DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 09 September 2025. Claims 1-17 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 09 September 2025 are accepted by the examiner.
Claim Objections
Claim 9 is objected to because of the following informality:
In line 2, it appears that the phrase “the effective zone of inhibition” should read “an effective zone of inhibition” for consistency.
Claim 12 is objected to because of the following informality:
In line 1, it appears that the phrase “PAEK” should read “polyaryletherketone (PAEK)” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the antimicrobial agent having a surface area concentration that is sufficient to produce an effective zone of inhibition (see paragraphs 0008, 0027, 0037, 0039, and 0043), does not reasonably provide enablement for the biodegradable polymer thin film having a surface area coat weight that is sufficient to produce an effective zone of inhibition (see lines 13-15 of claim 1). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The above identified paragraphs of the current specification provide support for the surface area concentration of the antimicrobial agent being sufficient to produce an effective zone of inhibition. The examiner can find nothing in the current specification providing support for the surface area coat weight of the biodegradable polymer thin film being sufficient to produce an effective zone of inhibition. This raises the following question: what feature is responsible for producing the effective zone of inhibition (e.g. the surface area concentration, the surface area coat weight, both, etc.)? The examiner respectfully requests the applicant’s assistance in identifying where in the disclosure support for the claimed limitation is provided...if proper as written. Since claims 2-17 are dependent upon claim 1, they contain the same issue.
Note: It appears that amending lines 13-15 of claim 1 to read “wherein the antimicrobial agent has a surface area concentration that is sufficient to produce an effective zone of inhibition of at least 0.5 mm from a periphery of the outer implant surface” would overcome this rejection. For examination purposes, claim 1 will be treated as such.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13 and 15-18 of U.S. Patent No. 12,446,933 (see Claim Mapping Table below). Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus, the invention of the patent claims are in effect a "species" of the "generic" invention of the application claims. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Mapping Table
Current Application – 19/322,756
U.S. Patent No. 12,446,933
Claim 1: a method for reducing a loss of release torque resulting from an antimicrobial treatment of an orthopedic implant system that includes
an orthopedic implant body defining an outer implant surface, the orthopedic implant body further defining one or more apertures extending from the outer implant surface through the implant body and configured to receive a bone fastener, and
a bone fastener configured to be disposed within the one or more apertures so as to secure the orthopedic implant body to a bone, the bone fastener defining an outer fastener surface;
the method comprising:
applying to one of the apertures, the corresponding outer fastener surface, or both a biodegradable polymer thin film, and,
incorporating a vaporizable antimicrobial agent into the thin film,
wherein
the antimicrobial agent has a surface area concentration that is sufficient to produce an effective zone of inhibition of at least 0.5 mm from a periphery of the outer implant surface, and,
a torque required for releasing one of the fasteners from a corresponding aperture of the orthopedic implant body following use of an insertion torque that is suitable for implantation of the orthopedic implant body in a subject is not less than about 90% of a torque required for releasing an uncoated and otherwise identical fastener from a corresponding aperture of an uncoated but otherwise identical orthopedic implant body for up to 5 days following implantation of the orthopedic implant body in the subject.
Claim 1: a system for reducing microbial infection at an orthopedic implant surgical site comprising:
an orthopedic implant body defining an outer implant surface, the orthopedic implant body further defining one or more apertures extending from the outer surface through the implant body and configured to receive a bone fastener;
a bone fastener configured to be disposed within the one or more apertures so as to secure the orthopedic implant body to a bone, the bone fastener defining an outer fastener surface;
a biodegradable polymer thin film disposed within at least one of the one or more apertures or the corresponding outer fastener surface; and,
a vaporizable antimicrobial agent disposed within the biodegradable polymer thin film,
wherein the biodegradable polymer thin film has a surface area coat weight of about 50-250 μg/cm.sup.2,
the vaporizable antimicrobial agent has a surface area concentration of about 5-85 μg/cm.sup.2,
the antimicrobial agent has a surface area concentration that is sufficient to produce an effective zone of inhibition of at least 0.5 mm from a periphery of the outer implant surface, and,
a torque required for releasing the fastener from a corresponding aperture of the orthopedic implant body following use of an insertion torque that is suitable for implantation of the orthopedic implant body in a subject is not less than about 90% of a torque required for releasing an uncoated and otherwise identical fastener from a corresponding aperture of an uncoated but otherwise identical orthopedic implant body for up to 5 days following implantation of the orthopedic implant body in the subject.
