Prosecution Insights
Last updated: September 17, 2026
Application No. 19/571,722

Lamotrigine Salts, Co-Crystals, and Compositions

Final Rejection §103§112§DOUBLEPATENT
Filed
Mar 19, 2026
Priority
Sep 25, 2024 — provisional 63/698,821 +3 more
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Azurity Pharmaceuticals Ireland Limited
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
1y 9m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
1298 granted / 1785 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+18.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
87 currently pending
Career history
1868
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
29.2%
-10.8% vs TC avg
§102
10.9%
-29.1% vs TC avg
§112
36.8%
-3.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1785 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
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 . Claims 1-19 are pending. 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. Previously presented rejection of claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chappa, Materials Today: Proceedings 14, 2019, 504-513; Galcera Crystal Growth & Design, Vol. 9, No. 1, 2009, 327-334; Kavanagh, Modulation of the powder properties of lamotrigine by crystal forms, International Journal of Pharmaceutics Volume 595, 15 February 2021, 120274; Sawyer US 4602017; Floyd US 5942510; Lu, US10653626; and Galcera, Cryst.Eng.Comm (2012), 14(23), 7898-7906 is maintained. Galcera 2012 (see 03/27/2026 IDS NPL #&) is included above to clarify previously presented teaching from Galcera 2009. Applicant arguments are not persuasive. Applicants arguments focus on the following: PNG media_image1.png 82 624 media_image1.png Greyscale Further, according to Applicant, because of the difference in properties of maleic and fumaric acids, one of skill in the art (osa) PNG media_image2.png 44 624 media_image2.png Greyscale Response: The rejection is not under 35 USC § 102. First of all, the statement PNG media_image3.png 54 616 media_image3.png Greyscale Implies PNG media_image4.png 14 122 media_image4.png Greyscale of lamotrigine is Applicant’s invention. As previously pointed out lamotrigine hemifumarate is prior art compound taught by Galceras as LM+2, see Galcera 2012, Table 3, LM+2. The basis of the rejection is making PNG media_image5.png 24 160 media_image5.png Greyscale of previously known drug/compound PNG media_image6.png 42 604 media_image6.png Greyscale to arrive at alternate versions of existing pharmaceutical composition of known APIs is routine in the art. Previous action (re-entered below) 06/02/2026 starting at page 3 explicitly discusses teachings from the prior art for why and how for arriving at new improved versions of pharmaceutical composition of the known API lamotrigine. There is nothing in the claims (that is no limitation in the claims), what specific excipients and their relative % amounts that provides desirable composition that overcomes alleged PNG media_image7.png 14 160 media_image7.png Greyscale . Also see section under 112-1. Obviousness can 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. Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103. From previous action: Lamotrigine belongs to biopharmaceutical classification system class II drug with poor aqueous solubility. Chappa, titled ‘Co-crystallization of Lamotrigine with diprotic acids: synthesis, single crystal analysis, and in-vitro evaluation’ at page 504, ‘The quest for novel solid forms like polymorphs, salts, co-amorphous systems and co-crystals etc. is one of the major areas of research in the pharmaceutical industry for expansion of patent portfolios and lifecycle management of active pharmaceutical ingredients (API) [1, 2]. Of all the solid forms co-crystals, which are dissociable multicomponent supramolecular complexes composed of two or more components within the same crystal lattice wherein the components are in neutral state and interact via hydrogen bonding interactions represent a new path of medicines [3-6]. Numerous studies report significant improvement in physicochemical properties especially solubility and solid-state stability [7-9]; and also, bioavailability enhancement [7, 10] with co-crystals when compared to pure API. Designed supramolecular systems have shown enhanced in vitro dissolution rate as well as better intrinsic dissolution properties compared to pure API. These forms with improved dissolution rates can be used for development of dosage form which can be successfully utilized in the treatment of various ailments like specific cluster headaches, migraine, Dravet syndrome, Meniere’s disease, migrane-associated vertigo and especially neuropathic pain. Chappa teaches maleic acid (isomer of fumaric acid) salt of Lamotrigine. Maleic acid and fumaric acid are suggestive of each other. For example, Galcera