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 .
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 requires “wherein the first material and the second material are the same” and also from parent claim 1 “a second material…having a second susceptibility that is different from the first susceptibility [of the first material]”. The conditions of having different [magnetic] susceptibilities and being the same material seem to be contradictory, since magnetic susceptibility is an intrinsic property of a material. That is, if the materials are the same, then they will have the same magnetic susceptibility. As such, claim 2 does not include all the limitations of the parent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-11, 13-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over JPH10314137 to Murata in view of US 20040193140 to Griffin.
Regarding Claim 1, Murata discloses a medical device, comprising:
an elongate member having a proximal end, a distal end (distal end 3, Figures 2, 4), and a circumferential wall having an outer surface and an inner surface that defines a lumen (central lumen as shown in cross-section in Figures 2, 4);
a reinforcement member disposed within the circumferential wall (reinforcing woven coil 5 is positioned between inner layer 3 and outer layer 4, Figures 2, 4), extending along a length of the elongate member (as shown in Figures 2, 4), and formed of a first material having a first magnetic susceptibility (stainless steel, par. 0017); and
a marker (thin film element 2, Figures 2, 4) attached to the elongate member (between inner layer 3 and outer layer 4, Figures 2, 4) and formed of a second material (alloys or metals of iron, nickel, cobalt. Nickel is a preferred material, par. 0015; specific examples given are alloy of NiCoCrAlCu, par. 0024, and nickel, par. 0025) and having a second magnetic susceptibility that is different than the first magnetic susceptibility (the magnetic susceptibility of nickel (which is ferromagnetic) is inherently higher compared with any stainless steel, including ferritic types).
Murata does not teach a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion.
Griffin teaches a tubular medical device with marker (60, Figure 3) and reinforcement member (26, Figure 3). Griffin further teaches wherein the reinforcement member is made to achieve the desired structural and imaging characteristics, e.g. elasticity, radiographic visualization (par. 0045). Griffin further teaches wherein the tubular medical device has a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion (reinforcement 26 with apertures 44 does not extend through the proximal portion 36 or proximal end 18, Figure 2). Griffin teaches this arrangement provides the desired level of lateral flexibility as well as have the ability to transmit torque and pushing forces from the proximal region to the distal region (par. 0040) and also provide more flexibility in the distal region than in the proximal region (par. 0042).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the reinforcement member of Murata not extending into the proximal portion as in Griffin, in order to provide the desired bending and strength characteristics for pushing, torque, and flexibility as in Griffin (Figure 2, par. 0040, 0042). For example, one of ordinary skill would recognize that a more solid proximal end portion would increase the pushing ability.
Regarding Claim 3, Murata further teaches wherein the first material and the second material are different (first material is stainless steel, par. 0017, 0025, second material is nickel, par. 0015, 0025).
Regarding Claim 4, Murata discloses wherein the second material comprises a ferromagnetic material (nickel, par. 0015, 0025). However, Murata does not expressly disclose wherein the first material is paramagnetic. While Murata teaches stainless steel as an acceptable material for the first material (par. 0017, 0025), Murata does not say which type of stainless steel it is.
Regarding Claim 5, Murata teaches wherein first material for the reinforcement member is stainless steel (par. 0017, 0025) and the second material for the marker is nickel, stainless steel, or alloy of NiCoCrAlCu, alloys or metals of iron, nickel, cobalt (par. 0015, 0024, 0025). For the second material, the stainless steel is said to be ferromagnetic, therefore implicitly being ferritic type. As such, it would be implicitly an alloy containing at least 50% Iron by weight, since ferritic stainless steels have majority Iron as the main component (e.g. 65-72% Iron). However, Murata does not teach the proportions of metals in the stainless steel in the first material and it cannot be otherwise inferred from Murata that it is an alloy containing less than or equal to 1% Iron by weight.
Regarding Claim 6, Murata does teach wherein the second material comprises a stainless steel alloy (ferritic stainless steel, par. 0015). However, Murata does not teach wherein the first material comprises Cobalt Chromium alloy. Instead, Murata teaches the first material is stainless steel (par. 0017, 0025).
Regarding Claim 7, Murata does teach wherein the second material comprises a stainless steel alloy (ferritic stainless steel, par. 0015). However, Murata does not teach wherein the first material comprises Nickel Cobalt alloy. Instead, Murata teaches the first material is stainless steel (par. 0017, 0025).
Griffin teaches a tubular medical device with marker (60, Figure 3) and reinforcement member (26, Figure 3). Griffin further teaches wherein the reinforcement member is made to achieve the desired structural and imaging characteristics, e.g. elasticity, radiographic visualization, and suitable materials include 304V stainless steel (which is paramagnetic), 316LVM stainless steel (which is the same as 316L stainless steel and paramagnetic), Cobalt Chromium alloy, Nickel Cobalt alloy, an alloy containing less than or equal to 1% Iron by weight, (par. 0045, MP35-N is a composition of Nickel, Cobalt, Chromium alloy with a maximum of 1% Iron by weight – therefore being a type of Cobalt Chromium alloy, Nickel Cobalt alloy, and an alloy containing less than or equal to 1% Iron by weight).
