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 .
DETAILED ACTION
This office action is response to communication filed on 06/04/2026.
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 06/04/2026, wherein claims 3-4 are cancelled. The objections to claims 3 and 4, and rejections of claims 3 and 4 under 35 USC 112(b) and (d) are withdrawn.
Election/Restriction
Applicant elected without traverse of morphic form λ of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo- 1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6- carbonitrile, in the reply filed on 02/02/2026. Claims 1 and 5-10 read on the elected species.
Claim Status
Claims 1 and 5-10 are pending and currently under examination in this office action.
Priority
This instant application 19/303,585, filed on 08/19/2025, is a continuation application of U.S. Patent Application No. 18/949,309, filed November 15, 2024, which is a divisional application of U.S. Patent Application No. 17/257,070 (now abandoned), which is a U.S. National Stage Entry application under 35 U.S.C. § 371 of International Application No. PCT/US2019/040276, filed July 2, 2019, which claims the benefit of and priority to U.S. Provisional Application No. 62/692,914, filed July 2, 2018.
Claim interpretation
Instantly claimed compound, 2-[3,5-dichloro-4-(5-isopropyl-6- oxo-1 ,6-dihydropyridazin-3-yloxy)phenyl]-3,5-dioxo-2,3,4,5- tetrahydro[1 ,2,4]triazine-6-carbonitrile (Compound A) (CAS# 920509-32-6) is also known as Resmetirom, MGL-3196, VIA-3196, Rezdiffra (retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/15981237).
As disclosed in instant specification(See [00216]): the term "about" when used in conjunction with numerical values and/or ranges generally refers to those numerical values and/or ranges near to a recited numerical value and/or range. In some instances, the term "about" can mean within ±10% of the recited value.
Response to Declaration
The Declaration under 37 CFR 1.132 by Dr. Aeri Park filed 06/04/2026 is fully considered.
Park Declaration focused on interpretation of XRPD pattern, and argues Hester II does not disclose an XRPD pattern or XRPD peaks for Form λ and does not describe any methods for making Form λ . Hester II discloses Form I of resmetirom, which is a different morphic form of resmetirom than Form λ claimed in the present application
As instant specification [00216 ] discloses and cited by Park Declaration (See para 23) : The term "substantially similar" used in reference to XRPD patterns means that the XRPD pattern of a polymorph may display "batch to batch" variations due to differences in the types of equipment used for the measurements, and fluctuations in both experimental conditions (e.g. purity and grain size of the sample) and instrumental settings (e.g. X-ray wavelengths; accuracy and sensitivity of the diffractometer; and "instrumental drift") normally associated with the X-ray diffraction measurement. Due to these variations, the same polymorph may not contain XRPD peaks at exactly the same positions or intensities shown in the figures disclosed herein”. Thus, Park Declaration argument based on superimposing instant Fig 27 with Figure 1 of Hester II’ 473 is not appropriate.
The examiner does not dispute the margin of error for XRPD peaks is ±0.2 degrees 2θ as Park Declaration argues ( See para 24 ). In instant case, Hester II’ 473 teaches the XRPD peaks of morphic Form I prepared from ethanol (See Example 6) , at about 10.5, 11.2, 15.7, 16.4, 17.7, 18.7, 22.9, 23.6, 24.7 degrees 2θ, wherein 10.5 is within ±0.2 of instantly claimed 10.6, 16.4 is within ±0.2 of instantly claimed 16.2, 17.7 is within 0.2 of instantly claimed 17.6 and 18.0, 24.7 is within 24.5 ±0.2 degrees 2θ similar as instantly claimed about 24.3. Although instant claims do not recite peak at 11.2 and 15.7, instant claimed Form λ has peaks at 11.2 and 15.6 as shown in Fig. 27 and Table 29.
PNG
media_image1.png
383
509
media_image1.png
Greyscale
PNG
media_image2.png
465
542
media_image2.png
Greyscale
Thus, instant claimed form λ is considered substantially similar as Form I taught by Hester II’ 473.
