DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicant’s Amendments and Remarks, filed 28 January 2026, in the matter of Application No. 18/543,767. Said documents have been entered onto the record. The Examiner notes the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12, 14-18, and 21-24 are pending.
Claims 1 has been amended.
No claims have been cancelled.
Thus, claims 1-12, 14-18, and 21-24 represent all claims currently under consideration.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendments are sufficient to overcome the claim objections.
35 U.S.C.§ 112
Applicant’s amendments to the claims have fully overcome the rejections over instant claims 1-12, 14-18, and 21-24.
REJECTIONS MAINTAINED
MANTAINED Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12, 14-18, and 21-24 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,883,394.
Although the claims at issue are not identical, they are not patentably distinct from each other. U.S. Patent No. 11,883,394 claims the following:
PNG
media_image1.png
899
932
media_image1.png
Greyscale
Claims 1-2 of U.S. Patent No. 11,883,394 teach every limitation of instant claims 1-2, with the exception of specifying temperature ranges for homogenizing the recrystallization solution. However, claims 12-14 of U.S. Patent No. 11,883,394 teach homogenizing temperatures that overlap or reside within the range recited in the instant claims. MPEP § 2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” Furthermore, one of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that subjecting a compound solution to heating is a well-established method for homogenizing solutions via increasing compound solubility as a function of temperature and is a fundamental technique in the purification of organic compounds by recrystallization. Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E).
Claims 3-19 of U.S. Patent No. 11,883,394 teach every limitation of instant claims 3-12, 14-18, 21, and 23.
Regarding instant claim 22, claim 3 of U.S. Patent No. 11,883,394 teaches every limitation of instant claim 21 (relating to the process of instant claim 1), but does not specifically teach every limitation of instant claim 22 (relating to the process of instant claim 2). However, the process of instant claim 2 merely repeats the process of instant claim 1. One of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that the process of recrystallization is oftentimes repetitive (i.e., the sequence of heating and cooling to induce crystallization commonly needs to be repeated to achieve the desired result). If crystallized particles of about 0.50 to about 3.3 m2/g do not readily form after the first attempt (as disclosed by claim 3 of U.S. Patent No. 11,883,394), it is not surprising or inventive for this expected result to occur upon another cycle of heating the solution (to homogenize the solution) and cooling the solution (to form crystals again). Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E). Furthermore, duplicative operations are prima facie obvious to one of ordinary skill in the art, as described in MPEP § 2144.04(VI)(B).
Regarding instant claim 24, claim 12 of U.S. Patent No. 11,883,394 teaches every limitation of instant claim 23 (relating to the process of instant claim 1), but does not specifically teach every limitation of instant claim 24 (relating to the process of instant claim 2). However, the process of instant claim 2 merely repeats the process of instant claim 1, in which a temperature range of about 31 ºC to about 38 ºC is employed to achieve homogenization of the solution (as disclosed by claim 12 of U.S. Patent No. 11,883,394). One of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that temperature ranges required to homogenize a solution during recrystallization can also be utilized once again if the practitioner wishes to further homogenize a solution after an initial recrystallization attempt. Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E). Furthermore, duplicative operations are prima facie obvious to one of ordinary skill in the art, as described in MPEP § 2144.04(VI)(B).
Claims 1-12, 14-18, and 21-24 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 and 23-24 of U.S. Patent No. 10,973,816.
Although the claims at issue are not identical, they are not patentably distinct from each other. U.S. Patent No. 10,973,816 claims the following:
PNG
media_image2.png
794
593
media_image2.png
Greyscale
PNG
media_image3.png
626
593
media_image3.png
Greyscale
Claims 1-2, 20-21, and 23-24 of U.S. Patent No. 10,973,816 teach every limitation of instant claims 1-2, with the exception of specifying temperature ranges for homogenizing the recrystallization solution. However, claims 12-14 of U.S. Patent No. 10,973,816 teach homogenizing temperatures that overlap or reside within the range recited in the instant claims. MPEP § 2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” Furthermore, one of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that subjecting a compound solution to heating is a well-established method for homogenizing solutions via increasing compound solubility as a function of temperature and is a fundamental technique in the purification of organic compounds by recrystallization. Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E).
Claims 3-19 of U.S. Patent No. 10,973,816 teach every limitation of instant claims 3-12, 14-18, 21, and 23.
Regarding instant claim 22, claim 3 of U.S. Patent No. 10,973,816 teaches every limitation of instant claim 21 (relating to the process of instant claim 1), but does not specifically teach every limitation of instant claim 22 (relating to the process of instant claim 2). However, the process of instant claim 2 merely repeats the process of instant claim 1. One of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that the process of recrystallization is oftentimes repetitive (i.e., the sequence of heating and cooling to induce crystallization commonly needs to be repeated to achieve the desired result). If crystallized particles of about 0.50 to about 3.3 m2/g do not readily form after the first attempt (as disclosed by claim 3 of U.S. Patent No. 10,973,816), it is not surprising or inventive for this expected result to occur upon another cycle of heating the solution (to homogenize the solution) and cooling the solution (to form crystals again). Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E). Furthermore, duplicative operations are prima facie obvious to one of ordinary skill in the art, as described in MPEP § 2144.04(VI)(B).
