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 .
Receipt is acknowledged of Applicant’s Argument filed on 03/02/2026.
Claims 1-9, 11-26 are pending in the instant application.
Claims 5, 19-25 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-9, 11-18, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,771,543; 11,103,613; 10,414,864; 10,280,261; 10,537,660; 9,988,492; 9,745,414 in view of GOMURASHVILI et al (US 2009/0253809) and PULAPURA et al (US 2012/0052292).
The patents recite an amino acid-based poly(ester urea) polymer (see US 9,745,414; at claim 1).
The patents do not recite drug or mesh pouch has a shape for encasing a medical device.
GOMURASHVILI teaches a polymer composition comprised of poly(ester urea) (PEU) consisted of nontoxic building blocks, such as amino acids (see abstract; [0003]; formula at [0041]-[0042]), which reads on amino acid-based poly(ester urea) polymers and Applicant’s formula; bioactive agents can be dispersed/mixed with the polymer within the composition (see [0024]-[0025]), such as antibiotics (see [0084]). The polymer composition can shaped into various articles, such as pins and screws (see [0032]), or used as an over coating of articles of manufacturer to control release any dispersed bioactive agent (see [0181]-[0183]). Additional disclosures include: porosity in the composition (see [0136]).
PULAPURA teaches the prior art had known of biodegradable/resorbable polymer coatings (see [0013]), wherein the polymer coating includes a drug, such as an antibiotic (see abstract), to avoid infection (see [0005]-[0007]). Additional disclosures include: mesh pouches (see [0187]; [0204]); coating medical devices (see [0096]), such as screws (see [0202]), or form pouches, coverings, pockets for implantable medical devices (see [0204]), such as pacemaker (see [0204]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a drug, such as an antibiotic. The person of ordinary skill in the art would have been motivated to make those modifications, because it would prevent infections, and reasonably would have expected success because the references dealt in the same field of endeavor, such as polymer coatings.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the coating as a mesh pouch for medical devices, such as a pacemaker, and covering the medical device completely. The person of ordinary skill in the art would have been motivated to make those modifications, because it would prevent infection when implanting the medical device, and reasonably would have expected success because the references dealt in the same field of endeavor, such as polymer coatings.
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.
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, 6-9, 11-18, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over BECKER et al (herein after “BECKER2”; US 2016/0250382) in view of PULAPURA et al (US 2012/0052292).
BECKER2 teaches a resorbable amino acid-based poly(ester urea) polymer (see abstract), wherein the polymer has the same formula as claimed by Applicant. Additional disclosures include: prior art biodegradable polymers have been applied to a number of applications in drug delivery and regenerative medicine (see [0003]); porosity can be controlled in the electrospinning process (see [0065]); the polymer may be formed into a wide variety of 3-dimensitonal structures include tissue scaffolds, coatings and films (see [0064]).
BECKER2 does not teach using a drug, such as an antibiotic; or the details of coating what object, such as medical devices; or mesh pouch with a shape for encasing a medical device.
PULAPURA teaches the prior art had known of biodegradable/resorbable polymer coatings (see [0013]), wherein the polymer coating includes a drug, such as an antibiotic (see abstract), to avoid infection (see [0005]-[0007]). Additional disclosures include: mesh pouches (see [0187]; [0204]); coating medical devices (see [0096]), such as screws (see [0202]), or form pouches, coverings, pockets for implantable medical devices (see [0204]), such as pacemaker (see [0204]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a drug, such as an antibiotic, and completely coat the medical device. The person of ordinary skill in the art would have been motivated to make those modifications, because it would prevent infections, and reasonably would have expected success because the references dealt in the same field of endeavor, such as polymer coatings.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the coating as mesh pouch for medical devices, such as a pacemaker, and covering it 100% completely. The person of ordinary skill in the art would have been motivated to make those modifications, because it would prevent infection when implanting the medical device, and reasonably would have expected success because the references dealt in the same field of endeavor, such as polymer coatings, and the prior art had known of coatings and mesh pouches.
The references do not specifically teach the porosity and drug evenly distributed as claimed by Applicant. The porosity and drug evenly distributed in a porous drug coating composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal porosity and drug evenly distributed in order to best achieve the desired results, such as electrical need of the pacemaker and evenly controlled drug release. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Claim(s) 1-4, 6-9, 11-18, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOMURASHVILI et al (US 2009/0253809) in view of PULAPURA et al (US 2012/0052292).
GOMURASHVILI teaches a polymer composition comprised of poly(ester urea) (PEU) consisted of nontoxic building blocks, such as amino acids (see abstract; [0003]; formula at [0041]-[0042]), which reads on amino acid-based poly(ester urea) polymers and Applicant’s formula; bioactive agents can be dispersed/mixed with the polymer within the composition (see [0024]-[0025]), such as antibiotics (see [0084]). The polymer composition can shaped into various articles, such as pins and screws (see [0032]), or used as an over coating of articles of manufacturer to control release any dispersed bioactive agent (see [0181]-[0183]). Additional disclosures include: porosity in the composition (see [0136]).
GOMURASHVILI does not teach mesh pouches; or a specific medical device, such as a pace maker.
PULAPURA teaches the prior art had known of biodegradable/resorbable polymer coatings (see [0013]), wherein the polymer coating includes a drug, such as an antibiotic (see abstract), to avoid infection (see [0005]-[0007]). Additional disclosures include: mesh pouches (see [0187]; [0204]); coating medical devices (see [0096]), such as screws (see [0202]), or form pouches, coverings, pockets for implantable medical devices (see [0204]), such as pacemaker (see [0204]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the polymer coating as mesh pouch for medical devices, such as a pacemaker, and coating/covering the medical device completely or as necessary. The person of ordinary skill in the art would have been motivated to make those modifications, because it would prevent infection when implanting the medical device, and reasonably would have expected success because the references dealt in the same field of endeavor, such as polymer coatings, and the prior art had known of coatings and mesh pouches for medical devices.
The references do not specifically teach the porosity and drug evenly distributed as claimed by Applicant. The porosity and having the drug evenly distributed in a porous drug coating composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal porosity and drug evenly distributed in order to best achieve the desired results, such as drug release rate and evenly/constant controlled drug release. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Response to Arguments
Applicant argues that Becker2 discloses resorbable amino acid-based poly(ester urea) polymer or copolymer scaffold for vascular graft tissue engineering. The Office concedes that Becker2 does not teach "using a drug, such as an antibiotic, or the details of coating what object, such as medical devices, wherein coating reads on a pouch with a shape for encasing a medical device." (OA at 9). And while Becker2 does speak in general terms of forming the amino acid-based poly(ester urea)s into a "wide variety of 3-dimensional structures" it does not teach or reasonably suggest that the polymers in these structures would be "drug loaded." Nor does it teach or reasonably suggest a structure formed into a "freestanding mesh pouch . . . [having] a shape for encasing a medical device" that are large enough that "said pouch encases at least 50% of the volume of said medical device," as recited in claim 1 or a "freestanding resorbable mesh pouch sized to at least partially enclose an implantable medical device" ... that is large enough that "said pouch encases at least 50% of the volume of said medical device," as recited in claim 12.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, the secondary reference PULAPURA teaches these limitations.
Applicant argues that Pulapura does little to address the shortcomings of Becker2. Pulapura is directed to a coating for medical devices. \Vhile the coating disclosed in Palapura may contain a drug, these coatings use completely different polymers, namely tyrosine-derived polyarylates, linear polyesteramides, dihydroxybenzoate polymers, and resorcinol- derived polymers. (See, Pulapura at Abstract). As set forth above, claims 1 and 12 are directed to a "freestanding" mesh pouch or a "freestanding" resorbable mesh pouch. The claims do not cover mere coatings. As set forth above, coatings are, by definition, not freestanding. Moreover, the Office's claims that Pulapura teaches use of its drug loaded polymers to "form pouches ... pockets for implantable medical devices," are incorrect, or at least incomplete. (see OA at 9). When taken as a whole, as it must be, all Pulapura reasonably teaches is coatings. The Office attempts to rely upon paragraph [0204] for support its position. What paragraph [0204] actual says is "[t]he coatings of the present invention can also be used to coat meshes which are formed into or to form pouches, coverings, pockets and the like for implantable medical devices." When read in light of the specification as a whole, one of ordinary skill the art would understand this passage to mean that the pouches, coverings, pockets were coated with the "coating of the present invention."
The Examiner finds this argument unpersuasive, because PULAPURA is a secondary reference to show that the prior art had known of using the prior art had known of biodegradable/resorbable polymer coatings (see [0013]), wherein the polymer coating includes a drug, such as an antibiotic (see abstract), to avoid infection (see [0005]-[0007]). Additional disclosures include: mesh pouches (see [0187]; [0204]); coating medical devices (see [0096]), such as screws (see [0202]), or form pouches, coverings, pockets for implantable medical devices (see [0204]), such as pacemaker (see [0204]).
Applicant argues that Gomurashvili fails to disclose, expressly or inherently, all of the elements of independent claims 1 and 12. It does not teach or reasonably disclose a "freestanding mesh" pouch, as recited in claim 1 or a "freestanding" resorbable "mesh" pouch as recited in claim 12 where "said pouch encases at least 50% of the volume of said medical device," as recited in both independent claims 1 and 12.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, the secondary reference PULAPURA teaches these limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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