Claim 2: the method according to claim 1, wherein the biodegradable polymer thin film comprises a poly(α-hydroxy ester) polymer.
Claim 3: the system according to claim 1, wherein the biodegradable polymer thin film comprises a poly(α-hydroxy ester) polymer.
Claim 3: the method according to claim 1, wherein the biodegradable polymer thin film comprises poly(glycolic acid) (PGA), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(ε-caprolactone) (PCL), or any copolymer or mixture thereof.
Claim 4: the system according to claim 3, wherein the biodegradable polymer thin film comprises poly(glycolic acid) (PGA), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly (ε-caprolactone) (PCL), or any copolymer or mixture thereof.
Claim 4: the method according to claim 1, wherein the biodegradable polymer thin film comprises poly(l-lactic acid) (PLLA), poly(d-lactic acid) (PDLA), poly(d,1-lactic acid) (PDLLA), or any copolymer or mixture thereof.
Claim 5: the system according to claim 3, wherein the biodegradable polymer thin film comprises poly(l-lactic acid) (PLLA), poly(d-lactic acid) (PDLA), poly(d, l-lactic acid) (PDLLA), or any copolymer or mixture thereof.
Claim 5: the method according to claim 1, wherein the vaporizable antimicrobial agent comprises a halogenated hydroxyl ether, an acyloxydiphenyl ether, or a combination thereof.
Claim 7: the system according to claim 1, wherein the vaporizable antimicrobial agent comprises a halogenated hydroxyl ether, a acyloxydiphenyl ether, or a combination thereof.
Claim 6: the method according to claim 1, wherein the vaporizable antimicrobial agent comprises 2,4,4′-trichloro-2′-hydroxydiphenyl ether (triclosan).
Claim 8: the system according to claim 1, wherein the vaporizable antimicrobial agent comprises 2,4,4′-trichloro-2′-hydroxydiphenyl ether (triclosan).
Claim 7: the method according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce an effective zone of inhibition of about 0.5-4 mm from a periphery of the outer implant surface.
Claim 9: the system according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce an effective zone of inhibition of about 0.5-4 mm from a periphery of the outer implant surface.
Claim 8: the method according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce an effective zone of inhibition of about 1-2 mm from a periphery of the outer surface.
Claim 10: the system according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce an effective zone of inhibition of about 1-2 mm from a periphery of the outer implant surface.
Claim 9: the method according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce an effective zone of inhibition up to about 6, 12, 18, 24, 36, 48, or 72 hours following implantation of the orthopedic implant body into a human subject.
Claim 11: the system according to claim 1, wherein the surface area concentration of the antimicrobial agent is sufficient to produce the effective zone of inhibition up to about 6, 12, 18, 24, 36, 48, or 72 hours following implantation of the orthopedic implant body into a human subject.
Claim 10: the method according to claim 1, wherein the outer implant surface comprises metal, polymer, or both.
Claim 13: the system according to claim 1, wherein the body outer surface comprises metal, polymer, or both.
Claim 15: the system according to claim 1, wherein the outer implant surface comprises a metal or metal alloy.
Claim 11: the method according to claim 10, wherein the outer implant surface comprises titanium, stainless steel, or an alloy containing titanium or steel.
Claim 16: the system according to claim 15, wherein the metal is titanium, stainless steel, or an alloy containing titanium or steel.
Claim 12: the method according to claim 1, wherein the outer implant surface comprises polyaryletherketone (PAEK), and wherein the PAEK is polyetheretherketone (PEEK) or a copolymer thereof.
Claim 17: the system according to claim 1, wherein the outer implant surface comprises PAEK, and wherein the PAEK is polyetheretherketone (PEEK) or a copolymer thereof.
Claim 13: the method according to claim 1, wherein the outer implant surface comprises polyalkene, and wherein the polyalkene is polyethylene or a copolymer thereof.
Claim 18: the system according to claim 1, wherein the outer implant surface comprises polyalkene, and wherein the polyalkene is polyethylene or a copolymer thereof.
Claim 14: the method according to claim 1 wherein the surface area coat weight of the biodegradable polymer thin film is about 50-250 μg/cm.sup.2 relative to an area of the surface of the body.
