DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites “10 nm to about 60 nm” which should read as “10 mm to about 60 mm”.
Appropriate correction is required.
Claim Rejections - 35 USC §103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
on sale or otherwise available to the public before the effective filing date of the claimed
invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US20190358166A1) in view of Patel et al. (US20210113664A1) hereinafter Patel.
Regarding claims 1-20, Schnieder is drawn to an implantable device for delivery of a macromolecular drug compound is provided. The device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound having a molecular weight of about 0.5 kDa or more, the polymer matrix containing a hydrophobic polymer. Further, the membrane layer comprises a membrane polymer matrix within which the macromolecular drug compound is optionally dispersed. The membrane polymer matrix contains a hydrophobic polymer in combination with a hydrophilic compound, and the weight ratio of the hydrophobic polymer to the hydrophilic compound within the membrane polymer matrix ranges from about 0.25 to about 200 (abstract).
Schneider discloses the device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound [0003]. Particular examples of suitable macromolecular drug compounds may include, for instance, proteins, peptides [0037]. The core polymer matrix may contain an ethylene vinyl acetate polymer, which is a copolymer that is derived from at least one ethylene monomer and at least one vinyl acetate monomer [0035]. The olefin copolymer has a melting temperature of from about 40° C. to about 140° C. as determined in accordance with ASTM D3418-15 (Claim 15). The hydrophobic polymer of the core polymer matrix, membrane polymer matrix, or both has a melt flow index of from about 0.2 to about 100 grams per 10 minutes as determined in accordance with ASTM D1238-13 at a temperature of 190° C. and a load of 2.16 kilograms (Claim 17).
Schneider does not explicitly disclose a therapeutic agent comprising one or more glucagon-like peptide-1 (GLP-1) receptor agonists.
However, Patel is drawn to implants which comprise lipophilic pharmaceutical substances. Excipients are used which provide appropriate and controllable/tunable release of the lipophilic drug from the matrix of the implant. The implants can be implanted into a patient for release of the pharmaceutical substances (abstract).
Patel discloses the lipophilic pharmaceutical substance comprises a fatty acid covalently conjugated to a peptide, such as liraglutide [0010].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings as previously disclosed by Schneider, wherein the pharmaceutical substance is liraglutide, as previously disclosed by Patel, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Schneider and Patel are both in the field of controlled release, and Patel discloses controllable release of lipophilic drug from the matrix of the implant wherein the drug is liraglutide (abstract; [0010]), thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claim 2, Schneider discloses wherein hydrophilic polymers constitute from about 1 wt. % to about 50 wt. % of the membrane polymer matrix (claim 26).
Regarding claim 3, Schneider discloses the membrane polymer matrix contains a combination of a hydrophobic polymer and a hydrophilic compound (e.g., hydrophilic polymer) that is soluble and/or swellable in water. To help achieve the desired release of the macromolecular drug compound, the weight ratio of the hydrophobic polymers to the hydrophilic compounds within the membrane polymer matrix is selectively controlled [0029].
Regarding claim 4, Schneider discloses the core contains a core polymer matrix that includes a hydrophobic polymer and a macromolecular drug compound that is dispersed within the core polymer matrix [0029].
Regarding claim 5, Patel discloses the lipophilic pharmaceutical substance comprises a fatty acid covalently conjugated to a peptide, such as liraglutide [0010].
Regarding claim 6, Schneider discloses wherein the macromolecular drug compound constitutes from about 1 wt. % to about 40 wt. % of the membrane layer. (claim 22) and wherein the membrane polymer matrix constitutes from about 30 wt. % to 100 wt. % of the membrane layer (claim 20).
Regarding claims 7 and 10, Schneider discloses the implantable device may have a variety of different geometric shapes, such as cylindrical (rod) or disc [0028].
Regarding claim 8, Schneider discloses the device will typically have a diameter of from about 0.5 to about 50 millimeters [0028].
Regarding claim 9, Schneider discloses the length of the device may vary, but is typically in the range of from about 1 to about 25 millimeters [0028].
Regarding claim 11, Schneider discloses the resulting discs had a thickness of 0.5 millimeters [0061].
Regarding claim 12, Schneider discloses the implantable device can release the drug compound for a time period of about 5 days or more, in some embodiments about 10 days or more, in some embodiments from about 20 days to about 60 days, and in some embodiments, from about 25 days to about 50 days (e.g., about 30 days) [0030].
Regarding claim 13, Patel discloses the defined period of time can be about two months, about three months, about four months, about five months, or about six months [0066].
Regarding claim 14, Schneider discloses an effective amount will typically range from about 5 μg to about 200 mg [0031] and Patel discloses the lipophilic pharmaceutical substance comprises a fatty acid covalently conjugated to a peptide, such as liraglutide [0010].
Regarding claims 15-16, Schneider discloses an effective amount will typically range from about 5 μg to about 200 mg, in some embodiments from about 5 μg to about 100 mg per day, and in some embodiments, from about 10 μg to about 1 mg of the macromolecular drug compound delivered per day [0031]. Patel discloses the lipophilic pharmaceutical substance comprises a fatty acid covalently conjugated to a peptide, such as liraglutide [0010].
Regarding claim 17, Schneider discloses the device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core (abstract), a wide variety of such copolymers may generally be employed in the polymer composition, such as ethylene vinyl acetate copolymers [0034].
Regarding claim 18, Schneider discloses the core may also optionally contain one or more excipients if so desired, such as radiocontrast agents [0038].
Regarding claim 19, Schneider discloses after a time period of 15 days, for example, the cumulative release ratio of the implantable device may be from about 20% to about 70%, in some embodiments from about 30% to about 65%, and in some embodiments, from about 40% to about 60%. Likewise, after a time period of 30 days, the cumulative release ratio of the implantable device may still be from about 40% to about 85%, in some embodiments from about 50% to about 80%, and in some embodiments, from about 60% to about 80% [0030].
Regarding claim 20, Schneider discloses a method for prohibiting and/or treating a condition, disease, and/or cosmetic state of a patient, the method comprising subcutaneously implanting the device of claim 1 in the patient (claim 35).
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615