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 .
Benefit
This application claims benefit as a National Stage entry under 35 USC 371 to PCT/US 2023/019797 (25 April 2023), which claims benefit to US Provisional 63/333,439 (25 April 2022).
Formal Matters
Claims 2-4, 6, 9, 10, 14, 15, 17-19, 20-25, 27-29, 31-33, 36-38, 41-43, and 46-48 are cancelled. Claims 1, 5, 7, 8, 11-13, 16, 20-22, 26, 30, 34, 35, 39, 40, 44, 45, and 49 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 24 October 2024 has been considered by the examiner. A signed copy is attached.
Claim Interpretation
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 Objections
Claim 22 is objected to because of the following informalities: UV radiation is typically taught in units and of mW/cm2 or J/cm2 (per centimeter squared) of energy. For example, the recitation of 5 J/cm2 would be considered a moderate level of UV radiation intensity. However, claim 22 recites 5 J/cm3. The cubing of the centimeter may be a typographical error, as it is not a standard UV unit. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 5, 8, 13, 21, 26, and 49 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 claims 5, 8, 13, 26, and 49, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 21, the phrase "for example" as “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 21, the claim recites “a viscosity of at least 500,000 cP at body temperature” but no upper end of the range is recited. Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite."
Claim Rejections - 35 USC § 112 (a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 7, 8, 11-13, 16, 20-22, 26, 30, 34, 35, 39, 40, 44, 45, and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed subject matter must be described in the specification to ensure that applicant had in his possession, as of the filing of the application, the specific subject matter claimed. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date. In re Glass, 492 F.2d 1228, 181 USQ 31 (CCPA 1974).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purpose of the ‘written description’ requirement, whatever is now claimed.” (See p. 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now claimed.” (See Vas-Cath, at 1116). Adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of using it. The compound itself is required. See, Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, at 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
The claims are drawn to a method of occluding a left atrial appendage (LAA) of a patient comprising injecting a photocurable biomaterial into the LAA and irradiating the photocurable biomaterial with actinic radiation (e.g. UV light), thereby inducing crosslinking of the photocurable biomaterial in situ in the LAA to form an interpenetrating network or semi-interpenetrating network (sIPN) comprising a first network polymer and a second network polymer, wherein the first network polymer comprises a hydrophilic polymer and the second network polymer comprises a silicone rubber.
The nature of the invention is drawn to chemical compositions of precursor polymers that are combinable, polymerizable, and photocurable under UV light. Additionally, the compositional components must be biocompatible and available to be combined in situ in the left atrial appendage of the human heart.
The state of the art includes Otero, et al., US 20140277070 (18 September 2014). Otero discloses a method of occluding a left atrial appendage (LAA) of a patient (¶10) comprising: injecting (¶¶10, 81) a photocurable (UV irradiation, ¶¶41, 82) biomaterial (crosslinkable biomaterial, ¶41) into the LAA of the patient (¶41); and irradiating the photocurable biomaterial with actinic radiation (UV irradiation, ¶41), thereby inducing crosslinking (accelerator induced to ensure uniform and rapid curing of the crosslinkable biomaterial to form a biocompatible matrix, ¶41) of the photocurable biomaterial (¶41) in situ in the LAA (¶10), wherein the first network polymer comprises a hydrophilic polymer (first precursor as polyethylene glycol (PEG), ¶53; second precursor as a polysaccharide ¶54 to form a PEG-Dextran hydrogel (¶¶93-96); and wherein the second network polymer comprises a silicone rubber (“suitable fluids to inject can include saline and silicone”, ¶70). Otero does not expressly use the terms “interpenetrating network (IPN) semi-interpenetrating network (sIPN) comprising a first network polymer and a second network polymer”.
