DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/03/2025, has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2025, 11/24/2025 and 12/12/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, each of the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1-16, 18-19 and 21-29 are pending.
Applicants’ arguments, filed 10/03/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 10/03/2025, have each been entered into the record. Applicants have amended claims 1 and 21. Applicants have cancelled claims 17 and 20. Applicants have newly added claims 25-29. Therefore, claims 1-16, 18-19 and 21-29 are subject of the Office Action below.
Claim Rejections - 35 USC § 112-2nd Paragraph
Maintained/New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 1-16, 18-19 and 21-24, is maintained and newly added claims 25- 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated. Claims 2-16, 18-19 and 25-29 depend from claim 1 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below. Claims 22-24 depend from claim 21 and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Each of independent claims 1 and 21 recites “the oral contraceptive composition provides: a Tmax of EE ranging from 3.1 hours to 4.7 hours, and
a Tmax of DNG ranging from 3.0 hours to 4.4 hours”,
when referring to the administration of a controlled release composition comprising 2 mg of 17α-cyanomethyl-17-β-hydroxyestra-4,9-dien-3-one (dienogest, DNG) and 0.02 mg of 17α-ethinylestradiol (ethynylestradiol, EE). However, a person skilled in the art would not be reasonably apprised of the meets and bounds of the of the composition that the Applicant is claiming. This is because, it is not clear from either the specification or the common teachings in the art how this limitation further limits the claim. For example, it is not clear if this limitation is limiting to a certain patient population, the active ingredient, or an unnamed excipient.
The specification does not teach or provide a nexus between the functional result that Applicant claims to achieve by the claimed composition with any particular component of the formulation or the manner in which it is administered. There is no description as to the pharmaceutical approach that makes this result possible (i.e., what cause “the oral contraceptive composition provides: a Tmax of EE ranging from 3.1 hours to 4.7 hours, and a Tmax of DNG ranging from 3.0 hours to 4.4 hours”), nor does Applicants teach any polymeric matrix forming agent(s) and diluent(s) or chemical approaches to avoid. Furthermore, it is unclear to one skilled in the art as to, for example:
1) what controlled release composition of claims 1 and 21, would provide:
a Tmax of EE ranging from 3.1 hours to 4.7 hours, and
a Tmax of DNG ranging from 3.0 hours to 4.4 hours.
2) what controlled release composition of claims 1 and 21, would not provide:
a Tmax of EE ranging from 3.1 hours to 4.7 hours, and
a Tmax of DNG ranging from 3.0 hours to 4.4 hours.
Thus, a person of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
For the purpose of examination: i) an administration of a controlled release composition comprising 2 mg DNG and 0.02 mg EE, within the limitation of administration period of claim 1 or claim 21, is included in the interpretation of “the oral contraceptive composition provides:
a Tmax of EE ranging from 3.1 hours to 4.7 hours, and
a Tmax of DNG ranging from 3.0 hours to 4.4 hours”.
It is recommended that Applicant amend claims 1 and 21 to recite specific controlled release composition that performs the recited function of “the oral contraceptive composition provides:
a Tmax of EE ranging from 3.1 hours to 4.7 hours, and
a Tmax of DNG ranging from 3.0 hours to 4.4 hours”,
in order to overcome the rejection. Appropriate correction is required.
Claims 4-19 and 23-24 similarly recites the limitation:
1) wherein the overall Pearl index of contraception is: a) <0.7 with a confidence interval of at least 95% (claim 4); and b) ≤ 0.2 with a CI of 95% (claim 5);
2) wherein, when the oral contraceptive composition is administered to a plurality of female subjects over a period of at least 9 menstruation cycles no more than: a) 90% (claims 6, 9); or b) 60% (claim 7); or c) 55% (claims 8, 11-12); or d) 50% (claims 10); or e) 10% (claim 13), of the female subjects’ experience bleeding, spotting, or a combination thereof, during menstruation cycles 2-9;
3) wherein the DNG and the EE are formulated such that the composition exhibit DNG and EE dissolution profiles recited therein, when the composition is subjected to an in vitro dissolution test (claims 14-15 and 23);
4) wherein after single-dose oral administration to the female subject, the oral contraceptive composition provides:
i) EE Cmax of 29.2 pg/ml to 36.9 pg/ml and DNG Cmax of 34.9 ng/ml to 48.5 ng/ml (claims 16, 19 and 24);
ii) EE Tmax of 3.1 hours to 4.7 hours and DNG Tmax of 3.0 hours to 4.4 hours (claims 17, 19 and 24); and
iii) EE AUC0-72hr of 435 pgxh/ml to 562 pgxh/ml and DNG AUC0-72hr of 545 ngxh/ml to 689 ngxh/ml (claims 18-19 and 24).
