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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2025 has been entered.
Priority
This application is a CON of 17/135,081 filed 12/28/2020.
Information Disclosure Statement
The information disclosure statements submitted on 09/29/2025 has been considered by the examiner.
Claim Status
Claims 8, 16-31 are pending. Claims 8, 16-31 are being examined on the merits in this office action.
Claim Rejections - Withdrawn
The rejection of claims 8, 16-31 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/514,644 in view of Ishida et al. (US20150232478A1 – hereinafter “Ishida”) and Clinical pharmacology (accesdata.fda.gov –published online June 30, 2015) and as evidenced by US 8535695 B2 (hereinafter “the ‘695 patent”)-IDS 12/28/2020 is withdrawn in view of Applicant arguments.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 09/25/2025 is insufficient to overcome the rejection of claims 8, 16-31 based upon 35 USC § 103 as set forth in the last Office action because: the method of administering oral octreotide in combination with lisinopril is known in the art.
Applicant Arguments
Applicant argues that it was discovered that lisinopril' s bioavailability increased when administered to subjects concomitantly with MYCAPSSA compared to patient that were administered lisinopril alone (Page 1-2 of Declaration). Applicant argues that the '710 Publication does not disclose co-administering oral octreotide and lisinopril in separate dosage forms. Applicant argues that the increased bioavailability disclosed in the '695 Patent relates to situations where the AI is included or "packed-in" the formulation and not when the agent is administered separately (Page 2-3 of Declaration). Applicant argues that data show that there is a lack of predictability regarding whether and how the co-administration of MYCAPSSA with a second therapeutic agent will affect bioavailability, e.g., neither the existence of any such an effect, nor its direction (i.e., increase or decrease bioavailability), nor its magnitude is predictable across the tested drugs (Page 3-4 of Declaration). Applicant argues that CP provides no information related to the specific situation of the pending claims, i.e., administering oral octreotide to a patient that is already taking lisinopril therapy (Page 4-5 of Declaration).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the instant claims are drawn to a method of administering both octreotide and lisinopril, monitoring blood pressure, decreasing the dose of lisinopril and wherein the octreotide and lisinopril are administered in separate dosage forms. The method of administering both octreotide and lisinopril to a subject known in the art as taught by the ‘710 reference. Even though ‘710 discloses monitoring or observing the primary and secondary outcomes of the co-administration (page 31, Example 2 and 3), ‘710 does not disclose observing or monitoring the blood pressure of the subject and then adjusting the dose of Lisinopril administered. However, it is known in the art that lisinopril is a blood pressure medication as taught by CP. CP further discloses that the dosage should be adjusted according to blood pressure response (page 3, section 2.1). Adjusting lisinopril dose according to blood pressure response is thus known in the art. Further, it is expected and obvious to monitor a subject receiving blood pressure medication and adjust the dose accordingly. In addition, the limitation of increasing bioavailability, is an intended result of unappreciated property. It is known in the art as evidenced by ‘695 that TPE formulated octreotide as recited in the instant claims, exhibited a high or improved bioavailability (col. 1, line 55) by enhancing the GI wall/barrier permeability to the drug molecules. For example, a composition described herein may facilitate absorption by permeating the GI wall/barrier primarily via unsealing of the tight junctions between GI epithelial cells, although it may also work by transcellular absorption (col. 2, line 1-6). ‘695 further discloses that combinations of two small molecules can be used when one of them generally has poor absorption or bioavailability (col. 10, line 65-67). This teaching of ‘695 suggests that co-administration of octreotide formulated with PVP and other drugs that have poor availability such as lisinopril may lead to improved bioavailability, thus prompting monitoring the blood pressure by one of ordinary skill in the art.
Given that the co-administration of octreotide and lisinopril is known in the art, one of ordinary skill in the art would indeed be motivated to monitor the blood pressure of the subject in case of increase in bioavailability of lisinopril co-administered with oral octreotide which might lead to a decrease in blood pressure. In addition, since Clinical pharmacology discloses that Lisinopril lowers the blood pressure and since prior art teaches that the bioavailability of Lisinopril will be increased, there is an expectation that the blood pressure will be reduced relative to the standard.