Additionally, Myung et al., US 20120045651 (23 February 2012) teaches hydrophobic and hydrophilic interpenetrating polymer networks derived from hydrophobic polymers and methods of preparing the same (Abstract). Myung teaches that “an "interpenetrating polymer network" or "IPN" is a material comprising two or more polymer networks which are at least partially interlaced on a molecular scale, but not covalently bonded to each other, and cannot be separated unless chemical bonds are broken. A "semi-interpenetrating polymer network" or "semi-IPN" is a material comprising one or more polymer networks and one or more linear or branched polymers characterized by the penetration on a molecular scale of at least one of the networks by at least some of the linear or branched macromolecules. As distinguished from an IPN, a semi-IPN is a polymer blend in which at least one of the component polymer networks is not chemically crosslinked by covalent bonds”) (¶9). Myung teaches that crosslinked polymer chains (macromolecules) based on monomers may be used in the second network and that biological molecules may carry certain benefits such as intrinsic biocompatibility or therapeutic properties that make them useful as material components (¶161). Myung teaches that depending on the initiator used, exposure to UV light, infrared, or visible light leads to polymerization and crosslinking of ionizable monomers within the hydrophobic polymer to form an interpenetrating polymer network (IPN) (¶154). Additionally, Myung teaches that polymers cured in UV light can also form semi-IPNs (¶205). Myung teaches that homopolymers and copolymers of silicone may also be used in the network (¶211). Myung teaches wherein the hydrophilic polymer comprises a hydrophilic polyacrylate, such as poly(hydroxyethyl)methacrylate (¶151) or a copolymer thereof, a hydrophilic urethane acrylate as (polycarbonate urethane acrylate (Bionate 55D), ¶226). Myung teaches that after polymerization and crosslinking, the sIPNs swelled and became lubricious and that the addition of silicone (polydimethylsiloxane) in the polyurethane adds an extra level of biostability to the material as well as potentially useful surface chemistry and properties (¶228).
The level of skill of those in the art is that of someone with a graduate degree in chemistry or chemical engineering and a background in biomedical or biomechanical engineering due to the nature of the polymer chemistry required to formulate the multi-variate polymers of the claimed generic genus of precursors, test the same for function, and biocompatibility.
As to claim 1, Example I of the specification discloses a PEG-dextran hydrogel composition, meeting the requirement of claim 1 for a first network polymer comprising hydrophilic polymer. However, the specification only generically discloses “a hydrophilic or hydrophobic silicone rubber” as the second network polymer. Nothing more specific is disclosed in the specification. As to claim 5, the specification does not disclose specific hydrophobic polymers comprising a hydrophilic polyacrylate beyond the mere mention of poly(hydroxyethyl)methacrylate. There is no disclosure of “copolymers thereof”. There is no disclosure of anything beyond the mere mention of “a hydrophilic urethane acrylate”. There is no disclosure of any combination thereof.
As to claims 7, 8, 11-13, 16, and 20, there is no disclosure in the specification of the photocurable biomaterial comprising a bifunctional epoxy siloxane monomer, as recited in claim 7. The bifunctional epoxy siloxane monomer is not the same kind of chemical structure as “a silicone rubber” recited in claim 1. There is no disclosure in the specification of the bifunctional epoxy siloxane monomer comprising one or more hydrophilic functional groups. There is no disclosure in the specification as to claim 11, wherein the one or more additional epoxy monomers comprise at least three epoxy groups. There is no disclosure in the specification of any specific chemical structure where the one or more polyfunctional epoxy siloxane monomers and the bifunctional epoxy siloxane monomers are present in any photocurable material in the claimed molar ratios.
There is no disclosure of specific chemical compounds in the specification that would permit the determination of a molar ratio of claim 13 because the precise chemical formula is needed determine the moles of the various substances in the composition before one can calculate a molar ratio. As to claim 16, there is no disclosure of the first network polymer and the second network polymer to determine whether they are co-continuous. It is also not entirely clear what co-continuous means in a polymeric composition, but a broadest reasonable interpretation can glean that the two precursors have been polymerized or perhaps photocured and polymerized.
