DETAILED ACTION
Claims 1-5 and 8-10 are currently pending. Claims 1-5 and 8 are currently under examination.
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
Applicant’s Informational Disclosure Statement, filed on 03/19/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claim 2 under 112(b) is withdrawn in light of Applicant’s amendment to remove “one or more of” in instant claim 2, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 03/19/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 03/19/2026, it is noted that claims 1-2 and 8 have been amended and no new matter or claims have been added.
Modified Rejection:
The following rejections are modified based on Applicant’s claim amendments.
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.
Claim(s) 1-4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN110292701 (previously applied) and Zweers (previously applied).
Regarding claim 1, the limitation of a drug coating for an expandable balloon catheter comprising the following preparation of raw materials in parts by weight of 20-28 parts of drug, 10-17 parts of phospholipid, 5-60 parts of an excipient and 5-60 parts of a copolymerized excipient is met by the ‘701 publication teaching a drug eluting balloon catheter [0001]. The drug preparation for coating the drug eluting balloon catheter is taught to dissolve the drug and biodegradable polymer in an organic solvent containing an emulsifier to form a microsphere suspension and disperse the drug suspension in an aqueous solution containing phospholipids and an excipient ([0014]-[0017]). The drug is taught to be rapamycin at 1-500 mg/ml [0018]. The biodegradable polymer is chosen from a list which includes MPEG-PDLGA at 1 to 500 mg/ml [0019]. The phospholipid is taught to include soybean lecithin at 0.2-3% by mass [0023]. The excipient is taught to be selected from a group which includes polyethylene glycol at 0.01-10% [0024]. The limitation of the copolymerized excipient is mPEG-PLGA block copolymer is met by the ‘701 publication teaching MPEG-PDLGA [0019].
That being said and in lieu of objective evidence of unexpected results, the coating ingredients can be viewed as a variable which achieves the recognized result of successfully releasing the drug in a patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
It would have been prima facie obvious to one ordinary skill in the art before the filing date of the claimed invention to optimize the amounts of drug, phospholipid, excipient and copolymerized excipient as the ‘701 publication teaches a range for each ingredient. As MPEP 2144.05 recites “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 optimization”.
Regarding claim 2, the limitation of wherein the drug is rapamycin is met by the ‘701 publication teaching rapamycin [0018].
Regarding claim 3, the limitation of wherein the phospholipid is soybean phospholipid is met by the ‘701 publication teaching soybean lecithin as the phospholipid [0023].
Regarding claim 4, the limitation of wherein the excipient is PEG is met by the ‘701 publication teaching PEG [0024].
Regarding claim 8, the limitation of wherein the mass ratio of the phospholipid to the excipient is met by the ‘701 publication teaching the phospholipid is taught to include soybean lecithin at 0.2-3% by mass [0023]. The excipient is taught to be selected from a group which includes polyethylene glycol at 0.01-10% [0024]. As MPEP 2144.05 recites “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 optimization”.
The ‘701 publication does not specifically teach a number-average molecular weight of mPEG in the mPEG-PLGA block copolymer is 200-8,000 and a number average molecular weight of PLGA is 5,000-60,000 (claim 7).
Zweers teaches rapamycin loaded nanoparticles based on poly(ethylene oxide) and poly(D,-lactic-glycolide) block copolymers (PEO-PLGA) were prepared without additional stabilizer (abstract). PEO block is taught to be 3,000 g/mol and PLGA block is taught to be 8,2000 g/mol (2.1 materials). The PEO-PLGA nanoparticle are taught as carrier for restenoic agents (page 318, first column, first paragraph).
It must be remembered that “[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.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a drug, phospholipid, excipient and copolymerized excipient in the disclosed ranges) from within the prior art disclosure of the ‘701 publication, to arrive at the instantly claimed drug coating “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the mPEG-PLGA copolymer in block form in the molecular weight as taught by Zweers for the biodegradable polymer taught by the ‘701 publication because the ‘701 publication teaches the use of drug and biodegradable polymer of MPEG-PLGA to form particles and Zweers teaches the formation of rapamycin PEO-PLGA nanoparticles. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘701 publication teaches the combination of rapamycin and m-PEG-PDLGA and the Zweens teaches the PEO PLGA to be known to be formed in block form of specific molecular weights used in combination of rapamycin, thus it would be obvious to use the known block formation of the copolymer and molecular weights as taught by Zweens for the copolymer taught by the ‘701 publication.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN110292701 as applied to claims 1-4 and 8 above, and further in view of US 6,458,867 (previously applied).