Claims 4-19 and 23-24 are also similarly rejected as in claims 1 and 21 above. Appropriate correction is required.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see pages 9-10 of Remarks), alleging that the rejection is improper on the grounds that:
1) Applicants merely cite MPEP § 2173.02 and a list of case law citations therein (see pages 9-10 of Remarks).
Response:
Applicants’ response fails to link the MPEP § 2173.02 and the legal concepts to the facts of the application under examination.
2) the recited functional limitation of, for example, “wherein the overall Pearl Index of contraception is less than 0.7 with a confidence interval (CI) of at least 95%”, is a well-known property that can be measured by one skilled in the art, in order to determine which composition exhibits the recited functional limitation and which composition does not exhibit the recited functional limitation (see page 10 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because the lack of clarity regarding, for example:
a) what composition of claim 1, would not exhibit the function recited in claim 4; and
b) what composition of claim 1, would exhibit the function recited in claim 4,
makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
Claim Rejections - 35 USC § 112-4th Paragraph, Maintained
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The rejection of claims 14-15 and 23-24, under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
Claims 14-15 and 23-24 recite that the oral contraceptive composition of claim 1 and 21 exhibit a dissolution recited therein, which appears to be an inherent property of the oral contraceptive composition. Thus, it does not appear that claims 14-15 and 23-24 limit claim 1 and 21, the claim upon which claims 14-15 and 23-24 depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to the Applicant’s Arguments
Applicant alleges that the rejection is improper because claims 14-15 and 23-24 impose specific limitation characteristics for an oral contraceptive that do not necessarily encompass all embodiments falling within the scope of claims 1 and 21 (see pages 10-12 of Remarks).
Response:
Each of claims 1 and 21, recites an oral contraceptive composition. Since claims 14-15 and 23-24 depend from claims 1 and 21, dependent claims 14-15 and 23-24 inherit an oral contraceptive composition from the claims in which they depend. Therefore, any property exhibited by an oral contraceptive composition of claims 1 and 21 in claims 14-15 and 23-24, is an inherent property of the oral contraceptive composition. Accordingly, the rejection of claims 14-16 and 23-24 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is proper.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Claim Rejections - 35 USC § 102-Maintained
Maintained/ New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claims 21-24 is maintained and amended/newly added claims 1-2, 4-19, 25-27 and 29, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colli of record (WO2022034209A1), for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
By way of a background, Applicants’ invention is directed to a two-phase 28 days method for using an oral contraceptive composition comprising 2 mg of DNG and 0.02 mg of EE, in an extended-release matrix. Please see instant specification at, for example, page 3 (lines 10-13), page 5 (lines 28-34) page 6 (lines 1-3).
Independent claim 1 is directed to a two-phase 28 days1 method for using an oral contraceptive composition comprising 2 mg DNG and 0.02 mg EE, in an extended-release matrix2.
Independent claim 21 is directed to a two-phase 28 days3 method for using an oral contraceptive composition comprising 2 mg DNG and 0.02 mg EE, in an extended-release matrix4.
Regarding claim 1, Colli teaches a two-phase 28 days5 method for using an oral contraceptive composition comprising 2 mg DNG and 0.02 mg EE, in a phase II clinical trial (see pages 3-4). Colli (see Formulations 1-5 in Tables 7-10), teaches extended-release compositions comprising 2 mg DNG and 0.02 mg EE, wherein the matrix comprises HPMC or Eudragit (a polymeric matrix, see pages 15-17), lactose monohydrate or mannitol (a diluent, see page 17), HPMC and povidone (a binder, see page 17) and magnesium stearate (a lubricant, see page 18).
