 40C ([0049, 0051]).
Regarding Claim 22, Champ teaches cooling to room temperature (Examples), i.e. the temperature kept in the claimed range.
Regarding Claim 23, Champ teaches 100 g of crystals to 5 kg of melt (Examples 2 and 4).
Regarding Claim 24, Champ teaches the seed crystals having a particle size of less than 100 microns (Examples 2 and 4).
Regarding Claim 25, Champ teaches a which is cooled to a temperature of between 25-40C ([0018]). Orban teaches melt crystallization in an extruder (Example 2).
Regarding Claim 28, Champ teaches a stirred vessel ([0019]). Orban teaches heating until a liquid melt is obtained (Example 1), cooling the liquid to obtain a subcooled melt (Example 1-2), and feeding the subcooled melt into a vessel for stirring (Example 2).
Regarding Claim 29, Champ teaches a temperature of 60C is applied and wherein the temperature in the mixing is 35C ([0056]).
Regarding Claim 34, Champ teaches a preferred stirring speed of 100-600 rpm ([0020]) and does not explicitly teach speeds of 5-50 rpm; however, Champ teaches embodiments of stirring speeds below the preferred range (80 rpm, Example 5) and teaches crystallization also occurs under embodiments of no stirring (Comparative Examples). Champ teaches time is dependent on the speed of the stirrer ([0020]). It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize the stirring speed of the combined references to achieve a desired crystallization time, as suggested by Champ, and in such an optimization one of ordinary skill in the art would have arrived at applicant’s claimed stirring speeds.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive.
Applicant argues claim 16 requires that crystallization be completed within 12 hours, and further requires a low stirring speed. Applicant argues the only examples of Champ that use seeding require longer crystallization times. Applicant argues the use of the claimed low stirring speeds is clearly discouraged by Champ. In response to Applicant’s argument, Champ does not explicitly teach the time of an embodiment including addition of seed crystals with stirring. While Champ teaches a preferred stirring speed of 100-600 rpm ([0020]), Champ teaches embodiments of stirring speeds below the preferred range (80 rpm, Example 5) and teaches crystallization also occurs under embodiments of no stirring (Comparative Examples). Champ teaches time is dependent on the speed of the stirrer ([0020]), which provides motivation to one of ordinary skill in the art to optimize the stirring speed of the combined references, in an embodiment which also includes addition of seed crystals, to achieve a desired crystallization time.
Applicant argues the description of Orban would lead to no predictability as to DHHB. Applicant argues Orban does also not provide any motivation to reduce the stirring speeds taught in Champ because Orban uses high shear equipment. Applicant argues DHHB crystallization obviously does not require seeding crystals, as Champ demonstrates, and there is no need to even consider the teachings of Orban which explicitly aims at solving the problem of generating amorphous solid material instead of crystal material. In response to applicant’s argument, while Orban does not teach the same compound as that of Champ, Orban suggests solvent-free crystallization of a melt wherein seed crystals are added while stirring is a known method in the art such that one of ordinary skill in the art would have been motivated to modify the mixing of Champ to include seeding as in Orban. The teachings of Champ and Orban provide a reasonable expectation of success for a process which includes melt crystallization of the claimed material under an optimized stirring speed, with the addition of seed crystals.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TABATHA L PENNY whose telephone number is (571)270-5512. The examiner can normally be reached M-F 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Cleveland can be reached at 5712721418. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TABATHA L PENNY/ Primary Examiner, Art Unit 1712
Prosecution Insights