Regarding all of Claims 4-7, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize any of 304V stainless steel, 316L stainless steel, or MP35-N as the material choice for the reinforcement member of Murata, as taught by Griffin to be functionally equivalent for providing reinforcement member materials in a tubular medical device to achieve the desired elasticity and radiographic imaging qualities (par. 0045 of Griffin).
Regarding Claim 9, Murata teaches wherein the reinforcement member comprises a coil (reinforcing coil 5 is positioned between inner layer 3 and outer layer 4, Figures 2, 4; the wires are woven together in a spiral pattern and therefore represent a series of coils).
Regarding Claim 10, Murata teaches wherein the reinforcement member comprises a mesh (reinforcing coil 5 is positioned between inner layer 3 and outer layer 4, Figures 2, 4; the wires are woven together in a mesh).
Regarding Claim 11, Murata further teaches wherein the marker comprises a band (element 2 makes a ring-shaped band, par. 0015, Figures 2, 4).
Regarding Claim 13, Murata further teaches wherein the marker is disposed within the circumferential wall (positioned between inner layer 3 and outer layer 4, Figures 2, 4).
Regarding Claim 14, Murata further teaches wherein the marker is disposed distal to the reinforcement member (as shown in Figures 2, 4, and described in par. 0017 the distal end extending at least 1 cm does not have the reinforcement member).
Regarding Claim 15, Murata teaches a second marker formed of a third material (Figure 4 shows multiple markers 2, par. 0019) and having a third susceptibility that is different from the first susceptibility (the markers 2 have the same susceptibility as the second susceptibility by virtue of being the same material, i.e. alloys or metals of iron, nickel, cobalt. Nickel is a preferred material, par. 0015; specific examples given are alloy of NiCoCrAlCu, par. 0024, and nickel, par. 0025. As such, the first susceptibility (of the reinforcement member, stainless steel) is inherently different than the third susceptibility (e.g. nickel), since they are made of different materials.)
Regarding Claims 16-17, Murata further teaches wherein the first marker is disposed distal to the reinforcement member and the second marker is disposed distal to the reinforcement member (as shown in Figure 4, and described in par. 0017 the distal end extending at least 1 cm does not have the reinforcement member; the areas of the markers 2 do not overlap with the reinforcement member 5 as in Figure 4).
Regarding Claim 18, Murata discloses a medical device, comprising:
an elongate member having a proximal end, a distal end (distal end 3, Figures 2, 4), and a circumferential wall having an outer surface and an inner surface that defines a lumen (central lumen as shown in cross-section in Figures 2, 4);
a reinforcement member comprising a coil disposed within the circumferential wall (reinforcing member 5 is positioned between inner layer 3 and outer layer 4, Figures 2, 4), extending along a length of the elongate member (as shown in Figures 2, 4), and formed of a first material having a first magnetic susceptibility (stainless steel, par. 0017); and
a marker (thin film element 2, Figures 2, 4) disposed within the circumferential wall distal to the reinforcement member (between inner layer 3 and outer layer 4, Figures 2, 4) and formed of a second material different from the first material (alloys or metals of iron, nickel, cobalt. Nickel is a preferred material, par. 0015; specific examples given are alloy of NiCoCrAlCu, par. 0024, and nickel, par. 0025) and having a second magnetic susceptibility that is greater than the first magnetic susceptibility (the magnetic susceptibility of nickel (which is ferromagnetic) is inherently higher compared with any stainless steel, including ferritic types).
Murata does not teach a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion.
Griffin teaches a tubular medical device with marker (60, Figure 3) and reinforcement member (26, Figure 3). Griffin further teaches wherein the reinforcement member is made to achieve the desired structural and imaging characteristics, e.g. elasticity, radiographic visualization (par. 0045). Griffin further teaches wherein the tubular medical device has a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion (reinforcement 26 with apertures 44 does not extend through the proximal portion 36 or proximal end 18, Figure 2). Griffin teaches this arrangement provides the desired level of lateral flexibility as well as have the ability to transmit torque and pushing forces from the proximal region to the distal region (par. 0040) and also provide more flexibility in the distal region than in the proximal region (par. 0042).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the reinforcement member of Murata not extending into the proximal portion as in Griffin, in order to provide the desired bending and strength characteristics for pushing, torque, and flexibility as in Griffin (Figure 2, par. 0040, 0042). For example, one of ordinary skill would recognize that a more solid proximal end portion would increase the pushing ability.
