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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 48 and 55 pertaining to the amended limitations of “a Shore A hardness of biocompatible elastomeric material of the elongate carrier varies across a cross=section of the elongate carrier”, “an elastomeric material of an elongate carrier has a variable hardness” and “an elongate carrier is formed from an elastomeric material comprising a first region having a first hardness and a second region having a second hardness, greater than the first hardness” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, none of either Risi, Selkee, Cooper, Imran, Kennelly or Chodowski are relied upon to disclose the above-cited limitations pertaining to a variable hardness. As the currently-pending claims (41-60) are new and thus not previously examined, a new grounds of rejection for the claims is provided below.
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.
Claim 60 is 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 60 recites, “wherein the first hardness has at least 33% greater Shore A hardness than the second hardness.” It is unclear how the “first hardness” can comprise a Shore A hardness greater than the “second hardness”, as claimed, since the “second hardness” is recited to be greater than the “first hardness” within the limitations of claim 55, from which claim 60 depends. As the examiner cannot determine which “hardness” comprises the greater value based on contradicting limitations, claim 60 is rendered indefinite. For the purposes of examination, claim 60 is interpreted to recite, “wherein the second hardness has at least 33% greater Shore A hardness than the first hardness” to remain consistent with the limitations of claim 55.
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.
Claim(s) 41-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Risi (US 2009/0030483 A1)(previously of record) in view of Reo (US 2021/0008356 A1), further in view of Zhou (US 2003/0125712 A1).
Regarding claim 41, Risi discloses:
An electrode array (electrode assembly 200, see Fig. 2A) comprising:
an elongate carrier (carrier member 202, see Fig. 2A);
a plurality of stimulating electrodes (electrodes 212, see Fig. 2A) spaced along the elongate carrier (see Fig. 2A); and
a wire bundle (collection of wires 252, see Figs. 2C-2D) embedded within the elongate carrier (see Figs. 2C-2D and Para. [0035]), wherein each of the plurality of stimulating electrodes is electrically connected to at least one wire from the wire bundle (see Para. [0035]-[0036]).
However, Risi does not expressly disclose:
Wherein the elongate carrier is formed from a biocompatible elastomeric material; and
wherein a Shore A hardness of the biocompatible elastomeric material of the elongate carrier varies across a cross-section of the elongate carrier.
In the same field of endeavor, namely elongate carrier devices configured to be navigated through a patient’s anatomy (within the ear/nose/throat areas) to an intended use site, Reo teaches wherein an elongate carrier member (carrier member 306, see Figs. 5-6) is formed from medical-grade silicone (see Para. [0004] and [0070]) which is a soft, flexible and biocompatible material that provides enhanced compatibility and interaction with surgically-penetrated tissue; wherein the normal Shore A hardness for said medical-grade silicone is within a range of 60-80 (see Para. [0004]).
Since Risi does not disclose a material used to construct the disclosed carrier member, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for a known flexible material to be used to construct a surgical carrier device of Risi since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). As Reo discloses wherein medical grade silicone within a Shore A hardness range of 60-80 is a known flexible material used to form elongate carrier devices, one of ordinary skill in the art would have expected the carrier member of Risi to function appropriately should it be formed from medical-grade silicone within the disclosed Shore A hardness range of 60-80.
In the same field of endeavor, namely elongate body catheter devices configured to navigate and guide additional instruments to a desired surgical site, Zhou teaches wherein an elongate catheter (catheter 13, see Fig. 1) may comprise multiple layers increase in Shore hardness towards the radial center thereof (i.e., Shore hardness increases from a radially-outward position to radially-inward position) which provides the catheter with increased stiffness and rigidity without significantly affecting the catheter’s ability to retain its initial/desired shape during navigation to a target site (see Para. [0032]).
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 the carrier member of Risi to comprise a varied Shore hardness (i.e., the hardness of the silicone used to form the carrier member, as incorporated from the teachings of Reo) that increases (within the disclosed range of between 60 to 80 Shore A) in a radially-inward direction as taught and suggested by Zhou to, in this case, provides the carrier member with increased stiffness and rigidity without significantly affecting ability to retain its initial shape during navigation to a target site (see Zhou Para. [0032]).
