DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, 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 3-6, 8-10, 12, 16, 17, 21, 23-25, 27, 30-32 and 35 are pending in the instant invention. According to the Amendments to the Claims, filed August 31, 2026, claims 5, 6, 8, 9, 12, 16, 17 and 35 were amended and claims 1, 2, 7, 11, 13-15, 18-20, 22, 26, 28, 29, 33, 34 and 36 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/IB2023/050444, filed January 19, 2023, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 63/400,301, filed August 23, 2022; and b) 63/300,967, filed January 19, 2022.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on August 31, 2026, is acknowledged: a) Group III - claims 3-6, 8-10, 12, 16, 17 and 35; and b) CYP 11b2 beta hydroxylase inhibitor of the Formula (A) - p. 11, shown to the left above, and hereafter referred to as N-[trans-4-(acetylamino)cyclohexyl]-4-[5-(4-methylphenyl)-1,2,4-triazin-3-yl]-1-piperazineacetamide. Claims 3-6, 8-10, 12, 16, 17 and 35 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that since supposed errors in the restriction requirement were not distinctly and specifically pointed out, the election has been treated as an election, without traverse. See MPEP § 818.03(a).
Likewise, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Next, the inventor or joint inventor should further note that the elected species, shown to the left above, was not found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 21, 23-25, 27 and 30-32 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 3-6, 8-10, 12, 16, 17 and 35 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Formula (A) into the abstract, to overcome this objection.
Claim Objections
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or comply with the Requirement for Restriction/Election of Species, mailed on June 30, 2026, the existing recitation should be replaced with the following recitation(s):
3. A method for treating hypertension in a hypertensive subject, wherein the method comprises:
(a) administering to the hypertensive subject once daily a sufficient amount of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A):
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(A)
or a pharmaceutically acceptable salt thereof;
wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once daily inhibits cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase’s activity in an amount greater than or equal to 50% for a period in the range of from one hour to sixteen hours; or
(b) administering to the hypertensive subject once or twice daily a sufficient amount of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A):
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(A)
or a pharmaceutically acceptable salt thereof;
wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily reduces the serum aldosterone level of the hypertensive subject by an amount in the range of from 50% to 90% relative to the pre-drug level of serum aldosterone of the hypertensive subject for a period not less than eight hours and not greater than sixteen hours; or
(c) administering to the hypertensive subject once or twice daily a sufficient amount of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A):
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(A)
or a pharmaceutically acceptable salt thereof;
wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the ambulatory systolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the ambulatory systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
37. The method of claim 3, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once daily inhibits cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase’s activity in an amount greater than or equal to 50% for a period in the range of from three hours to eight hours.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of claim 3, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily:
(a) reduces the serum aldosterone level of the hypertensive subject by an amount in the range of from 60% to 80% relative to the pre-drug level of serum aldosterone of the hypertensive subject for a period not less than eight hours and not greater than sixteen hours; or
(b) allows the serum aldosterone level of the hypertensive subject to return to an amount equal to or greater than the pre-drug level of serum aldosterone in the hypertensive subject during a period in the range of from sixteen hours to twenty-four hours after the administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(c) reduces the serum aldosterone level of the hypertensive subject by an amount in the range of from 60% to 80% relative to the pre-drug level of serum aldosterone of the hypertensive subject for a period not less than eight hours and not greater than sixteen hours; and
allows the serum aldosterone level of the hypertensive subject to return to an amount equal to or greater than the pre-drug level of serum aldosterone in the hypertensive subject during a period in the range of from sixteen hours to twenty-four hours after the administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation(s):
5. The method of claim 3, wherein the hypertensive subject is taking or has taken a hypertension medication selected from the group consisting of an angiotensin converting enzyme (ACE) inhibitor, an angiotensin receptor blocker, a calcium channel blocker, and a diuretic, or a combination thereof.
38. The method of claim 5, wherein the hypertensive subject is taking or has taken at least two hypertension medications selected from the group consisting of an angiotensin converting enzyme (ACE) inhibitor, an angiotensin receptor blocker, a calcium channel blocker, and a diuretic.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation(s):
The method of claim 3, wherein:
(a) the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject once daily; or
(b) the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject twice daily.
