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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2025 has been entered.
Status of the Claims
The amendment filed 04/24/2025 has been entered. Claims 1, 3-5, 7-10, 12, 13 and 15-18 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Rejections - 35 USC § 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 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 1, 3-5, 7-10, 12, 13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reiley et al (US 20030191414 A1) in view of Biegun (US 20060111725 A1)
Regarding claim 1, Reiley substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A single-procedure medical device, comprising:
a surgical device (figure 1, composite instrument 10) comprised of
(a) at least one integral indicator ([0089-0090] handle 12 made of heat degradable material), wherein the integral indicator is composed of a polymeric material configured to irreversibly transition from a surgically operative conformation to a surgically inoperative conformation in response to an exposure after the single-procedure ([0089-0090] the handle irreversibly deform from a surgically operative conformation to inoperative conformation in response heat sterilization); and
(b) one or more non-indicator domains (figure 1, cannula 50) that: (i) are not composed of the polymeric material, or (ii) remain in the surgically operative conformation in response to the exposure, or the combination of both (i) and (ii);
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500%;
wherein the surgical device comprises a proximal end region (figure 1, proximal end region comprising handle 12), a distal end region (figure 1, distal end 34) and a conduit region (figure 1, cannula 50) disposed between the proximal end region and the distal end region;
wherein the distal end region is arranged as to contact a patient for treatment (figure 9), and the proximal end region is arranged as to be contacted by a clinician during use of the surgical device and not contact the patient (figure 9, the handle 12 contacted by a clinician and not contact the patient during procedure); and
wherein the at least one integral indicator is disposed in the proximal end region (figure 9 and [0089-0090] the composite handle 12 disposed in the proximal end region 12 comprises the integral indicator).
Reiley does not expressly teach the integral indicator is composed of a polymeric material;
The one or more non-indicator domains: (i) are not composed of the polymeric material, or (ii) remain in the surgically operative conformation in response to the exposure, or the combination of both (i) and (ii);
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500%;
Biegun teaches a medical device concerns an accessory for treating bone material, which relatively pertinent to the problem posed by applicant of providing destructible portion of the medical device after sterilization process, comprising at least one integral indicator (figure 5, [0012 and 0028-0033] rasp part 3 made of plastic, notably low or high-density polyethylene (LDPE, HDPE), polypropylene, polyacetal, PVC, etc.) is composed of a polymeric material; and
the one or more non-indicator domains (figure 5 and [0033], inserts 4 formed of a harder material, for example metal): (i) are not composed of the polymeric material, or (ii) remain in the surgically operative conformation in response to the exposure, or the combination of both (i) and (ii);
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500% ([0028-0033] part 3 made of polyethylene, and the polyethylene inherently possess the claimed properties above as indicated by instant application tables 1-2 and [0128]);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reiley to incorporate the teachings of Biegun and provides the integral indicator and the one or more non-indicator domains as claimed for the purpose of providing harder material that is sufficiently resistant to wear to attack the bone and providing the device irreversibly inoperable after sterilization while simplifying manufacturing process and reducing production cost as taught by Biegun ([0003-0004, 0022 and 0033]).
Regarding claim 3, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the polymeric material is selected from the group consisting of polyolefins, polyethylene, polyolefin copolymers, poly(ethylene-co-acetate), poly(ethylene-co-acrylate), polyesters, polycaprolactone and aliphatic homopolymers thereof, polyethers, polyethyleneoxide, fluoropolymers, polypropyleneoxide, olyisoprene, polyamide, polystyrene, polysulphone, polyoxymethylene, polycarbonate, polyvinyl chloride, and acrylnonitrile butadiene styrene, and filled embodiments thereof, and combinations thereof (Biegun; [0028] Rasp part 3 is made of plastic, notably low or high-density polyethylene (LDPE, HDPE), polypropylene, polyacetal, PVC, etc.).
Regarding claim 4, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the exposure (Reiley; [0089]-[0090] autoclaving the device) comprises subjecting the surgical device comprised of the integral indicator to: (i) one or more steam sterilization cycles, or (ii) an average temperature sufficient to precipitate the irreversible transition, or both.
Regarding claim 5, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the exposure (Reiley; [0089-0090] autoclaving the instrument 10 to an average temperature sufficient to precipitate the irreversible transition) comprises: (i) subjecting at least 20% of the total surface area of the integral indicator to one or more steam sterilization cycles, or (ii) subjecting the total volume of the integral indicator to an average temperature sufficient to precipitate the irreversible transition, or both.
Regarding claim 7, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the one or more non-indicator domains are composed of one or more materials selected from the group consisting of metals, metal alloys, shape memory alloys, titanium, nickel, copper, plastics, polymers, ceramic materials, composite materials, and stainless steel, and combinations thereof (Biegun; [0033] metal)
Regarding claim 8, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the surgical device is selected from the group consisting of reamers, awls, rod benders, drill guides, guide tubes, distance gages, inserters, implant holders, clamps, portals, screwdrivers, spacers, distracters, plate benders, broaches, fusion plates, fusion screws, spinal rods, spinal connectors, artificial discs, tissue-anchoring devices, fixation devices, dilators, joint spreaders, rasps, fusion cages, shavers, blades, burs, Kerrisons and Rongeurs, and combinations thereof (Reiley; [0012 and 0050] guide tubes).