Regarding claim 42, the combination of Risi, Reo and Zhou disclose the invention of claim 41, Risi, as modified by Reo and Zhou, further discloses wherein the elongate carrier is formed from at least two grades of the biocompatible elastomeric material (carrier member of Risi is formed from layers of medical-grade silicone that increase in Shore A hardness towards the radial center, as incorporated from the teachings of Reo) each having a different Shore A hardness (the silicone used to form the carrier member increases in Shore A hardness towards the radially-inward central portion, as incorporated from the teachings of Zhou).
Regarding claim 43, the combination of Risi, Reo and Zhou disclose the invention of claim 41, Risi, as modified by Reo, further disclose wherein the elongate carrier is formed from medical grade silicone (see Reo Para. [0004] and [0070]).
However, while Reo discloses wherein the medical-grade silicone used in medical devices may range from 60-80 Shore A hardness (see Reo Para. [0004]), and Zhou discloses wherein the Shore hardness of the material used to form the carrier member increases radially-inwardly (see Zhou Para. [0032]), the combination does not expressly disclose wherein medical-grade silicone varies from a first Shore A hardness of about 60 to a second Shore A hardness of about 80 across the cross-section of the elongate carrier.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Shore A hardness of the silicone used to form the carrier member of Risi to range from between 60 and 80 (i.e., the range disclosed by Reo) as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0057]-[0058] mentioning that the difference in hardness of the material used to form the elongate carrier may range from between 10-100%, with “one example” having the Shore A hardness range from 60 to 80) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 44, the combination of Risi, Reo and Zhou disclose the invention of claim 41, Risi, as modified by Zhou, further discloses wherein the Shore A hardness of the biocompatible elastomeric material in an area at or near the center of the cross-section of the elongate carrier is greater than the Shore A hardness of the biocompatible elastomeric material in an area at the periphery of the cross-section of the elongate carrier (see Zhou Para. [0032] and Fig. 5 showing/mentioning wherein the Shore hardness of the material used to form the radially-inward portion of the catheter is of a greater Shore hardness than the material used to form the radially-outward peripheral portion).
Regarding claim 45, the combination of Risi, Reo and Zhou disclose the invention of claim 41, Risi, as modified by Zhou, further discloses wherein the wire bundle is embedded in a region of the elongate carrier that is formed from the biocompatible elastomeric material having the Shore A hardness that is less than a maximum Shore A hardness of the biocompatible elastomeric material (see Risi Para. [0035] mentioning wherein the wires may be embedded either within a central volumetric core or at or near the surface of the carrier member; in this instance, the embodiment wherein the wires are embedded at or near the surface of the carrier member would have the wires embedded in a portion of the carrier member that does not comprise the maximum Shore A hardness).
Regarding claim 46, the combination of Risi, Reo and Zhou disclose the invention of claim 41, Risi, as modified by Zhou, further discloses wherein the elongate carrier comprises a first cross-sectional region of the biocompatible elastomeric material having a first Shore A hardness (radially-outward peripheral portion of the carrier member of Risi is formed from silicone having a first Shore A hardness, as incorporated from the teachings of Reo and Zhou) and a second cross-sectional region of the biocompatible elastomeric material having a second Shore A hardness, wherein the second Shore A hardness is greater than the first Shore A hardness (the radially-inward central portion of the carrier member is formed from silicone having a greater Shore A hardness compared the radially-outward peripheral portions(s), as incorporated from the teachings of Reo and Zhou).
Regarding claim 47, the combination of Risi, Reo and Zhou disclose all of the limitations of the invention of claim 46.
However, none of the combination expressly discloses wherein the second cross-sectional region of the biocompatible elastomeric material comprises between about 10% and about 90% of a cross-sectional area of the elongate carrier.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the carrier member of Risi et al. to have the second cross-sectional region of the biocompatible elastomeric material comprise between 10% to 90% of a cross-sectional area of the elongate carrier since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the carrier member of Risi et al. would not operate differently with the claimed dimension(s) since the only stipulation of the combination is that the radially-outward region of the carrier member comprises a greater Shore A hardness than the radially-inward region. None of either Risi or Zhou provide any required or functional dimensions for the different portions and thus one of ordinary skill would have had a reasonable expectation that having the “second cross-sectional region” comprise between 10% to 90% of the cross-section of the carrier member would not impact the functionality of the device. Further, applicant places no criticality on the range claimed, indicating simply that the second cross sectional region “may” be within a range of between 10% to at least 90% (inclusive) of the total cross-section of the device (see Specification Para. [0060]).
