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 June 2, 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-18, in the response dated 6/2/2026, is acknowledged. The traversal is on the ground(s) that dependent claims 19 and 20 incorporate all of the features of claim 1; that restriction requirements are “optional in all cases”; and that there is no undue burden on the Examiner to search the subject matter of all of Groups I, II, and III.
The Examiner acknowledges each of these arguments but is not persuaded. While claims 19 and 20 recite the limitations of claim 1, they also recite limitations not recited in claim 1 that require a search beyond the search for the limitations of claim 1. Specifically, claim 19 requires the additional search of a balloon catheter and claim 20 requires the additional search of a method of inserting a medical device, a limitation not recited in claim 1.
Regarding the argument the optional nature of restrictions and undue burden, since the inventions of claims 19 and 20 are distinct in view of separate status in the art in view of different classification from Group I and the requirement of employing different search strategies in view of the fact that the inventions of Group II and Group III require a search of a balloon catheter (claim 19) or a medical device insertion method (claim 20).
The requirement is still deemed proper and is therefore made FINAL.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim Status
Claims 1-20 are pending.
Claims 19-20 are withdrawn.
Claims 1-18 are examined on the merits in this prosecution.
CLAIM REJECTIONS
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 1-9, 12-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Alargova (US 9,750,818; of record), in view of Wang (US 2014/0017165 A1; cited hereinafter as “Z. Wang”; of record).
Alargova teaches pharmaceutical formulations comprising nanoparticles and microparticles containing conjugates of an active therapeutic agent (Abstract). It is noted that the conjugates of Alargova are considered analogs or derivatives of the active agent, and the instant specification discloses the active agent may be in the form of analogs or derivatives (Specification, [0198]).
For claim 1, Alargova teaches the conjugate or active agent can be encapsulated (col 156: 18-19; col 158: 6-13). Alargova teaches the particles may comprise suitable neutral and anionic lipids including synthetic, saturated and unsaturated, 1,2-diacyl-sn-glycero-3-phosphocholines, such as 1,2-diheptanoyl-sn-glycero-3-phosphocholine, or 1-acyl-2-acyl-sn-glycero-3-phosphocholines (col 142: 12-13 and 32-35; col 154: 63-65).
Regarding the newly added limitation to claim 1 of “a therapeutic agent that is sirolimus, paclitaxel, or a combination thereof,” Alargova teaches the active agent may be a conjugate of paclitaxel (col 28:17). Alargova teaches “Conjugates include an active agent or prodrug thereof attached to a targeting moiety, e.g., a molecule that can bind to an SSTR [somatostatin receptor], by a linker (col 25: 27-30). Therefore, Alargova meets the newly added limitation since it teaches the “active agent” or chemotherapeutic agent (col 26: 19-24) is paclitaxel, and the remainder of the conjugate is a targeting moiety, not an active agent. Furthermore, the instant specification discloses: “The therapeutic agent can include paclitaxel, docetaxel, taxol, an mTOR inhibitor, rapamycin, sirolimus, zotarolimus, everolimus, tacrolimus, umirolimus, an analogue thereof, and combinations thereof ([0072]; emphasis by the Examiner). As such, the instant Specification teaches the therapeutic agent may be an analogue of paclitaxel.
Alargova teaches: “The conjugates can be present on the interior of the particle, on the exterior of the particle, or both. The particles may comprise hydrophobic ion-pairing complexes or hydrophobic ion-pairs formed by one or more conjugates” (col 137: 51-55). Alargova further teaches “In some embodiments, the particles are polymeric particles or contain a polymeric matrix” (col 135: 59-63), and the polymer or the matrix may comprise neutral and/or anionic particles (col 142: 12-35).
For claim 2, Alargova teaches paclitaxel as a therapeutic agent (col 28: 17-18), and the conjugated paclitaxel is present in about 20% to about 30% or about 60% to about 70% of the particle (col 139: 7-19).
For claim 3, Alargova teaches the particles may contain poly(lactic acid-co-glycolic acids). See col 140: 12-15.
