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 Request for Continued Examination and Amendment filed on 02/13/2025.
Claims 1-9, 11-22, 24-25 have been amended.
Claim 26 has been added.
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Claims 5, 19-25 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/13/2025 has been entered.
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. Note, US 10,280,261 and 9,988,492 recites coating or film, wherein coating would read on non-free-standing pouch.
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]), wherein an over coating over a screw would read on a pouch shape for encasing a medical device, such as a screw. 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 or screws or meshes, 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 § 102/103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-9, 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over BECKER et al (herein after “BECKER1”; US 2016/0237212).
BECKER1 teaches a composition comprised of: amino acid-based poly(ester urea) polymers (PEU) with bioactive peptides (see abstract) or small molecule drugs (see [0123]), wherein the polymers are fabricated into the desired structure (see [0113], such as coating (see [0046]) and screw coating (see [0046], wherein coating would read on non-free-standing pouch and the screw would inherently or obviously be completely coated, which would read on “encased at least 50% of the volume of the medical device”. Additional disclosures include: meshes (see [0117]; [0185]-[0186]); the structure of the polymer (see [0101]), which reads on Applicant’s polymer structure/formula and would have the same chemical/physical properties as claimed by Applicant; porosity (see [0122]); the polymer shaped or formed for a particular application (see [0112]), wherein the polymers may be formed into a wide variety of both 2-dimensional and 3-dimensional structures including, without limitation, tissue scaffolds, nanofibers, microfibers, coatings, and films (see [0114]).
Claim(s) 1-4, 6-9, 11-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over GOMURASHVILI et al (US 2009/0253809).
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]), wherein an over coating would read on pouch shape for encasing a medical device, such as a screw, or internal fixation devices and other surgical implants (see [0180]) and the screw or surgical implant would inherently or obviously be completely coated, which would read on “encased at least 50% of the volume of the medical device”.. Additional disclosures include: porosity in the composition (see [0136]).
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]), wherein coatings would read on non-free-standing pouch.
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).
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]), wherein an over coating over a screw would read on a pouch shape for encasing a medical device, such as a screw. 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 coating as mesh pouch for medical devices, such as a pacemaker, and coating 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 Beckerl does not teach or reasonably disclose a "freestanding rnesh pouch for implantation in the body'' that is 'formedfrom a drug loaded amino acid-based poly(ester urea) polymer or copolymer" and sized to encase "at least 50% of the volume of said medical device," it does not anticipate any of the pending claims.
The Examiner finds this argument unpersuasive, because as discussed in the rejection above, BECKER1 does teach these limitations, wherein BECKER1 teaches coated screws.
Applicant argues that the polymers of Gomurashvili are significantly different from the claimed polymers. Specifically, Gomurashvili teaches elastomeric polymer networks and semi -interpenetrating networks in which a linear PEA, PEUR or PEU polymer is cross linked by ester or alpha-amino-acid containing cross-linkers that polymerize upon exposure to active species" (See Gomurashvili at Abstract). And like Becker1, any drugs to be included were added after the polymeric structures were formed, and are not distributed homogeneously throughout the polymer. [0132], Gomurashvili states "a variety of therapeutic and palliative agents, which can be dispersed within the invention compositions to locally or systemically deliver the incorporated diagnostic agents following administration and cross linking of the composition or implant of an article of manufacture made using or comprising the composition.
The Examiner finds this argument unpersuasive, because the bioactive agent can also be dispersed in the polymers of the composition (see [0024]).
Applicant argues that nowhere does Pulapura describe the invention as anything other than a coating. When viewed in context, it is clear that the passages in [204] and [0187] of Pulapura, upon which the Office relies, are only referring to meshes that have been coated and not to mesh pouched formed from the polymer.
The Examiner finds this argument unpersuasive, because as discussed in the rejection PALAPURA 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]).
Applicant argues that we note that the coatings of Pulapura are made from polymers that are very different from the claimed polymers. Pulapura does not teach PEU polymers, much less the use of "a drug loaded amino acid-based poly(ester urea) polymer or copolymer." Instead, it teaches the use of tyrosine-derived polyarylates, linear polyesteramides, dihydroxybenzoate polymers, and resorcinol derived polymers." (See, Pulapura at Abstract).
The Examiner finds this argument unpersuasive, because the primary reference teaches Applicant’s polymer. PULAPURA is used as a secondary reference to show the prior art had known of using polymers to make coatings and pouches for medical devices.
Applicant argues that with respect to claims 11 and 14, the Office concedes that the cited 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 cannot be dismissed as "a result effective parameter that a person of ordinary skill in the art would routinely optimize" Neither the porosity nor the even distribution of the drug in the polymer are quantified in the claims. This is not a case where a variable can be evaluated to determine an optimum value. Claim 11 simply requires enough porosity to electrically ground the encased medical device. (See also, [0032] ("said pouch is sufficiently porous to permit said medical device to be electrically grounded to surrounding tissue) and [00116] ("the pouch of the present invention will be porous ... the pouch may be formed from an antibiotic-loaded poly(ester urea) film as described above that has been perforated to allow bodily fluid to pass through it")). The same is true for the drug being "evenly distributed throughout" the polymer as recited in claims 14 and 26. (See, e.g., <JI [0081] ("the drug is substantially uniformly distributed throughout said degradable amino acid based poly(ester urea) polymer"); <]{[00111] ("it is believed that the drug is substantially evenly distributed throughout the film, most likely because the film is formed while the drug is solution with the polymer, and is trapped in the polymer as the solvent evaporates and the polymer solidifies"); <JI [00126] "Content uniformity helps to quantify actual antibiotic content in the film and helps to characterize whether the antibiotic is uniformly dispersed over the surface entire area of the film."); see also, <JI <JI [0013], [0034 ]).
The Examiner finds this argument unpersuasive, because as discussed in the rejection, 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. Few skilled in the art would desire an erratic release of drugs by having an uneven dispersion for controlled release.
Applicant argues that the combination of Gomurashvili and Pulapura do not teach or reasonably disclose mesh pouches formed from "a drug loaded amino acid-based poly(ester urea) polymer or copolymer" or that "said pouch encases at least 50116 of the volume of said medical device," as now claimed. The Referenced patents do not remedy these deficiencies. In fact, the Office correctly concedes that "[t]he [referenced] patents do not recite drug or mesh pouch has a shape for encasing a medical device." (See, FOA at 4). Despite this, the Office incorrectly take the position that the invention of at least one of claims 1-4, 6-9, 11-18 "is not patentably distinct from a reference claim(s) in each one of the referenced patents because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s)." (See, FOA at 2). Given that the Office has conceded that the referenced patents do not teach the drug or the size of the mesh pouch and, as set forth above, these elements are likewise missing from Gomurashvili and Pulapura, it is difficult to see how the Office can contend that there is obviousness in their combination. As they do not teach a mesh pouch or drug, it must be that the Office has only relied upon the referenced patents for their teachings of PEU polymers. However, the PEU polymers claimed in the referenced patents are all significantly different than the claimed "drug loaded amino acid-based poly(ester urea) polymer or copolymer." Moreover, the Office's assertion that the "patents recite an amino acid-based poly(ester urea) polymer," while true as far as it goes, is misleading as the referenced patents all use PEU polymers that are different from what is claimed and each other. The claim exemplified by the Office (Claim 1 of the '414) neatly illustrates the problem with the Office's position.
The Examiner finds this argument unpersuasive, because Applicant recitation of “amino acid-based poly(ester urea)” is broader in scope than the polymers in the patent, wherein as discussed in the rejection, the secondary references teach using polymers as coatings and pouches for medical devices.
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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