Regarding claim 48, Risi discloses:
An electrode array (electrode assembly 200, see Fig. 2A) comprising:
an elongate carrier (carrier member 202, see Fig. 2A);
a plurality of stimulating electrodes (electrodes 212, see Fig. 2A) supported by the elongate carrier (see Figs. 2A), wherein the plurality of stimulating electrodes is spaced along the elongate carrier (see Figs. 2A); and
a wire bundle (collection of wires 252, see Figs. 2C-2D) embedded within the elongate carrier (see Figs. 2C-2D and Para. [0035]), wherein each of the plurality of stimulating electrodes is electrically connected to at least one wire from the wire bundle (see Para. [0035]-[0036]).
However, Risi does not expressly disclose:
Wherein the elongate carrier is formed from a biocompatible elastomeric material; and
wherein the elastomeric material of the elongate carrier has variable hardness.
In the same field of endeavor, namely elongate carrier devices configured to be navigated through a patient’s anatomy (within the ear/nose/throat areas) to an intended use site, Reo teaches wherein an elongate carrier member (carrier member 306, see Figs. 5-6) is formed from medical-grade silicone (see Para. [0004] and [0070]) which is a soft, flexible and biocompatible material that provides enhanced compatibility and interaction with surgically-penetrated tissue; wherein the normal Shore A hardness for said medical-grade silicone is within a range of 60-80 (see Para. [0004]).
Since Risi does not disclose a material used to construct the disclosed carrier member, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for a known flexible material to be used to construct a surgical carrier device of Risi since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). As Reo discloses wherein medical grade silicone within a Shore A hardness range of 60-80 is a known flexible material used to form elongate carrier devices, one of ordinary skill in the art would have expected the carrier member of Risi to function appropriately should it be formed from medical-grade silicone within the disclosed Shore A hardness range of 60-80.
In the same field of endeavor, namely elongate body catheter devices configured to navigate and guide additional instruments to a desired surgical site, Zhou teaches wherein an elongate catheter (catheter 13, see Fig. 1) may comprise multiple layers increase in Shore hardness towards the radial center thereof (i.e., Shore hardness increases from a radially-outward position to radially-inward position) which provides the catheter with increased stiffness and rigidity without significantly affecting the catheter’s ability to retain its initial/desired shape during navigation to a target site (see Para. [0032]).
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 the carrier member of Risi to comprise a varied Shore hardness (i.e., the hardness of the silicone used to form the carrier member, as incorporated from the teachings of Reo) that increases (within the disclosed range of between 60 to 80 Shore A) in a radially-inward direction as taught and suggested by Zhou to, in this case, provides the carrier member with increased stiffness and rigidity without significantly affecting ability to retain its initial shape during navigation to a target site (see Zhou Para. [0032]).
Regarding claim 49, the combination of Risi, Reo and Zhou disclose the invention of claim 48, Risi, as modified by Zhou, further discloses wherein the elastomeric material of the elongate carrier comprises a first hardness and a second hardness, the second hardness being greater than the first hardness (the medical-grade silicone used to form the carrier member of Risi, as incorporated from the teachings of Reo, comprises a Shore A hardness that increases (within the disclosed range of 60 to 80 Shore A) from a radially-outward portion to a radially-inward portion, as incorporated from the teachings of Zhou).
Regarding claim 50, the combination of Risi, Reo and Zhou disclose the invention of claim 49, Risi, as modified by Zhou, further discloses an elongate stiffener (stiffening member 208, see Fig. 2C), wherein the elongate stiffener is embedded within the elastomeric material of the first hardness (see Fig. 2C of Risi showing wherein the stiffening member 208 is disposed at the radial center of the carrier member, which would be embedded within and radially surrounded by the outer layer comprising the “first hardness hardness”, as incorporated from the teachings of Zhou).
However, while Risi discloses wherein the stiffening member may be formed from “any materials now or later developed”, Risi does not expressly disclose wherein the stiffener is formed from the elastomeric material of the second hardness.
Since Risi discloses wherein “any material” may be used to form the stiffener member, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the harder variety of silicone used to form the “second hardness” of the carrier member to construct the stiffening member of Risi since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). As Zhou discloses wherein having a harder material used within the radially-inward portion of an elongate catheter member increases rigidity and stiffness without comprising flexibility, one of ordinary skill in the art would have expected the stiffening member to function appropriately when made from the “second hardness” variety of silicone since the material is inherently flexible and elastomeric.