Even if the XRPD peaks of Form I taught by Hester II’ 473 ( and Taub) are slightly different from instant claimed form λ , the difference between Form I and instant form λ is within the meaning of obviousness under 35 USC 103. Park Declaration and instant specification do not disclose any other assay/analysis of instant claimed form λ that distinguishes from Form I. Park Declaration does not provide any evidence that instant claimed Form λ exhibit any superior or different physical property compared with the Form I taught by Hester II’ 473. Instant claimed From λ is merely one of many polymorph form of compound A as disclosed by instant specification. It is common practice in the pharmaceutical industry to explore different polymorphs of active compounds for purpose of solubility, stability, and bioavailability etc. as illustrated by Hester II’ 473. Instant claimed form λ could have been considered as routine experimentation/ optimization of polymorph taught by Hester II’ 473 if not the same.
As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions". Thus, claims 1 and 5-10 remain rejected over Hester II’ 473 and Taub.
Response to Arguments
Applicant's remarks filed 06/04/2026 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office action.
Applicant’s argument based on the interpretation of XRPD pattern is similar to Park Declaration, please see Response to Park Declaration. Claims 1, 5-10 are rejected under 35 USC § 102/103 as being unpatentable over Hester II’ 473 and Taub in absence of convincing evidence to the contrary.
Claims 1-10 of copending U.S application No 18/949,309 are cancelled, thus the statutory double patenting rejection over 18/949,309 is withdrawn. Claims 1, and 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of copending Application No. 18/949,309.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 and 5-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hester II et al.(US 2015/0203473 A1, Hester II’ 473, Applicant’s IDS dated 10/01/2025, corresponding to US 9,266,861 B2).
Hester II’ 473 discloses preparation of pyridazinone compounds(e.g. Compound A), solvate, pharmaceutical salt, morphic forms thereof, and pharmaceutical composition comprising aforementioned as thyroid hormone analogs for treating resistance to thyroid hormone (RTH) (See abstract, [0031], claims 1-5, 11-13). Hester II’ 473 teaches embodiments of pharmaceutically acceptable salts with base (e.g. lysine, arginine, alkali metal, etc.), wherein pharmaceutically acceptable salts include solvent addition forms (solvates) or crystal forms (polymorphs) of the same salt (See [0175],0176]).
Hester II’ 473 explicitly discloses preparation of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2.3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile (Compound
A), and conversion of Compound A to solid Form I characterized by XRPD (See Example 4-6, [0213]-0215], [0222]-[0224], Table 11 and Fig. 1). Hester II’ 473 also discloses conversion of Compound A solvate to solid Form I characterized by XRPD , which was further analyzed for interaction between Compound A and thyroid hormone receptor(See Example 7, [0226]-[0230]). Hester II’ 473 teaches the XRPD peaks of morphic Form I, at about 8.2, 10.5, 11.2, 15.7, 16.4, 17.7, 18.7, 22.9, 23.6, 24.7, 30.0, and 32.2 degrees 2θ (See [0048]-[0052], Fig.1, Table 11).
Regarding claims 5-7, Hester II’ 473 teaches the morphic form has a purity of 95% or greater , e.g. 99.6% by HPLC (See [0060]-[0061], [0073]-0074], [0214], [0226], Example 7, claim 4) .
Regarding claim 8 and 9, Hester II’ 473 teaches pharmaceutical composition comprising morphic form of Compound A and a variety of pharmaceutically acceptable carrier (See [0161], [0167]-[0168], claim 5).
Regarding claim 10, Hester II’ 473 teaches therapeutic composition can be in variety of dosage forms, e.g. tablets, suspension, etc. for administration(See [0166]-[0167]).
Hester II’ 473 teaches XRPD of Compound A Form I that is substantially similar to instant claims. Please note X-ray diffraction pattern/peaks are the property of morphic form /polymorph once the morphic form is obtained and could be easily measured by a person skilled in the art through a normal measurement method as taught by Hester II’ 473. It is well recognized in the art that X-ray diffraction patterns may have different appearance(e.g. peak locations, intensities, and/or presence) due to artifacts and solvent. One of skilled in the art would have known XRPD data might not produce exactly the same peaks even for the same crystalline form due to instrumental variation, sample preparation, scientific error, etc.