Regarding claim 20, there is no disclosure in the specification as to a photocurable biomaterial such that a viscosity of from 1 cP to 10,000 cP at 25C can be reasonably determined.
However, the prior art of Crivello et al., US 5,639,413 (17 June 1997) teaches colorless liquid compositions of low viscosity (col 6, lines 59-64) comprising epoxy-functional silicone containing monomers (col 4, lines 4-8) that are solidifiable when subjected to stimulation comprising light (col 1, lines 29-32). Crivello teaches that preparations of epoxy-functional silicone monomers and oligomers well known in the art since at least 1959 (col 4, lines 4-8), Crivello teaches that the monomers and oligomers undergo exceptionally rapid photopolymerization in the presence of photoinitiators (col 6, lines 52-55). Crivello teaches wherein the one or more additional epoxy monomers comprise one or more polyfunctional epoxy siloxane monomers (col 3, lines 1-32; claims 2, 3, 5). Crivello teaches wherein the one or more polyfunctional epoxy siloxane monomers comprise at least three epoxy groups (col 3, structures I-VIII; col 4, lines 15-25, as formula IV; col 5, line 41). Crivello teaches an overlapping range to claim 20, wherein the specific epoxy-functional silicone monomers taught Crivello in the photocurable composition have a viscosity of “50 to about 2000 cPs at 25C”, col 10, lines 28-30.
Regarding claim 21, without the disclosure of the specific chemical structure of an IPN or an sIPN, viscosity, which is an innate physical property of a composition, cannot be determined. The specification does not adequately disclose IPNs or sIPNs such that a complete structure can be determined and viscosity can be calculated at body temperature. Additionally, the baseline recitation of 500,000 has no upper limit, as recited in the claim.
Regarding claim 22, actinic radiation is commonly defined as electromagnetic radiation that has enough energy to induce photochemical reactions, primarily in the UV range (short wavelengths of light). 5 J/cm2 of energy would be considered a moderate level of UV radiation intensity. However, the claim recites “5 J/cm3” which may be a typographical error.
Regarding claim 26, the recitation of the generic IPN and sIPN further comprising a generic bioactive agent where the bioactive agent comprises a “silencing agent” is not disclosed. It is unclear from the specification or the prior art what a “silencing agent” might be. It is unclear what is to be silenced, given the lack of disclosure in the specification. The art provides many examples of apoptotic agents, including lipopolysaccharide. Similarly, contrast agents are also known in the art for various uses. However, the specification does not adequately disclose any particular apoptotic agents or contrast agents or combinations that are to be used with the IPN or sIPN moieties.
Regarding claim 30, the claim is directed to a method of claim 1 where the LAA is trabeculated and where the photocurable biomaterial conforms to the internal anatomy of the LAA prior to crosslinking, but the compositional components of the IPN or sIPN are not disclosed such that one would be able to reasonably understand that Applicant was in possession of the method as recited in claim 30.
Similarly, claim 34 recites method steps for positioning an occlusion device within the ostium of the LAA and injecting “the photocurable biomaterial” into the LAA and photocuring it. However, there is no complete exemplified disclosure of the photocurable biomaterial in the specification. The recitations of IPNs and sIPNs are entirely generic. Without knowing the chemical composition of the biomaterials to be photocured, one of ordinary skill in the art would not be reasonably apprised that Applicant was in possession of the polymers to be photocured. This carries forward for claims 35, 39, 40, 44, 45, and 49, as they are all dependent on claim 34, which does not recite any structure for the biomaterial to be placed in the LAA and no complete chemical compositions for the same are disclosed in the specification.
With regard to claim 49, there is no disclosure of a water light pipe such that a person of ordinary skill in the art would reasonably be apprised that Applicant was in possession of it. In it broadest reasonable interpretation, it could be a fluid compatible fiber optic, but that is not adequately disclosed in the specification as originally filed.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(1), the court states, “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.”