Regarding claim 21, Colli teaches a two-phase 28 days6 method for using an oral contraceptive composition comprising 2 mg DNG and 0.02 mg EE, in a phase II clinical trial (see pages 3-4). Colli (see Formulations 1-5 in Tables 7-10), teaches extended-release compositions comprising 2 mg DNG and 0.02 mg EE, wherein the matrix comprises HPMC or Eudragit (a polymeric matrix, see pages 15-17), lactose monohydrate or mannitol (a diluent, see page 17), HPMC and povidone (a binder, see page 17) and magnesium stearate (a lubricant, see page 18).
Regarding claims 1 and 21, the recitation of the intended outcome of the administration an oral contraceptive composition of claims 1 and 21, resulting in providing a Tmax of EE ranging from 3.1 hours to 4.7 hours, and a Tmax of DNG ranging from 3.0 hours to 4.4 hours, is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited (see Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Please see claim interpretation in the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, discussed above.
Since Colli teaches a method of claims 1 and 21 (see discussions above), the method of Colli must necessarily produce the same outcome recited in claims 1 and 21. This is because the recited outcome is a natural process that flows from the female subject and the administered composition. Therefore, claims 1 and 21 are anticipated by Colli.
Regarding claim 2, Colli (see page 9, lines 35 through page 10, lines 1-2), discloses that the dosage form is suitable for dosing every 24 hours.
Regarding claims 4-13, 16-19 and 24, the recitation of the intended outcome of the method of claims 1 and 21 resulting in each of the outcomes recited in claim 4-13, 16-19 and 24, is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited. Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Please see claim interpretation in the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, discussed above.
Since Colli teaches a method of claims 1 and 21 (see discussions above), the method of Colli must necessarily produce the same outcomes of recited in claims 4-13, 16-19 and 24. This is because each of the recited outcome is a natural process that flows from the subject and the administered composition of claims 1 and 21. Therefore, claims 4-13, 16, 18-19 and 24 are anticipated by Colli.
Regarding claims 14-15 and 23, each of the recited dissolution of profile is an inherent property of the oral contraceptive composition of claims 1 and 21, when the composition is, for example, subjected to an in vitro dissolution test. Since Colli, teaches an oral contraceptive composition of claims 1 and 21 (see discussions above), the oral contraceptive composition of Colli must necessarily exhibit the same dissolution profile, when the composition is subjected to an in vitro dissolution test. For example, Colli (see page 11), discloses that in some embodiments, the compositions describe herein is characterized by EE, preferably DNG and EE, respectively, having a dissolution profile characterized in that:
(i) no more than 25% of the amount initially present in said composition is dissolved within 1 hour; and
(ii) between 30% and 60% of the amount initially present in said composition is dissolved within 2 hours.
Regarding claims 22, 26-27 and 29, Colli teaches that polymeric matrix can comprise HPMC (see page 16) and diluent can comprise a lactose monohydrate (see page 17).
Regarding claim 25, Colli teaches an extended-release matrix (see discussions above).
Response to Applicants’ Arguments/Remarks
Applicants argue (see pages 12-13 of Remarks), alleging that the rejection is improper on the grounds that the recited intended outcome of the method of claim 21 resulting in providing the pharmacokinetic (PK) parameter “Tmax”, is allegedly not an intended result, but, instead, is a measurable property of the claimed method.
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive.
This is because claim 21 requires that the functional limitation of providing “a Tmax”, is only achieved after administration of an oral composition of claim 21 to a female subject. Therefore, the functional limitation of providing “a Tmax”, is an intended outcome of the active steps of a method of claim 21 and is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited (see discussions above).
Since Colli teaches a method of claim 21 (see discussions above), the method of Colli must necessarily produce the same outcomes of recited in claim 21. This is because each of the recited outcome is a natural process that flows from the female subject and the administered composition.
Claim Rejections - 35 USC § 103
Maintained/New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16, 18-19, 21-27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Colli of record (WO2022034209A1), as applied to claims 1-2, 4-19, 21-27 and 29 above, and further in view of Perrin of record (U.S. Pub. No. 20150290222), for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
The limitations of claims 1-2, 4-19, 21-27 and 29, as well as the corresponding teachings of Colli are described above, and hereby incorporated into the instant rejections.