Regarding claim 51, the combination of Risi, Reo and Zhou disclose the invention of claim 50, Risi further discloses a plurality of conductors (material used to form the wire(s) 252, see Para. [0036] which is electrically conductive; this is seen to be the same interpretation used in the claimed invention per Para. [0047] of the Specification which discloses that the wires themselves are the conductor(s) without any additional conductor elements mentioned which connect to the electrodes), wherein each of the plurality of electrodes is electrically connected to at least one of the plurality of conductors (see Para. [0036]), and the elongate stiffener and the plurality of electrodes are disposed on opposite sides of the plurality of conductors (see Para. [0035] mentioning wherein wires 252 may be embedded closer to surface 216 from the central axis; since the stiffening member 208 is positioned within the central core (see Fig. 2B), conductive wire would be positioned between the stiffening member and the electrodes, which are positioned along the surface of 216 as evident from Fig. 2A)
Regarding claim 52, the combination of Risi, Reo and Zhou disclose the invention of claim 50, Risi, as modified by Zhou, further discloses wherein the second hardness of the elastomeric material is greater than the first hardness of the elastomeric material (see Zhou Para. [0032] mentioning wherein the material of the radially-inward portion is made from a harder material than the radially-outward portion).
Regarding claim 53, the combination of Risi, Reo and Zhou disclose the invention of claim 48, Risi, as modified by Zhou, further discloses wherein the elastomeric material of the elongate carrier varies from a Shore A hardness of 60 to a Shore A hardness of 80.
However, while Reo discloses wherein the medical-grade silicone used in medical devices may range from 60-80 Shore A hardness (see Reo Para. [0004]), and Zhou discloses wherein the Shore hardness of the material used to form the carrier member increases radially-inwardly (see Zhou Para. [0032]), the combination does not expressly disclose wherein the elastomeric material of the elongate carrier varies from a Shore A hardness of 60 to a Shore A hardness of 80.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the Shore A hardness of the silicone used to form the carrier member of Risi to range from between 60 and 80 (i.e., the range disclosed by Reo) as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0057]-[0058] mentioning that the difference in hardness of the material used to form the elongate carrier may range from between 10-100%, with “one example” having the Shore A hardness range from 60 to 80) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 54, the combination of Risi, Reo and Zhou disclose the invention of claim 48, Risi, as modified by Zhou, further discloses wherein the elastomeric material comprises at least two grades (carrier member of Risi is formed from layers of medical-grade silicone that increase in Shore A hardness towards the radial center, as incorporated from the teachings of Reo) having different hardnesses (the silicone used to form the carrier member increases in Shore A hardness towards the radially-inward central portion, as incorporated from the teachings of Zhou).
Regarding claim 55, Risi discloses:
An electrode array (electrode assembly 200, see Fig. 2A) comprising:
a plurality of stimulating electrodes (electrodes 212, see Fig. 2A);
a wire bundle (collection of wires 252, see Figs. 2C-2D), wherein each of the plurality of stimulating electrodes is electrically connected to at least one wire from the wire bundle (see Para. [0035]-[0036]); and
an elongate carrier (carrier member 202, see Fig. 2A) supporting the plurality of stimulating electrodes and the wire bundle (see Fig. 2A and 2C-2D).
However, Risi does not expressly disclose:
wherein the elongate carrier is formed from an elastomeric material comprising a first region having a first hardness and a second region having a second hardness, greater than the first hardness.
In the same field of endeavor, namely elongate carrier devices configured to be navigated through a patient’s anatomy (within the ear/nose/throat areas) to an intended use site, Reo teaches wherein an elongate carrier member (carrier member 306, see Figs. 5-6) is formed from medical-grade silicone (see Para. [0004] and [0070]) which is a soft, flexible and elastomeric material that provides enhanced compatibility and interaction with surgically-penetrated tissue; wherein the normal Shore A hardness for said medical-grade silicone is within a range of 60-80 (see Para. [0004]).
Since Risi does not disclose a material used to construct the disclosed carrier member, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for a known flexible material to be used to construct a surgical carrier device of Risi since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). As Reo discloses wherein medical grade silicone within a Shore A hardness range of 60-80 is a known flexible material used to form elongate carrier devices, one of ordinary skill in the art would have expected the carrier member of Risi to function appropriately should it be formed from medical-grade silicone within the disclosed Shore A hardness range of 60-80.