In response to Applicant’s argument regarding the MYCAPSSA label arguing that MYCAPSSA decreased bioavailability of other drugs, Examiner notes that the bioavailability limitation is a property that is inherently present. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977) (See MPEP 2112(I). . Examiner maintains that when the teachings of the cited references are combined, the instant invention is rendered obvious.
Claim Rejections - 35 USC § 103 - Maintained
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 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.
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.
Claim Interpretation
Examiner is interpretation the claims as follows:
The recitation of “…commencing oral octreotide administration in a subject that is being administered lisinopril…” is interpretated as a combination treatment wherein the subject is administered oral octreotide and lisinopril. The instant disclosure supports this interpretation.
Claims 8, and 16-30 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/127710 A1 (hereinafter “the ‘710 publication”) in view of Clinical pharmacology (accesdata.fda.gov –published online June 30, 2015) as evidenced by US 8535695 B2 (hereinafter “the ‘695 patent”)-IDS 12/28/2020 – all references are cited and enclosed in previous office action.
‘710 teaches a method of treatment where the subject is administered an oral somatostatin receptor ligand (SRL) such as an oral formulation of octreotide (Abstract; claim 21, 23-26, 30-36) in combination with a therapeutically effective amount of a second therapeutic agent such as an angiotensin-converting enzyme inhibitor (claim 21) and that the angiotensin-converting enzyme inhibitor is Lisinopril (claim 37). Examiner notes that this part of the disclosure reads on administering oral octreotide to a subject that is concomitantly administered lisinopril. ‘710 teaches that the oral octreotide is administered in an oral dosage form, comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of octreotide, at least one salt of a medium chain fatty acid and polyvinylpyrrolidone (PVP) (which is a TPE formulation), and wherein the at least one salt of a medium chain fatty acid salt is present in the composition at an amount of at least 10% or more by weight (e.g., about 10% to 40% by weight or about 12% to 18% by weight) (Page 17, last paragraph, line 1-10). ‘710 teaches in Example 3 that subjects were administered oral octreotide alone or in combination with a 2nd therapeutic agent alone, wherein the 2nd therapeutic agent includes lisinopril (Example 3). Examiner notes that the method of ‘710 thus administers the octreotide and lisinopril in separate dosage forms.
Even though ‘710 discloses monitoring or observing the primary and secondary outcomes of the co-administration (page 31, Example 2 and 3), ‘710 does not disclose observing or monitoring the blood pressure of the subject and then adjusting the dose of Lisinopril administered.
Clinical pharmacology (CP) discloses that lisinopril oral solution for the treatment of hypertension, adjunct treatment of heart failure and treatment of acute myocardial infarction in adults and treatment of hypertension (page 2, section 1.1) CP further discloses that the dosage should be adjusted according to blood pressure response (page 3, section 2.1).
With regards to the recited limitation of “…increase the bioavailability of lisinopril…”, as evidenced by the ‘695 patent, TPE formulated octreotide administered in combination with a second agent, increases the bioavailability of the second agent. Specifically, ‘695 teaches TPE formulated octreotide (col. 16, lines 44-60) which exhibited a high or improved bioavailability (col. 1, line 55) by enhancing the GI wall/barrier permeability to the drug molecules. For example, a composition described herein may facilitate absorption by permeating the GI wall/barrier primarily via unsealing of the tight junctions between GI epithelial cells, although it may also work by transcellular absorption (col. 2, line 1-6). ‘695 further discloses that combinations of two small molecules can be used when one of them generally has poor absorption or bioavailability (col. 10, line 65-67). The ‘695 patent teaches a method of treating a subject suffering from acromegaly (claim 1, 21).