Regarding instant claim 24, claim 12 of U.S. Patent No. 10,973,816 teaches every limitation of instant claim 23 (relating to the process of instant claim 1), but does not specifically teach every limitation of instant claim 24 (relating to the process of instant claim 2). However, the process of instant claim 2 merely repeats the process of instant claim 1, in which a temperature range of about 31 ºC to about 38 ºC is employed to achieve homogenization of the solution (as disclosed by claim 12 of U.S. Patent No. 10,973,816). One of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that temperature ranges required to homogenize a solution during recrystallization can also be utilized once again if the practitioner wishes to further homogenize a solution after an initial recrystallization attempt. Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E). Furthermore, duplicative operations are prima facie obvious to one of ordinary skill in the art, as described in MPEP § 2144.04(VI)(B).
Claims 1-12, 14-18, and 21-24 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 22-23 of U.S. Patent No. 10,478,434.
Although the claims at issue are not identical, they are not patentably distinct from each other. U.S. Patent No. 10,478,434 claims the following:
PNG
media_image4.png
804
612
media_image4.png
Greyscale
PNG
media_image5.png
609
593
media_image5.png
Greyscale
Claims 1-2, 19-20, and 22-23 of U.S. Patent No. 10,478,434 teach every limitation of instant claims 1-2 and 23-24, with the exception of employing a temperature range of about 31 ºC to about 43 ºC in part (d) of instant claim 1 and part (g) of instant claim 2. Instead, claims 1-2 of U.S. Patent No. 10,478,434 disclose a temperature range of about 31 ºC to about 38 ºC in part (d) of instant claim 1 and part (g) of instant claim 2, ranges that anticipate instant claims 23-24. However, this temperature range also significantly overlaps with the range cited in instant claims 1-2. MPEP § 2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Claims 3-18 of U.S. Patent No. 10,478,434 teach every limitation of instant claims 3-12, 14-18, and 21.
Regarding instant claim 22, claim 3 of U.S. Patent No. 10,478,434 teaches every limitation of instant claim 21 (relating to the process of instant claim 1), but does not specifically teach every limitation of instant claim 22 (relating to the process of instant claim 2). However, the process of instant claim 2 merely repeats the process of instant claim 1. One of ordinary skill in the art of synthetic chemistry and the purification of chemicals would realize that the process of recrystallization is oftentimes repetitive (i.e., the sequence of heating and cooling to induce crystallization commonly needs to be repeated to achieve the desired result). If crystallized particles of about 0.50 to about 3.3 m2/g do not readily form after the first attempt (as disclosed by claim 3 of U.S. Patent No. 10,478,434), it is not surprising or inventive for this expected result to occur upon another cycle of heating the solution (to homogenize the solution) and cooling the solution (to form crystals again). Such a practice can be considered as “obvious to try,” as described in MPEP § 2143(I)(E). Furthermore, duplicative operations are prima facie obvious to one of ordinary skill in the art, as described in MPEP § 2144.04(VI)(B).
Claims 1-12, 14-18, and 21-24 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,064,859.
Although the claims at issue are not identical, they are not patentably distinct from each other. U.S. Patent No. 10,064,859 claims the following:
PNG
media_image6.png
949
600
media_image6.png
Greyscale
Claims 1-2 of U.S. Patent No. 10,064,859 teach every limitation of instant claims 1-2 and 21-24, with the exception of employing a temperature range of about 31 ºC to about 43 ºC in part (d) of instant claim 1 and part (g) of instant claim 2. Instead, claims 1-2 of U.S. Patent No. 10,064,859 disclose a temperature range of about 31 ºC to about 38 ºC in part (d) of instant claim 1 and part (g) of instant claim 2, ranges that anticipate instant claims 23-24. However, this temperature range also significantly overlaps with the range cited in instant claims 1-2. MPEP § 2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Claims 3-17 of U.S. Patent No. 10,064,859 teach every limitation of instant claims 3-12 and 14-18.
Response to Arguments
Claim Rejections – Double Patenting
Applicant's arguments filed 28 January 2026, indicate that Applicant respectfully requests that the nonstatutory double patenting rejections over U.S. Patent No. 11,883,394, U.S. Patent No. 10,973,816, U.S. Patent No. 10,473,434, and U.S. Patent No. 10,064,859 be held in abeyance until the claims are considered otherwise allowable. The Examiner notes that the filing of a terminal disclaimer would ameliorate these double patenting rejections.
Conclusion
No claims are allowed.
Applicant’s amendment under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on 28 January 2026 necessitated and prompted the maintained 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 extension fee 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 Derek Rhoades whose telephone number is (703)-756-5321. The Examiner can normally be reached Monday–Thursday, 7:30 am-5:00 pm EST; Friday, 7:30 am-4:00 pm EST.
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, Scarlett Goon can be reached on (571)-272-5241. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-8300.
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.
/D.R./Examiner, Art Unit 1692
/AMY C BONAPARTE/Primary Examiner, Art Unit 1692