FINAL 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 .
Priority
The certified English translation of foreign Application: FRANCE FR2110538 provided with the response filed on 06/11/2026 is accepted.
The updated Priority is as follows:
This application is a 371 of PCT/EP2022/077597 filed 10/04/2022.
This application also claim foreign benefit of FRANCE FR2110538 filed 10/05/2021.
Accordingly, pending claims 16-26 and 28-37 of the instant application are afforded the effective filing date of 10/05/2021.
Status of the Claims
This action is in response to papers filed 06/11/2026 in which the specification was amended; claims 1-15 and 27 were canceled; claims 16, 19, 20, 25, 28, 30, and 35 were amended; and claims 36 and 37 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 16-26 and 28-37 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn.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.
Maintained-Modified Objection
Claim Objections
Claim 30 is objected to because of the following informalities: the recitation of “the active ingredient for release in the uterine cavity is selected from the group consisting of antibiotics, antifungals or antivirals; steroidal or non-steroidal anti-inflammatory drugs; vasoconstrictors; vasodilators; uterine relaxants; oxytocics; hormones, hormone analogues, hormone agonists, hormone antagonists; anti-cancer drugs; and mixtures thereof” remained an improper Markush language due to the multiple “or” in the Markush group language (e.g., antifungals or antivirals; steroidal or non-steroidal anti-inflammatory drugs). Please amend claim 30 to: The degradable intrauterine system according to claim 16, wherein the active ingredient for release in the uterine cavity is selected from the group consisting of antibiotics, antifungals, antivirals, steroidal anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, vasoconstrictors, vasodilators, uterine relaxants, oxytocics, hormones, hormone analogues, hormone agonists, hormone antagonists, anti-cancer drugs, and mixtures thereof. Note that each alternative species in the Markush group is separated by a comma and not a combination of semicolons and commas. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended to make the necessary corrections. (Remarks, page 7, 3rd paragraph).
In response, while Applicant’s has amended claim 30 in attempt to put said claim in proper Markush language, said amendment has not adequately put claim 30 in proper Markush group language. As discussed above in the standing objection, the recitation of “the active ingredient for release in the uterine cavity is selected from the group consisting of antibiotics, antifungals or antivirals; steroidal or non-steroidal anti-inflammatory drugs; vasoconstrictors; vasodilators; uterine relaxants; oxytocics; hormones, hormone analogues, hormone agonists, hormone antagonists; anti-cancer drugs; and mixtures thereof” remained an improper Markush language due to the multiple “or” in the Markush group language (e.g., antifungals or antivirals; steroidal or non-steroidal anti-inflammatory drugs).
As a result, for the reason above, the objection to claim 30 is maintained.
New Objection
Claim Objections
Claim 16 is objected to because of the following informalities: please remove the dash (-) (recited before “a polymer matrix”) in the claim. It is noted that [w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP §608.01(m). Appropriate correction is required.
Claim 16 is objected to because of the following informalities: for claim language clarity, please add “in the A and B block copolymer” after the recitation of “the ethylene oxide unit/ester unit molar ratio” in line 9 of claim 16. Appropriate correction is required.
New Rejections
Necessitated by Applicant’s Claim Amendments
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-26, 28, 30 and 32-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al (US 2017/0224883 A1) in view of Ishihara et al (International Journal of Pharmaceutics, 2010, 385: 170-175).
Regarding claims 16 and 35, Coudane teaches a degradable composition comprising a degradable A and B block copolymer, wherein the A block is a polyester and the B block is a polyoxyethylene (PEG) with a weight-average molecular weight of higher than or equal to 50 kDa, and the ethylene oxide unit/ester unit molar ratio is between 0.5 and 5 (Abstract; [0009]-[0026], [0041]-[0070] and [0079]-[0119]; claims 15-24). Coudane teaches the polyester A block is selected from poly(lactic acid) (PLA), poly-caprolactone (PCL), poly-butyrolactone (PBL), and copolymers thereof ([0042]-[0047]). Coudane teaches the degradable composition is in form of a polymer matrix ([0063] and [0070]). Coudane teaches the degradable composition further contains an active ingredient that is dispersed in the polymer matrix ([0070]). Coudane teaches the degradable composition is inserted into the uterine cavity using a hollow cylindrical inserter ([0067] and [0087]-[0089]). While Coudane does not expressly mentioned “kit” as recited in claim 35, it is noted that [w]here the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Also see, MPEP §2112.01 (III).
