DETAILED ACTION
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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, in the response dated 3/5/2026, is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Status
Claims 1-20 are pending.
Claims 13-20 are withdrawn.
Claims 1-12 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claim 3 contains the trademark/trade name “Dextron”, a trademark owned by the Power Plastics Corp. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polymer and, accordingly, the identification/ description is indefinite.
Claim 12 recites the term “The coating of claim 1, wherein thickness of the hydrophobic layer….” Claim 1 does not recite the term “the hydrophobic layer.” As such, there is insufficient antecedent basis for this limitation in the claim.
Obviousness Rejection
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 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 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.
1) Claims 1-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ding (CN 110124115 A; citations below are from the English Translation of CN 110124115 A provided by Espacenet).
Ding teaches a hydrophobic coating, a preparation method thereof, an application thereof and an absorbable implantable device. Ding teaches the hydrophobic coating is formed by cross-linking of hydrophobic monomers (Abstract).
Ding teaches the absorbable implantable devices is a cardiovascular stent, a cerebrovascular stent, a peripheral vascular stent, a biliary stent, an esophageal stent, an airway stent, a urethral stent, an occluder, an orthopedic implant, or an absorbable suture (pg 23: 9-14).
Ding teaches the hydrophobic polymer may be composed of polydimethylsiloxane, perfluoropolyether, or a polyvinylidene fluoride-hexafluoropropylene copolymer (pg 56, claim 3), the last of which is the elected species and reads on claim 2. Ding teaches the hydrolytic polymer may comprise polyglycolide, polyglycolic acid, poly-L-lactide, poly D,L-lactide (the elected species), polyhydroxybutyrate, poly-ε-caprolactone, poly-ε-alkane At least one of a caprolactone, a poly-delta-valerolactone, a poly-β-hydroxybutyrate, a polycarbonate, or a polyether ester (pg 57, claim 4), reading on claim 3.
For claim 4, Ding teaches the coating has a thickness of from 0.01 to 100 μm (10 nm to 100,000 nm), overlapping the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. As the limitation of claim 12 are interpreted by the Examiner as identical to those of 4, claim 12 is also rejected by this teaching of Ding.
For claim 5, Ding teaches the coating has a mass ratio of the hydrophobic monomer to the non-degradable component of 1:100 to 1:0.01, overlapping the claimed range.
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Ding. However, the claimed combination of components, including the hydrophobic polymer and biodegradable hydrolytic polymer, is taught as known and used as a coating for a bioresorbable scaffold such as a stent. It would have therefore been prima facie obvious to a person having ordinary skill in the art to utilize the coating comprising the claimed combination of ingredients, including the elected polymers of PVDF-HFP and poly-D,L-lactic acid on a bioresorbable scaffold with a reasonable expectation of success that the treatment would be efficacious, as taught by Ding.
2) Claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ding (cited above), in view of Sun (US 2019/0365959 A1).
The teachings of Ding are discussed above.
Ding does not teach a drug or drug layer on the absorbable implantable devices.
Sun teaches the missing elements of Ding.
Sun teaches drug eluting stents, wherein the stents contain a drug-containing layer (Abstract). Sun teaches the drug layer may comprise sirolimus, a drug used to coat coronary stents; the drug also has immunosuppressant functions. The drug layer may contain other active agents such as paclitaxel, everolimus, tacrolimus, and zotarolimus (pg 13, [0234]; pg 21, claim 75). These teachings read on claims 6-8.
For claim 9, Sun teaches a stent utilized in an in vivo rabbit model comprising a drug-containing layer of biodegradable polymer (PLGA, 3.5-10 mm) (pg 16, [0267]). See also pg 14, [0237] (“In some embodiments, the stent has a drug content of from about 5 μg to about 500 μg.”)
For claim 10, Sun teaches the drug amount per area is with 1.4 mg/mm2 of sirolimus ([0267]). While not an amount of drug per unit length of the coating, the coating must necessarily have an area, as taught by Sun. As such, routine optimization of Sun's coating would have led to the claimed range of mass of drug per length since one of ordinary skill can determine the amount of, in this assay, for example, an amount of drug that achieves the improvement in the implantation.
For claim 11, Sun teaches “the content of the drug in the drug-containing layer is from 0.5-50% by weight” (pg 14, [0237]), overlapping the claimed range.
The skilled artisan would have expected success in applying Sun's drug-comprising coating to the scaffold taught by Ding because Ding teaches a scaffold comprising the claimed durable hydrophobic polymer is useful as a stent and Sun teaches a stent comprising the claimed drug sirolimus, in the claimed amount,
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
Prosecution Insights