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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/22/25 has been entered.
Claim Rejections - 35 USC § 102
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) 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reisberg (US PG Pub No. 2011/0106182).
Regarding Claim 21, Reisberg discloses an adjustable implant template (Figs. 1-3) comprising: a flexible (Paragraphs [0007, 0011-0012, 0016]), radiopaque (titanium, Paragraph [0029]) trial plate (1) having a monolithic (Paragraph [0028]) main body and two arms extending from opposing sides of said main body (See examiner annotated Fig. 2 below); each said arm comprising: at least two subarms arranged serially to define a length of said arm (See examiner annotated Fig. 2 below, which depicts each of the subarms appearing as successive parts, arranged sequentially in a series/serial manner, and defining an overall length of each respective arm); one or more slots interposed between said subarms and at least partially separating said subarms (See examiner annotated Fig. 2 below); and, ribs connecting said subarms and separating said subarms from said main body, defining said one or more slots (See examiner annotated Fig. 2 below); wherein removal of at least one of said subarms from at least one end of said two arms reduces a length of said trial plate (Paragraphs [0010, 0028, 0032], See examiner annotated Fig. 2 above, which shows removal of one or more of the subarms from either end of each arm would reduce the length of that respective side/arm of the plate, and when subarms in the same location within each arm are removed from the 1st arm and the 2nd arm, an overall length of the plate would be reduced.).
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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.
Claim(s) 1-4, 6-8, & 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reisberg (US PG Pub No. 2011/0106182) in view of Hynes et al. (US PG Pub No. 2010/0137916).
Regarding Claims 1 & 11, Reisberg discloses an adjustable implant template (Figs. 1-3) comprising: a flexible (Paragraphs [0007, 0011-0012, 0016]) trial plate (1) having a monolithic (Paragraph [0028]) main body and two arms extending from opposing sides of said main body (See examiner annotated Fig. 2 above); each of said arms comprising: at least two subarms arranged serially to define a length of said arm (See examiner annotated Fig. 2 above, which depicts each of the subarms appearing as successive parts, arranged sequentially in a series/serial manner, and defining an overall length of each respective arm); one or more slots interposed between said subarms and at least partially separating said subarms (See examiner annotated Fig. 2 above); and ribs connecting said subarms and separating said subarms from said main body, defining said one or more slots (See examiner annotated Fig. 2 above); wherein removal of a subarm from at least one end of said two arms reduces a length of said trial plate (Paragraphs [0010, 0028, 0032], See examiner annotated Fig. 2 above, which shows removal of one or more of the subarms from either end of each arm would reduce the length of that respective side/arm of the plate, and when subarms in the same location within each arm are removed from the 1st arm and the 2nd arm, an overall length of the plate would be reduced.); and wherein said trial plate can be formed from “all sorts of materials suitable for implantation into the human body, such as suitable metals, resorbable materials, memory materials, etc.” (Paragraph [0029]).
Reisberg does not disclose wherein said trial plate is formed from radiolucent material and a portion of said radiolucent material is combined with radiopaque material, such that at least a portion of said trial plate is radiopaque and at least a portion of said trial plate is radiolucent, and a marker configured to provide a visual cue for positioning of an implant.
Hynes et al. discloses various bone plates (Figs. 1-22) constructed of any suitable medical grade material, wherein “desired features of the particular component, such as strength, flexibility, radiopaque/radiolucent, hardness, weight, wear resistance, and/or other characteristics, are considered in selecting the suitable material. Suitable biocompatible materials include metals, ceramics, polymers, and combinations thereof. For example, in some embodiments metals such as cobalt-chromium alloys, titanium alloys, nickel titanium alloys, and stainless steel alloys are suitable. In other embodiments, ceramic materials such as aluminum oxide or alumina, zirconium oxide or zirconia, compact of particulate diamond, or pyrolytic carbon are suitable. In yet other embodiments polymer materials are used, including members of the polyaryletherketone (PAEK) family such as polyetheretherketone (PEEK), carbon-reinforced PEEK, other modified PEEK materials, or polyetherketoneketone (PEKK); polysulfone; polyetherimide; polyimide; ultra-high molecular weight polyethylene (UHMWPE); cross-linked UHMWPE; silicon, polycarbonate urethanes, and nano-material treated polymers. In some instances, the materials are imbedded with one or more radiographic markers.” (Paragraph [0068]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the material of the implant of Reisberg to be made from a polymeric material such as PEEK imbedded with one or more radiographic markers as taught by Hynes et al. so that the plate is thinner, lighter and better tolerated by the patient after implantation and allows for clear visualization of the bone during post-operative monitoring.
