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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, claims 16-35 of the instant application are afforded the effective filing date of 10/04/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/05/2024 and 01/14/2025 have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
Claims 16-35 are pending in this instant application, and examined herein on the merits for patentability.
Claim Objections
Claim 19 is objected to because of the following informalities: the recitation of “the A and B block copolymer is selected from AB diblock copolymers and ABA and BAB triblock copolymers, and mixtures thereof” is an improper Markush language. It is noted that a proper Markush language for the above recitation can be: the A and B block copolymer is selected from the group consisting of AB diblock copolymers, ABA triblock copolymers, BAB triblock copolymers, and mixtures thereof. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the recitation of “the A and B block copolymer is selected from ABA and BAB triblock copolymers, and mixtures thereof” is an improper Markush language. It is noted that a proper Markush language for the above recitation can be: the A and B block copolymer is selected from the group consisting of ABA triblock copolymers, BAB triblock copolymers, and mixtures thereof. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: the recitation of “the A block is selected from poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polybutyrolactone (PBL), polyhydroxyalkanoates (PHA), and copolymers thereof” is an improper Markush language. It is noted that a proper Markush language for the above recitation can be: the A block is selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polybutyrolactone (PBL), polyhydroxyalkanoates (PHA), and copolymers thereof. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: the recitation of “the homopolymer (b) is selected from poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polybutyrolactone (PBL) and polyhydroxyalkanoates (PHA), and mixtures thereof” is an improper Markush language. It is noted that a proper Markush language for the above recitation can be: the homopolymer (b) is selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polybutyrolactone (PBL) and polyhydroxyalkanoates (PHA), and mixtures thereof. Appropriate correction is required.
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 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; or mixtures thereof” is an improper Markush language. It is noted that a proper Markush language of the above recitation can be: 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. Appropriate correction is required.
It is noted that when materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.
Claim Rejections - 35 USC § 112
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.
Claims 27, and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 27, the recitation of “mixtures thereof” in the Markush group of homopolymer (b) renders claim 27 indefinite because claim 27 is drawn to “homopolymer” and thus, “mixtures thereof” of the homopolymer would not be a homopolymer but rather a copolymer. As such, it is unclear how “mixtures thereof” would meet the require alternative species of “homopolymer (b),” as mixtures thereof would be copolymers or a polymer blend. Clarification in claim 27 is required.
Regarding claim 28, the recitation of “the homopolymer (b) is a PLA and/or PCL” renders claim 28 indefinite because while it is clear that the homopolymer (b) can be a PLA or PCL, it is not clear how a homopolymer (b) can be PLA and PCL, as PLA and PCL combination is a polymer blend or a copolymer, and thereby is not a “homopolymer.” Clarification in claim 28 is required.
As a result, claims 27 and 28 do not clearly set forth the metes and bounds of patent protection desired.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 35 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and the broadest reasonable interpretation of claimed “means for inserting the system in the uterine cavity” is interpreted to cover the corresponding structure described in the specification as performing the claimed function. The structure disclosed in the specification that supports the recited function is a hollow cylindrical inserter (see Specification: page 17, lines 26-34).
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) 16-30 and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al (US 2017/0224883 A1) in view of Wen et al (US 2007/0275027 A1).
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 degradable composition further contains an active ingredient ([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, it would have been obvious to include a polyester homopolymer in the degradable composition of Coudane in view of the guidance from Wen.
Wen teaches a degradable polymer matrix comprising a first polymer, a second polymer, and a bioactive agent, wherein the polymer matrix provides sustained release of the bioactive agent, which the release of the bioactive is over a longer and more therapeutically useful time period (Abstract; [0015]-[0119]; claims 1-20). Wen teaches the first polymer is a biodegradable copolymer such as a AB or ABA type block copolymer, and the second polymer is a polyester homopolymer ([0018], [0063]-[0070], [0083], [0089]; claims 14 and 15). Wen teaches the second polymer is more slowly degrading, thereby reduces the rate of release of the bioactive agent from the matrix ([0063]-[0070]).
It would have been obvious to one of ordinary skill in the art to include a polyester homopolymer 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 Wen 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 that provides sustained release of the bioactive agent, which the release of the bioactive is over a longer and more therapeutically useful time period (Wen: Abstract; [0015]-[0119]; claims 1-20). Thus, an ordinary artisan seeking to provide a degradable composition that provides sustained release of the bioactive agent would have looked to including a polyester homopolymer in the degradable composition of Coudane per guidance from Wen, 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 1, 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 Wen and thus, the degradable composition of Coudane in view of Wen 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, Wen teaches the amount polymeric material in the matrix can be optimize at a concentration of about 0.1 mg/ml to about 2.5 mg/ml ([0016] and [0057]-[0130]) so as to achieve the desired sustained release. Thus, it would have been reasonably obvious to optimize the ratio of 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 claims 27-29, Wen teaches the homopolymer is selected from poly(lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid) or polycaprolactone, wherein the molecular weight of the homopolymer is between 50,000 daltons to 150,000 daltons ([0060]-[0070] and [0202]).
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, as discussed above, Wen 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 that provides sustained release of the bioactive agent, which the release of the bioactive is over a longer and more therapeutically useful time period (Wen: Abstract; [0015]-[0119]; claims 1-20). Furthermore, as discussed above, Wen teaches the second polymer (polyester homopolymer) is more slowly degrading, thereby reduces the rate of release of the bioactive agent from the matrix (Wen: [0063]-[0070]). Wen further teaches that 50% of the bioactive agent is released from the matrix on or before 17, 15, 13, or 11 days (Wen: [0024], [0033], [0179]). 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 Wen.
Regarding claim 34, as discussed above, Wen 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 that provides sustained release of the bioactive agent, which the release of the bioactive is over a longer and more therapeutically useful time period (Wen: [0016], [0018], [0063]-[0070], [0083], [0089]; claims 14 and 15). Furthermore, as discussed above, Wen teaches the second polymer (polyester homopolymer) is more slowly degrading, thereby reduces the rate of release of the bioactive agent from the matrix (Wen: [0063]-[0070]). Wen further teaches that 50% of the bioactive agent is released from the matrix on or before 17, 15, 13, or 11 days (Wen: [0024], [0033], [0179]).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 Wen.
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 Wen et al (US 2007/0275027 A1), as applied to claim 16 above, and further in view of Duesterberg et al (US 2018/0263899 A1).
The degradable intrauterine system of claim 31 is discussed above, said discussion being incorporated herein in its entirety.
However, Coudane and Wen 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 Wen 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.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613