39. The method of claim 6, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject once daily over a period selected from the group consisting of:
(i) for at least one week;
(ii) for at least two weeks;
(iii) for at least four weeks; and
(iv) for at least eight weeks.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation(s):
8. The method of claim 3, wherein the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is:
(a) selective for inhibition of cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase activity relative to inhibition of cytochrome P450 family 11 subfamily B member 1 (CYP 11b1) beta hydroxylase activity; or
(b) administered to the hypertensive subject in an amount below the amount which causes the hypertensive subject’s serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level to exceed 400 pmol/L; or
(c) administered to the hypertensive subject in an amount below the amount which causes an accumulation of 11-deoxycortisterone (11-DOC) above 0.1 ng/mL in the hypertensive subject; or
(d) administered to the hypertensive subject in an amount which does not cause a clinically meaningful upregulation of the adrenocortical hormone synthesis in the hypertensive subject; or
(e) administered to the hypertensive subject in an amount which:
(i) does not cause a clinically meaningful reduction of the serum cortisol level and/or plasma cortisol level in the hypertensive subject, relative to the serum cortisol level and/or plasma cortisol level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(ii) does not cause a clinically meaningful increase of the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject, relative to the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(iii) does not cause a clinically meaningful increase of the serum 11-deoxycortisol level and/or plasma 11-deoxycortisol level in the hypertensive subject, relative to the serum 11-deoxycortisol level and/or plasma 11-deoxycortisol level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(f) administered to the hypertensive subject in an amount which:
(i) does not cause a reduction of the serum cortisol level and/or plasma cortisol level in the hypertensive subject of more than 20%, relative to the serum cortisol level and/or plasma cortisol level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A);
(ii) does not cause an increase of the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject of more than 20%, relative to the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(iii) does not cause an increase of the serum 11-deoxycortisol level and/or plasma 11-deoxycortisol level in the hypertensive subject of more than 20%, relative to the serum 11-deoxycortisol level and/or plasma 11-deoxycortisol level in the hypertensive subject prior to administration a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
40. The method of claim 8, wherein the inhibition constant (Ki) for cytochrome P450 family 11 subfamily B member 1 (CYP 11b1) beta hydroxylase divided by the inhibition constant (Ki) for cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase is greater than 100.
41. The method of claim 8, wherein the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject in an amount below the amount which causes the hypertensive subject’s serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level to exceed 600 pmol/L.
42. The method of claim 8, wherein the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject in an amount which does not cause a reduction of the serum cortisol level and/or plasma cortisol level in the hypertensive subject of more than 10%, relative to the serum cortisol level and/or plasma cortisol level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
43. The method of claim 8, wherein the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject in an amount which does not cause an increase of the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject of more than 10%, relative to the serum 11-deoxycortisterone (11-DOC) level and/or plasma 11-deoxycortisterone (11-DOC) level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
44. The method of claim 8, wherein the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) is administered to the hypertensive subject in an amount which does not cause an increase of the serum 11-deoxycortisol level and/or plasma 11-deoxycortisol level in the hypertensive subject of more than 10%, relative to the serum 11-deoxycortisol level and/or plasma 11- deoxycortisol level in the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method of claim 3, wherein the method comprises administering to the hypertensive subject a sufficient amount of a hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
10. The method of claim 9, wherein the method comprises:
(a) orally administering to the hypertensive subject once daily an amount in the range of from 5 mg to 100 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(b) orally administering to the hypertensive subject once daily an amount in the range of from 10 mg to 50 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(c) orally administering to the hypertensive subject twice daily an amount in the range of from 5 mg to 100 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) every twelve hours; or
(d) orally administering to the hypertensive subject twice daily an amount in the range of from 10 mg to 50 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) every twelve hours.
45. The method of claim 10, wherein the method comprises:
(a) orally administering to the hypertensive subject once daily 12.5 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(b) orally administering to the hypertensive subject once daily 50 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(c) orally administering to the hypertensive subject once daily 100 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(d) orally administering to the hypertensive subject twice daily 12.5 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) every twelve hours; or
(e) orally administering to the hypertensive subject twice daily 25 mg of the hydrobromic acid (HBr) salt of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) every twelve hours.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
12. The method of claim 3, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily:
(a) lowers the office-measured systolic blood pressure of the hypertensive subject relative to the office-measured systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(b) lowers the office-measured diastolic blood pressure of the hypertensive subject relative to the office-measured diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(c) lowers the office-measured systolic and diastolic blood pressure of the hypertensive subject relative to the office-measured systolic and diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(d) lowers the 24-hour ambulatory systolic blood pressure of the hypertensive subject relative to the 24-hour ambulatory systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(e) lowers the ambulatory systolic and diastolic blood pressure of the hypertensive subject relative to the ambulatory systolic and diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(f) reduces the ambulatory systolic blood pressure of the hypertensive subject to less than 130 mmHg; or
(g) reduces the diastolic blood pressure of the hypertensive subject to less than 80 mmHg; or
(h) reduces the ambulatory systolic blood pressure of the hypertensive subject to less than 130 mmHg; and
reduces the diastolic blood pressure of the hypertensive subject to less than 80 mmHg.
