Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2023 is being considered by the examiner. The IDS has multiple patents that are without English translations or only have translations of the abstracts and claims, therefore, only the portion with an English translation is considered by the examiner. Please see annotated IDS.
Claim Interpretation
In regards to claim 13, the limitation of ‘wherein the delivery’ it is noted that the instant claims are composition claims and future intended use, such as delivery of a drug using the medical implant, is not given patentable weight. Thus any composition comprising the limitations of instant claim 1, from which claim 13 depends, will meet this limitation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 fails to add additional structural limitations, specifically the claim recites the phrase ‘configured to’ which fails to add structure and thus does not further limit the claim rendering the claim indefinite.
For the purpose of moving prosecution forward the limitation of “is configured to be delivered” is deemed to be future intended use of the composition/device which does not further limit the composition/device itself.
Claims 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “and a second total amount of said at least one therapeutic drug” which is unclear if the “second amount” is referring to an amount differing from the biodegradable material or is referring to an amount of a second drug, therefore, the claim is rendered indefinite.
For the purpose of moving prosecution forward, the examiner broadly interprets this to mean any amount of any drug.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein said matrix includes a first total amount of said at least one biodegradable material and a second total amount of said at least one therapeutic drug material” and further recites “said second total amount of said least one therapeutic drug material is greater than said first total amount of said at least one biodegradable material’ which fails to define what ‘total amount’ requires (i.e. 2mg or 400kg) therefore, ‘total amount’ renders the claim indefinite.
For the purpose of moving prosecution forward, the examiner broadly interprets ‘total amount’ to mean any amount of biodegradable material and therapeutic drug.
Claims 1 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites ‘said at least one biodegradable material has a varying concentrations within said material’ and claim 5 recites ‘at least one therapeutic drug material has a varying concentration within said matrix’ which is unclear what constitutes ‘varying concentrations’. For example, do some parts of the matrix have 2% of biodegradable material while others have 99% or is it a gradient or is the matrix made to have one portion contain a higher concentration of drug with a less concentration of biodegradable material.
For the purpose of moving prosecution forward, the examiner broadly interprets ‘varying concentration’ to include any concentration range.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (WO2005107727A1, published 11/17/2005, hereafter Huang) as evidenced by Oh et al. (Oh, I.J., Oh, J.Y. & Lee, K.C. Assessment of biodegradability of polymeric microspheresin vivo: Poly (DL-lactic acid), poly (L-lactic acid) and poly (DL-lactide-co-glycolide) microspheres. Arch. Pharm. Res. 16, 312–317 (1993). https://doi.org/10.1007/BF02977522, hereafter Oh), as evidenced by Zhao et al. (Zhao, S., Pinholt, E. M., Madsen, J. E., & Donath, K. (2000). Histological evaluation of different biodegradable and non-biodegradable membranes implanted subcutaneously in rats. Journal of Cranio-Maxillofacial Surgery, 28(2), 116–122. https://doi.org/10.1054/jcms.2000.0127, hereafter Zhao), and as evidenced by Stanger et al. (Stanger, Michael J., et al. "Anticoagulant activity of select dietary supplements." Nutrition reviews 70.2 (2012): 107-117., hereafter Stanger).
As evidenced by Oh, the biodegradability of poly(D,L-lactic acid) and poly(D,L-lactide-co-glycolide) have different biodegradability rates from each other (page 315, figures 5 and 6).
As evidenced by Zhao, polytetrafluoroethylene is not biodegradable (abstract).
As evidenced by Stanger, Gingko biloba has anticoagulant activity (page 109, table 1)
Huang teaches a steroid intraocular implant having an extended sustained release for a period of greater than two months (title; according to the claim limitations of the instant claim 1). Huang teaches the implant is used to treat a medical condition of the eye (page 10, lines 7-9; according to the claim limitations of the instant claim 1). Huang claims the biodegradable intraocular implant comprises a steroid associated with a biodegradable polymer matrix that releases drug at a rate effective to sustain release of a therapeutically effective amount of the steroid from the implant for a time greater than about two months from a time in which the implant is placed in an ocular site or region of an eye (claim 1; according to the claim limitations of the instant claim 1). Claim 5 of Huang claims the steroid is dispersed within the biodegradable polymer matrix (according to the claim limitations of the instant claims 1 and 4). Further, Huang teaches the biodegradable intraocular implant comprises a steroid 30 associated with a biodegradable polymer matrix, which comprises a mixture of different biodegradable polymers (page 18, lines 29-31; according to the claim limitations of the instant claims 3 and 12). Claim 6 of Huang claims the matrix comprises a mixture of a first biodegradable polymer having terminal acid groups, and a second biodegradable polymer having terminal acid group (according to claim limitations of the instant claims 9 and 12). Claim 7 of Huang claims the first biodegradable polymer is a poly (D,L- lactide-co-glycolide) (according to the claim limitations of the instant claims 9 and 12). Claim 8 of Huang claims the second biodegradable polymer is a poly (D,L-lactide) (according to the claim limitations of the instant claims 9 and 12). Claim 10 of Huang claims the matrix releases drug at a rate effective to sustain release of a therapeutically effective amount of the steroid from the implant for more than three months from the time the implant is placed in the vitreous of the eye (according to the claim limitations of the instant claim 1). Huang teaches the implants may be monolithic, i.e. having the active agent or agents homogenously distributed through the polymeric matrix, or encapsulated, where a reservoir of active agent is encapsulated by the polymeric matrix (page 20, lines 23-25; according to the claim limitations of the instant claims 2 and 4-6). Huang further teaches the greater control afforded by the encapsulated, reservoir-type implant may be of benefit in some circumstances, where the therapeutic level of the drug falls within a narrow window (page 20, lines 27-29; according to the claim limitations of the instant claims 2 and 4-6). Huang teaches the therapeutic component, including the steroid, may be distributed in a non-homogenous pattern in the matrix and teaches for example, the implant may include a portion that has a greater concentration of the steroid relative to a second portion of the implant (pages 20-21; lines 29-30 and 1-2 respectively; according to the claim limitations of the instant claim 5). Further, Huang teaches the size and form of the implant can also be used to control the rate of release, period of treatment, and drug concentration at the site of implantation (page 29, lines 17-20; according to the claim limitations of the instant claim 1). Huang teaches another embodiment wherein an intraocular implant comprises a therapeutic component, including a steroid, and a drug release sustaining component including a coating covering a core region of the implant (page 21, lines 4-6; according to the claim limitations of the instant claims 2 and 6). Huang teaches the outer layer (coating) may comprise a polymer such as polytetrafluoroethylene (non-biodegradable), polyfluorinated ethylenepropylene, polylactic acid (biodegradable), polyglycolic acid, silicone, or mixtures thereof (page 21, lines 11-13; according to the claim limitations of the instant claims 2-3, 7-8, and 12). Huang teaches in some aspects the implants with an outer layer coating contain a plurality of openings or holes through which the therapeutic component may pass from the drug delivery system to an external environment of the implant (page 21, lines 21-24; according to the claim limitations of the instant claim 6). Huang teaches the release of the steroid from the intraocular implant comprising a biodegradable polymer matrix may include an initial burst of release followed by a gradual increase in the amount of the steroid released, or the release may include an initial delay in release of the steroid followed by an increase in release (page 19, lines 13-16; according to the claim limitations of the instant claim 13). Huang teaches some relevant factors to be considered in choosing a polymeric composition include: compatibility of the polymer with the biological environment of the implant, compatibility of the drug with the polymer, ease of manufacture, a half-life in the physiological environment of at least several days, no significant enhancement of the viscosity of the vitreous, and 10 the desired rate of release of the drug (page 22, lines 5-10; according to the claim limitations of the instant claims 1-13). Huang teaches the steroid of the implant is preferably from about 10 to 90% by weight of the implant, and more preferably from about 50 to about 80% of the implant (page 14, lines 18-20; according to the claim limitations of the instant claim 1). Huang teaches the amount of polymer in the core to be from about 0% to 80% by weight (page 25, line 18; according to the claim limitations of the instant claim 1). Huang teaches the therapeutic agent can be deposited in a preformed coating as a dry powder, particles, granules, or as a compressed solid (page 25, lines 10-11; according to the claim limitations of the instant claim 14). Huang teaches in addition to the steroid or steroids included in the intraocular implants disclosed herein, the intraocular implants may also include one or more additional ophthalmically acceptable therapeutic agents (page 29, lines 5-7; according to the claim limitations of the instant claims 10 and 14).
Huang teaches the therapeutic agent may include one or more antihistamines, one or more antibiotics, one or more beta blockers, one or more different corticosteroids, one or more antineoplastic agents, one or more immunosuppressive agents, one or more antiviral agents, one or more antioxidant agents, and mixtures thereof (page 29; lines 7-11; according to the claim limitations of the instant claims 10 and 14). Further, Huang teaches examples of antioxidant agents include ascorbate, alpha-tocopherol, mannitol, reduced glutathione, various carotenoids, cysteine, uric acid, taurine, tyrosine, superoxide dismutase, lutein, zeaxanthin, cryotpxanthin, astazanthin, lycopene, N-acetyl-cysteine, carnosine, gamma-glutamylcysteine, quercitin, lactoferrin, dihydrolipoic acid, citrate, Ginkgo Biloba extract (anticoagulant), tea catechins, bilberry extract, vitamins E or esters of vitamin E, retinyl palmitate, and derivatives thereof (pages 31-32, lines 28-31 and 1-2 respectively; according to the claim limitations of the instant claims 10 and 14).
Huang does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Huang with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable rearranging the compositions/device of Huang in order to make the instant claims with predictable results.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611