Regarding Claim 2, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein said one or more slots are straight (As seen in the examiner annotated Fig. 2 above, the opposing sides at the upper portions of each U-shaped slot are straight.).
Regarding Claim 3, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein said one or more slots are curved (As seen in the examiner annotated Fig. 2 above, the bottom portion of each U-shaped slot is curved.).
Regarding Claim 4, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein said one or more slots have a curved portion and a straight portion (As seen in the examiner annotated Fig. 2 above, the bottom portion of each U-shaped slot is curved and the opposing sides at the upper portions are straight.).
Regarding Claim 6, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein said ribs are frangible (the ribs are easily broken/cut by a user to provide the implant in a desired length as stated in Paragraphs [0010, 0018, 0028] & Abstract).
Regarding Claim 7, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 6, and Reisberg further discloses wherein said two arms are configured to be reduced in length by removal of one or more of said at least two subarms extending from each arm by disassociating said subarm or subarms via breaking or cutting one of said frangible ribs (Paragraphs [0010, 0018, 0028] & Abstract).
Regarding Claim 8, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein a window (each opening 3, Figs. 1-2) is defined between said ribs configured at opposite ends of said arms extending from said main body.
Regarding Claim 10, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein a shape of said one or more slots is capable of approximating the outline of an implant (the U-shaped slots are fully and structurally capable of approximating an outline of an implant, such as a screw head).
Regarding Claim 12, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses a tool interface (each opening 3 can be used as a tool interface for bending or torquing, or for gripping, moving, or securing the implant, Paragraph [0024], Figs. 1-2).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reisberg (US PG Pub No. 2011/0106182) in view of Hynes et al. (US PG Pub No. 2010/0137916) and Gundolf (US Patent No. 5,250,048).
Regarding Claim 13, Reisberg discloses an adjustable implant template (Figs. 1-3) comprising: a flexible (Paragraphs [0007, 0011-0012, 0016]) trial plate (1) having a monolithic (Paragraph [0028]) main body and two arms extending from said main body (See examiner annotated Fig. 2 above); each of said arms integrally formed with said main body (Paragraph [0028]) and comprising: at least two removable subarms arranged serially to define a length of said arm (See examiner annotated Fig. 2 above, which depicts each of the subarms appearing as successive parts, arranged sequentially in a series/serial manner, and defining an overall length of each respective arm); one or more unbroken edges (curved bottom portion of each U-shaped slot, Fig. 2) configured to form a slot between said subarms that are adjacent (See examiner annotated Fig. 2 above); wherein a guide edge of each of said subarms is visible through said slot (side edges of each 4, as seen in Fig. 3); and wherein said trial plate can be formed from “all sorts of materials suitable for implantation into the human body, such as suitable metals, resorbable materials, memory materials, etc.” (Paragraph [0029]).
Reisberg does not disclose wherein said trial plate is formed from radiolucent material and a portion of said radiolucent material is combined with radiopaque material, such that at least a portion of said trial plate is radiopaque and at least a portion of said trial plate is radiolucent, and a marker configured to provide a visual cue for positioning of an implant.
Hynes et al. discloses various bone plates (Figs. 1-22) constructed of any suitable medical grade material, wherein “desired features of the particular component, such as strength, flexibility, radiopaque/radiolucent, hardness, weight, wear resistance, and/or other characteristics, are considered in selecting the suitable material. Suitable biocompatible materials include metals, ceramics, polymers, and combinations thereof. For example, in some embodiments metals such as cobalt-chromium alloys, titanium alloys, nickel titanium alloys, and stainless steel alloys are suitable. In other embodiments, ceramic materials such as aluminum oxide or alumina, zirconium oxide or zirconia, compact of particulate diamond, or pyrolytic carbon are suitable. In yet other embodiments polymer materials are used, including members of the polyaryletherketone (PAEK) family such as polyetheretherketone (PEEK), carbon-reinforced PEEK, other modified PEEK materials, or polyetherketoneketone (PEKK); polysulfone; polyetherimide; polyimide; ultra-high molecular weight polyethylene (UHMWPE); cross-linked UHMWPE; silicon, polycarbonate urethanes, and nano-material treated polymers. In some instances, the materials are imbedded with one or more radiographic markers.” (Paragraph [0068]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the material of the implant of Reisberg to be made from a polymeric material such as PEEK imbedded with one or more radiographic markers as taught by Hynes et al. so that the plate is thinner, lighter and better tolerated by the patient after implantation and allows for clear visualization of the bone during post-operative monitoring.
