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 1-30 are pending in the instant invention. According to the Amendments to the Claims, filed April 29, 2024, claims 4, 11, 13, 19, 26 and 28 were amended and claim 30 was added.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/IB2022/060430, filed October 29, 2022, which claims priority under 35 U.S.C. § 119(a-d) to IN 202121049524, filed October 29, 2021.
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 July 17, 2016, is acknowledged: Group I - claims 1-15 and 30. 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 the traversal is on the grounds that the restriction is improper since there would not be a serious search and examination burden if restriction were not required. This is not found persuasive because the multiple inventions in the instant invention are independent or distinct for the reasons disclosed in the Requirement for Restriction / Election of Species, mailed on May 20, 2026.
Likewise, the inventor or joint inventor should further note that there would be a serious burden on the examiner if restriction was not required because the inventions have acquired a separate status in the art due to their divergent subject matter and would require a different field of search.
Next, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that claims 16-29 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking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 1-15 and 30 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 - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound 1).
The following title is suggested: PHARMACEUTICAL COMPOSITION COMPRISING 7a,17b-3-(DIHYDROGEN PHOSPHATE)-7-[9-[(4,4,5,5,5-PENTAFLUOROPENTYL)SULFINYL]NONYL]-ESTRA-1,3,5(10)-TRIENE-3,17-DIOL FOR THE TREATMENT OF BREAST CANCER.
Appropriate correction is required.
Claim Objections
Claim 1 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):
1. A pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and a therapeutically effective amount of compound I:
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compound I
or a pharmaceutically acceptable salt or solvate thereof.
31. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises compound I, or a pharmaceutically acceptable salt or solvate thereof, at a concentration in the range of from 10 mg/mL to 300 mg/mL.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for brevity, 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:
32. The pharmaceutical composition according to claim 31, wherein the pharmaceutical composition comprises compound I, or a pharmaceutically acceptable salt or solvate thereof, at a concentration in the range of from 20 mg/mL to 300 mg/mL.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for brevity, 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:
33. The pharmaceutical composition according to claim 32, wherein the pharmaceutical composition comprises compound I, or a pharmaceutically acceptable salt or s0olvate thereof, at a concentration selected from the group consisting of:
(1) 20 mg/mL;
(2) 30 mg/mL;
(3) 40 mg/mL;
(4) 50 mg/mL;
(5) 60 mg/mL;
(6) 70 mg/mL;
(7) 80 mg/mL;
(8) 90 mg/mL;
(9) 100 mg/mL;
(10) 110 mg/mL;
(11) 120 mg/mL;
(12) 130 mg/mL;
(13) 140 mg/mL;
(14) 150 mg/mL;
(15) 160 mg/mL;
(16) 170 mg/mL;
(17) 180 mg/mL;
(18) 190 mg/mL;
(19) 200 mg/mL;
(20) 210 mg/mL;
(21) 220 mg/mL;
(22) 20 mg/mL;
(23) 230 mg/mL;
(24) 240 mg/mL;
(25) 250 mg/mL;
(26) 260 mg/mL;
(27) 270 mg/mL;
(28) 280 mg/mL;
(29) 290 mg/mL; and
(30) 300 mg/mL.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 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:
A method for maintaining fulvestrant blood plasma concentration in a subject in need thereof, wherein the method comprises intramuscularly administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and compound I:
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compound I
or a pharmaceutically acceptable salt or solvate thereof;
wherein the fulvestrant blood plasma concentration in the subject is maintained for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
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) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 4, wherein the fulvestrant blood plasma concentration in the subject is maintained for a desired period of time selected from the group consisting of:
(1) at least one week;
(2) at least two weeks;
(3) at least three weeks;
(4) at least four weeks;
(5) at least one month;
(6) at least two months; and
(7) at least three months.
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) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 4, wherein the fulvestrant blood plasma concentration in the subject is maintained at a concentration of at least 1 ng/mL for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for brevity, 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 according to claim 6, wherein the fulvestrant blood plasma concentration in the subject is maintained at a concentration in the range of from at least 2 ng/mL to at least 100 ng/mL for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for brevity, 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 according to claim 4, wherein the fulvestrant blood plasma concentration in the subject is maintained at a concentration in the range of from 1 ng/mL to 500 ng/mL for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for brevity, 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 according to claim 8, wherein the fulvestrant blood plasma concentration in the subject is maintained at a concentration in the range of from 1 ng/mL to 490 ng/mL for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for brevity, 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 according to claim 9, wherein the fulvestrant blood plasma concentration in the subject is maintained at a concentration in the range of from 2 ng/mL to 100 ng/mL for a desired period of time after intramuscularly administering to the subject a therapeutically effective amount of the pharmaceutical composition via injection.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for brevity, 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 according to claim 6, wherein the pharmaceutical composition comprises compound I, or a pharmaceutically acceptable salt or solvate thereof, at a concentration in the range of from 10 mg/mL to 300 mg/mL.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for brevity, 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 according to claim 11, wherein the fulvestrant blood plasma concentration in the subject is maintained for a desired period of time selected from the group consisting of:
(1) at least one week;
(2) at least two weeks;
(3) at least three weeks;
(4) at least four weeks;
(5) at least one month;
(6) at least two months; and
(7) at least three months.
Appropriate correction is required. See MPEP § 2173.02.
Claim 13 is objected to because of the following informalities: for brevity, 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 according to claim 8, wherein the pharmaceutical composition comprises compound I, or a pharmaceutically acceptable salt or solvate thereof, at a concentration in the range of from 10 mg/mL to 300 mg/mL.
