DETAILED ACTION
Applicant' s responses, filed 08 December 2025 and 11 March 2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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
Applicant's election with traverse of Group I and the species of bepotastine in the reply filed on 11 March 2026 is acknowledged. The traversal is on the ground(s) that the claims encompass subject matter drawn to a spherulite compound of formula (I) and a search related to methods of producing such a compound covered by elected claims of Group I would be co-extensive with a search for such a compound covered by claims 12-15 and would not be a serious search burden. This is not found persuasive because search burden is not a consideration under Unity of Invention.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-3, 5, 7-10, 12-15, and 19-22 are pending.
Claims 12-15 are withdrawn from consideration.
Claims 1-3, 5, 7-10, and 19-22 are rejected.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in [0166], [0192], and [0196]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claims 1-3 and 5 recite “critical degree of supersaturation”. The instant disclosure provides that the "Critical degree of supersaturation" in the present description means the lowest degree of
supersaturation required to obtain a specifically-shaped crystal (instant disclosure [0042]). The BRI of the “critical degree of supersaturation” in claims 1-3 and 5 is the lowest degree of
supersaturation required to obtain a spherulite crystal.
Claim 22 recites “descriptors including descriptors having the substantially same content” in lines 3, 4, 6, 7, 9, 11-15, and 17-19. The instant disclosure provides that the descriptor having the substantially same content refers to a descriptor represented by a different descriptor due to difference in software, etc. although it means a content which is the same as or similar to that of the above-mentioned descriptors. As an example, a descriptor which is ATSC 1 e in alvaDesc is represented by ATSC 1 se in Mordred, but only the name of the descriptor is different, and the content is the same. Some software sometimes adopts a descriptor in which only a numerical value used for the definition of the descriptor is different even if it is a descriptor having the same definition. Therefore, a descriptor meaning a similar content to that of one descriptor is intended to include a descriptor in which only a numerical value used for the definition is different (see instant disclosure [0089]). The BRI of the limitation of “descriptors having the substantially same content” are descriptors that represent the same underlying phenomena but differ in representation either by name or numerical value used for the definition.
Claim Rejections - 35 USC § 112
112/b
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.
The rejections below are newly recited necessitated by amendment.
Claim 1-3, 5, 7-10, and 19-22 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.
Claim 1 recites “the other descriptor group” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear what descriptor group “the other descriptor group” is referring to. It is further unclear what descriptors are encompassed in the “other descriptor group”. Dependent claims 2, 3, 5, 7-10, and 19-22 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, this limitation will be interpreted as “and other descriptor group” and the “other descriptor group” is interpreted as encompassing any descriptor used to represent a compound.
Claim 1 recites “a method for producing a spherulite of a compound” and “information on a compound obtained as a spherulite” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear if the “compound” in the preamble and the “compound obtained as a spherulite” are meant to be the same compound or if they are meant to be different compounds. If they are meant to be different compounds then it is further unclear if “the compound” in lines 7, 17, 19, and 21 is referring to the “compound” in the preamble or if “the compound” in lines 7, 17, 19, and 21 is referring to the “compound obtained as a spherulite”. It is further unclear if the “spherulite” in the preamble and the “spherulite” in the limitation of the “compound obtained as a spherulite” are meant to be the same spherulite or a different spherulite. If they are meant to be different spherulite then it is further unclear if “the spherulite” in lines 7, 18-19, and 21 of claim 1, claim 7, and claim 19 is referring to the “spherulite” in the preamble or if “the spherulite” in lines 7, 18-19, and 21, claim 7, and claim 19 is referring to the “spherulite” in the limitation of the “compound obtained as a spherulite”. Dependent claims 2, 3, 5, 7-10, and 19-22 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, the “compound” in the preamble and the “compound obtained as a spherulite” are interpreted as being the same compound, the “spherulite” in the preamble and the “spherulite” in the limitation of the “compound obtained as a spherulite” are interpreted as being different spherulites, and “the spherulite” in lines 7, claim 7 and claim 19 is interpreted as referring to the “spherulite” in the limitation of the “compound obtained as a spherulite” and “the spherulite” in lines 18-19 and 21 is interpreted as referring to the “spherulite” in the preamble of the claim.