Although Colli is not explicit in teaching non-consecutive administration proviso (claims 1 and 21), the claim invention would have been obvious over Colli. This is because at the time of the instant invention, it was known in the art that a patient can skip up to two non consecutive days of the active contraceptive drug, in an oral contraception method that allows for 28-day daily dosing regimen.
For example, Perrin discloses that in an oral contraception method that allows for 28-day daily dosing regimen, the patient may skip up to two non-consecutive days of the active contraceptive drug, provided the active contraceptive drug skipped dose is taken within about 24 hours. Please see ¶ 0015. Similar to Colli (see discussions above), Perrin (see ¶ 0017), discloses that in an embodiment, the oral contraceptive composition comprises one or more drugs selected from the group that includes, but not limited to drospirenone and dienogest (DNG). Commercially available drospirenone comprises both ethinyl estradiol (EE) and drospirenone (see (see ¶ 0096).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method for administering an oral contraceptive composition comprising DNG and EE, in which the patient may skip up to two non-consecutive days, from the disclosures of Colli and Perrin.
Therefore, claims 1 and 21 are obvious over Colli and Perrin.
Regarding claim 3, Perrin discloses that in an oral contraception method that allows for 28-day daily dosing regimen, the patient may skip up to two non-consecutive days of the active contraceptive drug, provided the active contraceptive drug skipped dose is taken within about 24 hours (see discussions above).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference. Therefore, the invention as a whole was prima facie obvious at the time it was made.
Claims 1-2, 4-19 and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Colli of record (WO2022034209A1), as applied to claims 1-2, 4-19, 21-27 and 29 above, and further in view of Williams III of record (Pharmaceutical Development & Technology, 2002), for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
The limitations of claims 1-2, 4-19, 21-27 and 29, as well as the corresponding teachings of Colli are described above, and hereby incorporated into the instant rejections.
Claim 28 is similar to claim 27, however, claim 28 differs slightly from claim 27 in that claim 28 requires a polymeric matrix and a diluent in a mass ratio of 2:1-10:1
Although Colli does not explicitly teach the limitation of claim 28, the claimed invention would have been obvious over Colli. This is because Colli discloses that an extended-release matrix can comprise: i) a polymeric matrix in an amount ranging from 10%-80% w/w (see pages 15, lines 23-29); and ii) a diluent in an amount ranging from about 20%-95% w/w (see page 170, lines 24-30). Furthermore, formulation an extended-release matrix comprising a polymeric matrix and a diluent in various amounts, was known in the art.
For example, Williams III, teaches an extended-release matrix comprising HPMC (a polymeric matrix, see discussions above) and lactose monohydrate (a diluent, see discussions above), in various amounts. Please see Table 1 and abstract. The level of lactose monohydrate influenced drug release by HPMC. Rapid drug dissolution was obtained, when only 9.1% w/w of lactose monohydrate was present (see abstract). The 9.1% w/w lactose is the lowest amount of lactose employed (HPMC and lactose at highest ratio of 4.4:1 (40% w/w:9.1% w/w), see Table 1).
The claimed polymeric matrix and diluent in a mass ratio of 2:1-10:1, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art (see discussions above). Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” It is noted that no criticality has been demonstrated in the specification with regard to the claimed polymeric matrix and diluent in a mass ratio of 2:1-10:1.
Accordingly, it would have been well within the purview of one skilled artisan to modify the amount of diluent, polymeric matrix forming agent, binder and lubricant to optimize the formulation to achieve the desired release profile to provide a safe and effective contraceptive without adverse side effects. A person skilled in the would have had a reasonable expectation that an extended-release matrix comprising high ratio of polymeric matrix:diluent (low amount of diluent to high amount of polymeric matrix), would provide rapid drug dissolution. Please see discussions above.
