DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This application is a national stage entry under 35 U.S.C. §371 of International Application No. PCT/CN2023/070854 filed 1/6/2023.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. §119(a)-(d) by Application No. 202211123650.6 filed 9/15/2022, which papers have been placed of record in the file.
Claims 1-10 are pending.
Election/Restrictions
Applicant's election with traverse of Group I claims 1-5, 7 in the reply filed on 2/16/2026 is acknowledged. The traversal is on the ground(s) that D1 makes no mention of the technical problem of adding nano-hydroxide to neutralize acidic degradation products. Further, D2 does not involve medical device of a joint balloon. This presents problems of dispersion issues, unpredictability, and lack of motivating suggestion.
This argument is not found persuasive since it is not necessary for D1 to teach the technical problem of the present invention. Further, D2 teaches the nanoparticles can be added to biodegradable polymers including polylactic acid copolymers. D1 discloses biodegradable polymers include PLLA, and therefore one skilled in the art would expect the nanoparticles of D2 to be dispersible with D1. Further, it is not necessary for D2 to specifically mention a joint balloon. Finally, the motivation to combine D1 and D2 is explained in detail in the rejection under 35 USC 103(a) below.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The disclosure is objected to because of the following informalities: The “single view" drawing is referred to as “FIG. 1”. In accordance with 37 CFR 1.84(u)(1), the specification should not refer to “FIG.” See CFR 1.84(u)(1).
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
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 (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.
Claims 1-3, 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shihao et al. (CN 111 821 522) in view of Jang Hye Jung et al.: "Effect of various shaped magnesium hydroxide particles on mechanical and biological properties of poly(lactic-co-glycolic acid) composites", J. Industrial Eng. Chem., vol. 59, 8 November 2017, p 266-276.
Regarding claim 1: Shihao is directed to a composition for degrading a joint balloon comprising a degradable polymer. A nano hydroxide is not mentioned.
Jang Hye Jung is directed to biodegradable polymers that comprise oligio(lactide)-grafted magnesium hydroxide nanoparticles. The nano hydroxide, and in particular Mg(OH)2, can be added to degradable polymers and co-polymers to neutralize the acidic pH deriving from the acidic by-products formed in the degradation of the polymeric scaffolds itself and thereby show an anti-inflammatory effect. The nanoparticles are reacted with OLA (equivalent to a dispersant) and used in claimed amounts. Specifically, the RA15-Mg-OLA10 nanoparticles are used in an amount of 80 wt% Mg(OH)2 and 20 wt% RA/OLA dispersant. The nanoparticles are then used in the degradable polymer in an amount of 0-20 wt% of the composition. It follows the amounts in Jang Hye Jung at least overlap the amounts recited in claim 1.
A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
One skilled in the art would have been motivated to have included the nano hydroxide polymers to neutralize the acidic pH deriving from the acidic by-products formed in the degradation of the polymeric scaffolds itself and thereby show an anti-inflammatory effect. Therefore, it would have been obvious to one skilled in the art to have included 0.1-10 parts nano magnesium hydroxide and 0.1-2 parts dispersant in the composition of Shihao.
Regarding claim 2: The Mg(OH)2 particle size is 209 ± 101 nm (108 nm-310 nm), and therefore overlaps the claimed particle size.
A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding claim 3: The particle distribution of the nano magnesium hydroxide is shown below. While the amounts at 20 nm, 50 nm and 100 nm appear slightly outside the claimed ratios, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In the present case, it is clear the properties of acidic pH deriving from the acidic by-products formed in the degradation of the polymeric scaffolds itself and thereby show an anti-inflammatory effects is the same properties of that in the present invention, and therefore a prima facia case of obviousness is provided.
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Regarding claim 5: The degradable polymer is PGA (polyglycolic acid), PLLA (polylactic acid), polycaprolactone, and copolymer of PLLA-PCL (Example 2 Shihao).
Regarding claim 7: A degradable joint balloon is disclosed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shihao et al. and Jang Hye Jung et al as applied to claim 1 above, and further in view of Kanasty et al. (US 2022/0387311).
Regarding claim 4: An inherent viscosity is not mentioned.
Kanasty is directed to a polymer used in gastric residence systems. Kanasty teaches the polymers including PCL can have an intrinsic viscosity of about 1.0-2.5 dL/g ([0383] Kanasty). One skilled in the art would have been motivated to have selected the polymers of Kanasty including PCL having the claimed intrinsic viscosity in Shihao since Shihao doesn’t mention a specific inherent viscosity, wherein Kanasty teaches the inherent viscosity of biodegradable polymers in the art. Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have selected the polymers of Kanasty including PCL having the claimed intrinsic viscosity in Shihao to arrive at claim 4 of the present invention.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT T BUTCHER whose telephone number is (571)270-3514. The examiner can normally be reached Telework M-F 9-5 Pacific Time Zone.
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/ROBERT T BUTCHER/Primary Examiner, Art Unit 1764