3DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The preliminary amendment filed 12/22/23 is acknowledged. Claim 1 has been canceled. Claims 2-21 have been added. Claims 2- 21 are pending and under examination.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,415,004. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are encompass a drug delivery device comprising adalimumb. The ‘004 claims teach solid tissue penetrating member fabricated from a therapeutic preparation comprising adalimumab, the solid tissue penetrating member shaped and configured to be inserted into the intestinal wall after oral ingestion wherein upon insertion, the preparation releases adalimumab into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of adalimumab. The ‘004 claims teach wherein the tissue penetrating member is adapted to be orally delivered in a swallowable capsule. The ‘004 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘004 claims teach wherein the tissue penetrating member is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the tissue penetrating member being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘004 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release adalimumab into the blood stream. The ‘004 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘004 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘004 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ’004 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release adalimumab into the blood stream. The ‘004 claims teach wherein a weight percent of adalimumab in the tissue penetrating member comprises between 8 to 12 percent. The ‘004 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘004 claims teach wherein the adalimumab is contained in the tissue penetrating member in a shaped section. The ‘004 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘004 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is up to ten times greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘004 claims teach wherein the preparation is configured produce a release of adalimumab to produce a selectable t1/2 in a range of 6 to 24 hours. The ‘004 claims teach wherein a dose of adalimumab in the preparation is in a range from 1 to 5 mg. Thus, the ‘004 claims anticipate the instant claims, and the instant claims and the patent claims are not patentably distinct.
Claims 2-5, 9, 12-13, 15-17, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,752,681. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are encompass a therapeutic preparation comprising adalimumab. The ‘681 claims teach a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration, and a solid Adalimumab preparation operably coupled to the actuator, the solid Adalimumab preparation comprising a therapeutically effective dose of Adalimumab, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the wall of the small intestine in the second configuration so as to insert the solid Adalimumab preparation into the wall of the small intestine wherein the solid Adalimumab preparation has a tissue penetrating shape configured for penetration of the wall of the small intestine; and actuating the actuator responsive to a condition in the small intestine to deliver the solid Adalimumab preparation into the wall of the small intestine. The ‘681 claims teach wherein the Adalimumab preparation comprises at least one pharmaceutical excipient. The ‘681 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘681 claims teach wherein a weight percent of Adalimumab in the preparation comprises between 8 to 12%. The ‘681 claims teach further comprising retaining the Adalimumab preparation within the intestinal wall after insertion. The ‘681 claims teach wherein the Adalimumab preparation produces a release of Adalimumab with a t½ in a range of 6 to 24 hours. The ‘681 claims teach wherein the dose of Adalimumab in the Adalimumab preparation is in a range from 1 to 5 mg. Regarding the limitation “wherein a Cmax achieved by delivering the preparation by insertion into an intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall”, the patent claims teach the same structure required by the instant claims, and therefore, the prior art structure would possess the same chemical properties recited in the instant claims. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Claims 2-6, 9-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 8,846,040 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘040 claims are drawn to a therapeutic preparation comprising etanercept, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases etanercept into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of etanercept. The ‘040 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘040 claims teach wherein the delivery means comprises at least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘040 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release etanercept into the blood stream. The ‘040 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘040 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘040 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘040 claims teach wherein a weight percent of etanercept in the tissue penetrating member comprises between about 8 to 12%. The ‘040 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘040 claims teach wherein the etanercept is contained in the tissue penetrating member in a shaped section wherein the shaped section has a cylinder or pellet shape. The ‘040 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘040 claims teach wherein a dose of etanercept in the preparation is in a range from about 1 to 5 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., etanercept) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 8,809,271 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘271 claims are drawn to a therapeutic preparation comprising liraglutide, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases liraglutide into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of liraglutide. The ‘271 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘271 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘271 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release liraglutide into the blood stream. The ‘271 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘271 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘271 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘271 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release liraglutide into the blood stream. The ‘271 claims teach wherein a weight percent of liraglutide in the tissue penetrating member comprises between about 3-6%. The ‘271 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘271 claims teach wherein the liraglutide is contained in the tissue penetrating member in a shaped section wherein the shaped section has a cylinder or pellet shape. The ‘271 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘271 claims teach wherein the preparation is configured produce a long-term release of liraglutide to produce a selectable t1/2. The ‘271 claims teach wherein the t1/2 is about 12 hours. The ‘271 claims teach wherein a dose of liraglutide in the preparation is in a range from about 0.1 to 1 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., liraglutide) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘271 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-6 and 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 8,764,733 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘733 claims are drawn to therapeutic preparation comprising vasopressin or a peptide vasopressin analogue, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases vasopressin or a peptide vasopressin analog into the blood stream from the intestinal wall, the tissue penetrating member having a proximal and distal portion, the proximal portion configured to be detachably coupled to an advancement means disposed in a swallowable capsule. The ‘733 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘733 claims teach wherein all of the preparation is in solid form. The ‘733 claims teach wherein the preparation is adapted to be orally delivered in a swallowable capsule. The ‘733 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘733 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘733 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release vasopressin or a peptide vasopressin analogue into the blood stream. The ’733 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘733 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ’733 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘733 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release vasopressin or a peptide vasopressin analogue into the blood stream. The ‘733 claims teach wherein a weight percent of vasopressin or peptide vasopressin analogue in the tissue penetrating member comprises between about 0.1 to 1%. The ‘733 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘733 claims teach wherein tissue penetrating member includes a shaped section in which the vasopressin or peptide vasopressin analogue is contained. The ‘733 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘733 claims teach wherein the preparation is configured to produce a long-term release of vasopressin or peptide vasopressin analogue. The ‘733 claims teach wherein the preparation is configured produce a long-term release of vasopressin or peptide vasopressin analogue to produce a selectable t1/2. The ‘733 claims teach wherein the t1/2 is about 10 hours.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., vasopressin) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug, the ‘733 discloses a range that is close to the claimed weight percent. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). The weight percent of the drug is a result effective variable and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8,969,293 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘293 claims are drawn to a therapeutic preparation comprising exenatide, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases exenatide into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of exenatide. The ‘293 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘293 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘293 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘293 claims teach wherein the preparation is adapted for insertion into the wall of the small intestine. The ‘293 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release exenatide into the blood stream. The ‘293 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘293 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘293 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ’293 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release exenatide into the blood stream. The ‘293 claims teach wherein the biodegradable material comprises maltose or PGLA. The ‘293 claims teach a weight percent of exenatide in the tissue penetrating member comprises between about 0.1 to 1%. The ‘293 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘293 claims teach wherein the tissue penetrating member includes a shaped section in which the exenatide is contained, wherein the shaped section has a cylinder or pellet shape. The ‘293 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘293 claims teach wherein the preparation is configured produce a long-term release of exenatide to produce a selectable t1/2. The ‘293 claims teach wherein the t1/2, is about 12 hours. The ‘293 claims teach wherein a dose of exenatide in the preparation is in a range of about 1 to 10 μg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., exenatide) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘293 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 9,861,683 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘683 claims are drawn to a therapeutic preparation comprising growth hormone, the preparation shaped as a solid tissue penetrating member having a shaft and tissue penetrating end shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion by the application of force onto a surface of the tissue penetrating member, wherein upon insertion, the preparation releases growth hormone into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of growth hormone. The ‘683 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘683 claims teach wherein at least a portion of the preparation is in solid form. The ’683 claims teach wherein the preparation is adapted to be orally delivered in a swallowable capsule. The ‘683 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘683 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘683 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release growth hormone into the blood stream. The ‘683 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘683 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘683 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘683 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release growth hormone into the blood stream. The ‘683 claims teach wherein the biodegradable material comprises maltose or PGLA. The ‘683 claims teach wherein a weight percent of growth hormone in the tissue penetrating member comprises between about 2 to 10%. The ‘683 