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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 9 and 10, the new matter is that the second electrode comprises a pad connectable to an electrical generator via a conductor. The original disclosure makes no mention of this feature of the second electrode in particular.
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 2, 3, 8, 9, 10 and all claims depending therefrom 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.
Claims 2, 3, 9 and 10 recite “an electrical generator”. However, claim 1 (upon which claims 2, 3, 9 and 10 depend) has been amended to recite “an electrical generator” as well. Claims 2, 3, 9 and 10 are therefore indefinite because it is not clear whether these claims are intended to refer back to the same electrical generator now recited in claim 1, or a new electrical generator.
For the purpose of examination, the aforementioned claims will be interpreted to refer to the electrical generator recited in claim 1.
Claim 8 recites that "the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which the elongate insertion shaft is inserted," which is inconsistent with claim 1 (upon which claim 6), in which the insertion shaft comprises the second electrode.
For the purpose of examination, the claim will be interpreted to mean that the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which a portion of the elongate insertion shaft is inserted.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 7, 9, 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hradetzky et al (U.S. 9,731,306 B2, hereinafter "Hradetzky").
Hradetzky discloses a claimed surgical material delivery system (see Figs. 2-5), comprising:
an electrical generator 300 (illustrated schematically in Fig. 2 but also understood to be connected to the electrodes in Figs. 3-5) configured to generate a first polarity and a second polarity opposite the first polarity (see col. 5, lines 14-25 and col. 9, line 65 to col. 10, line 14),
an elongate insertion shaft (see Figs. 2-5 showing shaft 1; and see col. 12, lines 62-64 disclosing the device 1 along with an endoscope, such that the shaft includes both the endoscope and the device 1) having a proximal end portion and a distal end portion;
a passageway (spray chamber 31; see Figs. 2-5) extending at least partially through the elongate insertion shaft at the distal end portion of the elongate insertion shaft;
a discharge opening (at the end of housing 30; see Figs. 2-5) fluidly connected to the passageway (see also col.11, lines 65-66);
a first electrode 100 (see Figs. 2- 5) connected to a portion of the elongate insertion shaft and connected to the electrical generator (which provides the appropriate charge to the first electrode) configured to impart a first electrical charge at the first polarity to surgical material flowing through the passageway (see col. 13, lines 19-22; and see Figs. 2-5 showing negative charge applied to droplets "D" of material; and see col. 9, line 65 to col. 10, line 14); and
a second electrode 200 (see Figs. 2-5) couplable to the electrical generator (which provides the appropriate charge to the second electrode) and configured to impart a second electrical charge at the second polarity to tissue (see col. 9, line 65 to col. 10, line 14) spaced apart from the discharge opening across an open anatomic space (the embodiments in Figs. 2-4 show a small amount of anatomic space between the end face 10a of the discharge opening and the tissue “T” created by the second electrode 200 extending beyond the end face 10a of the discharge opening 32; and see the embodiment in Fig. 5, disclosed at col. 12, lines 34-42 that a boundary region 32 defines an anatomic space such that no contact is made between the second electrode and the tissue “T”).
Regarding claim 2, Hradetzky discloses the surgical material delivery system of claim 1, and the first electrode comprises:
a first conductor (see col. 13, line 21 referring to electrode 100 as "electrically conductive”) extending along the elongate insertion shaft for coupling to an electrical generator 300 (see Figs. 2-5); and a ring attached to the elongate insertion shaft (see Figs. 2-5 showing the ring as the portion through which the reservoir 10 is inserted).
Regarding claim 3, Hradetzky discloses the surgical material delivery system of claim 1, wherein the first electrode comprises:
a first conductor (see col. 13, line 21 referring to electrode 100 as "electrically conductive”) extending along the elongate insertion shaft for coupling to an electrical generator 300 (see Figs. 2-5);
and a metallic spray tip 11 (see Figs. 2-5) connected (fluidically) to the discharge opening; wherein the metallic spray tip is configured to produce a variable diameter spray pattern of the surgical material (see col. 3, line 60 to col. 4, line 7 describing both the metallic spray tip and the variable diameter spray ability).