Claim 1 recites “a predictive model of a critical degree of supersaturation required to obtain the spherulite of the compound” in lines 6-7 and “a critical degree of supersaturation required to obtain the spherulite of the compound”, claim 2 recites “a critical degree of supersaturation”, and claim 3 recites “a critical degree of supersaturation” which renders the metes and bounds of these claims indefinite. The indefiniteness arises because it is unclear these limitations of “a critical degree of supersaturation required to obtain the spherulite of the compound” and “a critical degree of supersaturation” are meant to be the same critical degree of supersaturations or if they are meant to be different critical degrees of supersaturation. If they are meant to be different then it is further unclear if “the critical degree of supersaturation” in “wherein the critical degree of supersaturation corresponds to the predictive value” is referring to the “critical degree of supersaturation required to obtain the spherulite of the compound” in line 7 of claim 1 or if “the critical degree of supersaturation” is referring to the “critical degree of supersaturation required to obtain the spherulite of the compound” in lines 18-19 of claim 1. Dependent claims 5, 7-10, and 19-22 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, these critical degrees of supersaturation will be interpreted as being the same and being the predicted critical degree of supersaturation required to obtain the spherulite of the compound.
Claim 1 recites “wherein the on the solvent are selected from the group consisting of descriptors on a good solvent, descriptors on a poor solvent” and claim 22 recites “the descriptors on a good solvent are… the descriptors on a poor solvent are…” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because “good” and “poor” are subjective terms and it is unclear what solvents are good solvents or poor solvents (see MPEP 2173.05(b)(IV). Dependent claims 2, 3, 5, 7-10, and 19-22 are rejected by virtue of their dependency on a rejected claim without alleviating the indefiniteness. For the sake of furthering examination, this limitation will be interpreted as wherein the descriptors on the solvent are selected from descriptors of a first solvent and descriptors of a second solvent. Further the limitation in claim 22 will be interpreted as “the descriptors on a first solvent are… the descriptors on a second solvent are…”.
Claim 22 recites “descriptors including descriptors having the substantially same content” (in lines 3, 4, 6, 7, 9, 11-15, and 17-19) which renders the metes and bounds of the claim indefinite. The indefiniteness arises because it is unclear if a descriptor having the substantially same content is meant to have the substantially same content of the particular descriptors selected in the list preceding this limitation or if a descriptor having the substantially same content is meant to have the substantially same content of the group from which the list preceding this limitation is from (e.g., are the descriptors having the substantially same content in lines 3-4 meant to have substantially the same content of MATS5i, MATS6m, GATS8s, ATSC1e, GATS5i, and MATS2s or are they meant to have the substantially same content of Moran and Geary 2D autocorrelations). For the sake of furthering examination, the descriptors having the substantially same content is interpreted as having the substantially same content of the particular descriptors selected from the list preceding this limitation (e.g., MATS5i, MATS6m, GATS8s, ATSC1e, GATS5i, and MATS2s).
Claim 22 recites “the descriptors on a good solvent are… having the substantially same content; the descriptors on a poor solvent are…” which renders the metes and bounds of the claim indefinite. The indefiniteness arises because there is a missing conjunction between these last two limitations and it is unclear if the claim requires all of these limitations or if the claim requires only one of these limitations. For the sake of furthering examination, the claim will be interpreted as requiring all of these limitations “the descriptors on a good solvent are… having the substantially same content; and the descriptors on a poor solvent are…”.
Claim Rejections - 35 USC § 101
The rejection on the ground of 101 of claims 1-5 and 7-10 in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “preparing a supersaturated solution of the compound…wherein the critical degree of supersaturation corresponds to the predictive value” received 08 December 2025. The additional elements of “preparing a supersaturated solution of the compound… wherein the critical degree of supersaturation corresponds to the predictive value” and “precipitating the spherulite of the compound from the supersaturated solution” integrates the judicial exceptions into a practical application because the judicial exception for predicting the critical degree of supersaturation required to obtain a spherulite of a compound (a particular crystal morphology of a compound) interacts with these additional elements by preparing a supersaturated solution that is equal to or above the predicted critical degree of supersaturation required to obtain this particular crystal morphology of the compound and precipitating the compound in this particular crystal morphology. Thus, the additional elements which produce a spherulitic crystal from the compound by utilizing the predicted critical degree of supersaturation to obtain a particular crystal morphology integrates the judicial exception of predicting the critical degree of supersaturation for a compound to obtain a particular crystal morphology of the compound.