46. The method of claim 12, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the office-measured systolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the office-measured systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
47. The method of claim 12, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the office-measured diastolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the office-measured diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
48. The method of claim 12, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the office-measured systolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the office-measured systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) and lowers the office-measured diastolic blood pressure of the hypertensive subject by at least 5 mmHg relative to the office-measured diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
49. The method of claim 12, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the 24-hour ambulatory systolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the 24-hour ambulatory systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
50. The method of claim 12, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily lowers the ambulatory systolic blood pressure of the hypertensive subject by at least 10 mmHg relative to the ambulatory systolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) and lowers the ambulatory diastolic blood pressure of the hypertensive subject by at least 5 mmHg relative to the ambulatory diastolic blood pressure of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
16. The method of claim 3, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily:
(a) reduces the average systolic blood pressure of the hypertensive subject during sleep, relative to the average systolic blood pressure of the hypertensive subject during sleep, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A); or
(b) reduces the average systolic blood pressure of the hypertensive subject during sleep, relative to the average systolic blood pressure of the hypertensive subject in the daytime, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
51. The method of claim 16, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily reduces the average systolic blood pressure of the hypertensive subject during sleep by at least 10%, relative to the average systolic blood pressure of the hypertensive subject during sleep, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
52. The method of claim 51, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily reduces the average systolic blood pressure of the hypertensive subject during sleep, relative to the average systolic blood pressure of the hypertensive subject during sleep, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A), by an amount selected from the group consisting of:
(a) in the range of from 10% to 40%;
(b) in the range of from 10% to 30%; and
(c) in the range of from 10% to 20%.
53. The method of claim 16, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily reduces the average systolic blood pressure of the hypertensive subject during sleep by at least 8 mm Hg, relative to the average systolic blood pressure of the hypertensive subject during sleep, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
54. The method of claim 53, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once or twice daily reduces the average systolic blood pressure of the hypertensive subject during sleep, relative to the average systolic blood pressure of the hypertensive subject during sleep, prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A), by an amount selected from the group consisting of:
(a) by at least 10 mm Hg;
(b) in the range of from 8 mm Hg to 55 mm Hg;
(c) in the range of from 10 mm Hg to 45 mm Hg; and
(d) in the range of from 10 mm Hg to 25 mm Hg.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
17. The method of claim 3, wherein the sufficient amount of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) administered to the hypertensive subject once daily inhibits cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase’s activity in an amount greater than or equal to 50% for a period in the range of from one hour to sixteen hours which:
(a) is sufficient to maintain a state of sodium depletion and maintain a state of volume depletion in the hypertensive subject; or
(b) does not produce a persistent state of hyperkalemia or mild non-anion gap metabolic acidosis in the hypertensive subject; or
(c) does not accumulate the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) in the hypertensive subject; or
(d) is sufficient to maintain potassium levels of the hypertensive subject in a clinically normal range; or
(e) is sufficient to suppress aldosterone production in the hypertensive subject; or
(f) is sufficient to increase serum potassium levels and/or plasma potassium levels in the hypertensive subject; or
(g) is sufficient to increase plasma renin activity (PRA) in the hypertensive subject.
