DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-3 and 5-20 are currently pending.
Claim 4 is canceled.
Claims 1, 2, 19, and 20 are withdrawn.
Claims 6 and 7 are objected.
Claims 3-18 are being examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a CON of PCT/KR2022/017384 (11/07/2022) as reflected in the filing receipt issued May 03, 2024.
Election/Restriction
Applicant's election without traverse Group III (claims 3-18) with species election microspheres containing biodegradable polymers in the reply filed
on April 09, 2026 is acknowledged.
Claims 1, 2, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 09, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 6 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 6 recites that “the formulations are administered at the same or different times”. The kit in claim 3 only has two different formulations, and thus at the same time or different times are the only two options for administration of the formulations recited in claim 3. Thus, the scope of claim 6 is identical to that of claim 3.
Claim 7 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 7 recites that “ the first and second formulation are provided as a mixed formulation or a separate formulation”. The kit in claim 3 only has two different formulations, and thus the two being mixed or separate are the only two options for the formulations recited in claim 3. Thus, the scope of claim 7 is identical to the scope of claim 3.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5 and 6 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 3 states “the first formulation is for increasing bioavailability of the second drug contained in the second formulation”. It is unclear because there’s no comparison point recited in the claim to ascertain whether there was an increase in bioavailability. For example, is it an increase compared to without the first formulation? Is it an increase compared to the second drug not in delivery system?
Claim 5 states “The pharmaceutical kit according to claim 3, wherein the drug delivery system is microspheres containing biodegradable polymers; liposomes, micelles, depots, or hydrogels”, it is unclear which delivery system the claim is directed to, as claim 5 is dependent on claim 3, which discloses more than one delivery system. Is claim 5 referring to both systems of claim 3 or just one?
With regards to Claim 6, the claim is directed to a product, a pharmaceutical kit, but the claim recites that the formulations “are administered at the same time or at different times” implying method steps for using this product. Per MPEP 2173.05(p), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 3, 5, 6, 7, 8-11, and 16 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Liang et al (CN104548210A; Published on April 09, 2015; Filled on December 13, 2014, cited in IDS).
Liang et al throughout teaches the preparation of controlled release of polylactic acid-glycolic acid microspheres containing dexamethasone and transforming growth factor involves dissolving polylactic acid-glycolic acid copolymer and dexamethasone in dichloromethane.
For claim 3: Liang teaches dexamethasone (reads on first formulation that contains anti-inflammatory drug of the claim) polylactic acid-glycolic acid copolymer microspheres in combination with heparin-TGF-β3 (reads on the second formulation nanoparticles (Liang claim 1). Liang further discloses that the mentioned formulations are injected into a rat tail (Liang page 10 paragraph 47). The instant specification discloses that the anti-inflammatory agent is an agent for regulating or enhancing bioavailability of the second drug (instant spec. page 22, second paragraph). Dexamethasone contained within microspheres is exemplified in the examples of the instant specification for increasing bioavailability of the drug it is administered with. As the Liang reference as discussed above also exemplifies dexamethasone contained within microspheres being administered with another drug, absent evidence to the contrary, Liang’s dexamethasone contained within microspheres will also be able to increase the bioavailability of the second drug (instant spec. page 6, first paragraph; page 64, first paragraph).
For claim 5: Liang teaches the preparation of dexamethasone/polylactic acid-glycolic acid copolymer microspheres by dissolving PLGA (reading on biodegradable polymer) and DEX in dichloromethane (Liang claim 1).
For claim 6: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres are administered together into a rat tail for treatment and demonstrates a successful treatment (page 10, paragraph 0047).
For claim 7: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres (reads on the first and second formulations being provided as a mixed formulation) into a rat tail for treatment demonstrating successful treatment (page 10, paragraph 0047).
For claim 8: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres (reads on the first and second formulations being loaded together in the second parenteral drug delivery system) into a rat tail demonstrating successful treatment (page 10, paragraph 0047).
For claim 9: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres (reads on the first and second formulations being provided as a mixed formulation) into a rat tail demonstrating successful treatment (page 10, paragraph 0047).
For claim 10: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres into a rat tail demonstrating successful treatment (page 10, paragraph 0047). It is noted that the instant claim 10 is a product-by-process claim. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). Prior art reference Liang discusses dexamethasone, a known anti-inflammatory drug disclosed in the instant specification. The structures are the same and there's no evidence that the claimed process results in a different structure.
For claim 11: Liang teaches the preparation and fabrication of DEX/PLGA (reads on first drug formulation of the claim) microspheres and heparin-TGF-β3 nanoparticles (reads on second drug formulation of the claim) where each drug formulation is initially prepared as separate drug delivery systems, as disclosed in paragraphs 0029 to 0036 of the reference.
For claim 16: Liang teaches that the administration of drug treatment TGF-β3 and DEX from TGF-β3/DEX/PLGA microspheres into a rat tail demonstrating successful treatment (page 10, paragraph 0047), which reads on drug delivery provided intradermal of the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 12-15, 17, and 18 are rejected under 35 U.S.C 103 as being unpatentable over Liang et al (CN104548210A; Published on April 09, 2015; Filled on December 13, 2014, cited in IDS) in view of Pathak ( US20160243026A; Published on August 25, 2016) and Rabinow et al (US20150024031A1; Published on January 22, 2015)
Liang et al throughout teaches the preparation of controlled release of polylactic acid-glycolic acid microspheres containing dexamethasone and transforming growth factor involves dissolving polylactic acid-glycolic acid copolymer and dexamethasone in dichloromethane, as set forth above.
The teachings of Liang as they apply to Claims 3, 5, 6, 7, 8-11, and 16 are set forth above and incorporated herein.
Liang does not teach the amount of solid content of the mixed formulations as recited in claims 12-14. Liang also does not teach the AUC concentration, the route of administration, particle diameter, or the incorporation of a local anesthetic as recited in claims 15-18. Pathak and Rainbow are relied upon for these disclosures. Their teachings are set forth herein below.
Pathak throughout teaches a sustained drug delivery include a fluid carrier; a plurality of first polymeric microparticles having a bioactive agent dispersed in the fluid carrier; and a plurality of second polymeric microparticles having a visualization agent dispersed in the fluid carrier with the first microparticles (Pathak abstract).
For claims 12-14: Pathak teaches that it is known to use 1 to 50% relative weight of polymer (reads on biodegradable of claims) (Pathak claim 8). Pathak teaches first polymeric microparticles (reads on first formulation of the claim) or second polymeric microparticles (reads on the second formulation of the claims) are present from 1% to 99% of total microparticles (Pathak claim 8). Pathak further discusses biodegradable polymer (PLGA) based biodegradable sustained drug delivery composition comprising two different drugs encapsulated in PLGA for injection with different particle populations ( Pathak paragraph 00174).
Rabinow throughout teaches a method and pharmaceutical compositions for parenteral administration that reduces inflammation, pain, and immunological reactions.
For claim 15: Rabinow demonstrates in figure 2B the rate of dissolution for the pharmaceutical compositions as there is a decrease of 10% or less in respect to time, which reads on the area under the curve (Figure 2B, paragraph 0024).
For claim 17: Rabinow teaches microparticles of an analgesic agent in an amount effective to reduce the pain, inflammation, and/or immunological reaction associated with parenterally administering where the particle size is less than 20 micrometers (Rabinow claim 1 and abstract).
For claim 18: Rabinow teaches that analgesic agents include, but are not limited to, local anesthetic agents, which reads on the claim.
With regards to the amount of solid content (claims 12-14), as discussed above, Pathak exemplifies formulations where the weight percentage of the polymer and the solid contents amount both the first and second formulations are present in 1% to 50% and 1% to 99%. Both Liang and Pathak teach a dual drug delivery system that focus on sustained release, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to adjust the amount of polymer and solid contents in the formulation of the combined teachings of the prior art references to optimize the amount of each component based on the art recognized factors, such as desired release rate, for increasing drug efficacy, reducing side effects and number of drug administrations.
The adjustment of particular conventional working conditions (e.g., determining optimal or workable amount of polymer and solid content is deemed merely a matter of judicious selection and routine optimization, which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results, absent evidence of unexpected results. Where 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.
With regards to the AUC and local anesthetic (claims 15, 17, and 18), as discussed above, Rabinow exemplifies a pharmaceutical composition includes a local anesthetic and where the dissolution after administration decreases by 10% or less in respect to time. Both Liang and Rabinow teach pharmaceutical compositions for parenteral administration that reduces inflammation, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to incorporate an local anesthetic and formulate the composition as desired to have a AUC of 10% of less based on the art, such as desired for increasing drug efficacy, reducing side effects and number of drug administrations.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Conclusion
Claims 3-18 are rejected. No claims are allowed.
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/J.A.E./ Examiner, Art Unit 1616
/MONICA A SHIN/ Primary Examiner, Art Unit 1616
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