It would have been obvious to one of ordinary in the art before the effective filing date of the claimed invention to combine the teachings of ‘710 and Clinical pharmacology and further monitor the blood pressure of the subject and further adjusting the dose of the blood pressure agent since it is expected and obvious to monitor a subject receiving blood pressure medication. Further, the limitation of increasing bioavailability is an intended result of an unappreciated property and further, as evidenced by ‘695 teaches that TPE formulated octreotide in combination with a second low bioavailability drug, increases the bioavailability of the second drug, there is an expectation that the bioavailability of lisinopril would be increased, thus affecting the blood pressure of the subject warranting monitoring the subjects blood pressure and thus decreasing the dose. One of ordinary skill in the art would therefore have been motivated and would have had a reasonable expectation of success of preparing such a method since it is known in the art that octreotide and lisinopril have been co-administered at taught by ‘710 and adjusting lisinopril dose according to blood pressure response is known in the art as taught by CP. Further, with regards to the limitation of increase of bioavailability, Examiner notes that the limitation is an inherent unappreciated property and as evidenced by ‘695, TPE formulated octreotide increases the bioavailability of the second drug. Further, it is known in the art that octreotide is used to treat acromegaly as taught by ‘710 and ‘695. The disclosures render obvious claim 8.
Regarding claim 16, ‘710 teaches that the oral octreotide is administered in an oral dosage form, comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of octreotide, at least one salt of a medium chain fatty acid and polyvinylpyrrolidone (PVP), and wherein the at least one salt of a medium chain fatty acid salt is present in the composition at an amount of at least 10% or more by weight (e.g., about 10% to 40% by weight or about 12% to 18% by weight) (Page 17, last paragraph, line 1-10).
Regarding claim 17, ‘710 teaches the medium chain fatty acid salt has a chain length from about 6 to about 14 carbon atoms (Page 19, 3rd paragraph, line 1-2).
Regarding claims 18-19, ‘710 teaches that the medium chain fatty acid salt is sodium hexanoate, sodium heptanoate, sodium octanoate, sodium nonanoate, sodium decanoate, sodium undecanoate, sodium dodecanoate, sodium tridecanoate or sodium tetradecanoate, or a corresponding potassium or lithium or ammonium salt or a combination thereof (Page 19, 3rd paragraph, line 2-5).
Regarding claim 20, ‘710 teaches that the composition comprises 12-21% by weight sodium octanoate (page 19, line 1-2). Examiner notes that the cited range encompasses the instant range.
Regarding claims 21-25, ‘710 teaches that the composition comprises polyvinylpyrrolidone (PVP), (which is an example of a matrix forming polymer), wherein the polyvinylpyrrolidone is present in the composition at an amount of 2% or more by weight (e.g., about 2% to about 20% by weight or about 5% to about 15% by weight) (Page 17, last paragraph, line 4-10).
Regarding claims 26, ‘710 teaches that the medium chain fatty acid salt is sodium hexanoate, sodium heptanoate, sodium octanoate (Page 19, 3rd paragraph, line 2-5).
Regarding claims 27 and 29, ‘710 teaches that the composition comprises about 12-21% of sodium octanoate, about 5-10% of polyvinylpyrrolidone with a molecular weight of about 3000, about 20-80% of glyceryl tricaprylate, and about 3-10% surfactant (Page 18, last paragraph, line 10-13).
Regarding claim 28, ‘710 teaches that the surfactant is glyceryl monocaprylate or polyoxyethylene sorbitan monooleate (Page 19, 1st paragraph, line 4-5).
Regarding claim 30, ‘710 teaches that the dosage form is an enteric-coated capsule (Page 20, 1st paragraph, line 1).
Claim 31 remains rejected under 35 U.S.C. 103 as being unpatentable over Ishida et al. (US20150232478A1 – hereinafter “Ishida”) in view of Clinical pharmacology (accesdata.fda.gov –published online June 30, 2015) as evidence by US 8535695 B2 (hereinafter “the ‘695 patent”)-IDS 12/28/2020 – all references are cited and enclosed in previous office action.