For claim 4, Alargova teaches the particles have a diameter of 200-5000 nm (0.2 mm to 5 mm; col 9: 49-57), or from 10 nm to about 1 micron (col 142: 4-8), within or overlapping the claimed range. Because the claimed range overlaps with, or is within, the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 5, Alargova teaches DSPC in the in the polymer-encapsulated drug particle (col 143: 13-27). Alargova teaches the weight of the conjugate is from 0.05%; as such, the weight of the polymers and other ingredients in the particle is up to 99.95% (col 139: 7-19). Wang further teaches the amphiphilic compound such as DSPC is from 0.01 to 60 (wt phospholipid/wt of polymer) (col 143: 32-40). As such, Alargova provides one or ordinary skill with sufficient guidelines to construct the claimed drug-releasing coating with a reasonable expectation of success.
For claim 6, Alargova teaches the combination of the polymer encapsulated drug particles and release matrix are useful for a desired release profile (col 138: 16-19 and 29-38). As such, one of ordinary skill can, determine the concentration of drug particles within the coating with a reasonable expectation of success since the quantity of release matrix and first ionic additive and second ionic additive would be expected to control the rate of drug release
For claims 12 and 13, Alargova teaches antioxidants such as butylated hydroxytoluene may be added to the coating composition (col 146: 64 to col 147: 2).
Alargova does not teach a matrix comprising a second ionic or zwitterionic additive.
Z. Wang teaches the missing element of Alargova.
Z. Wang teaches a delivery system for drug delivery comprising nanoparticles comprising PLGA, PEG, and/or a charged polymer in a polymeric matrix (Abstract; pg 6, [0055]). Z. Wang teaches the particles can comprise anti-cancer agents such as paclitaxel (pg 3, [0039]).
For claim 7, Z. Wang teaches a release matrix comprising lipids (pg 6, [0061]), wherein the lipids may be phospholipids (pg 6, [0064]), and specifically teaches the examples of 1,2-dioleoyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, and 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (pg 7, [0066]).
For claims 8 and 9, Z. Wang teaches a release matrix comprising cationic polymers such as polylysine (pg 6, [0056]).
The skilled artisan would have expected success in substituting Z. Wang's release matrix comprising a zwitterionic additive such as 1,2-dioleoyl-sn-glycero-3-phosphocholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, and 1,2-dipalmitoyl-sn-glycero-3-phosphocholine in the drug release coating of Alargova, in the amounts recited in claim 7 because Z. Wang and Alargova teach the matrix is useful for manipulating the kinetics of active agent release rate.
2) Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Alargova (cited above), in view of Z. Wang (cited above) and Hsu (US 8,357,386; of record).
The teachings of Alargova and Z. Wang are discussed above.
The combination of Alargova and Z. Wang does not teach a drug releasing coating that is an anionic polymer such as hyaluronic acid.
Hsu teaches the missing element of the combination of Alargova and Z. Wang.
Hsu teaches a drug coating for a medical device comprises one or more drug composite layers. The drug composite layer comprises one or more therapeutic agents dispersed within one or more modified bioactive binders (Abstract). Hsu teaches the drug may be paclitaxel or rapamycin (sirolimus) (col 8: 2-6). Hsu teaches the second ionic layer can comprise hyaluronic acid (col 6: 46), for the purpose of binding a therapeutic agent (col 4: 1-5).
The skilled artisan would have expected success in substituting Hsu's hyaluronic acid for the cationic polymer in the composition of the combination of Alargova and Z. Wang since Hsu teaches that the negatively charged hyaluronic acid would be useful in binding therapeutic agents, presumably therapeutic agents with a positive charge, in contrast to the positively charged polyamines taught by Z. Wang, which would bind anionic or negatively charged therapeutic agents.
Regarding the amount of anionic polymer in the second ionic or zwitterionic polymer in the claimed coating, since the purpose of the coating is to control the release rate of the active agent, one of ordinary skill can determine the optimal amount of polymer constituents by routine experimentation.
3) Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Alargova (cited above), in view of Z. Wang (cited above) and Chappa (US 8,927,000; of record).
The teachings of Alargova and Z. Wang are discussed above.
The combination of Alargova and Z. Wang does not teach a topcoat comprising a third ionic or zwitterionic addition that is an anionic polymer such as hyaluronic acid.
Chappa teaches the missing element of the combination of Alargova and Z. Wang.