55. The method of claim 17, wherein the lack of accumulation of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) in the hypertensive subject allows for aldosterone levels of the hypertensive subject to return to the pre-drug baseline within a period in the range of twenty-four hours to forty-eight hours of administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
56. The method of claim 17, wherein the lack of accumulation of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A) in the hypertensive subject allows for aldosterone levels of the hypertensive subject to return to the pre-drug baseline within a period in the range of sixteen hours to twenty-four hours of administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
57. The method of claim 17, wherein the potassium levels of the hypertensive subject are mildly elevated relative to the potassium levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
58. The method of claim 57, wherein the potassium levels of the hypertensive subject are elevated by an amount in the range of from 0.01 mmol/L to 0.35 mmol/L, relative to the potassium levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
59. The method of claim 17, wherein the potassium levels of the hypertensive subject are maintained below a level of 5.5 mmol/L, relative to the potassium levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
60. The method of claim 17, wherein the potassium levels of the hypertensive subject are maintained at a level in the range of from 3.5 mEq/L to 5.1 mEq/L, relative to the potassium levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
61. The method of claim 17, wherein serum aldosterone AUC-24 and/or plasma aldosterone AUC-24 of the hypertensive subject is/are reduced by at least 25%, relative to the aldosterone levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
62. The method of claim 17, wherein the serum potassium levels and/or plasma potassium levels of the hypertensive subject are increased by at least 0.2 mMol/L, relative to the serum potassium levels and/or plasma potassium levels of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
63. The method of claim 17, wherein the plasma renin activity (PRA) of the hypertensive subject is increased by at least 5 ng/mL/hr, relative to the plasma renin activity (PRA) of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
64. The method of claim 17, wherein the aldosterone level of the hypertensive subject follows a normal circadian rhythm, relative to the aldosterone level of the hypertensive subject prior to administration of the cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 35 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation(s):
35. The method of claim 3, wherein the hypertensive subject has secondary hypertension.
65. The method of claim 35, wherein the secondary hypertension is primary aldosteronism.
66. The method of claim 3, wherein the hypertensive subject does not have primary aldosteronism.
67. The method of claim 66, wherein the hypertensive subject has primary hypertension.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 3, 5, 6, 8-10, 17 and 35 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 3 recites the broad limitation, 1 hour to 16 hours, with regard to b), and the claim also recites 3 hours to 8 hours, with regard to b), which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 6 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 6 recites the broad limitation, once per day, and the claim also recites in the morning, daily for at least one week, daily for at least two weeks, daily for at least four weeks, and daily for at least eight weeks, respectively, which are the narrower statements of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 8 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 8 recites the broad limitations, or, a), b), and f), respectively, and the claim also recites and and preferably…, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 9 and 10 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 9 recites the broad limitation, pharmaceutically acceptable salt, and the claim also recites HBr salt, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 10 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 10 recites the broad limitations, a), b), c), and d), respectively, and the claim also recites preferably…, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 12 recites the broad limitations, or, a), b), d), and e), respectively, and the claim also recites and and preferably…, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 16 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 16 recites the broad limitations, or and b), respectively, and the claim also recites and and preferably…, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 17 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 17 recites the broad limitations, or, c), d), and e), respectively, and the claim also recites and and preferably…, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 35 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 35 recites the broad limitations, (1) secondary hypertension; and (2) primary aldosteronism, respectively, and the claim also recites (1) primary aldosteronism; and (2) primary hypertension, respectively, which are the narrower statements of the limitations.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
US Patent No. 10,029,993
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Consequently, claims 3-6, 8-10, 12, 16, 17 and 35 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claim 12 of US Patent No. 10,029,993. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 12 in US 10,029,993 recites 3-[4-[[trans-4-(acetoamino)-cyclohexyl]carbamoylmethyl]piperazin-1-yl]-5-(p-tolyl)-1,2,4-triazine, shown to the left above, which is administered within the instantly recited method of treating hypertension in a hypertensive subject, the method comprising administering to the subject once per day a sufficient amount of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A), shown to the right above.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he 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. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Moreover, the inventor or joint inventor should further note that [A] claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. {See Sun Pharmaceuticals Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001 (Fed. Cir. 2008); and Geneva
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349 F.3d 1373, 68 USPQ2d 1865, (Fed. Cir. 2003)}.
US Application No. 18/250,402
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Claims 3-6, 8-10, 12, 16, 17 and 35 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 37-39, 41-46, 55 and 56 of copending US Application No. 18/250,402. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in the copending invention recites a method of treating hypertension in a subject, the method comprising orally administering to the subject once per day 25 mg or 50 mg of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A), shown to the left above, which provides overlapping subject matter with respect to the instantly recited method of treating hypertension in
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a hypertensive subject, the method comprising administering to the subject once per day a sufficient amount of a cytochrome P450 family 11 subfamily B member 2 (CYP 11b2) beta hydroxylase inhibitor of Formula (A), shown to the right above.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he 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. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that this is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Moreover, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Furthermore, the inventor or joint inventor should also note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