Regarding claim 7, Hradetzky discloses the surgical material delivery system of claim 4, wherein the elongate insertion shaft comprises an endoscope (see col. 12, lines 62-64; an endoscope may be used to transport the elongate insertion shaft).
Regarding claim 9, Hradetzky discloses the surgical material delivery system of claim 1, wherein the second electrode comprises a pad connectable to the electrical generator via a conductor (see Fig. 5, showing two electrodes in the form of a second positive electrode associated with P; these electrodes are depicted in Figs. 2-5 to be pad-shaped and are understood to be connected to the same electrical generator 300 depicted in Fig. 2 via conductive wiring), wherein the pad comprises a plurality of conducting zones, each conducting zone independently activatable to produce an electric field (see conducting zones 31a and 32a).
Regarding claim 10, Hradetzky discloses the surgical material delivery system of claim 1, wherein the second electrode comprises a pad connectable to an electrical generator via a conductor, wherein the pad comprises a two-dimensional or three-dimensional shape configured to correspond to an anatomic shape (see Figs. 2-5, showing two electrodes in the form of a second positive electrode associated with P; these electrodes are depicted in Figs. 2-5 to be pad-shaped and are understood to be connected to the same electrical generator previously discussed, via conductive wiring; further, these pads would conform to a flat anatomic shape).
Regarding claim 13, Hradetzky discloses the surgical material delivery system of claim 1, further comprising:
a surgical material reservoir 10 (see Figs. 2-5) fluidly connected to the passageway; and a propulsion system fluidly connected to the surgical material reservoir (see col. 10, lines 25-26, disclosing that the reservoir 10 is connected to a syringe pump that propels fluid along spraying direction S).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky.
Regarding claim 4, it is noted that Hradetzky, in the embodiments depicted in Figs. 2-5, does not appear to disclose that the second electrode is extendable from a working channel of the elongate insertion shaft to be distal of the discharge opening and is retractable to be proximal of the discharge opening.
However, Hradetzky discloses a “further embodiment” of the invention where an expandable pad electrode is configured to extend from the conductor upon advancement beyond the electrode outlet and to retract into the electrode outlet (see col. 3, line 59 to col. 4, line 11).
A skilled artisan would have found it obvious at the time of the invention to modify the devices of Hradetzky depicted in Figs. 2-5 according to the further teaching in Hradetzky, as a well-known way to enlarge the target area delimited by the second electrode, with a reasonable expectation of success (see Hradetzky at col. 4, lines 4-6).
Claims 5, 6, 27, 28, 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Long (U.S. Pub. 2002/0147447, hereinafter "Long").
Regarding claim 5, it is noted that Hradetzky does not appear to disclose that the second electrode comprises: a wire having an extension portion and a distal tip; and an insulation jacket extending along the extension portion to leave the distal tip exposed; wherein the distal tip includes a collapsible pad.
Long discloses an electrode for a medical system, comprising a wire 74 (see Fig. 12) having an extension portion 18 (see Fig. 12) and a distal tip 28 (see Fig. 12); and an insulation jacket extending along the extension portion to leave the distal tip exposed (see para [0049]; extension portion 18 comprises conductors that are electrically insulated from each other); wherein the distal tip includes a collapsible pad 28 (see Fig. 12 and para [0060]; the pad 28 can collapse into sled housing 76).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide the second electrode with a wire having an extension portion and a distal tip; and an insulation jacket extending along the extension portion to leave the distal tip exposed; wherein the distal tip includes a collapsible pad, as a well-known way to provide controlled electrical charge to the tissue and to stop the charge when the electrode is withdrawn, with a reasonable expectation of success.
Regarding claim 6, Hradetzky discloses that the second electrode extends from a portion of the elongate insertion shaft distally of the discharge opening (see Fig. 1, showing electrode elements 200b and 200c extending slightly beyond the opening of 30), but does not appear to disclose a cap couplable to a distal end face of the elongate insertion shaft; wherein the cap comprises: a cylindrical body configured to circumscribe the elongate insertion shaft; and a side port extending through the cylindrical body to allow surgical material to pass therethrough.