Appropriate correction is required. See MPEP § 2173.02.
Claim 14 is objected to because of the following informalities: for brevity, 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 according to claim 13, wherein the fulvestrant blood plasma concentration in the subject is maintained for a desired period of time selected from the group consisting of:
(1) at least one week;
(2) at least two weeks;
(3) at least three weeks;
(4) at least four weeks;
(5) at least one month;
(6) at least two months; and
(7) at least three months.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 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 pharmaceutical composition according to claim 1, wherein the pharmaceutical composition comprises at least one pharmaceutically acceptable excipient selected from the group consisting of an antioxidant, an oil, a polymer, a solvent, and a surfactant, or a mixture thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 30 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 pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further comprises benzyl benzoate.
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 1-3, 15 and 30 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 claim 1 recites the functional limitation and/or physicochemical property, …wherein the composition administered to a subject in need thereof has a concentration of compound I,… from about 10 mg/mL to about 300 mg/mL, in lines 1-6 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned functional limitation and/or physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a functional limitation and/or physicochemical property (i.e. concentration) without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)-sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, requires an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear functional limitation and/or physicochemical property, the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, due to an inability to establish the metes and bounds encompassed by the functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
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.
Claims 1-3, 15 and 30 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 the term, about, in claim 1, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
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 2 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 the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further 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).
Then, the inventor or joint inventor should further note that claim 2 recites the broad limitation, about 20 mg/mL to about 300 mg/mL, and the claim also recites about 30 mg/mL to about 300 mg/mL… and about 290 mg/mL to about 300 mg/mL, respectively, which are the narrower statements of the limitation.
Moreover, 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.
Also, 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 section of the rejection.
Claim 3 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 the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 4-10 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 claim 4 recites the functional limitation and/or physicochemical property, …wherein the composition administered to a subject in need thereof maintains blood plasma fulvestrant concentration for a desired period of time after injecting the composition comprising compound I…, in lines 1-7 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned functional limitation and/or physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a functional limitation and/or physicochemical property (i.e. concentration/bioavailability) without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)-sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, requires an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear functional limitation and/or physicochemical property, the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, due to an inability to establish the metes and bounds encompassed by the functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
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 5 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 5 recites the broad limitation, at least three months, and the claim also recites at least one week,… and at least two months, 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 7 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 7 recites the broad limitation, at least 100 ng/mL, and the claim also recites at least 2 ng/mL,… and at least 99 ng/mL, 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 the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
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 the term, about, in claim 9, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further 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).
Then, the inventor or joint inventor should further note that claim 9 recites the broad limitation, about 1 ng/mL to about 490 ng/mL, and the claim also recites about 1 ng/mL to about 480 mg/mL… and about 1 ng/mL to about 100 mg/mL, respectively, which are the narrower statements of the limitation.
Moreover, 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.
Furthermore, the inventor or joint inventor should also 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).
Also, 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 section of the rejection.
Claims 11 and 12 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 claim 11 recites the functional limitation and/or physicochemical property, …wherein the composition administered to a subject in need thereof… maintains blood plasma fulvestrant concentration… for a desired period of time after injecting the composition comprising compound I…, in lines 1-9 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned functional limitation and/or physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a functional limitation and/or physicochemical property (i.e. concentration/bioavailability) without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)-sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, requires an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear functional limitation and/or physicochemical property, the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, due to an inability to establish the metes and bounds encompassed by the functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
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.
Claims 11 and 12 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 the term, about, in claim 11, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
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.
Claims 13 and 14 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 claim 13 recites the functional limitation and/or physicochemical property, …wherein the composition administered to a subject in need thereof… maintains blood plasma fulvestrant concentration… for a desired period of time after injecting the composition comprising compound I…, in lines 1-9 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned functional limitation and/or physicochemical property renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a functional limitation and/or physicochemical property (i.e. concentration/bioavailability) without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)-sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, requires an additional unrecited component to be admixed therewith, such as a stabilizer, bulking agent, solvent or buffer, to impart the functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear functional limitation and/or physicochemical property, the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I), respectively, due to an inability to establish the metes and bounds encompassed by the functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
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.
Claims 13 and 14 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 the term, about, in claim 13, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the intramuscular composition comprising at least one pharmaceutically acceptable excipient and 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound I) has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
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 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 Application No. 17/058,390
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Consequently, claims 1-15 and 30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 7, 17 and 24 of copending US Application No. 17/058,390. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 7 in the copending invention recites a substituted 7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol of the formula (VII), shown to the left above, where each R12 = -H, or a diastereomer thereof, which provides overlapping subject matter, with respect to the instantly recited composition comprising at least one pharmaceutically acceptable excipient and… 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]-nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound 1), shown to the right above.
The inventor or joint inventor should note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
Moreover, 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.
US Application No. 17/779,015
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Claims 1-15 and 30 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claim 29 of copending US Application No. 17/779,015. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 29 in the copending invention recites a pharmaceutically acceptable salt of 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol, shown to the left above, which provides overlapping subject matter, with respect to the instantly recited composition comprising at least one pharmaceutically acceptable excipient and… 7a,17b-3-(dihydrogen phosphate)-7-[9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]-estra-1,3,5(10)-triene-3,17-diol (compound 1), shown to the right above, or a pharmaceutically acceptable salt thereof.
The inventor or joint inventor should note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
Similarly, 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.
Likewise, 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.
Next, the inventor or joint inventor should further 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.
Moreover, 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
Prosecution Insights