Office Action Predictor
Application No. 18/240,363

DRUG COATING FOR EXPANDABLE BALLOON CATHETER AND PREPARATION METHOD THEREFOR

Non-Final OA §103§112
Filed
Aug 31, 2023
Examiner
BECKHARDT, LYNDSEY MARIE
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Bio-Heart Biological Technology CO. LTD
OA Round
1 (Non-Final)
28%
Grant Probability
At Risk
1-2
OA Rounds
4y 7m
To Grant
79%
With Interview

Examiner Intelligence

28%
Career Allow Rate
156 granted / 553 resolved
Without
With
+51.0%
Interview Lift
avg trend
4y 7m
Avg Prosecution
83 pending
636
Total Applications
career history

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
47.6%
+7.6% vs TC avg
§102
11.3%
-28.7% vs TC avg
§112
22.2%
-17.8% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§103 §112
DETAILED ACTION Claims 1-10 are currently pending. Claims 1-8 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. Election/Restrictions Applicant's election with traverse of Group I in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground(s) that the permutation and combination of the elected compositions form the elected claims results in the same synergistic efficacy and do not create an additional burden. This is not found persuasive because the search a drug coating is not coextensive with a search for a method of making said coating. The invention require a different field of search such as employing different search queries thus demonstrating a search burden. The requirement is still deemed proper and is therefore made FINAL. Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/06/2025. Applicant’s election with traverse of “ single disclosed species ” in the reply filed on 10/06/2025 is acknowledged. Applicant has not properly elected for each of the named species of drug, phospholipid, excipient and copolymerized excipient; however the species election is withdrawn in light of Applicant’s amendments to the claims and upon further consideration. Priority The instant application is a continuation of PCT/CN2023/071403, filed 01/09/2023. Information Disclosure Statement No Information Disclosure Statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 C.F.R. 1.56. Claim Rejections - 35 USC § 112 (b) 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 appl icant regards as his invention. Claim 2 is 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 2 is directed to “one or more selected from” and lists rapamycin. Instant claim 2 has unclear metes and bounds as it is unclear how one or more can be selected from a group containing only a single ingredient. 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, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN110292701 . 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]. 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 6, the limitation of the copolymerized excipient is mPEG-PLGA block copolymer is met by the ‘701 publication teaching MPEG-PDLGA [0019] . Regarding claim 8, the limitation of wherein the mass ratio of the phospholipid to the excipient is met by the ‘701 publication teaching t he 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”. I t 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 c laimed drug coating “yielding no more than one would have expected from su ch an arrangement”. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN110292701 as applied to claims 1-4, 6 and 8 above, and further in view of US 6,458,867 . As mentioned in the above 103 rejection, all of the limitations of claims 1-4, 6 and 8 are taught by the ‘701 publicati on. 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. Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN110292701 as applied to claims 1-4, 6 and 8 above, and further in view of Zweers (Zweers, Miechel L.T. et al, Journal of Controlled Resease 114 (2006) 317-324) . As mentioned in the above 103 rejection, all of the limitations of claims 1-4, 6 and 8 are taught by the ‘701 publicati on. 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 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. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LYNDSEY MARIE BECKHARDT whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7676 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Brian-Yong Kwon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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
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Prosecution Timeline

Aug 31, 2023
Application Filed
Dec 16, 2025
Non-Final Rejection — §103, §112
Mar 19, 2026
Response Filed

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Prosecution Projections

1-2
Expected OA Rounds
28%
Grant Probability
79%
With Interview (+51.0%)
4y 7m
Median Time to Grant
Low
PTA Risk
Based on 553 resolved cases by this examiner