While Coudane does not expressly teach that the degradable composition contains at least one polyester homopolymer selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), polycaprolactone (PCL), polybutyrolactone (PBL), and mixtures thereof, it would have been obvious to include a polyester homopolymer in the degradable composition of Coudane in view of the guidance from Ishihara.
Ishihara teaches a degradable polymeric nanoparticle comprising a polymer matrix containing blend of PEG-PLA block copolymer, PLA homopolymer, and an active ingredient (betamethasone disodium phosphate -- BP) (Abstract; Introduction; pages 171-175). Ishihara teaches the polymeric nanoparticle provide sustained release of the active ingredient BP due to the presence of PLA homopolymer, as the PLA homopolymer degrades slowly during hydrolysis, thereby the active ingredient BP is gradually released from the polymer matrix (Abstract; pages 172-173; Figs 1-2).
It would have been obvious to one of ordinary skill in the art to include a polyester homopolymer such as poly(lactic acid) in the degradable composition of Coudane, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Ishihara provided the guidance to do so by teaching that the degradable composition (polymer matrix) of Coudane containing a block copolymer can further contain a polyester homopolymer such as poly(lactic acid) so as to provide a polymer matrix that provides sustained release of the active ingredient, in which the active ingredient is gradually released for prolonged duration, and thereby provide enhanced therapeutic efficacy (Ishihara: Abstract; Introduction, pages 185-188). Thus, an ordinary artisan seeking to provide a degradable composition that provides sustained release of the active ingredient would have looked to including a polyester homopolymer such as poly(lactic acid) in the degradable composition of Coudane per guidance from Ishihara, and achieve Applicant’s claimed invention with reasonable expectation of success.
With respect to the claimed “for the prolonged release of an active ingredient in the uterine cavity” as recited in the preamble of claim 16, it is noted that said recitation is an intended use. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As discussed above, the structures of the degradable intrauterine system of claim 16 have taught by Coudane in view of Ishihara and thus, the degradable composition of Coudane in view of Ishihara would have been capable of performing the intended use of the prolonged release of an active ingredient in the uterine cavity.
Regarding claims 17 and 18, Ishihara teaches a mixture of 2.8 mg of block copolymer and 42.2 mg poly(lactic acid) (PLA) is used in preparing the polymer matrix, wherein the weight amounts of block copolymer and PLA can be optimized to achieve the desired sustained release profile of the active ingredient (Introduction; pages 170- 171).Thus, it would have been reasonably obvious to optimize the weight ratio of block copolymer to homopolymer to the weight ratio as claimed so as to achieve the desired sustained release of the active ingredient. It is noted that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (I)-(II).
Regarding claims 19 and 20, Coudane teaches the A and B block copolymer is an AB diblock copolymer, ABA triblock copolymer, a BAB deblock copolymer, or a mixture thereof ([0015]-[0016], [0041]-[0059]; claim 16).
Regarding claim claims 21 and 22, Coudane teaches the weight-average molecular weight of the B blocks is between about 75 kDa and about 150 kDa, and preferably between about 80 and about 125 kDa ([0015] and [0048; claims 17-19).
Regarding claims 23 and 24, Coudane teaches the ethylene oxide unit/ester unit molar ratio in the copolymers is about 1 or about 3 ([0026] and [0053]; claim 20).
Regarding claims 25 and 26, Coudane teaches the A block is a polycaprolactone (PCL) or a poly(lactic acid) (PLA) having at least 50% of L-lactic acid ([0041]-[0047]).
Regarding claim 28, as discussed above, Ishihara teaches the homopolymer is poly(lactic acid) (PLA).