Regarding claim 9, Reiley teaches a single-procedure indicator system, comprising:
(a) a medical device (figure 1, composite instrument 10); and
(b) an integral indicator ([0089-0090] handle 12 made of heat degradable material that irreversibly transition from an operative conformation to an inoperative conformation in response to an heat exposure) composed of a polymeric material configured to irreversibly transition from an operative conformation to an inoperative conformation in response to an exposure after the single-procedure;
(c) wherein the integral indicator is a contiguous component of the medical device (figure 1, handle 12 is contiguous component of the composite instrument 10);
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500%;
wherein the medical device comprises a proximal end region (figure 1, proximal end region comprising handle 12), a distal end region (figure 1, distal end 34) and a conduit region (figure 1, cannula 50) disposed between the proximal end region and the distal end region;
wherein the distal end region is arranged as to contact a patient for treatment (figure 9), and the proximal end region is arranged as to be contacted by a clinician during use of the medical device and not contact the patient (figure 9, the handle contacted by a clinician and not contact the patient during procedure); and
wherein the at least one integral indicator is disposed in the proximal end region (figure 1 and [0089-0090] the handle 12 disposed in the proximal end region comprising the at least one integral indicator).
Reiley does not expressly teach the integral indicator composed of a polymeric material;
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500%;
Biegun teaches a medical device concerns an accessory for treating bone material, which relatively pertinent to the problem posed by applicant of providing destructible portion of the medical device after sterilization process, comprising at least one integral indicator (figure 5, [0012 and 0028-0033] rasp part 3 made of plastic, notably low or high-density polyethylene (LDPE, HDPE), polypropylene, polyacetal, PVC, etc.) is composed of a polymeric material; and
wherein the polymeric material possesses at least one of a melt flow rate ranging from 5-1000 g/10 minute, a tensile strength ranging from 10-200 MPa, a tensile modulus ranging from 2-500 GPa, or a strain-at-break ranging from 2-500% ([0028-0033] part 3 made of polyethylene, and the polyethylene inherently possess the claimed properties above as indicated by instant application tables 1-2 and [0128]);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reiley to incorporate the teachings of Biegun and provides the integral indicator as claimed for the purpose of providing the device irreversibly inoperable after sterilization while simplifying manufacturing process and reducing production cost as taught by Biegun ([0003-0004, 0022 and 0033]).
Regarding claim 10, Reiley, as modified by Biegun, teaches the system of claim 9.
The combination does not expressly teach wherein the medical device further comprises one or more non-indicator domains that: (i) are not composed of the polymeric material, or (ii) remain in the operative conformation in response to the exposure, or the combination of both (i) and (ii).
Biegun teaches a medical device concerns an accessory for treating bone material, which relatively pertinent to the problem posed by applicant of providing destructible portion of the medical device after sterilization process, comprising one or more non-indicator domains (figure 5 and [0033], inserts 4 formed of a harder material, for example metal): (i) are not composed of the polymeric material, or (ii) remain in the surgically operative conformation in response to the exposure, or the combination of both (i) and (ii);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reiley, as modified by Biegun, to incorporate the teachings of Biegun and provides the integral indicator as claimed for the purpose of providing harder material that is sufficiently resistant to wear to attack the bone as taught by Biegun ([0003-0004, 0022 and 0033]).
Regarding claim 12, Reiley, as modified by Biegun, teaches the system of claim 9.
The combination further teaches wherein the polymeric material is selected from the group consisting of polyolefins, polyethylene, polyolefin copolymers, poly(ethylene-co-acetate), poly(ethylene-co-acrylate), polyesters, polycaprolactone and aliphatic homopolymers thereof, polyethers, polyethyleneoxide, fluoropolymers, polypropyleneoxide, olyisoprene, polyamide, polystyrene, polysulphone, polyoxymethylene, polycarbonate, polyvinyl chloride, and acrylnonitrile butadiene styrene, and filled embodiments thereof, and combinations thereof. (Biegun; [0028] Rasp part 3 is made of plastic, notably low or high-density polyethylene (LDPE, HDPE), polypropylene, polyacetal, PVC, etc.)
Regarding claim 13, Reiley, as modified by Biegun, teaches the system of claim 9.
The combination further teaches wherein the exposure (Reiley; [0089]-[0090] autoclaving the device) comprises subjecting the surgical device comprised of the integral indicator to: (i) one or more steam sterilization cycles, or (ii) an average temperature sufficient to precipitate the irreversible transition, or both.
Regarding claim 15, Reiley, as modified by Biegun, teaches the system of claim 10.
The combination further teaches wherein the one or more non-indicator domains are composed of one or more materials selected from the group consisting of metals, metal alloys, shape memory alloys, titanium, nickel, copper, plastics, polymers, ceramic materials, composite materials, and stainless steel, and combinations thereof (Biegun; [0033] metal)
Regarding claim 16, Reiley, as modified by Biegun, teaches the system of claim 9.
The combination further teaches wherein the surgical device is selected from the group consisting of reamers, awls, rod benders, drill guides, guide tubes, distance gages, inserters, implant holders, clamps, portals, screwdrivers, spacers, distracters, plate benders, broaches, fusion plates, fusion screws, spinal rods, spinal connectors, artificial discs, tissue-anchoring devices, fixation devices, dilators, joint spreaders, rasps, fusion cages, shavers, blades, burs, Kerrisons and Rongeurs, and combinations thereof (Reiley; [0012 and 0050] guide tubes).
Regarding claim 17, Reiley, as modified by Biegun, teaches the system of claim 9.
The combination further teaches wherein the polymeric material possesses a melting temperature ranging from 50-121°C (Biegun; [0028]-[0033] part 3 is made of polyethylene, for example LDPE, which melts at 108-120° C)
Regarding claim 18, Reiley, as modified by Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the polymeric material possesses a melting temperature ranging from 50-121°C (Biegun; [0028]-[0033] part 3 is made of polyethylene, for example LDPE, which melts at 108-120° C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/ Examiner, Art Unit 3781
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