DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 11, 2026 has been entered.
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 24 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.
Regarding Claim 24, the limitation “wherein the reinforcement member has a reinforcement member proximal end that does not extend into the proximal portion” appears to be already required by the parent claim 1. As such, claim 24 does not limit its parent claim and is not a proper dependent 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, 3-7, 11, 13-17, 24 are rejected under 35 U.S.C. 103 as being unpatentable over JPH10314137 to Murata in view of US 20040193140 to Griffin.
Regarding Claims 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 comprising a coil 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), the coil comprising a plurality of turns extending in a single direction (woven coils are comprised of multiple wires each comprising a plurality of turns extending in a single direction, i.e. along the length of the medical device; examiner notes the claim does not preclude multiple or woven coils); 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 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).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over JPH10314137 to Murata in view of US 20040193140 to Griffin and US 20180078743 to Kubo (submitted in IDS).
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, the first material comprising a nickel-containing alloy (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), the second material comprising 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; Examiner notes the claim does not preclude nickel-containing alloys).
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.
Further, Murata does not teach wherein the first material comprises a nickel alloy. While Murata teaches the first material is stainless steel (par. 0017, 0025), Murata does not specify the type of stainless steel.
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 contains nickel), 316LVM stainless steel (which is the same as 316L stainless steel and contains nickel), Cobalt Chromium alloy, Nickel Cobalt alloy, (par. 0045, MP35-N is a composition of Nickel, Cobalt, Chromium alloy– therefore being a type of nickel-containing alloy).
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).
Additionally, Murata does not teach wherein the coil comprises a plurality of turns having a gap disposed between adjacent turns of the plurality of turns, the gap free of the reinforcement member. Instead, Murata teaches a woven mesh, which although it implicitly includes coils comprising a plurality of turns having a gap disposed between adjacent turns of the plurality of turns, the gap between the turns of the coil also includes portions of the reinforcement member (i.e. the other coils woven into the mesh).
Kubo teaches an elongate medical device with reinforcement member embedded between layers, wherein the reinforcement member is chosen between a woven mesh (Figure 6) or a single coil with gaps not containing the reinforcement portions (Figure 2, gaps 25, par. 0027). Kubo also teaches the reinforcement member is made of a material containing nickel (par. 0029).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the single coil of Kubo as a replacement for the woven mesh of Murata, since both are considered functional equivalents for providing a reinforcing portion in an elongate medical device as shown by Kubo and only expected results would occur for replacing one for the other. For example, one of ordinary skill would be motivated to select the single coil because it is easier to manufacture.
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.
Regarding Claim 24, the same reasoning is used as for claim 1 above.
Claims 25-26 and 27 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 20190351182 to Chou (submitted in IDS).
Regarding Claims 25-26, Murata does not teach wherein the elongate member includes a taper along the outer surface of the elongate member; and wherein the marker is disposed at a transition to the taper.
Similar to Murata, Chou teaches an elongated medical device with tracking marker (224a, Figures 8A-8C, par. 0135) and coiled reinforcement layer (803, Figure 8B, par. 0135). Chou further teaches wherein the elongate member includes a taper along the outer surface of the elongate member (Figure 8C shows the taper) and the marker is disposed at a transition to the taper (224a is positioned at the location where the taper starts, Figure 8C).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the taper of Chou in the system of Murata in order to allow the device to move in tortuous passageways with less friction and to place the marker band at the transition of the taper so it provides accurate position tracking of the distal end as in Chou.
Claim 27 is rejected for the same teachings of Murata, Griffin, and Chou as applied to claim 1+25+26 above.
Response to Arguments
Applicant's arguments filed June 11, 2026 have been fully considered but they are not entirely persuasive. Regarding the prior art, Applicant argues the amended limitation of claim 1, “the coil comprising a plurality of turns extending in a single direction” is not taught by Murata because Murata teaches a woven mesh. However, Examiner disagrees because a woven mesh is made up of a plurality of coils that are braided together. This is seen more clearly in the Chou reference (US20180078743, Figure 6), for example. Examiner notes that the claim language does not preclude additional components (i.e. a single coil plus additional components). In efforts to advance prosecution, the claim 20 language of “a gap free of the reinforcement member” is taken to mean a single coil because it precludes other components being placed in between adjacent turns of the coil. However, the Chou reference is applied to teach functional equivalents between mesh and single coil.
Conclusion
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.
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, 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.
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.
ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights