DETAILED ACTION
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 .
Status of the Claims
Claims 49-68 are pending.
Priority
This application, filed on 11/07/2024, is CON of U.S. application No. 17/069,453, filed on 10/13/2020 (ABN), which is a CON of PCT/US2019/030110, filed on 05/01/2019, which claims priority to U.S. provisional application No. 62/668,384, filed on 05/08/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/14/2025 and 06/24/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, each of the information disclosure statements is being considered by the examiner.
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.
Claims 49-68 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. Claims 50-61 depend from claim 49 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below. Claims 63-68 depend from claim 62 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph,
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Each of claims 49 and 62 recite the phrase “1:2” in parenthesis when referring to hydrochloride salt of compound API-1, however, a person skilled in the art cannot reasonably determine the meets and bounds of the limitations in claims 49 and 62. This is because it not clear whether the parenthetical subject matter is a limitation or an option for hydrochloride salt of compound API-1. It is recommended that Applicants amend claims 49 and 62, so that claims 49 and 62 “hydrochloride” or “dihydrochloride” salt of compound API-1. For the purpose of examination, compound API-1 is being interpreted as a dihydrochloride salt. Appropriate correction is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 61 recites the broad recitation “from 100 mg to 1500 mg”, and the claim also recites “from 100 mg to 1400 mg, from 100 mg to 1300 mg, from 100 mg to 1200 mg, from 200 mg to 1500 mg, from 200 mg to 1400 mg, from 200 mg to 1300 mg, from 200 mg to 1200 mg, from 300 mg to 1500 mg, from 300 mg to 1400 mg, from 300 mg to 1300 mg, or from 300 mg to 1200 mg”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
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.
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.
Claims 49-68 are rejected under 35 U.S.C. 103 as being unpatentable over Mjalli et al (hereinafter “Mjalli”, WO2010114824A1, published 10/07/2010) in view of Mjalli et al (hereinafter “Mjalli2015”, U.S. Pub. No. 20150313908, published 11/05/2015).
By way of a background, Applicants’ invention (see e.g., pages 1-3 of the specification), is directed to a method for using a glucagon-like peptide 1 receptor (GLP1R) agonist for treating type 2 diabetes and obesity.
In view of the ambiguity associated with claims 49 and 62 (see above rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph), each of claims 49 and 62 is being interpreted as a method comprising the active step of administering to a human with obesity, between about 50 mg and about 350 mg of (S)-2-{[(3S,8S)-3-[4-(3,4- dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7, 8,9-hexahydro- [1,4] dioxino [2,3 -g]isoquinoline-8-carbonyl] -amino }-3- [4-(2,3 -dimethyl-pyridin-4-yl)- phenyl]-propionic acid dihydrochloride (API-1):
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, in order to: i) treat obesity in the human (claim 49); or ii) lower body weight or delay gastric emptying in the human (claim 62).
Similar to the Applicants’ invention (see discussions above), Mjalli (see e.g., abstract, pages 1-3, 312-313, 378, 384-389, claims 1, 21-23, 30, Table 1 and discussions therein), teaches a GLP1R agonist compound of Formula (I):
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, which includes compound 179:
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, or a pharmaceutically acceptable salt thereof, and a method of treating at least one disorder selected from type 2 diabetes, obesity and slowing gastric emptying in a human, comprising administering at least 0.1 mg of any one of the compounds of the invention.
Pharmaceutically acceptable salts of compounds of Formula (I), include, but not limited to chloride and dihydrochloride salts (see page 381). Dihydrochloride salt of compound 179, would correspond to Applicants’ compound API-1.
In an embodiment, the pharmaceutical compositions containing a compound of Formula (I), or pharmaceutically acceptable salts thereof, may be in a form suitable for oral use, for example, as tablets (see page 378).
Validation of GLP1R agonists as an established therapeutic target for type 2 diabetes was known in the art, however, dosing of the GLP1R agonist (Exendin-4), was by subcutaneous administration. Mjalli thus envisioned a need for an oral GLP1R agonist that would provide glycemic control, while offering the convenience of oral dosing. Please see pages 1-2.
Mjalli teaches biochemical assay for evaluating the efficacy of the exemplary GLP1R agonists (see page 389). Compound 179 exhibited an EC50 of 5 nM, which is among the highest rated activity level (see Table 2).
The compounds of the invention can be used alone or in combination with one or more medically effective compounds (see pages 382-384).
Accordingly, at the time of the instant invention, it would have been obvious to a person skilled in the art that Mjalli envisioned administering at least 0.1 mg (e.g., between about 50 mg to about 350 mg) of a compound of Formula (I), or a pharmaceutically acceptable salt thereof, such as dihydrochloride salt of compound 179, to a human with obesity.
Mjalli differs from the claimed invention only insofar as Mjalli is not explicit in teaching dihydrochloride salt of compound 179 in an amount of between about 50 mg to about 350 mg. However, the claimed invention would have been obvious over Mjalli. This is because the amount administered can vary depending on various factors such as weight of the subject, sex of the subject and severity of the disease.
For example, Mjalli2015 (see ¶ 0042), discloses that GLP1R agonist such as OAD2, a pharmaceutically acceptable salt thereof, can be administered in an amount that ranges from 1 mg/day to 1000 mg/day, or from 25 mg/day to 800 mg/day, or from 50 mg/day to 750 mg/day, or from 75 mg/day to 600 mg/day, or from 100 mg/day to 400 mg/day, or from 1 mg to 200 mg/day, or from 1 mg to 150 mg/day, or from 1 mg to 100 mg/day, or from 1 mg to 50 mg/day, or from 10 mg to 50 mg/day, of from 25 mg to 75 mg/day, or from 50 mg to 100 mg/day, or from 75 mg to 125 mg/day, or from 100 mg to 150 mg/day, or from 125 mg to 175 mg/day, or from 150 mg to 200 mg/day, or from 175 mg to 225 mg/day. The amount of the GLP1R agonist administered can vary depending on various factors, including but not limited to, the weight of the subject, the nature and/or extent of the subject’s disease, etc. OAD2 is compound 179 (see ¶ 0018).
The claimed between about 50 mg to about 350 mg (claims 49-50, 53-54, 62-64), overlap or lie inside ranges disclosed by the prior art (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the claimed between about 50 mg to about 350 mg, overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
The recited dosage ranges are art-recognized variables (see discussions above). Therefore, the selection specific amount of compound 179 or a pharmaceutically acceptable salt thereof (e.g., dihydrochloride salt of compound 179), would have been routinely determined and optimized in the pharmaceutical art.
MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
In the instant case, it is noted that no criticality (emphasis added) has been demonstrated in the specification regarding the claimed dosage ranges in claims 49-50, 53-54, 62-64.
Therefore, at the time of the instant invention, a person skilled in the art would have envisaged a method comprising administering to a human with obesity, between about 50 mg to about 350 mg) of a compound of Formula (I), or a pharmaceutically acceptable salt thereof, such as dihydrochloride salt of compound 179, in the disclosures of Mjalli with Mjalli2015. A person skilled in the art would have had a reasonable expectation that the administration of dihydrochloride salt of compound 179 to a human with obesity, would treat, for example obesity in the human.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
A reference is good not only for what it teaches by the direct anticipation but also for what one of ordinary skill might reasonably infer from the teachings. In re Opprecht 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode 193 USPQ 12 (CCPA 1976). A reference is not limited to working examples. In re Fracalossi 215 USPQ 569 (CCPA 1982).
It is therefore reasonable to conclude that the strength of correlation between GLP1R agonism and treating obesity in a human patient, gives rise to reasonable expectation of success.
Therefore, claims 49-50, 53-54, 62-64 are obvious over Mjalli and Mjalli2015.
Regarding claims 50-57 and 62-67, each of the dosing schedules is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art.
MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
In the instant case, it is noted that no criticality (emphasis added) has been demonstrated in the specification regarding the claimed dosing schedules in claims 50-55 and 62-65.
Regarding claims 56-57 and 66-67, the recitation of the intended outcome of the step of administering compound API-1 (dihydrochloride salt of compound 179) to a human with obesity, resulting in, for example, a weight reduction of 0.9 kg±0.5 kg (claims 56 and 66), is not given any patentable weight, because the recited limitations are simply expressing the intended result of a process positively recited. Please see i) MPEP § 2111.04 and ii) Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
Since Mjalli and Mjalli2015 combine to disclose a method claims 49 and 62 (see discussions above), the method of Mjalli and Mjalli2015 must necessarily produce the same outcome of recited in claims 56-57 and 66-67, because the recited outcome is a natural process that flows from the subject and the administered dihydrochloride salt of compound 179.
