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 02/02/2026.
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 2 and 11-30 are cancelled by Applicant. Claims 1 and 3-10 read on the elected species.
Claim Status
Claims 1 and 3-10 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.
Information Disclosure Statement
The information disclosure statements filed on 10/01/2025 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent by the Examiner.
Specification/Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract is less than 50 words.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to clearly indicate precise values of characteristic peaks in XRPD spectrum in Figures 1-27 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Instant specification disclosed various morphic forms of 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 and XRPD pattern thereof. It is well recognized in the art that X-ray diffraction patterns may have different appearance due to artifacts and solvent, thus must be carefully evaluated for true new polymorphs. Without specifying the characteristic peak values, it’s not clear which peaks are characteristic XRPD pattern of instantly claimed morphic form λ that differentiate Form λ from other crystalline forms, and purity of morphic form λ.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3 and 4 are objected as being significantly duplicative claims. Claims 1, 3 and 4 are not identical, but they are not patentably distinct from each other.
Claim 1 is directed to morphic form λ of 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, characterized by XRPD peaks at about 10.6, about 12.0, about 14.3, about 16.2, about 17.6, about 18.0 and about 24.3 degrees 2θ.
Claim 3 recites morphic form of claim 1 further characterized by an X-ray powder diffraction pattern including one or more additional peaks at about 11.2, about 15.6, about 17.3, and about 22.3 degrees 2θ. Claim 4 recites the morphic form having X-ray diffraction pattern “substantially similar to that set forth in FIG. 27”.
The peaks recited in claims 1, 3 and 4 are essentially the same set of XRPD peaks. XRPD pattern is the property of particular morphic form/polymorph of instantly claimed compound. Thus, crystalline form as recited in claims 1, 3 and 4 are the same morphic form and not patentably distinct from each other.
Applicant is advised that should claim 1 be found allowable, claims 3 and 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 4 recites the morphic form having X-ray diffraction pattern “substantially similar to that set forth in FIG. 27”. It is well recognized in the art that X-ray diffraction patterns may have different appearance due to artifacts and small differences in X-ray diffraction may be due to solvent, thus must be carefully evaluated for true new polymorphs. Without specifying the peak value, it is unclear what thresholds of each peak are used to determine whether a XRD pattern is “substantially similar to that set forth in FIG. 27”.
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As stated in MPEP § 2173.05(s): “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3 recites the morphic form of claim 1 further charactered by XRPD pattern including one or more additional peaks. Claim 4 recites the morphic form of claim 1 having X-ray diffraction pattern “substantially similar to that set forth in FIG. 27”.
XRPD pattern is the property of particular morphic form/polymorph of instantly claimed compound. Claims 1, 3 and 4 are directed to the same set of XRPD peaks of the same morphic form of compound. Thus, claims 3 and 4 fail to further limit the morphic form of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1 and 3-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hester II et al.(US 2015/0203473 A1, hereafter Hester II’ 473, Applicant’s IDS dated 10/01/2025, corresponding to US 9,266,861 B2 listed in Applicant’s IDS dated 10/01/2025).
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). Please note the XPRD peaks of morphic Form I read on ± 10% of peaks recited in instant claims.
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]).
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.
Hester II’ 473 teaches XRPD of Compound A morphic form comprising peaks at about 10.5, 11.2, 15.7, 16.4, 17.7, 18.7, 22.9, 23.6, 24.7 degrees 2θ (See [0224], Table 11, Fig 1) that read on ± 10% of peaks recited in instant claims. As such, Hester II’ 473 anticipates instant invention.
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 3-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by 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 f (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 comprising peaks at about 10.5, 11.2, 15.7, 16.4, 17.7, 18.7, 22.9, 23.6, 24.7 degrees 2θ (See Table 11, Fig 1) that read on ± 10% of peaks recited in instant claims. Taub’ 126 collectively teaches morphic form of compound A that anticipates instant invention.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, and 3-10 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 3-10 of copending Application No. 18/949,309 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Reference claims are directed to the same 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 same set of XRPD peaks.
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.
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 3-9 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). The XRPD peaks of reference morphic form read on ± 10% of peaks recited in instant claims.
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 ).
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 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-15 of US 9,968,612 B2 (corresponding to US 2016/0243126 A1 in preceding 103 rejection) 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 102 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 3-9 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. The XRPD peaks of reference morphic form read on ± 10% of peaks recited in instant 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 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.
Conclusion
No claim is allowed.
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.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628