While “examples explicitly covering the full scope of the claim language” typically will not be required, a sufficient number of representative species must be included to “demonstrate that the patentee possessed the full scope of the [claimed] invention.” Lizardtech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005). In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features (see, Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1895 (Fed. Cir. 2004); accord Ex Parte Kubin, 2007-0819, BPAI 31 May 2007, opinion at p. 16, paragraph 1).
However, as set forth above, the specification does not clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is claimed (see Vas-Cath at page 1116). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112 (a) –Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 7, 8, 11-13, 16, 20-22, 26, 30, 34, 35, 39, 40, 44, 45, and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability, 5) existence of working samples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to a method of occluding a left atrial appendage (LAA) of a patient comprising injecting a photocurable biomaterial into the LAA and irradiating the photocurable biomaterial with actinic radiation (e.g. UV light), thereby inducing crosslinking of the photocurable biomaterial in situ in the LAA to form an interpenetrating network or semi-interpenetrating network (sIPN) comprising a first network polymer and a second network polymer, wherein the first network polymer comprises a hydrophilic polymer and the second network polymer comprises a silicone rubber.
The nature of the invention is drawn to chemical compositions of precursor polymers that are combinable, polymerizable, and photocurable under UV light. Additionally, the compositional components must be biocompatible and available to be combined in situ in the left atrial appendage of the human heart.
The state of the art includes Otero, et al., US 20140277070 (18 September 2014). Otero discloses a method of occluding a left atrial appendage (LAA) of a patient (¶10) comprising: injecting (¶¶10, 81) a photocurable (UV irradiation, ¶¶41, 82) biomaterial (crosslinkable biomaterial, ¶41) into the LAA of the patient (¶41); and irradiating the photocurable biomaterial with actinic radiation (UV irradiation, ¶41), thereby inducing crosslinking (accelerator induced to ensure uniform and rapid curing of the crosslinkable biomaterial to form a biocompatible matrix, ¶41) of the photocurable biomaterial (¶41) in situ in the LAA (¶10), wherein the first network polymer comprises a hydrophilic polymer (first precursor as polyethylene glycol (PEG), ¶53; second precursor as a polysaccharide ¶54 to form a PEG-Dextran hydrogel (¶¶93-96); and wherein the second network polymer comprises a silicone rubber (“suitable fluids to inject can include saline and silicone”, ¶70). Otero does not expressly use the terms “interpenetrating network (IPN) semi-interpenetrating network (sIPN) comprising a first network polymer and a second network polymer”.
Myung et al., US 20120045651 (23 February 2012) teaches hydrophobic and hydrophilic interpenetrating polymer networks derived from hydrophobic polymers and methods of preparing the same (Abstract). Myung teaches that “an "interpenetrating polymer network" or "IPN" is a material comprising two or more polymer networks which are at least partially interlaced on a molecular scale, but not covalently bonded to each other, and cannot be separated unless chemical bonds are broken. A "semi-interpenetrating polymer network" or "semi-IPN" is a material comprising one or more polymer networks and one or more linear or branched polymers characterized by the penetration on a molecular scale of at least one of the networks by at least some of the linear or branched macromolecules. As distinguished from an IPN, a semi-IPN is a polymer blend in which at least one of the component polymer networks is not chemically crosslinked by covalent bonds”) (¶9). Myung teaches that crosslinked polymer chains (macromolecules) based on monomers may be used in the second network and that biological molecules may carry certain benefits such as intrinsic biocompatibility or therapeutic properties that make them useful as material components (¶161). Myung teaches that depending on the initiator used, exposure to UV light, infrared, or visible light leads to polymerization and crosslinking of ionizable monomers within the hydrophobic polymer to form an interpenetrating polymer network (IPN) (¶154). Additionally, Myung teaches that polymers cured in UV light can also form semi-IPNs (¶205). Myung teaches that homopolymers and copolymers of silicone may also be used in the network (¶211). Myung teaches wherein the hydrophilic polymer comprises a hydrophilic polyacrylate, such as poly(hydroxyethyl)methacrylate (¶151) or a copolymer thereof, a hydrophilic urethane acrylate as (polycarbonate urethane acrylate (Bionate 55D), ¶226). Myung teaches that after polymerization and crosslinking, the sIPNs swelled and became lubricious and that the addition of silicone (polydimethylsiloxane) in the polyurethane adds an extra level of biostability to the material as well as potentially useful surface chemistry and properties (¶228).
