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 .
Any new grounds of rejection set forth below are necessitated by Applicant’s amendment. For this reason, the present action is properly made final.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claims 1-10 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite …wherein the nano hydroxide and the dispersant are combined by physical mixing… However, support cannot be found. No examples are given that comprise physical mixing, and a method comprising physically mixing is not mentioned.
Claims 2-5, 7 are subsumed by this rejection because of their dependence.
Claim Rejections - 35 USC § 103
Claims 1-2, 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 nanohydroxide and dispersant are combined by physically mixing when reacted together (p. 6918 Figure 1 and Results and Discussion). 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 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.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Specifically, while Lih discloses the particle distribution of the nano magnesium hydroxide shown below, a particle size of 20 nm, 50 nm, and 100 nm in a weight ratio of (2-4):(4-6):(1-3) is not reasonable suggested. Further, Applicant has demonstrated the claimed particle size and weight ratios leads to burst pressure and folding performance as well as a synergistic effect.
PNG
media_image1.png
187
243
media_image1.png
Greyscale
Response to Arguments
Applicant's arguments filed 6/12/2026 (herein “Remarks”) have been fully considered but they are not persuasive.
Applicant argues Lih fails to teach or suggest a composition wherein “the nano hydroxide and the dispersant are combined by physical mixing”. Shihao fails to teach or suggest this limitation because Shihao is silent as to the nano hydroxide. Lih teaches OLA chemically grafted to the surface of MgOH2 particles to form RA15-Mg-OLA10. However, Lih fails to teach or suggest OLA being physically mixed with unmodified Mg(OH)2 particles. On page 6919, Lih teaches away from using unmodified particles since unmodified PLGA/Mg(OH)2 was excluded from the experimental group.
This argument is not found persuasive since it is hard to imagine how the RA15-Mg-OLA10 without mixing unmodified particles with PLA. Although the two are chemically bonded, a step of mixing is required and not excluded by the present claims.
Applicant argues regarding claim 3, the use of Titanium Metals is not applicable because Lih does not teach a particle distribution for unmodified nano hydroxide. Applicant has demonstrated the claimed particle size and weight ratios leads to burst pressure and folding performance as well as a synergistic effect.
This rejection has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lanee Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT T BUTCHER/Primary Examiner, Art Unit 1764
Prosecution Insights