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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 16-32 and 34) in the reply filed on 4/6/2026 is acknowledged.
Claim 33 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/6/2026.
Information Disclosure Statement
The information disclosure statement filed 1/19/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 17 is objected to because of the following informalities: the recitation of “the haemostatic agent is selected from thrombin, tranexamic acid, calcium ions, gelatin, collagen, calcium alginate, fibrinogen, and oxidized cellulose” is improper Markush language. It is noted that proper Markush language for a list of alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C". Examiner would like to note that claim 17 is also rejected below for lack of antecedent basis with regards to “the haemostatic agent” and thus is being interpreted to read, “the at least one haemostatic agent” (see below).
Claim 22 is objected to because of the following informalities: the recitation of “the super-disintegrant is selected from modified starches, modified celluloses and crosslinked
polyvinylpyrrolidones” is improper Markush language. Examiner would like to note that claim 22 is also rejected below for lack of antecedent basis with regards to “the super-disintegrant” and thus is being interpreted to read, “the at least one super-disintegrant” (see below).
Claim 26 is objected to because of the following informalities: the recitation of “copolymers selected from AB diblock copolymers and ABA and BAB triblock copolymers, and mixtures thereof” is improper Markush language. Examiner would like to note that claim 26 is also rejected below for lack of clarity regarding the groupings of the copolymer elements recited.
Appropriate correction is required.
Claim Interpretation
Claims 16 and 26 recite “degradable polymer matrix based on…”. In light of the specification (page 4 lines 26 et seq), “based on” is being interpreted to mean “comprising”.
Claim Interpretation - 35 U.S.C. 112(f)
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 34 invokes 35 U.S.C. 112(f) and the broadest reasonable interpretation of the claimed “means for inserting the system into the uterine cavity” is interpreted to cover the corresponding structure described in the specification and performing the claimed function. The structure disclosed in the specification that supports the recited function is a hollow, cylindrical inserted [Specification pg. 16, lines 14-25].
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 16-34 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.
Claim 16 recites “copolymers comprising at least one A and B block copolymer”. The recitation of plural copolymers followed by “at least one” makes it unclear if the degradable polymer matrix requires more than one copolymer. Additionally, the use of “at least one” followed by “and” renders the limitation unclear because the use of “at least one” seems to imply that A and/or B blocks can be used, but the use of “and” seems to imply that both A and B blocks must be present, thus “at least one” and “and” contradict each other. However, the claim limitation, “the ethylene oxide unit/ester unit mole ratio is between 0.5 and 5” suggests that both A and B blocks must be present. For purposes of compact prosecution, claim 16 is being interpreted to read, “a degradable polymer matrix comprising at least one copolymer comprising at least one A block and at least one B block".
Claims 16 and 27-28 also recite “the A block”, “the B block” and/or “the blocks B”. There is insufficient antecedent basis for these limitations in the claims because it is unclear if “the blocks B” refers to the at least one B block, more than one B block, or all B blocks present in the invention. The same logic applies to “the A block” and “the B block”. For purposes of compact prosecution, if the prior art teaches the claimed ratio, then it will be considered to read on the limitation. Additionally, Examiner suggests amending “the blocks B” to “the at least one B block” for consistency and amending “the A block” to “the at least one A block”.
Claims 17-34 depend from claim 16 and do not cure the deficiencies of claim 16. Therefore, claims 17-34 inherit the deficiencies of parent claim 16.
Claims 17-20 and 24-25 recite “the haemostatic agent” but depend from claim 16, which recites “at least one haemostatic agent”. There is insufficient antecedent basis for this limitation in the claim because it is unclear if “the haemostatic agent” refers to the at least one haemostatic agent, more than one haemostatic agent, or all haemostatic agents present in the invention. For purposes of compact prosecution, claims 17-20 and 24-25 are being interpreted to read, “the at least one haemostatic agent”.
Claim 23 recites “the super-disintegrant” but depends from claim 22 which recites “at least one super-disintegrant”. There is insufficient antecedent basis for this limitation in the claim because it is unclear if “the super-disintegrant” refers to the at least one super-disintegrant, more than one super-disintegrant, or all super-disintegrants present in the invention. For purposes of compact prosecution, claim 23 is being interpreted to read, “the at least one super-disintegrant”.