Even if the Form I taught by Hester II’ 473 is slight different from instant claimed form λ , the difference between Form I and instant form λ is within the meaning of obviousness under 35 USC 103. It is common practice in the pharmaceutical industry to explore different polymorphs of active compounds for purpose of solubility, stability, and bioavailability etc. as illustrated by Hester II’ 473. It would have been prima facie obvious for an ordinary skilled in the art before the effective filing date of instant invention to explore different polymorphs of compound A based on the collective teaching of Hester II’ 473 and general knowledge of crystallography and pharmaceutical composition, and arrive at instantly claimed invention with reasonably expectation of success.
As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions".
Claims 1 and 5-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Taub et al.(US 2016/0243126 A1, hereafter Taub’ 126, corresponding to US 9,968,612 B2, Applicant’s IDS dated 10/01/2025).
Taub’ 126 is continuation of Hester II’ 473. Taub’ 126 discloses preparation of pyridazinone compounds(e.g. compound A), solvate, pharmaceutical salt, morphic forms thereof, and pharmaceutical composition comprising aforementioned as thyroid hormone analogs for treating resistance to thyroid hormone (RTH) ( See abstract, [0036], claims 1, 4-15). Taub’ 126 teaches embodiments of pharmaceutically acceptable salts with an base (e.g. lysine, arginine, alkali metal, etc.), and pharmaceutically acceptable salts include solvent addition forms (solvates) or crystal forms (polymorphs) of the same salt (See [0177],[0178]).
Taub’ 126 explicitly discloses preparation of compound A, conversion of Compound A to solid Form I characterized by XRPD (See Example 4- 6, [0227]-[0238], Table 11 and Fig. 1). Taub’ 126 also discloses conversion of Compound A solvate to solid Form I characterized by XRPD, which was further analyzed for interaction between compound A and thyroid hormone receptor (See Example 7, [0240]-[0243]).
Regarding claims 5-7, Taub’ 126 teaches the morphic form has a purity of greater than 95% or greater than 99%, greater than 99.2%, greater than 99.5%, or greater than 99.8% (See [0061]-[0062], [0240], Example 7, claims 7, 11) .
Regarding claim 8-10, Taub’ 126 teaches pharmaceutical composition comprising morphic form of compound A and a variety of pharmaceutically acceptable carrier, wherein the composition can be in a variety of dosage form (e.g. tablet) (See [0162]-[0169]).
Please note X-ray diffraction pattern/peaks are the property of morphic form /polymorph once the morphic form is obtained and could be easily measured by a person skilled in the art through a normal measurement method as taught by Taub’ 126. Taub’ 126 teaches XRPD of Compound A morphic form Hester II’ 473 teaches XRPD of Compound A Form I that is substantially similar to instant claims. Please note X-ray diffraction pattern/peaks are the property of morphic form /polymorph once the morphic form is obtained and could be easily measured by a person skilled in the art through a normal measurement method as taught by Taub’ 126. It is well recognized in the art that X-ray diffraction patterns may have different appearance(e.g. peak locations, intensities, and/or presence) due to artifacts and solvent. One of skilled in the art would have known XRPD data might not produce exactly the same peaks even for the same crystalline form due to instrumental variation, sample preparation, scientific error, etc.
Even if the Form I taught by Taub’ 126 is slight different from instant claimed form λ , the difference between Form I and instant form λ is within the meaning of obviousness under 35 USC 103. It is common practice in the pharmaceutical industry to explore different polymorphs of active compounds for purpose of solubility, stability, and bioavailability etc. as illustrated by Taub’ 126. It would have been prima facie obvious for an ordinary skilled in the art before the effective filing date of instant invention to explore different polymorphs of compound A based on the collective teaching of Taub’ 126 and general knowledge of crystallography and pharmaceutical composition, and arrive at instantly claimed invention with reasonably expectation of success.
As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions".
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 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of US 9,266, 861 B2 (corresponding to US 2015/0203473 A1 in preceding 103 rejection).
Reference claims 1-5 are directed to a morphic form of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2.3,4,5-tetrahydro-1,2,4-triazine-6-carbonitril(Compound A) characterized by the same set of XRPD peaks at about 10.5, 18.7, 22.9, 23.6, and 24.7 degrees 2θ (claim 1), further including peaks at about 8.2, 11.2, 15.7 16.4, 17.7, 30.0, and 32.2 degrees 2θ(claim 2).