Regarding claim 30, Coudane teaches the active ingredient is a therapeutic molecule such as an antibiotic ([0070]).
Regarding claim 32, Coudane teaches the copolymer-based composition is a polymer matrix to which the active ingredient is dispersed therein ([0063] and [0070]), thereby the active ingredient of Coudane is not covalently bound to the copolymer a).
Regarding claim 33, Ishihara provided the guidance to do so by teaching that the degradable composition of Coudane can further contain a polyester homopolymer so as to provide a degradable composition in which the active ingredient is gradually released for prolonged duration, and thereby provide enhanced therapeutic efficacy (Ishihara: Abstract; Introduction; pages 171-175). Furthermore, Ishihara teaches the release of the active ingredient (BP) from the nanoparticles in vivo is over 14 days and in vitro is over 44 days (Ishihara: Abstract; pages 172-173). Thus, claimed release property of “said system releasing the active ingredient over at least 10 days” would have been implicit in the degradable composition of Coudane in view of Ishihara.
Regarding claim 34, as discussed above, Ishihara provided the guidance to do so by teaching that the degradable composition of Coudane can further contain a polyester homopolymer so as to provide a degradable composition in which the active ingredient is gradually released for prolonged duration, and thereby provide enhanced therapeutic efficacy (Ishihara: Abstract; Introduction; pages 171-175). Furthermore, Ishihara teaches the release of the active ingredient (BP) from the nanoparticles in vivo is over 14 days and in vitro is over 44 days (Ishihara: Abstract; pages 172-173).Thus, claimed degradation property of “said system degrading after a residence time in an aqueous or humid environment of between 10 days and 12 months” would have been implicit in the degradable composition of Coudane in view of Ishihara.
Regarding claims 36 and 37, Ishihara teaches that the polymer matrix is form by mixing the block copolymer, the PLA, and the active ingredient (page 171).
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al (US 2017/0224883 A1) in view of Ishihara et al (International Journal of Pharmaceutics, 2010, 385: 170-175), as applied to claim 16 above, and further in view of Lee et al (Advanced Drug Delivery Reviews, 2016, 107: 176-191).
The degradable intrauterine system of claim 16 is discussed above, said discussion being incorporated herein in its entirety.
However, Coudane and Ishihara do not teach the number-average molar mass of the homopolymer (b) of claim 29.
Regarding claim 29, Lee teaches PLA nanoparticles in which different PLA molecular weights from as low as 10,000 to as high as 209,000 can be used to form the polymer matrix of the nanoparticles that provides sustained release of the drug, wherein the higher the molecular weight the slower the release of the drug (Abstract; pages 179-180 and 185-187).
It would have been obvious to one of ordinary skill in the art to select and use a poly(lactic acid) (PLA) with a high molecular weight between 25,000 g/mol and 250,000 g/mol as the poly(lactic acid) (PLA) included in the degradable composition (polymer matrix) of Coudane in view of Ishihara, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Lee provided the guidance to do so by teaching that different PLA molecular weights from as low as 10,000 to as high as 209,000 can be used to form the polymer matrix that provides sustained release of the drug, wherein the higher the molecular weight the slower the release of the drug. Thus, an ordinary artisan seeking to provide a degradable composition that provides sustained release of the active ingredient over a prolonged period of time would have looked to selecting and using a poly(lactic acid) (PLA) with a high molecular weight between 25,000 g/mol and 250,000 g/mol as the poly(lactic acid) (PLA) included in the degradable composition (polymer matrix) of Coudane in view of Ishihara, per guidance from Lee, and produce Applicant’s claimed invention with reasonable expectation of success.
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al (US 2017/0224883 A1) in view of Ishihara et al (International Journal of Pharmaceutics, 2010, 385: 170-175), as applied to claim 16 above, and further in view of Duesterberg et al (US 2018/0263899 A1).
The degradable intrauterine system of claim 16 is discussed above, said discussion being incorporated herein in its entirety.