Ishida teaches a method of treating a somatostatin related disease, comprising administering to a mammal in need thereof an effective amount of the compound represented by the general formula (I), wherein the somatostatin related disease is acromegaly (claim 7; Abstract; col. 11, line 63-64; col. 13, line 35-36). Ishida teaches that the present invention compounds are used not just alone but in combination with other active substances (col. 46, line 15-18), and that when the compounds are used for the prevention and/or treatment for acromegaly, medicines used in combination with the present invention compounds include, for example, somatostatin analogs (col. 46, line 24-27) such as octreotide (col. 47, line 10-11). Ishida teaches that patients with acromegaly are frequently associated with an adult disease such as diabetes, hypertension (col. 46, line 29-31), and that the present invention compound may be used in combination with antihypertensive drug (e.g., angiotensin-converting enzyme inhibitor drug) (col. 46, Line 44-45) such as lisinopril (col. 48, line 31-32).
Ishida does not disclose observing or monitoring the blood pressure of the subject and then adjusting the dose of Lisinopril administered and does not teach the composition comprising a suspension which is an admixture of a hydrophobic medium.
Clinical pharmacology (CP) discloses that lisinopril oral solution for the treatment of hypertension, adjunct treatment of heart failure and treatment of acute myocardial infarction in adults and treatment of hypertension (page 2, section 1.1) CP further discloses that the dosage should be adjusted according to blood pressure response (page 3, section 2.1).
With regards to suspension which is admixture of a hydrophobic medium, ‘695 teaches that the composition comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form wherein the solid form comprises a therapeutically effective amount of octreotide, at least one salt of a medium chain fatty acid and polyvinylpyrrolidone (PVP), wherein the at least one salt of a medium chain fatty acid is present in the composition at an amount of at least 12% by weight and wherein the polyvinylpyrrolidone is present in the composition at an amount of 3% or more by weight (claim 1). Further, with regards to the recited limitation of “…increase the bioavailability of lisinopril…”, as evidenced by the ‘695 patent, TPE formulated octreotide administered in combination with a second agent, increases the bioavailability of the second agent. Specifically, ‘695 teaches TPE formulated octreotide (col. 16, lines 44-60) which exhibited a high or improved bioavailability (col. 1, line 55) by enhancing the GI wall/barrier permeability to the drug molecules. For example, a composition described herein may facilitate absorption by permeating the GI wall/barrier primarily via unsealing of the tight junctions between GI epithelial cells, although it may also work by transcellular absorption (col. 2, line 1-6). ‘695 further discloses that combinations of two small molecules can be used when one of them generally has poor absorption or bioavailability (col. 10, line 65-67). The ‘695 patent teaches a method of treating a subject suffering from acromegaly (claim 1, 21).
It would have been obvious to one of ordinary in the art before the effective filing date of the claimed invention to combine the teachings of Ishida, Clinical pharmacology and ‘695 and treat a subject with acromegaly by administering octreotide and lisinopril and monitor the blood pressure of the subject and further adjusting the dose of the blood pressure agent since Ishida teaches that hypertension is one of the conditions experienced in subjects with acromegaly and teaches use of drugs such as lisinopril and it is expected and obvious to monitor a subject receiving blood pressure medication. Further, the limitation of increasing bioavailability is an intended result of an unappreciated property. In addition, ‘695 teaches that TPE formulated octreotide in combination with a second low bioavailability drug, increases the bioavailability of the second drug, there is an expectation that the bioavailability of lisinopril would be increased, thus affecting the blood pressure of the subject warranting monitoring the subjects blood pressure and thus decreasing the dose. One of ordinary skill in the art would therefore have been motivated and would have had a reasonable expectation of success of preparing such a method since it is known in the art that octreotide and lisinopril have been co-administered to subjects with acromegaly. Further, since CP teaches adjusting lisinopril dose according to blood pressure response, it would be obvious to monitor the blood pressure. Further, the limitation of increase of bioavailability is an inherent unappreciated property that is found in TPE formulated octreotide. The disclosures render obvious claim 31.