at page 328 column A, teaches Lamotrigine hemi fumarates. For generic structures see page 329 Scheme 1. Using Chappa’s method at page 507, using fumaric acid in the place of maleic acid one of skill in the art would arrive at the first option hemi fumarate in the instant claim. Sawyer teaches pharmaceutical compositions containing Lamotrigine (3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine). Pharmaceutical composition of this Sawyer ‘preferred compound’ (column 2) having instantly claimed dosage (column 4, lines 28-41, column 10 Sawyer claim 5), column 3 (lines starting at 18 including fumaric salt), liquid form (Sawyer claim 5), inert ingredients (column 3, line 67 onto column 4, line 11) corresponds to the instantly claimed composition. Floyd also teaches injectable formulation of Lamotrigine mesylate having pH of from 2.5 to 4 is stable, column 2 lines 37-49 and at column 6 lines 11-17. Sawyer and Floyd do not teach lamotrigine hemi fumarate of instant claim 1 The teachings of Chappa’s and Galcera teach how to make hemi fumarate. 10653626 (emphasis added by the Examiner): PNG media_image8.png 1134 836 media_image8.png Greyscale The position taken by the Examiner is that, taken together the teachings of Sawyer and Floyd reads on the instant dependent claim limitations. For example, note that Sawyer tablet (solid) is useful in injectable form and also note that Pharmaceutical formulations of Lamotrigine are well-known in the art, see specification page 2 [0003]. Further, as to the dose (vaguely recited, see section under 112-2) limitation, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration (or temperature) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). In addition, see Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). see MPEP § 2144.05 part II A. Although the prior art did not specifically disclose the amounts of each constituent, it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of components because concentrations of the claimed components are art-recognized result effective variables because they have the ability for controlling parasites, which would have been routinely determined and optimized in the pharmaceutical art. According to Kavanagh teaching titled Modulation of the powder properties of lamotrigine by crystal forms, the mechanical properties of powders determine the ease of manufacture and ultimately the quality of the oral solid dosage forms. Although poor mechanical properties of an active pharmaceutical ingredient (API) can be mitigated by using suitable excipients in a formulation, the effectiveness of that approach is limited for high dose drugs or multidrug tablets. In this context, improving the mechanical properties of the APIs through solid form optimization is a good strategy to address such a challenge. PNG media_image9.png 194 514 media_image9.png Greyscale Note that the rejection is not under 35 USC § 102. The cited reference are good not only for what they teach by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made. With the combined teachings of the prior one of skill in the art would have reasonable expectation of success at arriving at Lamotrigine formulation with the limitations of the instant claims. Note that as per specification page 9 [0061], a liquid composition may be a solution, a suspension, or an emulsion. Obviousness can 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) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103. 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. Previously presented rejection of claims 1-19 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 is maintained. Applicants arguments are not persuasive. Response: First of all, it is noted that the claim is interpreted based on the commonsense understanding that a --suspension in a liquid is a heterogeneous mixture where solid particles are dispersed throughout the liquid but do not dissolve- and -the solid part of the suspension in the formulation is the lamotrigine hemi fumarate- Applicant is encouraged to place on record that the above interpretation is incorrect and the solid part of in the claimed suspension is the very poorly soluble API lamotrigine. Applicant argues osa knows what the term ‘equivalent’ means. None of the Applicant pointed out portions in the specification shows that a specific amount of the lamotrigine hemi fumarate is released to make the corresponding free base. See section under 112-1. Applicant relies on disclosure in the specification for the limitations of the claim 1. See Applicant Remarks page 13, second full paragraph, line 3 onwards. Applicant points out Formulation 1 and Formulation 2 that osa would consider as reflective of the claimed invention. PNG media_image10.png 74 632 media_image10.png Greyscale and PNG media_image11.png 18 230 media_image11.png Greyscale That Formulation 