MPEP 2143(e) states: The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference. Therefore, the invention as a whole was prima facie obvious at the time it was made.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see pages 13-15 of Remarks), alleging that the rejection is improper on the grounds that:
1) Applicants have amended claims 1 and 21 to require that oral administration of a controlled release composition of claims 1 and 21 provides a Tmax of EE ranging from 3.1-4.7 hours, and a Tmax of TNG ranging from 3.0-4.4 hours (see page 13 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive. The recitation of the intended outcome of the administration an oral contraceptive composition of claims 1 and 21, resulting in providing a Tmax of EE ranging from 3.1 hours to 4.7 hours, and a Tmax of DNG ranging from 3.0 hours to 4.4 hours, is not given any patentable weight because the recited clause is simply expressing the intended result of a process positively recited (see Please see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Please see claim interpretation in the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, discussed above. Since Colli teaches a method of claims 1 and 21 (see discussions above), the method of Colli must necessarily produce the same outcome recited in claims 1 and 21. This is because the recited outcome is a natural process that flows from the female subject and the administered composition.
2) Williams III cannot be employed to address the deficiencies in the teachings of Colli because Williams III only relates to one active drug, whereas, the claimed invention requires combination of DNG and EE (see page 13 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because similar to Colli (see discussions above), Williams III was cited for disclosing that the ratio of polymeric matrix to diluent in an extended-release matrix, is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art (see discussions above). Therefore, the use of Williams III in order to address the deficiencies in the teachings of Colli, is proper.
3) Perrin cannot be employed to address the deficiencies in the teachings of Colli because Perrin only relates to one active drug, whereas, the claimed invention requires combination of DNG and EE (see pages 13-14 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because Perrin (see ¶ 0017), discloses that in an embodiment, the oral contraceptive composition comprises one or more drugs selected from the group that includes, but not limited to drospirenone and dienogest (DNG). Commercially available drospirenone comprises both ethinyl estradiol (EE) and drospirenone (see (see ¶ 0096).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method for administering an oral contraceptive composition comprising DNG and EE, in which the patient may skip up to two non-consecutive days, from the disclosures of Colli and Perrin. Therefore, the use of Perrin in order to address the deficiencies in the teachings of Colli, is proper.
4) In terms of missed pill window, a person skilled in the would not have considered employing an extended-release contraceptive composition comprising 2 mg DNG and 0.02 mg EE, because similar composition comprising 2 mg DNG and 3 mg EE, was found to be only effective for 12 hours. Applicants cite Australian Product Information, in support of the Applicants’ allegations. Please see page 14 of Remarks.
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because Colli (see page 8, lines 15-18), discloses the extended-release formulation is effective over period greater than about 10 hours, 12, 14, 16, 18, 20, 22 or 24 hours.
5) Applicants have surprisingly and unexpectedly discovered that an extended-release contraceptive composition comprising 2 mg DNG and 0.02 mg EE, was found to be effective for up to 24 hours (see pages 14-15 of Remarks).
Response
Regarding the advantageous results alleged by the Applicants for rebutting the obviousness of claimed invention, please note that advantageous results alone are not sufficient for overcoming an obviousness. The results must be unexpected. For the establishment of unexpected results, a few notable principles are well settled. It is Applicants’ burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). Further, A DECLARATION UNDER 37 CFR 1.132 must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case if obviousness. See, MPEP 716.02 (e).
In the instant case, Colli (see page 8, lines 15-18), discloses the extended-release formulation is effective over period greater than about 10 hours, 12, 14, 16, 18, 20, 22 or 24 hours. Therefore, at the time of the instant invention, it would not have been a surprising and an unexpected observation that an extended-release contraceptive composition comprising 2 mg DNG and 0.02 mg EE, was found to be effective for up to 24 hours.
For the reasons above and those made of record in the previous Office action, the rejections are maintained.
Non-Statutory Obviousness-Type Double Patenting-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The provisional rejection of claims 1-16, 18-19 and 21-24, is maintained and newly added claims 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Application Nos: i) 18/021,165; and ii) 18/660,021, for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants request that the obvious-type double patenting rejections be held in abeyance. Please see page 15 of Remarks filed.
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 composition is administered for 24 days, followed by 4 days of no composition.
2 comprising a polymeric matrix and a diluent (claims 25-27 and 29, which depends from claim 1).
3 composition is administered for 21-27 days, followed by 1-7 consecutive days of no composition.
4 comprising a diluent, a polymeric matrix, a binder and a lubricant.
5 composition is administered for 24 consecutive days, followed by 4 days of no composition (see page 21, lines 14-15)
6 composition is administered for 21-27 consecutive days, followed by 1-7 consecutive days of no composition (see page 21, lines 26-31).