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.
Previous Rejections
Applicant’s arguments, filed January February March April May June July August September October November December 1234567890, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Status
Claim 11 is cancelled.
Claims 21-29 are newly added.
Claims 1-10 and 12-29 are pending.
Claims 13-20 are withdrawn.
Claims 1-10, 12, and 21-29 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Failure to further limit a previous claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS: Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 29 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 29 recites the limitation “The coating of claim 1, comprising the degradation control layer comprising a blend of a durable hydrophobic polymer and a biodegradable hydrolytic polymer, a hydrophobic layer and a drug layer,” while claim 1 recites the limitation “comprising the degradation control layer consisting of a blend of a durable hydrophobic polymer and a biodegradable hydrolytic polymer.” Emphasis by the Examiner. Since the “comprising” language set forth in claim 29 allows other elements and the “consisting of” language of parent claim 1 is closed, claim 29 improperly broadens claim 1 and does not further limit the claim as required under 35 U.S.C. 112(d).
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-10, 12, 21-24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Pacetti (US 7,645,504).
Note that this rejection has been necessarily recast in view of applicant’s amendment dated 7/29/2026.
Pacetti teaches coatings for implantable medical devices including a layer comprising a hydrophobic polymer and a layer comprising a hydrophilic polymer, reading on a “hydrolytic polymer” (Abstract). Pacetti teaches the hydrolytic polymer may be hyaluronic acid, poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate-co-valerate ), poly(glycolic acid), or poly(D,L-lactic acid) (col 2: 56-60; col 8: 51-65). This teaching reads on claims 1 and 3.
Pacetti teaches the hydrophobic polymer poly(ethylene-co-vinyl alcohol), poly(vinyl acetate), poly(ethylene-co-vinyl acetate), poly(vinyl acetals), poly(methyl methacrylate), poly(ethyl methacrylate), poly(n-propyl methacrylate), poly(iso-propyl methacrylate), poly(n-butyl methacrylate), poly( ethyl methacrylate-co-n-butyl methacrylate), poly(iso-butyl methacrylate), poly(methyl acrylate), poly( ethyl acrylate), poly(n-propyl acrylate), poly(iso-propyl acrylate), poly(n-butyl acrylate), poly(iso-butyl acrylate), poly(vinyl chloride), poly(vinyl fluoride), hexamethylene-1,6-diisocyanate-butanediol-co-polydimethylsiloxane, poly (vinylidene chloride), poly(vinylidene fluoride), poly(hexafluoropropene), poly(hexafluoropropene-co-vinylidene fluoride), poly( ethylene-co-hexafluoropropene), and polytetrafluoroethylene (col 2: 36-56). This teaching reads on claims 1 and 2.
For claim 4, Pacetti teaches the degradation layer can be about 2 microns (2,000 nm) (col 12: 53-54), within the claimed range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 5, Pacetti teaches the hydrophobic polymer and the hydrophilic (hydrolytic) polymer have a mass ratio between about 49:1 and about 19:1 (col 15, claim 1), overlapping the claimed range.
For claim 6, Pacetti teaches the coating can comprise a drug layer or reservoir (col 2: 23-27, referring to Fig. 1).
For claims 7 and 8, Pacetti teaches the drug may be an immunosuppressant such as fluorouracil, doxorubicin, sirolimus (rapamycin), tacrolimus, EVEROLIMUS®, or dexamethasone (col 9: 29 and 53-59).
For claims 9 and 10, routine optimization of Pacetti's medical device coating would have led to the claimed range of a thickness and concentration of the drug since Pacetti teaches, for example, a concentration of immunosuppressant drug (EVEROLIMUS® or 40-O-(2-hydroxy)ethyl-rapamycin) of about 0.5% to about 5% in a coating, and the person of ordinary skill in the art would have found it obvious to optimize the amount of drug in the coating to achieve the desired immunosuppressive effect.
For claim 12, Pacetti teaches the coating can comprise a topcoat layer comprising a hydrophobic polymer (col 4:1-4, referring to Fig. 1).
For claims 21 and 22, Pacetti teaches the hydrophobic polymer and the hydrophilic (hydrolytic) polymer have a mass ratio between about 49:1 and about 19:1 (col 15, claim 1), overlapping the claimed range.
For claim 23, Pacetti teaches a “method for medicating stents involves the use of a polymeric carrier coated onto the surface of a stent. A solution which includes a solvent, a polymer dissolved in the solvent, and a therapeutic substance dispersed in the blend is applied to the stent. The solvent is allowed to evaporate, leaving on the stent surface a coating of the polymer and the therapeutic substance impregnated in the polymer (col 1: 56-63).