The level of skill of those in the art is that of someone with a graduate degree in chemistry or chemical engineering and a background in biomedical or biomechanical engineering due to the nature of the polymer chemistry required to formulate the multi-variate polymers of the claimed generic genus of precursors, test the same for function, and biocompatibility.
As to claim 1, Example I of the specification provides an example of a PEG-dextran hydrogel composition, meeting the requirement of claim 1 for a first network polymer comprising hydrophilic polymer. However, the specification only generically recites “a hydrophilic or hydrophobic silicone rubber” as the second network polymer. Nothing more specific is disclosed in the specification. As to claim 5, the specification does not provide any examples of a hydrophobic polymer comprising a hydrophilic polyacrylate beyond the mere mention of poly(hydroxyethyl)methacrylate. There are no examples of “copolymers thereof”. There are no examples of anything beyond the mere mention of “a hydrophilic urethane acrylate”. There are no examples of any combination thereof.
As to claims 7, 8, 11-13, 16, and 20, there are no examples in the specification of the photocurable biomaterial comprising a bifunctional epoxy siloxane monomer, as recited in claim 7. The bifunctional epoxy siloxane monomer is not the same kind of chemical structure as “a silicone rubber” recited in claim 1. There are no examples in the specification of the bifunctional epoxy siloxane monomer comprising one or more hydrophilic functional groups. There are no examples in the specification as to claim 11, wherein the one or more additional epoxy monomers comprise at least three epoxy groups. There are no examples in the specification of any specific chemical structure where the one or more polyfunctional epoxy siloxane monomers and the bifunctional epoxy siloxane monomers are present in any photocurable material in the claimed molar ratios. There are no specific chemical compounds exemplified in the specification that would permit the determination of a molar ratio of claim 13 because the precise chemical formula is needed determine the moles of the various substances in the composition before one can calculate a molar ratio. As to claim 16, there are no specific examples of the first network polymer and the second network polymer to determine whether they are co-continuous. It is also not entirely clear what co-continuous means in a polymeric composition, but a broadest reasonable interpretation can glean that the two precursors have been polymerized or perhaps photocured and polymerized. Regarding claim 20, there are no specific examples in the specification as to a photocurable biomaterial such that a viscosity of from 1 cP to 10,000 cP at 25C can be reasonably determined.
However, Crivello et al., US 5,639,413 (17 June 1997) teaches colorless liquid compositions of low viscosity (col 6, lines 59-64) comprising epoxy-functional silicone containing monomers (col 4, lines 4-8) that are solidifiable when subjected to stimulation comprising light (col 1, lines 29-32). Crivello teaches that preparations of epoxy-functional silicone monomers and oligomers well known in the art since at least 1959 (col 4, lines 4-8), Crivello teaches that the monomers and oligomers undergo exceptionally rapid photopolymerization in the presence of photoinitiators (col 6, lines 52-55). Crivello teaches wherein the one or more additional epoxy monomers comprise one or more polyfunctional epoxy siloxane monomers (col 3, lines 1-32; claims 2, 3, 5). Crivello teaches wherein the one or more polyfunctional epoxy siloxane monomers comprise at least three epoxy groups (col 3, structures I-VIII; col 4, lines 15-25, as formula IV; col 5, line 41). Crivello teaches an overlapping range to claim 20, wherein the specific epoxy-functional silicone monomers taught Crivello in the photocurable composition have a viscosity of “50 to about 2000 cPs at 25C”, col 10, lines 28-30.