Regarding Claim 20, Murata discloses a medical device, comprising:
an elongate member having a proximal end, a distal end (distal end 3, Figures 2, 4), and a circumferential wall having an outer surface and an inner surface that defines a lumen (central lumen as shown in cross-section in Figures 2, 4);
a reinforcement member comprising a coil disposed within the circumferential wall (reinforcing coil 5 is positioned between inner layer 3 and outer layer 4, Figures 2, 4; the wires are woven together in a spiral pattern and therefore represent a series of coils), extending along a length of the elongate member (as shown in Figures 2, 4), and formed of a first material having a first magnetic susceptibility (stainless steel, par. 0017); and
a marker (thin film element 2, Figures 2, 4) disposed within the circumferential wall distal to the reinforcement member (between inner layer 3 and outer layer 4, Figures 2, 4) and formed of a second material different from the first material (alloys or metals of iron, nickel, cobalt. Nickel is a preferred material, par. 0015; specific examples given are alloy of NiCoCrAlCu, par. 0024, and nickel, par. 0025) and having a second magnetic susceptibility that is greater than the first magnetic susceptibility (the magnetic susceptibility of nickel (which is ferromagnetic) is inherently higher compared with any stainless steel, including ferritic types).
Murata does not teach a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion.
Griffin teaches a tubular medical device with marker (60, Figure 3) and reinforcement member (26, Figure 3). Griffin further teaches wherein the reinforcement member is made to achieve the desired structural and imaging characteristics, e.g. elasticity, radiographic visualization (par. 0045). Griffin further teaches wherein the tubular medical device has a proximal portion including the proximal end, wherein the reinforcement member does not extend into the proximal portion (reinforcement 26 with apertures 44 does not extend through the proximal portion 36 or proximal end 18, Figure 2). Griffin teaches this arrangement provides the desired level of lateral flexibility as well as have the ability to transmit torque and pushing forces from the proximal region to the distal region (par. 0040) and also provide more flexibility in the distal region than in the proximal region (par. 0042).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the reinforcement member of Murata not extending into the proximal portion as in Griffin, in order to provide the desired bending and strength characteristics for pushing, torque, and flexibility as in Griffin (Figure 2, par. 0040, 0042). For example, one of ordinary skill would recognize that a more solid proximal end portion would increase the pushing ability.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over JPH10314137 to Murata in view of US 20040193140 to Griffin, as applied to Claim 1 above, in further view of US 20050165301 to Smith.
Regarding Claim 21, Murata does not teach wherein the marker is disposed on the outer surface of the elongate member. Instead, Murata shows an outer layer covering the marker.
Smith teaches a tubular medical device with MRI markers on the outer surface. Smith further teaches the MRI marker material is incorporated into a coating composition and coated onto a surface of the medical device, which increases its effective lifetime by reducing loss of the contrast into bodily fluid (par. 0049; e.g. MRI marker bands 102, 104, Figure 7).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the marker of Murata on the surface of the elongate member in order to advantageously highlight the outer boundary of the device in the MRI without losing the marker material to bodily fluids by blending it with the coating, as taught by Smith.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over JPH10314137 to Murata in view of US 20040193140 to Griffin, as applied to Claim 1 above, in further view of US 20120035434 to Ferren.
Regarding Claims 22-23, Murata further teaches wherein the second material comprises nickel (alloys or metals of iron, nickel, cobalt. Nickel is a preferred material, par. 0015; specific examples given are alloy of NiCoCrAlCu, par. 0024, and nickel, par. 0025); and further comprising a second marker formed of a third material (Figure 4 shows multiple markers 2, par. 0019). However, Murata does not teach wherein the second material or third material comprises functionalized magnetite.
Ferren teaches an invasive tubular device wherein an MRI marker is applied to its surface and the MRI marker material is ferumoxides (magnetite coated with dextran) or ferumoxsil (magnetite coated with siloxane), which are “functionalized” magnetite materials due to their coatings (par. 0186).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it routine in the art to select a marker material as functionalized magnetite in the system of Murata in view of the teachings of Ferren because it is functionally equivalent for performing the contrast marking for MRI and would produce only expected results. For example, one of ordinary skill would be motivated to select functionalized magnetite as the marker material because it is more biocompatible.
Response to Arguments
Applicant’s arguments filed November 21, 2025 with respect to claim(s) 1, 3-11, 13-18, 20-23 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. Applicant’s arguments with respect to claim 2 rejected under USC 112(d) have been considered but are not found persuasive.
Regarding the rejection of claim 2 under USC 112(d), Applicant argues the claim includes all limitation of the independent claim because elements can be the same material but different magnetic susceptibilities, e.g. by work-hardening or manipulated in some matter. However, examiner contends that if one material is work-hardened or manipulated in some matter, then it cannot be considered the “same” material as required by the claim. For sake of argument, there are no examples of work-hardening or manipulations to alter the first material to something else that would result in magnetic susceptibility differences. If construed on the merits, there is no way to determine what scope to put on the claim 2. Examiner maintains that claim 2 is an improper dependent claim since it contradicts the requirements of the parent claim.
Regarding the prior art rejection, Examiners agrees that Murata does not teach the newly added limitation of the reinforcement member does not extend into the proximal portion. Griffin is now used to teach such limitation in combination with Murata. Additional grounds of rejection are also entered for newly added claims 21-23.
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 ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights