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 .
Status of the Claims
The amendment filed 12/17/2025 has been entered. Claims 1, 3-5, 7-10 and 12, 13, and 15-18 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect to art rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 line 1 recites “the integral indicator” which should read “the single-procedure medical device”
Appropriate correction is required.
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 8 and 16 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.
Claim 8, which depends from the Claim 1, defines the surgical device as being selected from a Markush group including at least “screwdrivers”, “awls” and “clamps”, while Claim 1 recites a medical device comprising, among other feature, a “conduit region disposed between the proximal end region and the distal end region”. A person of ordinary skill in the art would understand the device above having solid-body, and do not necessarily have a “conduit” (i.e., a hollow channel, tube, or passage) as required by the independent claim 1. Consequently, it is not clear if the claim is intended to recite the device above with hollow conduit variant or the claim improperly encompasses solid tools that do not meet the limitation of claim 1.
Similarly, Claim 16, which depends from Claim 9, defines the surgical device as being selected from a Markush group including at least “screwdrivers”, “awls” and “clamps”, and therefore the claim is rejected under 112(b).
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 and 12, 13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Novak et al (US 6443969 B1) in view of Isola et al (US 20170007852 A1)
Regarding claim 1, Novak 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, blade 12) comprised of
(a) at least one integral indicator, 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; and
(b) one or more non-indicator domains (col 6 lines 12-23, body of blade 12 constructed of titanium or stainless steel) 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 3, proximal end region comprising thread 34 and shank 32), a distal end region (figure 3, opposite distal end region comprising blade edge 42) and a conduit region (figures 3 and 10 tapered portion 38 comprising bore 52) 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 10 and col 6 lines 24-34, the blade edge 42 is configured to contact with the surgical site), and the proximal end region is arranged as to not contact the patient (figure 10 and col 5 lines 12-20, opposite proximal end is configured to be mounted to probe 14 that is not configured to contact the surgical site); and
wherein the at least one integral indicator is disposed in the proximal end region.
Nova does not teach the surgical device comprised of
(a) at least one integral indicator, 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; and
wherein the at least one integral indicator is disposed in the proximal end region.
In the same field of endeavor, namely an ultrasonic medical probe with failsafe for sterility, Isola teaches the surgical device (figures 5 and 6, probe 300) is comprised of
at least one integral indicator (figures 5 and 6 and [0036] polymeric connector 312 is configured to be degraded or decomposed upon exposure to a source of extreme energy), 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; and
wherein the at least one integral indicator is disposed in the proximal end region (figures 5-6, the polymeric connector 312 positioned in the proximal end region).
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 Novak to incorporate the teachings of Isola and provides the surgical device as claimed for the purpose of configuring the device inoperable after sterilization as taught by Isola ([0017]).
The combination does not expressly teach 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 an accessories for removing 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 1 [0028], rasp part 3 made of plastic, for example low or high-density polyethylene or PVC, which is identical to the material of the claimed invention, i.e., claim 3 or specification [0009]. Consequently, the prior art inherently possess claimed properties below) comprising a 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%.
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 Novak, as modified by Isola, to incorporate the teachings of Biegun and provides the polymeric material 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]).
Regarding claim 3, Novak, as modified by Isola and 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, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the exposure (Isola;[0012]-[0017] the exposure include autoclave provide temperature sufficient to melt the connector) 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, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device of claim 1.
The combination further teaches wherein the exposure (Isola; [0012]-[0017] the exposure comprises autoclave cycle that subject the probe including the connector to a temperature sufficient to melt the connector) 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, Novak, as modified by Isola and 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 (Novak; col 6 lines 12-23 "Blade 12 may be constructed either of Titanium 6AL4V or Stainless Steel 17-4PH alloy.")
Regarding claim 8, Novak, as modified by Isola and 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 (Novak; abstract, namely an ultrasonic surgical blade).
Regarding claim 9, Novak teaches a single-procedure indicator system, comprising:
(a) a medical device (figure 1, blade 12); and
(b) an integral indicator 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;
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 3, proximal end region comprising thread 34 and shank 32), a distal end region (figure 3, opposite distal end region comprising blade edge 42) and a conduit region (figures 3 and 10 tapered portion comprising bore 52) 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 10 and col 6 lines 24-34, the blade edge 42 is configured to contact with the surgical site), and
the proximal end region is arranged as to not contact the patient (figure 10 and col 5 lines 12-20, opposite proximal end is configured to be mounted to probe 14); and
wherein the at least one integral indicator is disposed in the proximal end region.
Nova does not teach the single-procedure indicator system comprising:
(b) an integral indicator 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;
wherein the at least one integral indicator is disposed in the proximal end region.
In the same field of endeavor, namely an ultrasonic medical probe with failsafe for sterility, Isola teaches a single-procedure indicator system (figures 5 and 6, probe 300) comprising:
(b) an integral indicator (figures 5 and 6 and [00036] polymeric connector 312 is configured to be degraded or decomposed upon exposure to a source of extreme energy) 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 (figures 5 and 6, the polymeric connector 312 is contiguous component of probe 300) is a contiguous component of the medical device;
wherein the at least one integral indicator is disposed in the proximal end region (figures 5 and 6, the polymeric connector 312 positioned in the proximal end region).
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 Novak to incorporate the teachings of Isola and provides the surgical device as claimed for the purpose of configuring the device inoperable after sterilization as taught by Isola ([0017]).
The combination does not expressly teach 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 an accessories for removing 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 1 [0028], rasp part 3 made of plastic, for example low or high-density polyethylene or PVC, which is identical to the material of the claimed invention, i.e., claim 3 or specification [0009]. Consequently, the prior art inherently possess claimed properties below) comprising a 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%.
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 Novak, as modified by Isola, to incorporate the teachings of Biegun and provides the polymeric material 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]).
Regarding claim 10, Novak, as modified by Isola and Biegun, teaches the system of claim 9.
The combination further teaches wherein the medical device further comprises one or more non-indicator domains that: (i) are not composed of the polymeric material (Novak; col 6 lines 12-23, body of blade 12 constructed of titanium or stainless steel), or (ii) remain in the operative conformation in response to the exposure, or the combination of both (i) and (ii).
Regarding claim 12, Novak, as modified by Isola and 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, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device of claim 9.
The combination further teaches wherein the exposure (Isola; [0012]-[0017] the exposure comprises autoclave cycle that subject the probe including the connector to a temperature sufficient to melt the connector) 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 15, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device 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 (Novak; col 6 lines 12-23 "Blade 12 may be constructed either of Titanium 6AL4V or Stainless Steel 17-4PH alloy.").
Regarding claim 16, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device of claim 9.
The combination further teaches wherein the medical 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 (Novak; abstract, namely an ultrasonic surgical blade).
Regarding claim 17, Novak, as modified by Isola and 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, Novak, as modified by Isola and Biegun, teaches the single-procedure medical device 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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/S.H./Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781