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘683 claims teach wherein the growth hormone is contained in the tissue penetrating member in a shaped section. The ‘683 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘683 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The’683 claims teach wherein the preparation is configured to produce a long-term release of growth hormone. The ‘683 claims teach wherein the preparation is configured produce a long-term release of growth hormone to produce a selectable t1/2. The ‘683 claims teach wherein the t1/2 is about 12 hours. The ’683 claims teach wherein a dose of growth hormone in the preparation is in a range from about 0.1 to 4 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., growth hormone) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘683 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,259,386 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘386 claims are drawn to a therapeutic preparation comprising somatostatin or somatostatin analogue, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases somatostatin or somatostatin analogue into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of somatostatin or somatostatin analogue. The ‘386 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘386 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘386 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘386 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release somatostatin or somatostatin analogue into the blood stream. The ‘386 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘386 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘386 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ’386 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release somatostatin or somatostatin analogue into the blood stream. The ‘386 claims teach wherein a weight percent of somatostatin or somatostatin analogue in the tissue penetrating member comprises between about 0.3 to 8%. The ‘386 claims teach wherein the biodegradable material comprises maltose or wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘386 claims teach wherein the somatostatin or somatostatin analogue is contained in the tissue penetrating member in a shaped section wherein the shaped section has a cylinder or pellet shape. The ‘386 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘386 claims teach wherein the preparation is configured to produce a long-term release of somatostatin or somatostatin analogue. The ‘386 claims teach wherein the preparation is configured produce a long-term release of somatostatin or somatostatin analogue to produce a selectable t1/2. The ‘386 claims teach wherein the t1/2 is about 12 hours. The ‘386 claims teach wherein a dose of somatostatin or somatostatin analogue in the preparation is in a range from about 50 to 600 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., somatostatin or somatostatin analogue) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘386 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,284,367 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘367 claims are drawn to a therapeutic preparation comprising natalizumab, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion by an application of mechanical force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon insertion, the tissue penetrating member remains in intestinal tissue to release natalizumab into the blood stream from the intestinal wall by degradation of the tissue penetrating member; wherein the tissue penetrating member is fabricated from the preparation itself. The ‘367 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘367 claims teach wherein all of the preparation is in solid form. The ‘367 claims teach wherein the preparation is adapted to be orally delivered in a swallowable capsule. The ‘367 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘367 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘367 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release natalizumab into the blood stream. The ‘367 claims teach the biodegradable material comprises PGLA, a sugar or maltose. The ‘367 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘367 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘367 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release natalizumab into the blood stream. The ‘367 claims teach wherein the biodegradable material comprises maltose or PGLA. The ‘367 claims teach wherein a weight percent of natalizumab in the tissue penetrating member comprises between about 8 to 12%. The ‘367 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘367 claims teach wherein the natalizumab is contained in the tissue penetrating member in a shaped section. The ‘367 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘367 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘367 claims teach wherein the preparation is configured to produce a release of natalizumab of up to about 40 days. The ‘367 claims teach wherein a dose of natalizumab in the preparation is in a range from about 1 to 5 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., natalizumab) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,283,179 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘179 claims are drawn to a therapeutic preparation comprising GnRH or GnRH analogue, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases GnRH or GnRH analogue into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of GnRH or GnRH analogue. The ‘179 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘179 claims teach wherein the preparation is adapted for insertion into the wall of the small intestine. The ‘179 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘179 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘179 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release GnRH or GnRH analogue into the blood stream. The ‘179 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘179 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘179 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ’179 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release GnRH or GnRH analogue into the blood stream. The ‘179 claims teach wherein the biodegradable material comprises maltose or PGLA. The ‘179 claims teach a weight percent of GnRH or GnRH analogue in the tissue penetrating member comprises between about 2 to 15%. The ‘179 claims teach the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘179 claims teach the release GnRH or GnRH analogue is contained in the tissue penetrating member in a shaped section. The ‘179 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘179 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘179 claims teach wherein the preparation is configured to produce a long-term release of GnRH or GnRH analogue. The ‘179 claims teach wherein the preparation is configured produce a long-term release of GnRH or GnRH analogue to produce a selectable t1/2. The ‘179 claims teach wherein the t1/2 is about 12 hours. The ‘179 claims teach wherein a dose of GnRH or GnRH analogue in the preparation is in a range from about 0.3 to 1.5 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., GnRH or GnRH analogue) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘179 discloses a range that is close to the claimed weight percent and claimed dose. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9,402,806 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘806 claims are drawn to a therapeutic preparation comprising PTH or PTH analogue, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases PTH or PTH analogue into the blood stream from the intestinal wall by degradation of the tissue penetrating member to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of PTH or PTH analogue, wherein the tissue penetrating member has sufficient stiffness to be advanced completely into the intestinal wall by the application of a force to the tissue penetrating member. The ‘806 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘806 claims teach wherein all of the preparation is in solid form. The ’806 claims teach wherein the preparation is adapted to be orally delivered in a swallowable capsule. The ‘806 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘806 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘806 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release PTH or PTH analogue into the blood stream. The ‘806 claims teach wherein the biodegradable material comprises PGLA, a sugar or maltose. The ‘806 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘806 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘806 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release PTH or PTH analogue into the blood stream. The ‘806 claims teach wherein the biodegradable material comprises maltose or PGLA. The ‘806 claims teach wherein a weight percent of PTH or PTH analogue in the tissue penetrating member comprises between about 1 to 2%. The ‘806 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘806 claims teach wherein the retaining feature comprises at least one of a barb or an inverse taper shape of the tissue penetrating member. The ’806 claims teach wherein the PTH or PTH analogue is contained in the tissue penetrating member in a shaped section. The ‘806 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘806 claims teach wherein the preparation is configured to produce a long-term release of PTH or PTH analogue. The ‘806 claims teach wherein the long-term release of PTH or PTH analogue is about 12 hours. The ‘806 claims teach wherein a dose of PTH or PTH analogue in the preparation is in a range from about 10 to 30 μg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., PTH or PTH analogue) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘806 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-6 and 9-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9,402,807 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘807 claims are drawn to a therapeutic preparation fabricated with infliximab, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases infliximab into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of infliximab. The ‘807 claims teach wherein preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘807 claims teach wherein the preparation is adapted for insertion into the wall of the small intestine. The ‘807 claims teach wherein the preparation is adapted to be orally delivered in a swallowable biodegradable capsule. The ‘807 claims teach wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. The ‘807 claims teach wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. The ‘807 claims teach wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release infliximab into the blood stream. The ‘807 claims teach wherein the biodegradable material comprises polylactic-co-glycolic acid, a sugar or maltose. The ‘807 claims teach wherein the preparation comprises at least one pharmaceutical excipient. The ‘807 claims teach wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. The ‘807 claims teach wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release infliximab into the blood stream. The ‘807 claims teach wherein the biodegradable material comprises maltose or polylactic-co-glycolic acid. The ‘807 claims teach wherein a weight percent of infliximab in the tissue penetrating member comprises between 8 to 12 percent. The ‘807 claims teach wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. The ‘807 claims teach wherein the infliximab is contained in the tissue penetrating member in a shaped section. The ‘807 claims teach wherein the shaped section has a cylinder or pellet shape. The ‘807 claims teach wherein the tissue penetrating member has a stiffness to be advanced completely into the intestinal wall by the application of a force to the tissue penetrating member. The ‘807 claims teach wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is at least five times greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. The ‘807 claims teach wherein the preparation is configured to produce a release of infliximab of at least 6 hours. The ‘807 claims teach wherein the preparation is configured produce a release of infliximab to produce a selectable t1/2. The ‘807 claims teach wherein the t1/2 is 40 days. The ‘807 claims teach wherein a dose of infliximab in the preparation is in a range from 1 to 10 mg; wherein the dose of infliximab in the preparation is 5 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., infliximab) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 2-4, 9, 12, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 8,759,284 in view of Borhani et al. (US Patent Application Publication US 2010/034823 A1, published February 11, 2010).
The instant claims are drawn to a therapeutic preparation comprising adalimumab, the preparation being formed as, or disposed in, a solid tissue penetrating member shaped and configured to penetrate a gastro- intestinal (GI) wall of a patient after oral ingestion by an application of a force upon a surface of the solid tissue penetrating member from an expandable member operably coupled to the solid tissue penetrating member, wherein upon penetrating the GI wall, the solid tissue penetrating member degrades to release adalimumab in the patient.
