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 .
Response to Amendment
This office action is responsive to the amendment filed on 08/14/2025. As directed by the amendment: claims 37, 42 and 46 have been amended, claim 45 has been cancelled and no new claims have been added. Thus, claims 37, 41, 42, 44 and 46 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37, 41, 42, 44 and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Independent claim 37 sets forth the parameter of “the energy unit is designed and constructed to emit energy at a frequency that breaks off a number of the microcapsules from the absorbable polymer and increases at least one of the degradation, fragmentation, and dissolution rate of the microcapsules”, on lines 9-12; however, this parameter is found to be confusing since it is not clear what exactly, quantitatively, is meant by a frequency which “breaks off a number of the microcapsules from the absorbable polymer and increases at least one of the degradation, fragmentation, and dissolution rate of the microcapsules”. Furthermore, it is also unclear if the energy unit emitting/applying said “frequency” is the only thing that’s needed/what causes the microcapsules to break off from the absorbable polymer and increase at least one of the degradation, fragmentation, and dissolution rate of the microcapsules, or if some other physical/chemical structure is also further needed to achieve such a function. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 37, 41, 42, 44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp (US PG Pub. 2005/000867 1), as previously presented, hereinafter Antwerp, in view of Langer et al. (US Patent No. 4,779,806), as previously presented, hereinafter Langer, and Zhang et al. (US Patent No. 6,245,347), as previously presented, hereinafter Zhang.
Regarding claims 37, 41 and 46, Antwerp discloses an implant system comprising a medical implant configured to be implanted in a body of a subject; and an absorbable polymer coating coupled to and at least partially covering the medical implant ([0037]), wherein the absorbable polymer coating includes an absorbable polymer, comprised of a copolymer of polylactic acid and polyglycolic acid (PLGA), and microcapsules attached to the absorbable polymer, wherein at least one therapeutic agent is contained within each of the microcapsules, wherein the microcapsules are configured to release the at least one therapeutic agent after implanting the medical implant in the body ([0020], Last 4 Lines; [0028]; [0043]; [0044] – [0046]; [0055]; [0062] & [0101]); but does not teach the system further comprising an energy unit configured to apply ultrasonic energy to the absorbable polymer coating after the medical implant is implanted in the body, wherein the energy unit is designed and constructed to emit energy at a frequency that breaks off a number of the microcapsules from the absorbable polymer and increases at least one of the degradation, fragmentation, and dissolution rate of the microcapsules, thereby accelerating the release of the at least one therapeutic agent from the microcapsules.
However Langer teaches that it is known in the art to apply external ultrasonic energy to an implant comprising therapeutics/drugs delivered from a polymeric matrix, in order to increase degradation/dissolution rate of the polymer to accelerate the release of the therapeutics/drugs; and thereby providing control/modulation of the release of the therapeutics/drugs (Langer: Column 1, Line 60 – Column 2, Line 10 & Column 4, Lines 55-61). Furthermore, Zhang teaches that it is known in the art that applying ultrasound/ultrasonic energy breaks off particles into smaller ones, causing an increase in the release rate of the drug/therapeutic (Zhang: Column 26, Lines 7-8 & Column 31, Lines 13-15).
In view of the teachings of Langer and Zhang, it would have been obvious to one having ordinary skill in the art at the time of the invention for the implant system of Antwerp to further comprise an energy unit configured to apply ultrasonic energy to the absorbable polymer coating after the medical implant is implanted in the body, wherein the energy unit is designed and constructed to emit energy at a frequency/ultrasonic energy which can break off a number of the microcapsules from the absorbable polymer and increase the release/degradation rate of the microcapsules, thereby accelerating the release of the at least one therapeutic agent from the microcapsules, and thereby providing control/modulation of the release of the therapeutics/drugs, as taught by Langer and Zhang.
Regarding claim 42, Antwerp in view of Langer and Zhang disclose the implant system of claim 37, wherein Antwerp further teaches the at least one therapeutic agent in each of the microcapsules is a biologic agent (Antwerp: [0055] & [0062]).
Regarding claim 44, Antwerp in view of Langer and Zhang disclose the implant system of claim 37, wherein Antwerp further teaches the medical implant is a mesh/braid (Antwerp: [0073], Lines 6-10).
Response to Arguments
Applicant's arguments filed 08/14/2025 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 37 as being unpatentable over Antwerp in view of Langer and Zhang stating that “neither Lager nor Zhang teaches an energy unit that directs energy at a frequency to perform” both breaking off a number of microcapsules from the absorbable polymer and increase at least one of the degradation, fragmentation and dissolution rate of the microcapsules. Examiner respectfully disagrees with Applicant’s assertion. It is important to keep in mind that in device/apparatus claims, such as the currently pending claims, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device. Thus, in the instant case, the required structure of the final device comprises an implant system having an implant with an absorbable polymer coating, which at least partially covers the implant, microcapsules, containing a therapeutic agent, attached to the absorbable polymer coating, wherein the microcapsules are configured to, i.e. have the physical/structural ability to, release the therapeutic agent after implantation (all of which is taught by Antwerp), and an energy unit, designed and constructed to emit energy at a frequency/an ultrasonic energy, wherein the energy can be applied to the absorbable polymer coating after implantation (which is taught by Langer and Zhang). It is to be noted that the function of breaking off a number of microcapsules from the absorbable polymer and increasing at least one of the degradation, fragmentation and dissolution rate of the microcapsules is caused by the physical structure of the energy unit which emits a frequency/an ultrasonic energy frequency. It is further to be noted that Langer teaches that it is known in the art to apply a range of different frequencies and modulation extents based on the particular composition of the polymer matrix/coating (Langer: Column 4, Lines 34-55). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implant system of Antwerp to further comprise an energy unit designed and constructed to emit energy at a frequency/an ultrasonic energy frequency, which is configured to apply the ultrasonic energy to the absorbable polymer coating after the medical implant is implanted in the body, wherein the energy unit is designed and constructed to emit energy at a frequency/ultrasonic energy which can break off a number of the microcapsules from the absorbable polymer and increase the release/degradation rate of the microcapsules, thereby accelerating the release of the at least one therapeutic agent from the microcapsules, and thereby providing control/modulation of the release of the therapeutics/drugs, as taught by Langer and Zhang. Therefore, the rejection of independent claim 37 as being unpatentable over Antwerp in view of Langer and Zhang is deemed to be proper since all the structural limitations set forth in the claim are taught; hence, the rejection stands.
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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774