Regarding claim 58, Mjalli and Mjalli2015 combine to teach tablet (see discussions above).
Regarding claims 59-61 and 68: i) Mjalli discloses that compounds of the invention can be used alone or in combination with one or more medically effective compounds such as biguanides (see e.g., pages 382-384); and ii) Mjalli2015 (see ¶ 0045), discloses that OAD2 (compound 179 of Mjalli, see discussions above) or a pharmaceutically acceptable salt thereof (e.g., (dihydrochloride salt of compound 179), can be administered in combination with metformin, wherein the amount of metformin administered ranges from 250 mg/day to 2500 mg/day, or from 350 mg/day to 2000 mg/day, or from 400 mg/day to 1500 mg/day, or from 1000 mg/day to 2500 mg/day, or about 1000 mg/day, or about 1250mg/day, or about 1500 mg/day, or about 1750 mg/day, or about 2000 mg/day, or about 2250 mg/day, or about 2500 mg/day.
The claimed metformin ranges, overlap or lie inside ranges disclosed by the prior art (see discussions above).
A prima facie case of obviousness exists in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" (see MPEP § 2144.05). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP § 2144.05).
In the instant case, because the claimed metformin ranges, overlaps or lies inside ranges disclosed by the prior art (see discussions above), a prima facie case of obviousness exists.
MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
In the instant case, it is noted that no criticality (emphasis added) has been demonstrated in the specification regarding the claimed metformin ranges.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing 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 reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
Nonstatutory 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 49-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent No. 8,383,644 (‘644 patent) in view of: 1) Mjalli (WO2010114824A1); and 2) Mjalli2015 (U.S. Pub. No. 20150313908).
The corresponding teachings of Mjalli and Mjalli2015 are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘644 patent are similarly drawn to (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro- [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method comprising the active step of administering to a human with obesity, between about 50 mg and about 350 mg of (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid dihydrochloride (API-1), whereas, the claims of the ‘644 patent (e.g., claim 1), are directed to (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro-[1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof.
Although the ‘644 patent is not explicit in claiming a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity, the selection of a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity from the ‘644 patent embodiment would have been obvious in view of Mjalli and Mjalli2015.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 49-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent No. 8,987,295 (‘295 patent) in view of: 1) Mjalli (WO2010114824A1); and 2) Mjalli2015 (U.S. Pub. No. 20150313908).
The corresponding teachings of Mjalli and Mjalli2015 are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘295 patent are similarly drawn to (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro- [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method comprising the active step of administering to a human with obesity, between about 50 mg and about 350 mg of (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid dihydrochloride (API-1), whereas, the claims of the ‘295 patent (e.g., claim 1), are directed to (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro-[1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof.
Although the ‘295 patent is not explicit in claiming a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity, the selection of a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity from the ‘295 patent embodiment would have been obvious in view of Mjalli and Mjalli2015.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Claims 49-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent application No. 18/691,835 (‘835 application) in view of: 1) Mjalli (WO2010114824A1); and 2) Mjalli2015 (U.S. Pub. No. 20150313908).
The corresponding teachings of Mjalli and Mjalli2015 are described above and hereby incorporated into the instant rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application and the ‘835 application are similarly drawn to (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro- [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof. For example, the claims of the instant application (e.g., instant claim 1), are drawn to a method comprising the active step of administering (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro [1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid dihydrochloride (API-1) in an amount of between 50 mg and 350 mg, to a human with obesity, whereas, the claims of the ‘295 patent (e.g., claim 20), are directed to a composition comprising (S)-2-{[(3S,8S)-3-[4-(3,4-dichloro-benzyloxy)-phenyl]-7-((S)-1-phenyl-propyl)-2,3,6,7,8,9-hexahydro-[1,4]dioxino[2,3-g]isoquinoline-8-carbonyl]-amino}-3-[4-(2,3-dimethyl-pyridin-4-yl)-phenyl]-propionic acid, or a pharmaceutically acceptable salt thereof.
Although the ‘835 application is not explicit in claiming a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity, the selection of a method for administering API-1 in amount of between about 50 mg and about 350 mg to a human with obesity from the ‘835 application embodiment would have been obvious in view of Mjalli and Mjalli2015.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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