Response to Arguments
Applicant's arguments filed 09/25/2025 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant makes similar arguments made in the Declaration. Applicant argues that the cited references do not teach the claim elements of 1) co-administering oral octreotide and lisinopril in separate dosage forms, or 2) the step of monitoring blood pressure when a patient already on lisinopril therapy begins to take oral octreotide. Furthermore, contrary to the Examiner's assertions, the cited references do not provide any guidance or expectation that the bioavailability of lisinopril will be increased if lisinopril is co-administered with an oral octreotide-containing TPE formulation in separate dosage forms. Applicant argues that ‘710 does not disclose co-administering oral octreotide and a second therapeutic agent in separate dosage forms, let alone co-administering oral octreotide and lisinopril in separate dosage forms (Page 8-9 of Arguments).
Applicant argues that '695 Patent does not teach any guidance or expectation that the bioavailability of lisinopril will increase if lisinopril is co-administered with an oral octreotide-containing TPE formulation in separate dosage forms. Applicant argues that the Office fails to establish that the claim element of lisinopril's increased bioavailability is an inherent unappreciated property because the '695 Patent does not disclose or teach that the bioavailability of lisinopril necessarily must be increased, or as a natural result will be increased, or is expected to be increased, when co-administered with a TPE formulation in separate dosage forms. Applicant argues that the increased bioavailability disclosed in the '695 Patent relates only to situations where the active ingredient is included or "packed-in" the formulation. A skilled artisan reading the '695 Patent would not have understood this teaching to extend to situations where the active ingredient ( e.g., lisinopril) is administered in a separate dosage form from the TPE formulation (e.g., oral octreotide), as presently claimed (Page 9-12 of Arguments).
Applicant argues that CP provides no information related to the specific situation of the pending claims, i.e., administering oral octreotide to a patient that is already taking lisinopril therapy (Page 12-13 of Arguments).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the instant claims are drawn to a method of administering both octreotide and lisinopril, monitoring blood pressure, decreasing the dose of lisinopril and wherein the octreotide and lisinopril are administered in separate dosage forms. The method of administering both octreotide and lisinopril to a subject known in the art as taught by the ‘710 reference. Even though ‘710 discloses monitoring or observing the primary and secondary outcomes of the co-administration (page 31, Example 2 and 3), ‘710 does not disclose observing or monitoring the blood pressure of the subject and then adjusting the dose of Lisinopril administered. However, it is known in the art that lisinopril is a blood pressure medication as taught by CP. CP further discloses that the dosage should be adjusted according to blood pressure response (page 3, section 2.1). Adjusting lisinopril dose according to blood pressure response is thus known in the art. Further, it is expected and obvious to monitor a subject receiving blood pressure medication and adjust the dose accordingly. In addition, the limitation of increasing bioavailability, is an intended result of unappreciated property. It is known in the art as evidenced by ‘695 that TPE formulated octreotide as recited in the instant claims, exhibited a high or improved bioavailability (col. 1, line 55) by enhancing the GI wall/barrier permeability to the drug molecules. For example, a composition described herein may facilitate absorption by permeating the GI wall/barrier primarily via unsealing of the tight junctions between GI epithelial cells, although it may also work by transcellular absorption (col. 2, line 1-6). ‘695 further discloses that combinations of two small molecules can be used when one of them generally has poor absorption or bioavailability (col. 10, line 65-67). This teaching of ‘695 suggests that co-administration of octreotide formulated with PVP and other drugs that have poor availability such as lisinopril may lead to improved bioavailability, thus prompting monitoring the blood pressure by one of ordinary skill in the art.
Given that the co-administration of octreotide and lisinopril is known in the art, one of ordinary skill in the art would indeed be motivated to monitor the blood pressure of the subject in case of increase in bioavailability of lisinopril co-administered with oral octreotide which might lead to a decrease in blood pressure. In addition, since Clinical pharmacology discloses that Lisinopril lowers the blood pressure and since prior art teaches that the bioavailability of Lisinopril will be increased, there is an expectation that the blood pressure will be reduced relative to the standard.
In response to Applicant’s argument regarding the MYCAPSSA label arguing that MYCAPSSA decreased bioavailability of other drugs, Examiner notes that the bioavailability limitation is a property that is inherently present. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977) (See MPEP 2112(I). Examiner maintains that when the teachings of the cited references are combined, the instant invention is rendered obvious.