However, Coudane and Ishihara do not teach the content of active ingredient of claim 31.
Regarding claim 31, Duesterberg teaches an intrauterine delivery device having a polymer matrix composition that is degradable containing an active ingredient and a polymer material such as poly(lactic acid), poly(glycolic acid), or copolymers thereof (Abstract; [0038], [0048], [0050] and [0063]-[0072]). Duesterberg teaches the active ingredient is present in an amount of 0.5-60 wt-% ([0072]).
It would have been obvious to one of ordinary skill in the art to routine optimize the content or amount of active ingredient in the degradable composition of Coudane in view of Ishihara to an amount between 0.01% and 60% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Duesterberg teaches the amount of active ingredient dispersed in a degradable polymer matrix for delivery into the uterine cavity can be routinely optimize to amount of 0.5-60 wt-%, which is range that substantially overlaps the claimed range of between 0.01% and 60% by weight. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of content of active ingredient in the degradable intrauterine system would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 8-11 of the Remarks filed on 06/11/2026 as they pertain to Wen are moot, as the Wen reference was not used in the pending 103 rejection.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejections.
Applicant argues:
“as shown by the examples of the present application, the combination of (a) the specific degradable A and B block copolymer and (b) the polyester homopolymer mixed within a polymer matrix provides an intrauterine system that can be easily inserted into the uterine cavity, that unfolds by itself in the cavity by swelling without being expelled, that degrades in a controlled manner in order to enable the natural elimination thereof through the uterine cervix, and that enables the prolonged release, in a controlled manner, of an active ingredient in the region of the uterine wall for several days to months. In particular, Example 1 of the as-filed application demonstrates that the matrix comprising a copolymer and homopolymer as claimed unfolds by itself in the cavity by swelling without being expelled and enables an increase in surface area of 115% in 24 hours relative to the initial surface area of the film. Example 1 also shows that after 15 days of in vitro degradation, the film has lost 30% of its initial mass, and can be easily evacuated by natural routes under the clinical usage conditions. Furthermore, after 70 days of in vitro degradation, the film is completely solubilized in the degradation medium. Example 2 of the as-filed application shows that the addition of PCL (a polyester homopolymer) in an ABA block copolymer allows a release of the active flurbiprofen for 12 days under in-vitro release conditions. In absence of PCL homopolymer, more than 50 % of the flurbiprofen is released in 4 hours and this formulation is not acceptable for a prolonged-release (see, e.g., as-filed application, Figure 5). Figure 6 and Example 4 of the as-filed application also show that the combination of ABA block copolymer with PCL homopolymer or PLA50 homopolymer enables the modulation of the release kinetics of the active ingredient over time. The intrauterine system allows a release of flurbiprofen for 35 days under in-vitro release conditions.” (Remarks, pages 11-12).
In response, the Examiner disagrees. Applicant’s arguments and evidence of unexpected results of prolonged-release of the active ingredient from Examples 1, 2 and 4 and Figures 5-6 of the specification are considered, but found insufficient to obviate the pending 103 rejection over Coudane and Ishihara because the addition of polyester homopolymer such as PLA to a polymer matrix containing a block copolymer to provide prolonged release or sustained release of the active ingredient is reasonable an expected result in view of Ishihara. As discussed above in the pending 103 rejection, Ishihara teaches that a polymer matrix containing blend of PEG-PLA block copolymer, PLA homopolymer, and an active ingredient provides sustained release of active ingredient over a prolonged period in which the gradual release of the active ingredient for a prolonged duration is due the PLA slow degradation (Ishihara: Abstract; pages 172-173; Figs 1-2). Thus, it is noted that "[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). See MPEP §716.02(c). Furthermore, claim 16 is not adequately commensurate with the particular formulations used in Examples 1, 2 and 4 of the specification for showing the alleged unexpected results, as claim 16 is much broader than the formulations used in Examples 1, 2 and 4. MPEP §716.02(d) states [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support."
As a result, for at least the reasons discussed above, claims 16-26 and 28-37 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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