Claim 1: a system for reducing microbial infection at an orthopedic implant surgical site comprising: an orthopedic implant body defining an outer implant surface, the orthopedic implant body further defining one or more apertures extending from the outer surface through the implant body and configured to receive a bone fastener; a bone fastener configured to be disposed within the one or more apertures so as to secure the orthopedic implant body to a bone, the bone fastener defining an outer fastener surface; a biodegradable polymer thin film disposed within at least one of the one or more apertures or the corresponding outer fastener surface; and, a vaporizable antimicrobial agent disposed within the biodegradable polymer thin film, wherein the biodegradable polymer thin film has a surface area coat weight of about 50-250 μg/cm.sup.2, the vaporizable antimicrobial agent has a surface area concentration of about 5-85 μg/cm.sup.2, the antimicrobial agent has a surface area concentration that is sufficient to produce an effective zone of inhibition of at least 0.5 mm from a periphery of the outer implant surface, and, a torque required for releasing the fastener from a corresponding aperture of the orthopedic implant body following use of an insertion torque that is suitable for implantation of the orthopedic implant body in a subject is not less than about 90% of a torque required for releasing an uncoated and otherwise identical fastener from a corresponding aperture of an uncoated but otherwise identical orthopedic implant body for up to 5 days following implantation of the orthopedic implant body in the subject.
Claim 15: the method according to claim 1 wherein the surface area coat weight of the biodegradable polymer thin film is about 60-230 μg/cm.sup.2 relative to an area of the surface of the body.
Claim 2: the system according to claim 1, wherein the surface area coat weight of the biodegradable polymer thin film is about 60-230 μg/cm.sup.2.
Claim 16: the method according to claim 1, wherein the antimicrobial agent has a surface area concentration of about 5-85 μg/cm.sup.2.
Claim 1: a system for reducing microbial infection at an orthopedic implant surgical site comprising: an orthopedic implant body defining an outer implant surface, the orthopedic implant body further defining one or more apertures extending from the outer surface through the implant body and configured to receive a bone fastener; a bone fastener configured to be disposed within the one or more apertures so as to secure the orthopedic implant body to a bone, the bone fastener defining an outer fastener surface; a biodegradable polymer thin film disposed within at least one of the one or more apertures or the corresponding outer fastener surface; and, a vaporizable antimicrobial agent disposed within the biodegradable polymer thin film, wherein the biodegradable polymer thin film has a surface area coat weight of about 50-250 μg/cm.sup.2, the vaporizable antimicrobial agent has a surface area concentration of about 5-85 μg/cm.sup.2, the antimicrobial agent has a surface area concentration that is sufficient to produce an effective zone of inhibition of at least 0.5 mm from a periphery of the outer implant surface, and, a torque required for releasing the fastener from a corresponding aperture of the orthopedic implant body following use of an insertion torque that is suitable for implantation of the orthopedic implant body in a subject is not less than about 90% of a torque required for releasing an uncoated and otherwise identical fastener from a corresponding aperture of an uncoated but otherwise identical orthopedic implant body for up to 5 days following implantation of the orthopedic implant body in the subject.
Claim 17: the method according to claim 1, wherein the antimicrobial agent has a surface area concentration of about 45-55 μg/cm.sup.2.
Claim 6: the system according to claim 1, wherein the antimicrobial agent has a surface area concentration of about 45-55 μg/cm.sup.2.
Note: The examiner acknowledges 1) the differences in the phrasing of the preambles of the current application and the U.S. Patent, and 2) the “applying” and “incorporating” steps of the current application.
Regarding 1), it is the examiner’s position that the phrase “a torque required for releasing the fastener from a corresponding aperture of the orthopedic implant body following use of an insertion torque that is suitable for implantation of the orthopedic implant body in a subject is not less than about 90% of a torque required for releasing an uncoated and otherwise identical fastener from a corresponding aperture of an uncoated but otherwise identical orthopedic implant body for up to 5 days following implantation of the orthopedic implant body in the subject,” as recited in the U.S. Patent, anticipates the preamble of the current application.
Regarding 2), it is the examiner’s position that the phrase “disposed within” (i.e. 2 instances), as recited in the U.S. Patent, anticipates these steps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