As mentioned in the above 103 rejection, all of the limitations of claims 1-4 and 8 are taught by the ‘701 publication.
The ‘701 publication does not specifically teach wherein a number average molecular weight of the PEG is 8,000-30,000 (claim 5).
The ‘867 patent teaches a medical device comprising an inner and outer surface (abstract). Hydrophilic compounds have been used to impart lubricity in medical devices. The lubricous coating for a medical balloon and catheter are taught (column 2, lines 50-67). Lubricous hydrogel coating is taught. Blood compatible coatings is polyethylene glycol, methoxy polyethylene glycol or mixtures thereof having a molecular weight between about 100 and 20,000 grams per mole (column 3, lines 1-15).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the molecular weight of PEG as taught by the ‘867 patent for the PEG taught by the ‘701 publication because the ‘701 publication and the ‘867 publication are both directed to catheters with PEG coatings. It would have been prima facie obvious to one of ordinary skill in the art to use known PEG molecular weights in catheter coatings for the PEG containing catheter coating taught by the ‘701 publication. Oe of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the PEG taught by the ‘867 publication in the coating taught by the ‘701 publication and optimize the molecular weight as the ‘867 patent teaches the PEG coating to be blood compatible and known to be used on catheters.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘701 publication
Applicant argues the technical problem to be solved is how to provide a drug coating for an expandable balloon catheter, which has a high drug utilization rate and may be realize a controllable drug release. The inventor has surprisingly found that when the molecular weight of the mPEG is smaller, a drug release rate is more gentle, when the molecular weight of the mPEG is increased the drug release rate is also correspondingly faster and when it reaches mPEG 8,000, an obvious burst release occurs. These results are unexpected and not predictable from the ‘701 publication. The phospholipid prevents the coating from being washed away by blood in a delivery process of a balloon. Burst occurs and an effect of a long-term sustained release may not be achieved. Applicant points to Figure 2.
In response, the ‘701 publication teaching a drug eluting balloon catheter [0001]. The drug preparation for coating the drug eluting balloon catheter is taught to dissolve the drug and biodegradable polymer in an organic solvent containing an emulsifier to form a microsphere suspension and disperse the drug suspension in an aqueous solution containing phospholipids and an excipient ([0014]-[0017]). The drug is taught to be rapamycin at 1-500 mg/ml [0018]. The biodegradable polymer is chosen from a list which includes MPEG-PDLGA at 1 to 500 mg/ml [0019]. The phospholipid is taught to include soybean lecithin at 0.2-3% by mass [0023]. The excipient is taught to be selected from a group which includes polyethylene glycol at 0.01-10% [0024]. Zweers teaches rapamycin loaded nanoparticles based on poly(ethylene oxide) and poly(D,-lactic-glycolide) block copolymers (PEO-PLGA) were prepared without additional stabilizer (abstract). PEO block is taught to be 3,000 g/mol and PLGA block is taught to be 8,2000 g/mol (2.1 materials). The PEO-PLGA nanoparticle are taught as carrier for restenoic agents (page 318, first column, first paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the mPEG-PLGA copolymer in block form in the molecular weight as taught by Zweers for the biodegradable polymer taught by the ‘701 publication because the ‘701 publication teaches the use of drug and biodegradable polymer of MPEG-PLGA to form particles and Zweers teaches the formation of rapamycin PEO-PLGA nanoparticles. Thus, it would be obvious to one of ordinary skill in the art to use the molecular weights as taught by Zweers for the mPEG-PLGA taught by the ‘701 publication, wherein the release rate Applicant states is unexpected would necessarily be present as Zweers teaches mPEG-PLGA in the claimed range. Additionally, the examples presented are directed to a specific amount of mPEG-PLGA, 60 parts, wherein the claims are more broadly directed to 5-60 parts. Thus, Applicant’s results are not commensurate in scope with the instant claims. Further, Shi teaches PLGA-mPEG wherein higher mPEG proportion shows faster Mw reduction rate, mass loss rate and size decrease rate according to the in vitro degradation experiment (abstract, Table). Thus, the increase in molecular weight of mPEG in a mPEG-PLGA copolymer would be expected to increase release rate, and thus is not an unexpected property but routine optimization.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. 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.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
Prosecution Insights