Chappa teaches compositions for delivering therapeutic agents from a medical device, wherein the therapeutic agents include paclitaxel (Abstract; col 38: 36-38). Chappa teaches that a coating on the medical device also provides a coating on the particles that include the bioactive agent (col 2: 49-56), or the coating can be a topcoat over the bioactive agent (col 29: 22-24). Chappa teaches the coating can comprise a lipid such as steric acid, hexanoic acid, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, and/or 1,2-distearoyl-sn-glycero-3-phosphocholine (col 5: 64 to col 6: a col 8: 5-7).
For the amount of third ionic or zwitterionic additive in the topcoat layer, and the ratio of third ionic or zwitterionic additive to active agent as recited in claim 14, and the amount of topcoat required as recited in claim 18, routine optimization of the coatings taught by Chappa would have led to the claimed amounts because Chappa teaches that the coating is present to provide the desired release rate of a drug such as sirolimus or paclitaxel (col 34: 12-23), and one of ordinary skill in the art would have found it obvious to optimize the amount of coating required to release the active agent at the desired rate, and preparing such a formulation would have required only routine experimentation.
For claim 16, Z. Wang teaches the addition of BHT to the dosage form (pg 12, [0113]); one of ordinary skill is able to determine the location in the dosage form of the preservative and the amount of preservative required. It is noted that Chappa teaches excipients, including antioxidants and preservatives (col 34: 25-33).
For claim 17, Chappa teaches paclitaxel particles in a particle size of about 1-3 mm (col 38: 36-38).
The person of ordinary skill would have had a reasonable expectation of success in selecting a topcoat layer comprising a third ionic or zwitterionic additive comprising steric acid, hexanoic acid, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, and/or 1,2-distearoyl-sn-glycero-3-phosphocholine in the composition of the combination of Alargova and Z. Wang since Chappa teaches that the third layer comprising these elements is useful in releasing a bioactive agent in the desired amount and rate, and at a desired location when the topcoat containing the third ionic or zwitterionic additive is, or is not, coated on a delivery device. With regard to a composition comprising both a second and third additive for controlling rate, generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1. Claims 1-8 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of US 12,576,037 (formerly Application No. 17/180,338).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application always recite a drug-releasing coating comprising: the polymer-encapsulated drug particles of claim 1; and a release matrix comprising a second ionic or zwitterionic additive, wherein the second ionic or zwitterionic additive comprises a cationic molecule, an anionic molecule, a mismatched charged lipid and/or phospholipid. However, since this polyol reads upon the instantly recited limitation, the copending claims read upon the instantly recited composition.
2. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-17 of copending Application No. 18/672,320 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application always recite a drug-releasing coating comprising: the polymer-encapsulated drug particles of claim 1; and a release matrix comprising a second ionic or zwitterionic additive, wherein the second ionic or zwitterionic additive comprises a cationic molecule, an anionic molecule, a mismatched charged lipid and/or phospholipid. However, since this polyol reads upon the instantly recited limitation, the copending claims read upon the instantly recited composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 18-19 of copending Application No. 19/081,631 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims in the reference application always recite a drug-releasing coating comprising: the polymer-encapsulated drug particles of claim 1; and a release matrix comprising a second ionic or zwitterionic additive, wherein the second ionic or zwitterionic additive comprises a cationic molecule, an anionic molecule, a mismatched charged lipid and/or phospholipid. However, since this polyol reads upon the instantly recited limitation, the copending claims read upon the instantly recited composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
.
Examiner’s Reply to Attorney Arguments dated 6/2/2026
1. Rejection of claims 1-9, 12-13 and 17-18 under 35 U.S.C. § 103 over Alargova and Wang.
The applicant argues that Alargova teaches conjugates of an active agent bonded to a targeting moiety through a linker and “the claim language recites a therapeutic agent, not a conjugate.” The applicant argues the stated motivation does not address the fundamental structural distinction between Alargova's conjugate-containing particles and the claimed polymer-encapsulated free therapeutic agent particles.
As discussed above, the active agent (or therapeutic agent) taught by Alargova is paclitaxel. The broadest reasonable interpretation of claim 1, as understood by the Examiner, includes paclitaxel comprising another element since Alargova teaches paclitaxel as the active pharmaceutical agent and the somatostatin receptor binding moiety as a targeting element, not a therapeutic agent. Furthermore, the instant Specification discloses “analogs” of paclitaxel as active agents that are acceptable as therapeutic agents.