Reference claim 4 recites the morphic form has a purity of 95% or greater(which reads on instant claims 5 and 6).
Reference claim 5 recites pharmaceutical composition comprising a morphic form and a pharmaceutically acceptable carrier (which reads on instant claim 8 and 9 ).
It is common practice in the pharmaceutical industry to explore different polymorphs of active compounds for purpose of solubility, stability, and bioavailability etc.. It would have been prima facie obvious for an ordinary skilled in the art to explore different polymorphs of compound A as taught by reference claims and general knowledge of crystallography and pharmaceutical composition. Instant claimed form λ is considered as routine experimentation/optimization of polymorph taught by reference claims. As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions".
The instant application shares at least one common applicant with the reference patent. Further, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Claims 1 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-15 of US 9,968,612 B2 in view of Hester II et al.(US 2015/0203473 A1, Hester II’ 473).
Reference claims 1 and 4-15 are directed to method for treating a resistance to thyroid hormone
(RTH) syndrome with morphic form of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitril (compound A) characterized by XRPD peaks.
Reference claims 4-5, and 8-9 recite XRPD peaks , 10.5, 18.7, 22.9, 23.6, and 24.7 degrees 2θ (claim 4), further including peaks at about 8.2, 11.2, 15.7 16.4, 17.7, 30.0, and 32.2 degrees 2θ(claim 5). The XRPD peaks of reference morphic form read on ± 10% of peaks recited in instant claims.
Reference claims 7 and 11 recite the morphic form has a purity of 95% or greater(which reads on instant claims 5 and 6).
Reference claims are silent about the pharmaceutical composition. It’s common practice for an ordinary skilled in the art to formulate the active compound and pharmaceutical acceptable excipients into pharmaceutical composition.
The collective teachings of Hester II is elaborated in preceding 103 rejection and applied as before. Hester II’ 473 teaches pharmaceutical composition comprising morphic form of compound A characterized by XRPD peaks. A skilled artisan would be motivated to explore different crystalline/morphic forms of compounds for purpose of solubility, stability, and bioavailability etc. as taught by Hester II’ 473 and arrive at instantly claimed invention with reasonable expectation of success.
As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.".
The instant application shares at least one common applicant with the reference patent. Further, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Claims 1 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 11-22 of US 10,376,517 B2.
Reference claims are directed to morphic form of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitril (Compound A) characterized by XRPD peaks and method for treating nonalcoholic steatohepatitis with aforementioned morphic form. Reference claims 12-13 recite XRPD peaks at 10.5, 18.7, 22.9, 23.6, and 24.7 degrees 2θ , further including peaks at about 8.2, 11.2, 15.7 16.4, 17.7, 30.0, and 32.2 degrees 2θ.
As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions".
The instant application shares at least one common inventor and/or applicant with the reference patent. Further, the instant application is not related to the reference patent thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, and 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of copending Application No. 18/949,309 (reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to morphic form of 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2.3,4,5-tetrahydro-1,2,4-triazine-6-carbonitril, characterized by the XRPD peaks, including peaks at about 10.1, about 10.4, about 11.4, about 13.9, about 16.2, about 16.4, about 17.1, about 22.0 about 23.8, and about 29.5 degrees 2θ.
Reference claims 15 -17 recite the morphic form has a purity of 90% or 95% or 99%, or greater(which reads on instant claims 5-7).
Reference claims 18-20 recite pharmaceutical composition that read on instant claims 8-10.
It is common practice in the pharmaceutical industry to explore different polymorphs of active compounds for purpose of solubility, stability, and bioavailability etc.. It would have been prima facie obvious for an ordinary skilled in the art to explore different polymorphs of compound A as taught by reference claims and general knowledge of crystallography and pharmaceutical composition. Instant claimed form λ is considered as routine experimentation/optimization of polymorph taught by reference claims. As stated in MPEP 2144.05, " 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, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions".
Instant application is continuation of reference application 18/949,309. There is no restriction requirement on the record of reference application 18/949,309. There is no shield under 35 USC§121.
Conclusion
No claim is allowed.
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 LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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, Amy L Clark can be reached on (571)272-1310. 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.
/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights