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 .
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.
DETAILED ACTION
Claims 56-87 are pending, claims 1-55 are canceled in this application. This application is a national stage entry of PCT/EP2022/069416, filled on 07/12/2022. This application claims foreign priority to EP 21306016.3, filed on 07/19/2021 in Europe.
Election/Restrictions
Applicant’s election of group I, claims 56-81in the reply filed on 02/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 82-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 56-81 will presently be examined to the extent they read on the elected subject matter of record.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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 56-81 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hunter et al. (US 2002/0119202 A1) in view of Hunter et al. (US 2002/0192280 A1).
Hunter et al. (‘202) teach a method of treating rheumatoid inflammatory arthritis (the patient population includes patient population with acute and/or patient population with chronic and includes crystal-associated patient population or non- crystal-associated patient population in the instant claims 56, 61, and 62 and includes patient population with renal and/or hepatic impairment and patient population being simultaneously, separately or sequentially treated by atazanavir, etc., in the instant claim 81) with painful joints (the instant claim 56) (paragraph 166) comprising
intra-articular injection to an involved joint (including any joint, the instant claim 64) (paragraph 163-165) of composition in form of suspension (the instant claim 56) (paragraph 194) comprising
copolymer of lactic acid and glycolic acid or poly(caprolactone) sustained release microspheres (the instant claims 56, 59, 60, 76, and 78) (paragraph 129, 147, 217, and 429) comprising colchicine (the instant claim 56) or paclitaxel (paragraph 15 and 114 and claims 1, 2, and 6-11) with size of 10-30 µm (the instant claims 56, 71, and 72) (paragraph 120 and 263); and
exemplified intra-articular injection of 0.2 mL (0.5 mg microspheres) of a composition comprising paclitaxel-containing microspheres (obvious to be replaced by colchicine) in example 19 (the instant claim 56);
wherein a drug is release 80% at 1-10 days and about 40% at 12 hours (figure 12) and copolymers of lactic acid and glycolic acids have faster degradation rates than PLA and drug loaded microspheres prepared using these copolymers, the degradation lifetime of PLA is increased as the proportion of EVA in the blend is increased (paragraph 340), i.e., the release relate of a drug is related to the choice of microsphere polymer blend (the instant claims 56 and 65-68);
wherein microspheres have 5% by weight of paclitaxel loaded (obvious to be replaced by colchicine) (the instant claims 56, 78, and 79) (paragraph 323) and
the composition comprising microspheres of both quick and slow or prolonged release of paclitaxel (obvious to be replaced by colchicine) (the instant claim 75) (paragraph 119, 219, and 521).
With 0.2 mL composition comprising 0.5 mg microspheres and paclitaxel (obvious to be replaced by colchicine) is loaded at 5% by weight of the microspheres, the concentration of paclitaxel (obvious to be replaced by colchicine) is calculated to be 125 µg/mL (0.5 mg x 5%) / 0.2 mL → 0.025 mg / 0.2 mL → 25 µg / 0.2 mL → 125 µg/mL (the instant claims 56-58).
The limitation I the instant claim 63 is further limitation of an alternative limitation.
Hunter et al. are silent about the systemic concentration and synovial concentration of colchicine after intra-articular injection of colchicine (the instant claims 69 and 70), the method (the composition and route of administration) taught by Hunter et al. are the same as the claimed, the method taught by Hunter et al. would result in the same systemic concentration and synovial concentration of colchicine after intra-articular injection of colchicine. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
The limitation in the instant claim 73 is a product-by-process limitation of a product used in the claimed method. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of composition used in the claimed method resulted from the said process is different from that of composition disclosed in the prior art. See MPEP 2113.
Hunter et al. are silent about the viscosity of the composition (the instant claim 74). Since the composition in the method taught by Hunter et al. is suitable for intra-articular injection, as the composition used in the claimed method, it is reasonable to assume the composition in the method taught by Hunter et al. would have the similar viscosity as the claimed composition.
Hunter et al. do not specify the amount of composition for intra-articular injection into each specific joint in the instant claim 80.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to determine the dosage for intra-articular injection into each specific joint. The person of ordinary skill in the art is a health care provider, pharmacist, or medicinal chemist. The claimed drug is already known in the art, the art also recognizes what conditions are treatable by the claimed drug, and the route of administration is known. The claimed dosage for intra-articular injection into each specific joint represents no more than a determination of the workable range or amount of drug for achieving the known effect. Determining optimum dosages is routine in the pharmaceutical arts. Thousands of different drugs are sold to the public by prescription or over the counter, and for each of them, the appropriate or optimal dosage has been determined.
Claims 56-81 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hunter et al. (US 2002/0192280 A1) in view of Hunter et al. (US 2002/0119202 A1).
Hunter et al. (‘280) teach a method of (the patient population includes patient population with acute and/or patient population with chronic and includes crystal-associated patient population or non- crystal-associated patient population in the instant claims 56, 61, and 62 and includes patient population with renal and/or hepatic impairment and patient population being simultaneously, separately or sequentially treated by atazanavir, etc., in the instant claim 81) with painful joints (the instant claim 56) (paragraph 99) comprising
intra-articular injection to an involved joint (including any joint, the instant claim 64) (paragraph 99 and 103-106 and claim 104) of composition in form of suspension (the instant claim 56) (paragraph 25) comprising
anti-microtubule agent (colchicine)-containing polymeric microsphere carrier in form of dispersion (paragraph 53 and 75 and claim 105 and 112) with size of 10-30 µm (the instant claims 56, 71, and 72) (paragraph 75).
The limitation I the instant claim 63 is further limitation of an alternative limitation.
The limitation in the instant claim 73 is a product-by-process limitation of a product used in the claimed method. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of composition used in the claimed method resulted from the said process is different from that of composition disclosed in the prior art. See MPEP 2113.
Hunter et al. are silent about the viscosity of the composition (the instant claim 74). Since the composition in the method taught by Hunter et al. is suitable for intra-articular injection, as the composition used in the claimed method, it is reasonable to assume the composition in the method taught by Hunter et al. would have the similar viscosity as the claimed composition.
Hunter et al. (‘280) are silent about the viscosity of the composition (the instant claim 74). Since the composition in the method taught by Hunter et al. (‘280) is suitable for intra-articular injection, as the composition used in the claimed method, it is reasonable to assume the composition in the method taught by Hunter et al. (‘280) would have the similar viscosity as the claimed composition.
Hunter et al. (‘280) do not specify the amount of composition for intra-articular injection into each specific joint in the instant claim 80.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to determine the dosage for intra-articular injection into each specific joint. The person of ordinary skill in the art is a health care provider, pharmacist, or medicinal chemist. The claimed drug is already known in the art, the art also recognizes what conditions are treatable by the claimed drug, and the route of administration is known. The claimed dosage for intra-articular injection into each specific joint represents no more than a determination of the workable range or amount of drug for achieving the known effect. Determining optimum dosages is routine in the pharmaceutical arts. Thousands of different drugs are sold to the public by prescription or over the counter, and for each of them, the appropriate or optimal dosage has been determined.
Hunter et al. (‘280) do not teach the same claimed polymer of the sustained release microspheres in the instant claims 56, 59, 60, 76, and 78, the volume of the injection in the instant claim 56, the concertation of colchicine in the instant claims 56-58, the release profile in the instant claims 56 and 65-68, the composition comprising microspheres of both quick and slow or prolonged release of colchicine in the instant claim 75, the systemic concentration and synovial concentration of colchicine after intra-articular injection of colchicine in the instant claims 69 and 70.
This deficiency is cured by Hunter et al. (‘202) whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Hunter et al. (‘280) and Hunter et al. (‘202) to specify the polymer of the sustained release microspheres being copolymer of lactic acid and glycolic acid or poly(caprolactone) sustained release microspheres, the injection volume being 0.2 mL with 0.5 mg microspheres → 125 µg/mL anti-microtubule agent (colchicine) concertation, release 80% at 1-10 days and about 40% at 12 hours and the release relate of a drug is related to the choice of microsphere polymer blend, the composition comprising microspheres of both quick and slow or prolonged release of colchicine, the systemic concentration and synovial concentration of colchicine after intra-articular injection of colchicine. Colchicine being formulated for intra-articular injection to an involved joint for treating acute rheumatoid inflammatory arthritis as taught by Hunter et al. (‘202) was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614