In the same field of endeavor, namely elongate body catheter devices configured to navigate and guide additional instruments to a desired surgical site, Zhou teaches wherein an elongate catheter (catheter 13, see Fig. 1) may comprise multiple layers increase in Shore hardness towards the radial center thereof (i.e., Shore hardness increases from a radially-outward position to radially-inward position) which provides the catheter with increased stiffness and rigidity without significantly affecting the catheter’s ability to retain its initial/desired shape during navigation to a target site (see Para. [0032]).
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 the carrier member of Risi to comprise a varied Shore hardness (i.e., the hardness of the silicone used to form the carrier member, as incorporated from the teachings of Reo) that increases (within the disclosed range of between 60 to 80 Shore A) in a radially-inward direction as taught and suggested by Zhou to, in this case, provides the carrier member with increased stiffness and rigidity without significantly affecting ability to retain its initial shape during navigation to a target site (see Zhou Para. [0032]).
Regarding claim 56, the combination of Risi, Reo and Zhou disclose the invention of claim 55, Risi, as modified by Zhou, further discloses wherein the wire bundle is embedded in the first region of the elastomeric material (see Risi Para. [0035] mentioning wherein the wires may be embedded either within a central volumetric core or at or near the surface of the carrier member; in this instance, the embodiment wherein the wires are embedded at or near the surface of the carrier member would have the wires embedded in the first region of the carrier member that has the lowest Shore A hardness).
Regarding claim 57, the combination of Risi, Reo and Zhou disclose the invention of claim 55, Risi, as modified by Zhou, further discloses wherein the first region of the elastomeric material is positioned peripheral to the second region of the elastomeric material (see Zhou Para. [0032] and Fig. 5 showing/mentioning wherein the Shore hardness of the material used to form the radially-inward portion of the catheter (i.e., the “second region”) is of a greater Shore hardness than the material used to form the radially-outward (i.e., first region”) peripheral portion).
Regarding claim 58, the combination of Risi, Reo and Zhou disclose the invention of claim 55, Risi, as modified by Reo, further discloses wherein the elastomeric material comprises a silicone (see Reo Para. [0004] and [0070] mentioning wherein silicone is used to form the carrier member of Risi, as recited in the rejection of claim 55).
Regarding claim 59, the combination of Risi, Reo and Zhou disclose the invention of claim 55, Risi, as modified by Zhou, further discloses a stiffener (stiffener 208, see Risi Fig. 2C) disposed in the second region (see Risi Fig. 2C showing wherein the stiffener 208 is located in the central region, which would be encircled by the “second region” of harder material, as incorporated from the teachings of Zhou).
Regarding claim 60 (see 112(b) rejection above), the combination of Risi, Reo and Zhou disclose all of the limitations of the invention of claim 55.
However, while Reo discloses wherein the silicone used to form the carrier member is within a range of 60 to 80 Shore A hardness, and wherein Zhou discloses wherein the Shore hardness increases from a radially-outward portion to a radially-inward portion (see Zhou Para. [0032]), none of the combination express discloses wherein the second hardness has at least 33% greater Shore A hardness than the first hardness.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being “obvious to try” (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), to have obtained the predictable result of having the second hardness of the silicone used to form the carrier member be 33% greater than the first hardness. Since Zhou discloses wherein having a harder material at the center of an elongate member increases rigidity but is silent as to any express percentage of relative hardness, one of ordinary skill in the art could have chosen from a finite range of varying hardness ranges (i.e., 1 to 100%) to best optimize the rigidity of the carrier member of Risi. Further, since Applicant does not provide any written support for this “33%” value, the relative hardness between the first and second hardness values is not seen to be a critical feature to the functioning of the device and thus one of ordinary skill in the art would have expected the device of Risi, as modified by Reo and Zhou, to function appropriately should the “second hardness” be 33% greater than the “first hardness”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20150065941 A1 to Ross, US 20080097596 A1 to Christ, US 20170215918 A1 to Tao, US 20040059279 A1 to McWeeney, US 20240016640 A1 to McGowan, US 20100312063 A1 to Hess, US 20240016638 A1 to McGowan, US 20100268162 A1 to Shelton, US 20170020540 A1 to Chou, US 20240090903 A1 to Connor, US 20130150661 A1 to Rosen, US 20160220741 A1 to Garrison, US 20180064453 A1 to Garrison, US 20110202002 A1 to Gordon, US 20200022685 A1 to Brodbeck and US 20170311966 A1 to Ben-Ami all disclose catheter or carrier devices comprising material of a varying hardness along or across a length thereof.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771