The applicant argues that Wang does not suggest that its matrix system would be useful in combination with Alargova's targeted conjugate nanoparticles, nor does Wang address the use of a release matrix in combination with sirolimus or paclitaxel.
The Examiner acknowledges the argument presented, but does not consider it persuasive. As discussed above, Wang teaches a missing element of Alargova, namely a matrix comprising a second ionic or zwitterionic additive. Wang teaches a system for drug delivery comprising nanoparticles comprising PLGA, PEG, and/or a charged polymer in a polymeric matrix, that can comprise anti-cancer agents such as paclitaxel. Wang teaches advantages of the matrix include a means of modified release of the active agent. Such an advantage of modified release is an advantage also taught by Alargova (col 45: 4-10). Alargova also suggests that controlled release solid dosage forms can be prepared using coating technologies well known in the art (col 154: 6-14). As such, the teachings of Wang provide a coating system for the particles of Alargova that provide for controlled release of the active agent. See MPEP 2143, rationale (C), “Use of known technique to improve similar devices (methods, products) in the same way.”
It is noted that Wang teaches anti-cancer agents such as paclitaxel can be included in the formulation (pg 3, [0039]).
The applicant argues the proposed combination of Alargova and Wang appears to rely on impermissible hindsight. Both references are directed to free-circulating nanoparticles for systemic administration in cancer treatment, not to drug-releasing coatings for medical devices.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Regarding the allegation of impermissible, MPEP 2145(X)(A) states: "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In the instant case, both Alargova and Wang were publicly available prior to the filing of the instant application.
It is further noted that the claims are not drawn to drug-releasing coatings for medical devices, but to a drug-releasing coating comprising a therapeutic agent. As such, permissible drug delivery methods at least include the “tablets, dragees, capsules, pills, and granules” of Alargova (col 154: 7-8).
2. Rejection of claims 10-11 under 35 U.S.C. § 103 over Alargova, Wang, and Hsu.
The applicant argues at page 13 of the Remarks that Hsu does not overcome the alleged defects of the combination of Alargova and Wang.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As set forth above, it is the position of the Examiner that claim 1 is properly rejected. Since the applicant did not set forth additional arguments regarding the correctness of the rejection of claims 10-11, the rejection of these claims is considered proper and is maintained.
3. Rejection of claims 14-18 under 35 U.S.C. § 103 over Alargova, Wang, and Chappa.
The applicant argues at page 13 of the Remarks that Hsu does not overcome the alleged defects of the combination of Alargova and Wang.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As set forth above, it is the position of the Examiner that claim 1 is properly rejected. Since the applicant did not set forth additional arguments regarding the correctness of the rejection of claims 14-18, the rejection of these claims is considered proper and is maintained.
4. Provisional rejection of claims 1-8 and 11 for nonstatutory double patenting as being unpatentable over claims 13-17 of copending Application No. 17/180,338 (now USP 12,576,037).
The applicant “takes note of these rejections but does not take further action at this time inasmuch as no pending claim has yet to be allowed. Applicant will re-evaluate this rejection upon an indication of allowable claims.”
A complete response to a nonstatutory double patenting rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804. Because Applicant' s Remarks are nonresponsive to the rejections of record, the rejections are properly maintained and made again.
5. Provisional rejection of claims 1-16 for nonstatutory double patenting as being unpatentable over claims 1-3 and 15-7 of copending Application No. 18/672,320.
The applicant “takes note of these rejections but does not take further action at this time inasmuch as no pending claim has yet to be allowed. Applicant will re-evaluate this rejection upon an indication of allowable claims.”
A complete response to a nonstatutory double patenting rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Because Applicant' s Remarks are nonresponsive to the rejections of record, the rejections are properly maintained and made again.
5. Provisional rejection of claims 1-16 for nonstatutory double patenting as being unpatentable over claims 13-15 and 18-19 of copending Application No. 19/081,631.
The applicant “takes note of these rejections but does not take further action at this time inasmuch as no pending claim has yet to be allowed. Applicant will re-evaluate this rejection upon an indication of allowable claims.”
A complete response to a nonstatutory double patenting rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804. Because Applicant' s Remarks are nonresponsive to the rejections of record, the rejections are properly maintained and made again.
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
Prosecution Insights