Double Patenting – Maintained and Updated
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 8 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 24, 37 of copending Application No. 19/003,529 in view of WO2017127710A1 (hereinafter “the ‘710 publication”), US 8535695 B2 (hereinafter “the ‘695 patent”) and Clinical pharmacology (accesdata.fda.gov –published online June 30, 2015).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method of treating of a subject suffering from a polycystic disease which comprises oral administration to the subject of a therapeutically effective amount of an oral somatostatin receptor ligand (SRL) in combination with a therapeutically effective amount of a second or third therapeutic agent selected from the group consisting of an angiotensin-converting enzyme inhibitor, an angiotensin receptor blocker, an arginine vasopressin V2 receptor antagonist, a statin, a Src kinase inhibitor, an mTOR inhibitor and an injectable somatostatin receptor ligand (SRL) (claim 21), wherein the oral somatostatin receptor ligand (SRL) is octreotide (claim 24).
The claims of the instant application recite a method of treating a subject in need of oral octreotide and lisinopril, the method comprising: i) commencing oral octreotide administration in a subject that is being administered lisinopril; ii) monitoring the blood pressure of the subject of step (i); and iii) decreasing the dose of lisinopril administered to a subject having reduced blood pressure after step (i) relative to the subject's blood pressure before step (i), wherein the oral octreotide is administered in a dosage form, wherein the dosage form comprises: a composition comprising a suspension which is an admixture of a hydrophobic medium and a solid form, wherein the solid form comprises: a therapeutically effective amount of octreotide and a medium chain fatty acid salt, and wherein the composition comprises 12% to 21% by weight of the medium chain fatty acid salt; wherein the commencing of oral octreotide administration in the subject results in an increase in bioavailability of lisinopril in the subject; and wherein oral octreotide and lisinopril are administered in separate dosage forms (claim 8).
The difference between the claims of the copending application and the instant claims is that the claims of the copending application do not recite wherein the angiotensin-converting enzyme inhibitor is lisinopril, does not recite monitoring blood pressure and decreasing dose of lisinopril and does not teach octreotide formulated with fatty acids.
‘710 teaches a method of treatment where the subject is administered an oral somatostatin receptor ligand (SRL) such as an oral formulation of octreotide (Abstract; claim 21, 23-26, 30-36) in combination with a therapeutically effective amount of a second therapeutic agent such as an angiotensin-converting enzyme inhibitor (claim 21) and that the angiotensin-converting enzyme inhibitor is Lisinopril (claim 37).
The ‘695 patent teaches a method of treating a subject suffering from acromegaly (claim 1, 21) comprising administering an effective amount of a composition that comprises octreotide and that the composition further comprises polyvinylpyrrolidone (PVP-12, sodium octanoate, glyceryl tricaprylate, castor oil, glyceryl monocaprylate, and Tween 80 (col. 16, lines 44-60), which as, disclosed in the instant specification is the TPE formulation. The ‘695 patent discloses that the products exhibited a high or improved bioavailability (col. 1, line 55).
Clinical pharmacology (CP) discloses that lisinopril oral solution for the treatment of hypertension, adjunct treatment of heart failure and treatment of acute myocardial infarction in adults and treatment of hypertension (page 2, section 1.1) CP further discloses that the dosage should be adjusted according to blood pressure response (page 3, section 2.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the copending application to include lisinopril as the angiotensin-converting enzyme inhibitor since ‘710 teaches a method that comprises administering octreotide and lisinopril. It would have been obvious to include monitoring blood pressure and decreasing dose of lisinopril as taught by CP treatment of hypertension (page 2, section 1.1). It would have been obvious to formulate octreotide to include fatty acids as taught by ‘695 so as to increase bioavailability. One of ordinary skill in the art would have had a reasonable expectation of success in modifying the claims of the copending application to include the teachings of CP so to accurately administer the required dose of lisinopril rendering obvious the instant claims.
Conclusion
No claims are 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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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, Lianko G. Garyu can be reached at (571)270-7367. 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.
/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654