Regarding claim 26, the lack of a transitional phrase, recitation of plural copolymers, improper Markush grouping, and use of “and” between “ABA and BAB triblock polymer” renders this limitation confusing. It is unclear which elements are required in the claimed invention, for example, if the A and B block copolymers are selected from (i) AB diblock copolymers, and (ii) ABA and BAB triblock polymers (i.e. both ABA triblock and BAB triblock polymers are required), the “mixtures thereof” would require AB, ABA, and BAB copolymers. Alternatively, if the A and B block copolymers are selected from (i) AB diblock copolymers, (ii) ABA triblock polymers, and (iii) BAB triblock polymers, the “mixtures thereof” could comprise any combination of AB, ABA, and BAB. Furthermore, the inclusion of “mixtures thereof” suggests that the selection of one type of copolymer is permissible, however the instant limitation of “A and B block copolymers” suggests that more than one copolymer must be present. For purposes of compact prosecution, claim 26 is being interpreted to read, “degradable polymer matrix comprising at least one copolymer comprising at least one A block and at least one B block, the at least one copolymer being selected from the group consisting of AB diblock copolymers, ABA triblock copolymers, BAB triblock copolymers, and mixtures thereof.”
Claims 27-30 recite “the A and B block copolymer” but depend from claim 16 which recites “at least one A and B block copolymer”. There is insufficient antecedent basis for this limitation in the claim because it is unclear if “the A and B block copolymer” refers to the at least one A and B block copolymer, more than one A and B block copolymer, or all A and B block copolymers present in the invention. For purposes of compact prosecution, claims 27-30 are being interpreted to read, “at least one copolymer comprising at least one A block and at least one B block ”.
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.
Claims 16-17, 19-20, 24-32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al. (US 2017/0224883 A1, published 8/10/2017) in view of Rubin (US 2013/0337054 A1, published 12/19/2013, cited on the 4/5/2024 IDS)
Regarding claims 16-17, Coudane teaches a degradable [claim 30] composition based on copolymers comprising at least one A and B block polymer, wherein A is a polyester and B is a polyoxyethylene with a weight-average molecular weight of 50 kDa or greater, and the ethylene oxide unit/ester unit molar ratio is between 0.5 and 5 [0042, claim 16]. (See [0049] which defines “molecular mass” and “molecular weight” to be interchangeable with “weight average molecular weight.”) Coudane further teaches a medical device for placement in the uterine cavity comprising the polymer composition [0009]. Coudane teaches that the polymer composition can further comprise an active ingredient or therapeutic molecule, such as an antibiotic [0070], but does not explicitly teach a hemostatic agent.
Ruben teaches the intravaginal administration of a drug delivery device comprising a hemostatic agent such as tranexamic acid directly to a uterine cavity for reducing the volume of menstrual blood loss [claims 11-13]. Ruben discloses that the hemostatic agent can be delivered using any intravaginal delivery device known in the art, such as a vaginal ring, sponge, foam, or gel [0026]. It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the composition of Coudane and select a tranexamic acid as the active ingredient based on the teachings of Rubin. A skilled artisan would be motivated to make such a modification to produce an intrauterine device for the reduction of menstrual blood loss that reduces the undesirable side effects associated with oral use of such medications [0015].
Regarding claim 19, claim 19 further recites the limitation wherein the mass ratio of hemostatic agent to degradable polymer matrix is between 0.01% and 40%. The mass ratio of hemostatic agent to polymer matrix is fundamentally an expression of the concentration of hemostatic agent present in the polymer matrix. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). It would have been reasonably obvious to optimize the ratio of hemostatic agent to polymer matrix in order to achieve an effective desired dosage as Rubin teaches that the exact dose will need to be determined based on a number of factors such as drug potency, severity of symptoms, and patient characteristics such as age and weight [0019-0020].
Regarding claim 20, Coudane teaches the copolymer-based composition is a polymer matrix to which the active ingredient is dispersed therein [0063, 0070], thus the active ingredient of Coudane is not covalently bonded to the copolymer.
Regarding claims 24 and 25, these claims recite properties of the claimed invention. Since the prior art makes obvious the claimed composition comprising the uterine system, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. MPEP 2112.01.
Regarding claim 26, Coudane teaches that the composition may comprise AB diblock, or
ABA or BAB triblock copolymers, or mixtures thereof [0052].
Regarding claims 27 and 28, Coudane teaches that the B blocks in the A and B block copolymer may have a weight-average molecular mass between about 75 kDA and about 150 kDA [0050]. This overlaps with the instant claimed ranges of weight-average molecular mass and is prima facie obvious.
Regarding claim 29, Coudane teaches that the ethylene oxide unit/ester unit molar ratio is between 0.5 and 5 [0042]. This overlaps with the instant claimed ranges of weight-average molecular mass and is prima facie obvious.
Regarding claims 30 and 31, Coudane teaches that the A blocks of the copolymer may be poly(lactic) acids [0045], and may be poly(L-lactic acid), poly(D-lactic acid) or poly(D,L-lactic acid) [0047].