Reisberg further fails to disclose a break zone formed on at least a portion of said unbroken edge. Reisberg does disclose in Paragraph [0022] that “the area between the claims is bendable, and can be provided in a reduced width to facilitate bending” and in Paragraphs [0018 & 0028] that the implant can be shortened by the surgeon by cutting to a desired length.
Gundolf discloses a bone stabilization plate comprising a plurality of elongate sections (14) separated by a slotted portion (16) having predetermined weakened break points in the form of slots (34, Fig. 7) or perforations (36, Fig. 8) formed through the material of the plate so that specific sections of the plate can be broken off along one of the break points to provide the plate in a desired size “without any major preparations and at short notice to the treated location of the bone or fracture during an operation, and that quickly and without any major effort by bending along the respective line of contact 16, resulting in the breaking-off of the stabilizing element 10. The length of the stabilizing element may be varied as required.” (Col. 6, Lines 21-40)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the implant of Reisberg to add weakened break points in the form of slots or perforations formed perpendicular to the longitudinal axis of the implant through the curved bottom portion of each slot between each pair of subarms as taught by Gundolph in order to provide the implant with a means for allowing quicker and easier shortening of the implant length during a procedure without the need for an additional cutting tool.
Regarding Claim 14, the combination of Reisberg and Hynes et al. discloses the claimed invention as stated above in claim 1, and Reisberg further discloses wherein said slot between said adjacent subarms approximates the outline of an implant (the U-shaped slots are fully and structurally capable of approximating an outline of an implant, such as a screw head).
Response to Arguments
Applicant’s amendments, filed 10/2225, have overcome the objection to Claim 13.
In regards to Applicant’s arguments, filed 10/22/25, with respect to Claims 13-14 rejected under 103 as being unpatentable over Reisberg in view of Hynes et al. and Gundolf and Applicant’s contention that “no reasons exist for a person skilled in the art to have combined the references with a reasonable expectation of success since their objectives are mutually exclusive and combining them would destroy each reference’s functionality”: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Reisberg discloses in Paragraph [0029] that “Preferably, the device is made of an implantable material, especially titanium. However, the device can be made from all sorts materials suitable for implantation into the human body, such as suitable metals, resorbable materials, memory materials, etc.” Hynes et al. discloses “bone plates (Figs. 1-22) constructed of any suitable medical grade material, wherein “desired features of the particular component, such as strength, flexibility, radiopaque/radiolucent, hardness, weight, wear resistance, and/or other characteristics, are considered in selecting the suitable material. Suitable biocompatible materials include metals, ceramics, polymers, and combinations thereof. For example, in some embodiments metals such as cobalt-chromium alloys, titanium alloys, nickel titanium alloys, and stainless steel alloys are suitable. In other embodiments, ceramic materials such as aluminum oxide or alumina, zirconium oxide or zirconia, compact of particulate diamond, or pyrolytic carbon are suitable. In yet other embodiments polymer materials are used, including members of the polyaryletherketone (PAEK) family such as polyetheretherketone (PEEK), carbon- reinforced PEEK, other modified PEEK materials, or polyetherketoneketone (PEKK); polysulfone; polyetherimide; polyimide; ultra-high molecular weight polyethylene (UHMWPE); cross-linked UHMWPE; silicon, polycarbonate urethanes, and nano- material treated polymers. In some instances, the materials are imbedded with one or more radiographic markers.” (Paragraph [0068)]).” Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the material of the implant of Reisberg to be made from a polymeric material such as PEEK imbedded with one or more radiographic markers as taught by Hynes et al. so that the plate is thinner, lighter and better tolerated by the patient after implantation and allows for clear visualization of the bone during post-operative monitoring. Reisberg further fails to disclose a break zone formed on at least a portion of said unbroken edge. Reisberg does disclose in Paragraph [0022] that “the area between the claims is bendable, and can be provided in a reduced width to facilitate bending” and in Paragraphs [0018 & 0028] that the implant can be shortened by the surgeon by cutting to a desired length. Furthermore, Gundolf discloses a bone stabilization plate comprising a plurality of elongate sections (14) separated by a slotted portion (16) having predetermined weakened break points in the form of slots (34, Fig. 7) or perforations (36, Fig. 8) formed through the material of the plate so that specific sections of the plate can be broken off along one of the break points to provide the plate in a desired size “without any major preparations and at short notice to the treated location of the bone or fracture during an operation, and that quickly and without any major effort by bending along the respective line of contact 16, resulting in the breaking-off of the stabilizing element 10. The length of the stabilizing element may be varied as required.” (Col. 6, Lines 21-40) Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the implant of Reisberg to add weakened break points in the form of slots or perforations formed perpendicular to the longitudinal axis of the implant through the curved bottom portion of each slot between each pair of subarms as taught by Gundolph in order to provide the implant with a means for allowing quicker and easier shortening of the implant length during a procedure without the need for an additional cutting tool. Thus, the combination discloses the claimed invention as stated in Claims 13-14 and the Applicant’s argument has been fully considered but is not persuasive.
In regards to Applicant’s arguments, filed 10/22/25, with respect to independent Claim 1 as rejected under 103 as being unpatentable over Reisberg in view of Hynes et al. and independent Claim 12 rejected under 102 as being anticipated by Reisberg, and the Applicant’s contention for both that “The clamps (4) define the width of the implant, not the longitudinal length” and “if the Reisberg clamps (4) are interpreted as the “subarms” the removal of a clamp would not result in a reduction of the length of the device”: As seen in the office action above, Fig. 2 of Reisberg has been annotated to depict the claimed features and will be reinserted below for clarity. Reisberg discloses an adjustable implant template (Figs. 1-3) comprising: a flexible (Paragraphs [0007, 0011-0012, 0016]) trial plate (1) having a monolithic (Paragraph [0028]) main body (the main body is defined as the elongated central portion comprising the circular apertures) and two arms extending from opposing sides of said main body (See examiner annotated Fig. 2 above)(each arm is defined as the entire portion above and the entire portion below the main body, respectively, wherein each arm contains a plurality of subarms); each of said arms comprising: at least two subarms arranged serially to define a length of said arm (See examiner annotated Fig. 2 above, which depicts each of the subarms appearing as successive parts, arranged sequentially in a series/serial manner, and defining a length of each respective arm, wherein the arm lengths are depicted in the examiner annotated Fig. 2); one or more slots interposed between said subarms and at least partially separating said subarms (See examiner annotated Fig. 2 above); and ribs connecting said subarms and separating said subarms from said main body, defining said one or more slots (See examiner annotated Fig. 2 above); wherein removal of a subarm from at least one end of said two arms reduces a length of said trial plate (Paragraphs [0010, 0028, 0032], See examiner annotated Fig. 2 above, which shows removal of one or more of the subarms from either end of each arm would reduce the length of that respective side/arm of the plate, and when subarms in the same location within each arm are removed from the 1st arm and the 2nd arm, an overall length of the plate would be reduced.); and wherein said trial plate can be formed from “all sorts of materials suitable for implantation into the human body, such as suitable metals, resorbable materials, memory materials, etc.” (Paragraph [0029]). Thus, as seen in the Fig. 2 depiction/annotations, when one or more of the subarms of each arm at either end of the template are removed, both the length of the respective arm and a length of the trial plate is reduced. It is further noted that in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “overall length of said trial plate”) are not recited in the rejected claim(s). The Applicant recites “overall length” throughout the arguments, however the claims simply recite “a length of said arm” and “a length of said trial plate”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the combination discloses the claimed invention as stated in Claim 1 and Reisberg discloses the invention as stated in Claim 21, and the Applicant’s arguments have been fully considered but are not persuasive.
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775