For claim 24, Pacetti teaches the reservoir layer comprising the drug can comprise a hydrophobic polymer blended with a hydrophilic polymer such as hyaluronic acid or chitosan (col 4: 1-9 and col 2: 58-60).
For claims 26 and 27, routine optimization of Pacetti's drug coating would have led to the claimed ratio of drug to drug carrier (claim 26) or the thickness of the hydrophobic drug layer (claim 27) since Pacetti teaches, for example, a concentration of immunosuppressant drug (EVEROLIMUS® or 40-O-(2-hydroxy)ethyl-rapamycin) of about 0.5% to about 5% in a poly(ethylene-co-vinyl alcohol) coating (Example 5), and the person of ordinary skill in the art would have found it obvious to optimize the amount of drug in the coating to achieve the desired immunosuppressive effect.
For clam 28, Pacetti teaches the reservoir layer comprises a hydrophobic polymer (col 4: 1-2), and further teaches hydrophobic polymers include poly(vinylidene fluoride) (col 2: 53), styrene-butadiene-styrene triblock copolymers (col 5: 30), polyurethanes (col 8: 65), poly(methyl methacrylate) (col 16: 10), and poly(butyl methacrylate (col 16: 6).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Pacetti. However, the claimed combination of components, including the degradation layer consisting of a blend of a hydrophobic polymer and a hydrolytic polymer in the claimed amounts, is taught as known and used for coating a medical device. Further, Pacetti teaches a drug layer and a covering layer as shown in Fig. 1. It would have therefore been prima facie obvious to a person having ordinary skill in the art to utilize the claimed combination of ingredients as a coating of a medical device, with a reasonable expectation of success that the coating would provide the desired characteristics such as controlled release of an efficacious amount of an immunosuppressive drug treatment, as taught by Pacetti.
2) Claims 25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Pacetti (cited above), in view of Chen (US 8,852,620).
The teachings of Pacetti are discussed above.
Pacetti does not teach a drug carrier comprising a polymer such as polylactic acid.
Chen teaches the missing element of Pacetti.
Chen teaches medical devices having coatings comprising drug solubility, gradient-containing polymers and at least one drug (Abstract). Chen teaches the polymer can comprise two individual monomers, and one monomer may be lactide (col 3: 34; col 4: 45). Chen teaches the drug may be sirolimus (rapamycin), tacrolimus (FK506), or everolimus (col 6: 15-17).
For claim 29, Pacetti teaches a coating comprising a degradation control layer comprising or consisting of a blend of a hydrophobic polymer and a biodegradable hydrolytic polymer; a hydrophobic layer and a drug layer, as shown in Fig. 1.
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In Fig. 1, the layers of the coating are described by Pacetti as follows: the stent 1 can include an optional primer layer 2; a drug-polymer layer 3 ( also referred to as "reservoir" or "reservoir layer") 3; an optional topcoat layer 4; and a finishing coat layer 5. The drug-polymer layer 3 serves as a reservoir for the sustained release of the drug, and the reservoir layer 3 and/or the topcoat layer 4 of the stent coating can include a hydrophobic polymer, described above. The degradation layer of Fig. 1 consists of a blend of hydrophobic polymer a hydrolytic polymer, as described above, in the claimed ratio. The drug layer comprises a drug and a claimed carrier such as a polymer comprising polylactic acid, as taught by Chen.
The skilled artisan would have expected success in utilizing Chen's polylactide in Pacetti's scaffold coating because Pacetti teaches a coating that contains a drug in a pharmaceutical carrier and Chen teaches that a polymer comprising lactide as a subunit is useful for a drug releasing coating of a medical device such as stent (col 4: 7-18).
Examiner’s Reply to Attorney Arguments dated 7/29/2026
1. Rejection of claims 1-5 and 12 over Ding
The applicant argues that Ding does not teach the newly added limitation to claim 1 of a control layer consisting of a blend of polymers.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. In view of the newly added amendment to claim 1, applicant’s arguments with respect to claims 1-5 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
2. Rejection of claims 6-11 over Ding and Sun
The applicant argues that Sun does not remedy the deficiencies of Ding in view of the newly added amendment to claim 1.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. In view of the newly added amendment to claim 1, applicant’s arguments with respect to claims 6-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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)272-0580. 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