Upon reviewing the claims as a whole, it is clear to one of ordinary skill in the art that the “claimed invention” is a means of delivering a “drug” (e.g. SPECIES 1) using a solid therapeutic preparation “fabricated” in a particular manner for penetration into the wall of the gastrointestinal tract. This interpretation of the instantly claimed invention as being a fabricated delivery preparation generally applicable to any drug is supported by the specification definition of “preparation” as referred to below: the specification teaches that the preparation comprises a therapeutically effective dose of at least one therapeutic agent. It may be solid and can include one or more pharmaceutical excipients. The preparation has a shape and material consistency to be contained in embodiments of the swallowable capsule, delivered from the capsule into the intestinal wall and degrade within the wall to release the dose of therapeutic agent (See paragraph 0024). The specification teaches that the preparation will be shaped and otherwise configured to be contained in the lumen of a “tissue penetrating member”, such as a hollow needle which is configured to be advanced out of the capsule and into the wall of the small intestine (See paragraph 0025). Further, the specification teaches that the “tissue penetrating member” can be fabricated from various drugs and other therapeutic agents, one or more pharmaceutical excipients (e.g., disintegrants, stabilizers, etc.) and one or more biodegradable polymers (See paragraph 0123). Furthermore, the specification teaches that in various embodiments one or more tissue penetrating members 140 can carry the same or a different drug 101 (or other therapeutic agent) from other tissue penetrating members (See paragraph 0127). Table 1 lists adalimumab, insulin, exenatide, liraglutide, pramlinitide, growth hormone, somatostatin, GmRH, vasopressin, PTH, and interferons as drugs within the parameters of the pharmacokinetics of the claims. It should be noted that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
The ‘284 claims are drawn to a therapeutic agent preparation for delivery into a lumen of the intestinal tract, the lumen having a lumen wall, the preparation comprising a therapeutically effective dose of at least one therapeutic agent, wherein the preparation is a solid shaped as a tissue penetrating member having a dart-like structure, the tissue penetrating member configured to be contained in an oval shaped swallowable capsule and to be delivered from the capsule to penetrate and be advanced into the lumen wall by the application of force on the tissue penetrating member, wherein the solid degrades within the lumen wall to release the dose of therapeutic agent. The ‘284 claims teach wherein the preparation is configured to be coupled to an actuator having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the lumen wall in the second configuration. The ‘284 claims teach wherein the lumen is the small intestine and the preparation is configured to degrade within the wall of the small intestine. The ‘284 claims teach wherein the preparation comprises at least one pharmaceutical excipient.. The ‘284 claims teach wherein the incretin comprises a glucagon like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). The ‘284 claims teaches wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 μg. The ‘284 claims teach wherein the incretin comprises liraglutide and the dose is in a range from about 1 to 2 mg.
The patented claims do not teach that the drug is adalimumab.
However, Borhani et al. teach a pharmaceutical composition comprising crystals of an anti-TNF alpha antibody, D2E7 (adalimumab), and at least one pharmaceutical excipient for oral administration (See claims 30 and 40). Borhani et al. teach that the antibody is used for treating hTNF-alpha related disorders, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic plaque psoriasis (See paragraph 0063).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the drug species (i.e., GLP-1 or GLP-1 analogoue) of the copending claims for adalimumab, as recited in the instant claims, because doing so would allow for the oral delivery of adalimumab to the gastrointestinal tract. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses that “The simple substitution of one known, equivalent element for another is likely to be obvious when it does no more than yield predictable results”. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the weight percent of the drug and the dose of the drug, the ‘284 discloses a range that is close to the claimed weight percent and claimed dose. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Generally, differences in concentration or temperature 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). Both the weight percent of the drug and dose of the drug are result effective variables and thus, the optimal range of the weight percent of the drug and dose of the drug could be determined by one of ordinary skill in the art through routine experimentation.
Claims 2-5, 9, 12, 15-16, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,814,427. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a therapeutic preparation comprising adalimumab.
The ‘427 claims teach a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration, and a solid adalimumab preparation operably coupled to the actuator, the solid adalimumab preparation comprising a therapeutically effective dose of adalimumab, the solid adalimumab preparation being contained within the capsule in the first configuration and advanced into the wall of the gastrointestinal tract in the second configuration, wherein the solid adalimumab preparation has a shape configured for penetration of the wall of the gastrointestinal tract. The ‘427 claims teach wherein the adalimumab preparation comprises at least one pharmaceutical excipient. The ‘427 claims teach wherein a weight percent of adalimumab in the preparation comprises between 8 to 12%. The ‘427 claims teach wherein the solid adalimumab preparation advanced into the wall of the gastrointestinal tract is retained within the wall of the gastrointestinal wall to release the dose of adalimumab therein. The ‘427 claims teach wherein the t½ of the adalimumab advanced into the wall of the gastrointestinal tract is greater than the t½ for orally ingested adalimumab that is not advanced into the wall of the gastrointestinal tract. The ‘427 claims teach wherein the dose of adalimumab in the preparation is in a range of 1 to 5 mg.
Claim Status
No claims are allowed.
Conclusion
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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