Regarding claim 21, without the specific chemical structure of an IPN or an sIPN, viscosity, which is an innate physical property of a composition, cannot be determined. The specification does not provide any examples of IPNs or sIPNs such that viscosity can be calculated at a body temperature. Additionally, the baseline recitation of 500,000 has no upper limit, as recited in the claim.
Regarding claim 22, actinic radiation is commonly defined as electromagnetic radiation that has enough energy to induce photochemical reactions, primarily in the UV range (short wavelengths of light). 5 J/cm2 of energy would be considered a moderate level of UV radiation intensity. However, the claim recites “5 J/cm3” which may be a typographical error.
Regarding claim 26, the recitation of the generic IPN and sIPN further comprising a generic bioactive agent where the bioactive agent comprises a “silencing agent”. It is unclear from the specification or the prior art what a “silencing agent” might be. It is unclear what is to be silenced. The art provides many examples of apoptotic agents, including lipopolysaccharide. Similarly, contrast agents are also known in the art for various uses. However, the specification does not provide examples of any particular apoptotic agents or contrast agents or combinations that are to be used with the generic IPN or sIPN moieties.
Regarding claim 30, the claim is directed to a method of claim 1 where the LAA is trabeculated and where the photocurable biomaterial conforms to the internal anatomy of the LAA prior to crosslinking, but the compositional components of the IPN or sIPN are not exemplified such that one would be able to carry out the method as recited in claim 30.
Similarly, claim 34 recites method steps for positioning an occlusion device within the ostium of the LAA and injecting “the photocurable biomaterial” into the LAA and photocuring it. However, there is no complete exemplified embodiment of the photocurable biomaterial in the specification. The recitations of IPNs and sIPNs are entirely generic. Without knowing the chemical composition of the biomaterials to be photocured, one of ordinary skill in the art would not be reasonably apprised of how to make or use them in the method recited in claim 34. This carries forward for claims 35, 39, 40, 44, 45, and 49, as well, as they are all dependent on claim 34, which does not recite any structure for the biomaterial to be placed in the LAA and no chemical compositions for the same are exemplified in the specification.
With regard to claim 49, the specification does not exemplify a water light pipe. In its broadest reasonable interpretation, it could be a fluid compatible fiber optic, but that is not otherwise exemplified in the specification as originally filed.
Applicants’ claims are excessively broad due, in large part, to the lack of any specificity as to the chemical structure of the biomaterial to be photocured. No complete chemical biomaterial structure is taught or claimed with any degree of specificity. Therefore, based on the discussions above concerning the art’s recognition that although some components of photocurable and UV-curable polymers are known in the art, including hydrophilic polymer precursors and siloxane precursors, the specification fails to teach the skilled artisan how to make or use the claimed methods without resorting to undue experimentation.
Due to the large quantity of experimentation necessary to determine the structure of the biomaterial to be photocured in the claimed method, the lack of direction/guidance presented in the specification regarding same, the absence of sufficient working examples directed to same, the complex nature of the invention, the state of the prior art establishing that the genus of IPNs, and sIPNs are extremely large, and should be functionally tested for biocompatibility, and the breadth of the claims which fail to recite any specific polymer compositions comprising a first network polymer or a second network polymer within the same claim such that their use together could be reasonably be determined, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Van Tassel et al., US 20030191526 (9 October 2003) teaches a barrier device for ostium of left atrial appendage.
VanTassel et al., US 20050049573 (3 March 2005) teaches a barrier device for ostium of left atrial appendage.
Van Tassel et al., US 20030120337 (26 June 2003) teaches a barrier device for ostium of left atrial appendage.
Schmocker et al., US 20180140303 (24 May 2018) device and method for injection and photoactivation and solidification of liquid embolic material in the vascular system or other organic cavities.
Siegel et al., US 20160089151 (31 March 2016) teaches left atrial appendage occlusion devices and methods.
Richard, et al., US 20090092676 (9 April 2009) teaches cross-linked polymer particles.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771