Long discloses an electrode for a medical system, comprising a cap 116 coupled to a distal end face of an insertion shaft 63 (see Fig. 23), the cap comprising a cylindrical body that circumscribes the elongate insertion shaft and a side port 86 (see Fig. 23) extending through the cylindrical body to allow surgical material to pass therethrough (see para [0069]; side opening 86 allows fluid communication between endoscope 12 and the interior of the esophagus around ablation cap).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide a cap couplable to a distal end face of the elongate insertion shaft; wherein the cap comprises: a cylindrical body configured to circumscribe the elongate insertion shaft; and a side port extending through the cylindrical body to allow surgical material to pass therethrough, in order to provide more controlled positioning of the surgical material, with a reasonable expectation of success.
Regarding claims 27 and 30, Hradetzky discloses a claimed surgical material delivery system (see Figs. 2-5), comprising:
an elongate insertion shaft (see Figs. 2-5 showing shaft 1; and see col. 12, lines 62-64 disclosing the device 1 along with an endoscope, such that the shaft includes both the endoscope and the device 1);
a passageway (spray chamber 31; see Figs. 2-5) extending at least partially through the elongate insertion shaft;
a discharge opening (at the end of housing 30; see Figs. 2-5) fluidly connected to the passageway (see also col.11, lines 65-66);
an electrode channel (see col. 7, lines 12-20) extending through the elongate insertion shaft and terminating in an electrode outlet at a distal end of the elongate insertion shaft (see col. 7, lines 12-20);
a first electrode 100 (see Figs. 2- 5) connected to a portion of the elongate insertion shaft and configured to impart a first electrical charge to surgical material flowing through the passageway (see col. 13, lines 19-22; and see Figs. 2-5 showing negative charge applied to droplets "D" of material; and see col. 9, line 65 to col. 10, line 14);
a second electrode 200 (see Figs. 2-5) configured to impart a second electrical charge to tissue in contact therewith (see col. 9, line 65 to col. 10, line 14).
Hradetzky does not appear to disclose, in the embodiment depicted in Figs. 2-5, that the second electrode comprises:
an expandable pad connected to the distal tip, the expandable pad configured to expand radially outward from the conductor upon advancement beyond the electrode outlet and to collapse radially upon retraction into the electrode outlet, and as per claim 30, the expandable pad is self-expanding upon advancement beyond the electrode outlet.
However, Hradetzky discloses a “further embodiment” of the invention where an expandable pad electrode is configured to expand radially outward from the conductor upon advancement beyond the electrode outlet and to collapse radially upon retraction into the electrode outlet (see col. 3, line 59 to col. 4, line 11). Hradetzky discloses that in this embodiment, the expandable pad is self-expanding upon advancement beyond the electrode outlet (see col. 4, lines 10-16).
A skilled artisan would have found it obvious at the time of the invention to modify the devices of Hradetzky depicted in Figs. 2-5 according to the further teaching in Hradetzky, as a well-known way to enlarge the target area delimited by the second electrode, with a reasonable expectation of success (see Hradetzky at col. 4, lines 4-6).
Further, Hradetzky does not appear to disclose a conductor extending through the electrode channel and advanceable distally beyond the electrode outlet and retractable proximally of the electrode outlet; and an insulation jacket extending along the conductor to leave a distal tip of the conductor exposed.
Long discloses an electrode for a medical system, comprising a wire 74 (see Fig. 12) having an extension portion 18 (see Fig. 12) and a distal tip 28 (see Fig. 12); and an insulation jacket extending along the extension portion to leave the distal tip exposed (see para [0049]; extension portion 18 comprises conductors that are electrically insulated from each other).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide the second electrode with a conductor having an extension portion and a distal tip; and an insulation jacket extending along the extension portion to leave the distal tip exposed, as a well-known way to provide controlled electrical charge to the tissue and to stop the charge when the electrode is withdrawn, with a reasonable expectation of success.
Regarding claim 28, it is noted that Hradetzky does not appear to disclose, in the embodiments depicted in Figs. 2-5, that the expandable pad comprises a mesh structure having openings configured to allow surgical material to pass through the expandable pad to reach tissue contacted by the expandable pad.
However, Hradetzky discloses that another embodiment of its electrode comprises a circumferential free end region protruding from or out of the spray chamber towards the target (e.g. human tissue), wherein the free end region comprises or consists of an electrically conducting wire mesh (see col. 3, lines 42-45).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide the second electrode as a pad comprising a mesh structure having openings configured to allow surgical material to pass through the expandable pad to reach tissue contacted by the expandable pad, as a well-known way to provide the spraying capability already disclosed in Hradetzky, with a reasonable expectation of success in reaching tissue that would have otherwise been covered by the second electrode.
Regarding claim 31, it is noted that Hradetzky does not appear to disclose, in the embodiments depicted in Figs. 2-5, that the elongate insertion shaft further comprises an endoscope, and wherein the electrode channel comprises a working channel of the endoscope.
However, Hradetzky discloses that another embodiment of its device has the working channel of a tubular device being the working channel of an endoscope (see col. 7, lines 11-25).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide the elongate insertion shaft comprising an endoscope, and wherein the electrode channel comprises a working channel of the endoscope, in order to be able to position the housing close to a respective target, for example, a distal lung (see Hradetzky at col. 7, lines 18-20).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Hutchinson et al (U.S. Pat. 5,360,428, hereinafter "Hutchinson").
Regarding claim 8, it is noted that Hradetzky does not appear to disclose that the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which the elongate insertion shaft is inserted.
But Hradetzky teaches that its device enables minimally invasive access to various organ systems (see col. 15, lines 51-53).
Further, Hutchinson discloses that minimally invasive procedures can be performed using a laparoscopic technique using a trocar device, which is a tubular body into which the instrument is inserted (see col. 1, lines 25-30).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by providing a trocar device as part of the second electrode, the trocar device comprising a tubular body into which the elongate insertion shaft is inserted, as trocars were known to provide ports of openings for the introduction of the surgical material (see Hutchinson at col. 1, lines 25-30); and in making such a combination, a skilled artisan would have had a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Coffee et al (U.S. Pat. 4,634,057, hereinafter "Coffee").
Regarding claim 11, it is noted that Hradetzky discloses the system of claim 1, wherein the passageway of the elongate insertion shaft is lined (see col. 6, lines 30-36), but does not disclose that the lining is PTFE.
Coffee discloses a metal electrode assembly 70 supported in an insulating PTFE housing (see col. 4, lines 40-60).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by using PTFE as the lining of the elongate insertion shaft, with a reasonable expectation of success in insulating the electrode assembly.
Further, the selection of a known material based on its suitability for its intended use can support a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). In this case, PTFE was a well-known material for insulating electrodes.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Woloszko (U.S. Pat. 6,837,884, hereinafter "Woloszko").
Regarding claim 12, it is noted that Hradetzky does not appear to disclose that the surgical material delivery system comprises a conducting gel comprising electrically chargeable particles.
Woloszko discloses that an electrosurgical apparatus, in the analogous art to Applicant's invention, may use electrically conductive gel at the target site prior to delivery of a high frequency voltage (see col. 4, line 64 to col. 5, line 12 and col. 20, lines 11-24).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by providing a conducting gel comprising electrically chargeable particles as part of the surgical material delivery system, in order to achieve an improved current flow path between the first and second electrodes (as taught in Woloszko at col. 20, lines 11-13), with a reasonable expectation of success.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Long, further in view of Chandrasekaran et al (U.S. Pub. 2002/0072740 A1, hereinafter “Chandrasekaran”).
Regarding claim 29, it is noted that Hradetzky, in view of Long, does not appear to disclose that the expandable pad comprises a first portion and a second portion configured to pivot outward from the conductor to form a surface area for contacting target tissue.
Chandrasekaran discloses an electrode for delivering energy to a tissue site, comprising a first portion and a second portion in the form of wires, that pivot outward relative to a central conducting wire in order to contact surface tissue (see Figs. 1A, 1B and para [0019]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky so that the expandable pad has a first portion and a second portion configured to pivot outward from the conductor to form a surface area for contacting target tissue, as this was a well-known design for an energy-delivering electrode, and would have had a reasonable expectation of success when used in the Hradetzky device since the electrode would have been able to expand and collapse inside of a larger tubular sheath.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Long, further in view of Bakos et al (U.S. Pat. 9,078,662 B2, hereinafter “Bakos”).
Regarding claim 32, it is noted that Hradetzky, in view of Long, does not appear to disclose that the expandable pad comprises a blunted tip connected to the conductor to inhibit puncture of target tissue upon advancement beyond the electrode outlet.
Bakos discloses an electrode that can be fashioned from either a sharp tip or a blunted tip (see Figs. 11 and 12).
Since Hradetzky already discloses that its electrodes should be blunt and not designed to pierce skin (see Figs. 2-5 of Hradetzky), a skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky so that the expandable pad comprises a blunted tip connected to the conductor, to inhibit puncture of target tissue upon advancement beyond the electrode outlet, in order to maintain the safety of the patient by preventing inadvertent punctures of delicate tissue, with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments, filed in Remarks on 07/07/2026 have been considered. Applicant’s amendments and arguments have overcome the previous rejections under 35 U.S.C. 112.
Regarding the rejections under 35 U.S.C 102(a), Applicant argued that amended claim 1, in contrast to Hradetzky, requires that the second electrode configured to charge tissue that is spaced apart from the discharge opening across an open anatomic space (see Remarks, pg. 14).
But, as noted in the above rejection, Hradetzky discloses that the second electrode 200 (see Figs. 2-5) is couplable to the electrical generator (which provides the appropriate charge to the second electrode) and is configured to impart a second electrical charge at the second polarity to tissue (see col. 9, line 65 to col. 10, line 14) spaced apart from the discharge opening across an open anatomic space (the embodiments in Figs. 2-4 show a small amount of anatomic space between the end face 10a of the discharge opening and the tissue “T” created by the second electrode 200 extending beyond the end face 10a of the discharge opening 32; and see the embodiment in Fig. 5, disclosed at col. 12, lines 34-42 that a boundary region 32 defines an anatomic space such that no contact is made between the second electrode and the tissue “T”).
Applicant’s arguments regarding claim 4 (see Remarks, pg. 14) are moot in view of a new ground of rejection. claim 6, Applicant argued that Hradetzky, in view of Long, does not disclose the claimed invention, in particular, Long does not disclose an electrostatic electrode configured to impart an electrical charge to tissue across an open anatomic space (see Remarks, pg. 15). But this structure is already provided in Hradetzky. Long was relied upon for its teaching of the specifically claimed cap structure, not for its teaching of an electrode configured to impart an electrical charge to tissue across an open anatomic space.
Regarding claim 6, Applicant argued that Hradetzky, in view of Long, does not disclose the claimed invention, in particular, Long does not disclose an electrostatic electrode configured to impart an electrical charge to tissue across an open anatomic space (see Remarks, pg. 15). But this structure is already provided in Hradetzky. Long was relied upon for its teaching of the specifically claimed cap structure, not for its teaching of an electrode configured to impart an electrical charge to tissue across an open anatomic space.
Regarding claim 8, Applicant argued that Hradetzky, in view of Long, does not disclose the claimed invention, in particular, “utilizing a separate trocar device as an electrostatic electrode” (see Remarks, pg. 15). But the claims do not require that the trocar device be used as an electrode; rather, claim 8 requires that the elongate insertion shaft, to which a first electrode is connected, be merely inserted through a trocar device having a tubular body.
Regarding claims 9 and 10, Applicant argued that Hradetzky does not disclose a second electrode comprising a pad (see Remarks, pg. 15). But the term “pad” has been given its broadest reasonable interpretation consistent with the specification. In the specification, the pad is depicted as a rectangular shape (see Fig. 1), and is described as having a “two dimensional or three-dimensional shape configured to correspond to an anatomic shape” (see specification at para [00101]). In Hradetzky, the pad is depicted as having the same shape, and is three-dimensional. The pad may be thin and flat, as is shown in Hradetzky, but the broadest reasonable interpretation of a “pad” does not require a thin and flat structure.
Applicant argued that claims 5, 6, 8, 11, 12 were patentable due to their dependency from claim 1 (see Remarks pg. 17) but were otherwise not argued on their individual merits.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/02/2026