Regarding claim 32, Coudane teaches an exemplary composition that swells in phosphate-buffered saline (PBS) with a water uptake of about 300% after 5 minutes of incubation [0141]. The instant specification states that PBS is an aqueous medium and considered to have an osmolarity representative of biological fluids (see instant specification page 7). While Coudane does not explicitly state the swelling ratio of the composition after 10 minutes, a composition and its properties are inseparable. If the prior art teaches the identical
chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
Regarding claim 34, Coudane teaches a hollow cylindrical inserter for inserting the device into the uterine cavity [0087]. The inserter is used in conjunction with a plunger mounted to be slidable in translation relative to a distal end of the inserter, the opposite proximal end being the end by which the inserter is intended to be introduced into the uterine cavity, reading on kit [0088].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al. (US 2017/0224883 A1, published 8/10/2017) in view of Rubin (US 2013/0337054 A1, published 12/19/2013, cited on the 4/5/2024 IDS), as applied to claim 16 above, and further in view of Sharma et al. (WO 2013/066970A1, published 5/10/2013).
Regarding claim 18, the invention of claim 17 has been made obvious above by Coudane in view of Rubin, which teaches the use of tranexamic acid. Coudane and Rubin do not explicitly teach the use of thrombin as a hemostatic agent. Sharma teaches an implantable intrauterine device for treating postpartum hemorrhage [Abstract]. The device of Sharma comprises a pro-coagulant to promote clotting at the site of injury (reads on haemostatic agent) [0033]. Sharma further teaches that thrombin is a suitable substitute for tranexamic acid [0033]. Substituting equivalents known for the same purpose is prima facie obvious. MPEP 2144.06
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al. (US 2017/0224883 A1, published 8/10/2017) in view of Rubin (US 2013/0337054 A1, published 12/19/2013, cited on the 4/5/2024 IDS) as applied to claim 16 above, and further in view of Wen et al. (US 2007/0275027 A1, published 11/29/2007).
Regarding claim 21, claim 21 recites the further limitation wherein the intrauterine system comprises at least one polyethylene glycol or polyoxyethylene homopolymer, which is not covalently bonded to the polymer matrix. Wen teaches an implantable polymeric matrix for the release of a bioactive agent [Abstract]. Wen teaches that the matrix may comprise a first polymer comprising a biodegradable copolymer such as an AB or ABA type block copolymer [0070], and a second polymer comprising a homopolymer [0065]. Wen further teaches synthetic hydrophilic polymers are useful for matrix formation, and synthetic hydrophilic polymers may be prepared from any suitable monomer to form a polymer such as polyethylene glycol (PEG) [0136]. Wen teaches that homopolymers, copolymers, and mixtures thereof may be used in the polymeric matrix [0136]. Wen teaches that the inclusion of the second polymer, i.e. the homopolymer, serves to modulate the release of the bioactive agent from the matrix [claim 1]. Wen further teaches that the homopolymer may comprise reacted groups that covalently couple the polymer material together, covalently couple the polymeric to the surface of a device, or both [claim 5]. Thus, it would be obvious to couple the homopolymer to the surface of a device, and not to the polymer matrix of Coudane.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Coudane et al. (US 2017/0224883 A1, published 8/10/2017) in view of Rubin (US 2013/0337054 A1, published 12/19/2013, cited on the 4/5/2024 IDS) as applied to claim 16 above, and further in view of De Luigi Bruschi et al. (WO 2008/000683 A1, published 1/3/2008).
Regarding claims 22 and 23, De Luigi Bruschi teaches controlled-release tablets for vaginal drug delivery [pg. 1] comprising a hydrophilic polymeric matrix and disintegrant [Abstract], such as modified cellulose, starch, and cross-linked polyvinylpyrrolidone [claim 8]. De Luigi Bruschi teaches that drug release occurs due to swelling of the polymers constituting the matrix due to hydration in the presence of aqueous media [pg. 3]. Drug release is hindered in an environment without sufficient liquid to hydrate the matrix [pg. 4.] De Luigi Bruschi further teaches that the inclusion of a disintegrant in the matrix promotes rapid swelling of the matrix by accelerating hydration [pg. 5]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Coudane and Rubin with that of De Luigi Bruschi to include a disintegrant in the present invention in order to accelerate swelling and hydration of the polymer device and improve drug release in a non-liquid environment.
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 double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16, 26-30, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 19-25, and 35 of copending Application No. 18/698796 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a degradable intrauterine system for the release of an active ingredient into the uterine cavity comprising a degradable A and B block copolymer wherein the A block is a polyester such as PLA, the B block is a poly(oxyethylene) with a weight-average molecular mass of greater than or equal to 50 kDa, and the ethylene oxide unit/ester unit mole ratio is between 0.5 and 5 [claim 16]. Both applications also claim a kit comprising the intrauterine system and a device for inserting the system into the uterine cavity [claim 35]. Both teach using ABA and BAB triblock copolymers and AB diblock copolymers [claim 19].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/ Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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