1 as obtained by the procedure of Example 3 : PNG media_image12.png 80 628 media_image12.png Greyscale PNG media_image13.png 104 624 media_image13.png Greyscale As per Applicant’s arguments, the above mixing of two solutions makes a ‘suspension’ of PNG media_image11.png 18 230 media_image11.png Greyscale is what the base claim is drawn is confusing. It is one of commonsense that suspension in a liquid is a heterogeneous mixture where solid particles are dispersed throughout the liquid but do not dissolve. The base claim 1 is drawn to a suspension. Here it is unclear if the solid part is the ‘hemifumarate salt’ or some other material that did not dissolve in the liquid. Likewise, Example 4 using which Formulation 2 was made PNG media_image14.png 246 636 media_image14.png Greyscale In Example 3, 1 equivalent of L mixed with 1 equivalent of fumaric acid In Example 4, 1 equivalent of L mixed with 1 equivalent of disodium fumarate Critical components lamotrigine and fumaric acid (for Formulation 1) the disodium fumarate (for Formulation 2), mixed in a cocktail containing stronger tribasic acid (phosphoric acid) makes PNG media_image11.png 18 230 media_image11.png Greyscale a suspension of lamotrigine hemifumarate as per claim 1 is not persuasive to this Examiner. As per definition, hemifumarate corresponds to 2:1 (molar ratio) of lamotrigine and fumaric acid stoichiometry. That said, molar equivalent amount of amounts of lamotrigine and fumaric acid/salt, because of the presence of the strong tribasic acid, phosphoric acid, makes a suspension does not clarify the issue at hand. MW: lamotrigine 256; Fumaric acid 116; disodium fumarate 162 According to Applicant Table 2 formulations are the suspension because it has necessary amounts of the components lamotrigine and fumaric acid. The Table 2 includes many routinely used excipients which are not found in the claim. From previous action: Base claim 1 limitation with regards to the amount of the active ingredient is vaguely defined. The recited ingredients are anticipated to have different molecular weights (MW) based on the number of water molecules in the hydrates of lamotrigine hemifumarate. The term ‘equivalent’ renders the amount of hemifumarate or its hydrates intended unclear. The term is found about 4 dozen times in the specification without any definition of what it means. One of skill in the art would understand what ‘bio-equivalent’ is. What equivalency intended here is unclear. As such what and how much of the salt or its hydrate would be equivalent to the (desired) recited amount of free base is unclear. One of skill in the art would expect that the release of the salt (from the hydrate) prior to deprotonation would depend on the number and nature of the hydrate molecules. Note that the deprotonation depends on pH of the suspension. Dependent claims 7 and 10 recite pH of 3 to 5. It is unclear how much of free base is released in acidic condition is unclear. Dependent claims do not solve the problems of the base claim. As such claims 2-19 are rejected as well. Double Patenting 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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11-20 of copending Application No. 19570532 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter, as shown below. Base claim 1 of 19570532: PNG media_image15.png 188 650 media_image15.png Greyscale The instant base claim 1 limitations fall under the scope of the above, in genus (above) and species (instant) relationship. There is an approved terminal disclaimer for instant 19571722 in the file wrapper of 19570532. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. From previous action: The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804 Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use hydrate of lamotrigine hemifumarate. It is also not seen where in the specification that teaches how much lamotrigine hemifumarate suspension is needed to make the equivalent amount of lamotrigine free base. The specification does not reasonably provide enablement for making hydrates of the claimed compounds. The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the relevant factual considerations. Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to the claims, with the most relevant factors discussed below: The specification does not reasonably provide enablement for making hydrates of lamotrigine hemifumarate. The specification does not enable any person skilled in the art of organic chemistry to make the invention commensurate in scope with these claims. The factors to be considered in making an enablement rejection have been summarized above. In the present case the important factors leading to a conclusion of undue experimentation are the absence of any working example of a formed hydrate, the lack of predictability in the art, and the broad scope of the claims. There is no working example of any hydrate or hydrate formed. The claims are drawn to hydrates, yet the numerous examples presented all failed to produce a hydrate. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 "The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However ... there is no evidence that such compounds exist.., the examples of the '881 patent do not produce the postulated compounds.., there is ... no evidence that such compounds even exist." The same circumstance appears to be true here. There is no evidence that hydrates of these compounds actually exist; if they did, they would have formed. Hence, applicants must show that hydrates can be made, or limit the claims accordingly. g) The state of the art is that it is not predictable whether hydrates will form or what their composition will be. In the language of the physical chemist, a hydrate of organic molecule is an interstitial solid solution. This phrase is defined in the second paragraph on page 358 of West (West, Solid State Chemistry and Its Applications, john Wiley & Sons, 1984). The solvent molecule is a species introduced into the crystal and no part of the organic host molecule is left out or replaced. Note in this case solvent is water (H2O). In the first paragraph on page 365, West (Solid-State Chemistry) says, "it is not usually possible to predict whether solid solutions will form, or if they do form what is their compositional extent". Likewise, according to Tian (Journal of Pharmacy and Pharmacology 2010; 62: 1534–1546) each solid compound responds uniquely to the possible formation of hydrate, and hence generalizations of hydrate formation prediction are still not possible (column B, page 1536). Further Tian teaches that hydrates differ from polymorphs since the chemical composition is not the same for anhydrate and hydrate. The anhydrate/hydrate transformation is influenced by both the temperature and water activity in the surrounding medium. This clearly creates challenges in controlling the anhydrate/hydrate system since the active pharmaceutical ingredient is often exposed to varied pharmaceutical processing and storage conditions, including stress related to temperature, solvent and pressure. Excipients can interact with the active pharmaceutical ingredient, and thus have an influence on its stability. The picture becomes even more complex when the hydrate can exist as two or more different polymorphic forms. Therefore, the predictable formation and use of hydrates of the claimed compounds finds no support in the specification. The specification in view of the prior art (see section under 103), teaches how to make lamotrigine hemifumarate. However, there is no working example that guides how much of the lamotrigine hemifumarate would release how much lamotrigine (for the intended biological use). That one (molar) equivalent of lamotrigine hemifumarate (or corresponding hydrateS) would provide for (stoichiometric) one (molar) equivalent of lamotrigine free base finds no support in the specification and contradicts unpredictability in the pharmaceutical art. Also see section under 112-2 to the formation of lamotrigine hemifumarate in the Applicant pointed out sections in the specification. Thus, in the absence of experimentation one cannot predict if a particular solvent will hydrate any particular crystal. One cannot predict the stoichiometry of the formed hydrate, i.e. if one, two, or a half a molecule of solvent added per molecule of host. In the same paragraph on page 365 West (Solid State Chemistry) explains that it impossible to make meta-stable non-equilibrium hydrates, further clouding what Applicants mean by the word hydrate. Compared with polymorphs, there is an additional degree of freedom to hydrates, which means a different solvent or even the moisture of the air that might change the stabile region of the hydrate. h) The breadth of the claims includes all of the hundreds of thousands of compounds of formula (I) as well as the presently unknown list of solvents embraced by the term "hydrate". Thus, the scope is broad. THIS ACTION IS MADE FINAL. 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 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, Andrew Kosar can be reached at (571) 272-0913. 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. /NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

Mar 19, 2026
Application Filed
Jun 02, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
Aug 20, 2026
Response Filed
Sep 03, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT
Sep 11, 2026
Examiner Interview (Telephonic)
Sep 11, 2026
Examiner Interview Summary

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
91%
With Interview (+18.3%)
2y 3m (~1y 9m remaining)
Median Time to Grant
Moderate
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