Claim Rejections - 35 USC § 102
The rejection on the ground of 102 of claims 1-3 and 6-8 as being anticipated by Beck et al. (Journal of Crystal Growth, Volume 311, Issue 2, January 2009, Pages 320-326; previously cited) in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “a step of inputting data including: information on a compound obtained as a spherulite, and information on a solvent used for crystallization and a solution temperature during crystallization into a predictive model of a critical degree of supersaturation required… outputting a predictive value of the critical degree of supersaturation from the predictive model, wherein said information on a compound is variables for descriptors on the compound and said information on a solvent is variables from descriptors on the solvent used for crystallization, wherein the descriptors on the compound are selected from the group… wherein the descriptors on the solvent are selected from the group…” received 08 December 2025.
The rejection on the ground of 102 of claims 1-2, 4-6 and 19 as being anticipated by Toldy et al. (Crystal Growth & Design, Vol. 14, p. 3485-3492; previously cited) in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “a step of inputting data including: information on a compound obtained as a spherulite, and information on a solvent used for crystallization and a solution temperature during crystallization into a predictive model of a critical degree of supersaturation required… outputting a predictive value of the critical degree of supersaturation from the predictive model, wherein said information on a compound is variables for descriptors on the compound and said information on a solvent is variables from descriptors on the solvent used for crystallization, wherein the descriptors on the compound are selected from the group… wherein the descriptors on the solvent are selected from the group…” received 08 December 2025.
Claim Rejections - 35 USC § 103
The rejection on the ground of 103 of claims 1 and 4-5 as being unpatentable over Lovette and Doherty (Crystal Growth & Design, 2012, Vol. 12, No. 2, pages 656-669; previously cited) in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “a step of inputting data including: information on a compound obtained as a spherulite, and information on a solvent used for crystallization and a solution temperature during crystallization into a predictive model of a critical degree of supersaturation required… outputting a predictive value of the critical degree of supersaturation from the predictive model, wherein said information on a compound is variables for descriptors on the compound and said information on a solvent is variables from descriptors on the solvent used for crystallization, wherein the descriptors on the compound are selected from the group… wherein the descriptors on the solvent are selected from the group…” received 08 December 2025.
The rejection on the ground of 103 of claims 1-3, 7-8, and 19 as being unpatentable over Hao et al. (CN105111189A; previously cited) in view of Beck et al. (Journal of Crystal Growth, Volume 311, Issue 2, January 2009, Pages 320-326; previously cited) in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “a step of inputting data including: information on a compound obtained as a spherulite, and information on a solvent used for crystallization and a solution temperature during crystallization into a predictive model of a critical degree of supersaturation required… outputting a predictive value of the critical degree of supersaturation from the predictive model, wherein said information on a compound is variables for descriptors on the compound and said information on a solvent is variables from descriptors on the solvent used for crystallization, wherein the descriptors on the compound are selected from the group… wherein the descriptors on the solvent are selected from the group…” received 08 December 2025.
The rejection on the ground of 103 of claims 1-3, 6-10, and 19 as being unpatentable over Hao et al. (CN105111189A; previously cited) in view of Beck et al. (Journal of Crystal Growth, Volume 311, Issue 2, January 2009, Pages 320-326; previously cited) and Cotton et al. (US 6,369,085 B1; previously cited) in Office action mailed 23 July 2025 is withdrawn in view of the amendment of “a step of inputting data including: information on a compound obtained as a spherulite, and information on a solvent used for crystallization and a solution temperature during crystallization into a predictive model of a critical degree of supersaturation required… outputting a predictive value of the critical degree of supersaturation from the predictive model, wherein said information on a compound is variables for descriptors on the compound and said information on a solvent is variables from descriptors on the solvent used for crystallization, wherein the descriptors on the compound are selected from the group… wherein the descriptors on the solvent are selected from the group…” received 08 December 2025.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
The claims are free of the prior art of record. Toldy et al. (Crystal Growth & Design, Vol. 14, p. 3485-3492; previously cited) is the closest prior art of record for showing modeling supersaturation in the formation of spherulitic crystals. However, Toldy et al. or the prior art of record does not show or render obvious predicting the critical degree of supersaturation required to obtain a spherulite of a compound by inputting information on a compound (which is variables for descriptors on the compound), information on a solvent used for crystallization (which is variables for descriptors on the solvent used for crystallization) and a solution temperature into a predictive model to output a predictive value of the critical degree of supersaturation (which is interpreted as being the same as the critical degree of supersaturation required to obtain the spherulite of the compound).
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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