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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species 1A (Claims 1-9) in the reply filed on 2nd July 2026 is acknowledged. Claims 10-15 withdrawn from further consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 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.
Claim 1, ‘…shaft that is 350 mm or more and 750 mm or less from the distal end of…’, recites overlapping ranges which can lead to impossible sizes. It is unclear how the main body part be both 350 mm or more and 750 mm or less, comprising potentially two different positions (e.g., can be both 1000 mm and 100 mm from the distal end simultaneously). Claim 1 is rendered indefinite. Examiner interprets this limitation to intend that the main body part is a portion of the core shaft comprising a distance of between 350 mm and 750 mm from the distal end of the core shaft.
Claim 1, ‘…an outer diameter of the main body part is 0.58 mm or more and 0.73 mm or less …’, recites overlapping ranges which can lead to impossible sizes. It is unclear how the main body can have an outer diameter that is both 0.58 mm or more and 0.73 mm or less, comprising potentially two different positions (e.g., can be both 1 mm and 0.50 mm simultaneously). Claim 1 is rendered indefinite. Examiner interprets this limitation to intend that the main body part has an outer diameter of between 0.58 mm and 0.73 mm.
Claim 2, ‘…outer diameter of the main body part is 0.58 mm or more and 0.71 mm or less …’, recites overlapping ranges which can lead to impossible sizes. It is unclear how the main body can have an outer diameter that is both 0.58 mm or more and 0.71 mm or less, comprising potentially two different positions (e.g., can be both 1 mm and 0.50 mm simultaneously). Claim 2 is rendered indefinite. Examiner interprets this limitation to intend that the main body part has an outer diameter of between 0.58 mm and 0.71 mm.
Claims 7 recites ‘a blood vessel’, it is unclear if this is the same or part of ‘a blood vessel’ as previously recited in claim 7, or a distinct blood vessel, rendering Claim 7 indefinite.
Claim 8 recites ‘a blood vessel’, it is unclear if this is the same or part of ‘a blood vessel’ as previously recited in claim 7, or a distinct blood vessel, rendering Claim 8 indefinite.
Claims 2-9 are indefinite for their dependence on a rejected parent claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150148706 A1 to Abner.
Regarding Claim 1, Abner discloses a guide wire comprising a core shaft extending along a longitudinal axis from a rear end to a distal end (Abner: Fig. 1, item 10, item 12; Para. [0022]),
wherein the core shaft has a main body part (Abner: Fig. 1, D3; Para. [0028]), the main body part being a portion of the core shaft that is 350 mm or more and 750 mm or less from the distal end of the core shaft (Abner: Fig. 1, D3 (D3+D4+D5); Para. [0028-0030]), and
is made of a nickel-titanium alloy (Abner: Para. [0041] ‘Some example of suitable metals and metal alloys include …nickel-titanium alloy’), and
an outer diameter of the main body part is 0.58 mm or more and 0.73 mm or less (Abner: Para. [0028]).
Regarding Claim 2, Abner discloses the guide wire according to claim 1, Abner further discloses wherein the outer diameter of the main body part is 0.58 mm or more and 0.71 mm or less (Abner: Para. [0028]).
Regarding Claim 3, Abner discloses the guide wire according to claim 1, Abner further discloses wherein the core shaft further includes:
a small diameter portion having a smaller outer diameter than the main body part (Abner: Fig. 1, items 18 & 20), and
a large diameter portion having a larger outer diameter than the main body part (Abner: Fig. 1, items 26 & 24), and
the main body part is provided on a rear end side of the small diameter portion, and the large diameter portion is provided on a rear end side of the main body part (Abner: Fig. 1, D3; Para. [0028]).
Regarding Claim 4, Abner discloses the guide wire according to claim 3, Abner further discloses wherein the small diameter portion includes a straight portion and a tapered portion that is provided on a rear end side of the straight portion (Abner: Fig. 1, items 18 & 20),
an outer diameter of the straight portion is substantially constant along the longitudinal axis of the core shaft (Abner: Fig. 1, item 18; Para. [0023]), and
an outer diameter of the tapered portion gradually increases in size in a direction extending along the longitudinal axis toward the rear end of the core shaft (Abner: Fig. 1, item 20; Para. [0023], [0029]).
Regarding Claim 5, Abner discloses the guide wire according to claim 3, Abner further discloses wherein the large diameter portion includes a straight portion and a tapered portion that is provided on a distal end side of the straight portion (Abner: Fig. 1, items 26 & 24),
an outer diameter of the straight portion is substantially constant along the longitudinal axis of the core shaft (Abner: Fig. 1, item 26; Para. [0026]), and
an outer diameter of the tapered portion gradually increases in size in a direction extending along the longitudinal axis toward the rear end of the core shaft (Abner: Fig. 1, item 24; Para. [0027]).
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.
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.
In the case that Abner does not explicitly disclose “wherein the core shaft has a main body part , the main body part being a portion of the core shaft that is 350 mm or more and 750 mm or less from the distal end of the core shaft”, Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20150148706 A1 to Abner.
Regarding Claim 1, Abner discloses a guide wire comprising a core shaft extending along a longitudinal axis from a rear end to a distal end (Abner: Fig. 1, item 10, item 12; Para. [0022]),
wherein the core shaft has a main body part (Abner: Fig. 1, D3; Para. [0028]), , and
is made of a nickel-titanium alloy (Abner: Para. [0041] ‘Some example of suitable metals and metal alloys include …nickel-titanium alloy’), and
an outer diameter of the main body part is 0.58 mm or more and 0.73 mm or less (Abner: Para. [0028]).
Abner discloses the dimensions of the main body part (Abner: Fig. 1, D3 (D3+D4+D5); Para. [0028-0030]), Abner is silent on the main body part being a portion of the core shaft that is 350 mm or more and 750 mm or less from the distal end of the core shaft.
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the dimensions of the main body part of the core shaft of Abner by changing the length to be between 350 mm and 750 mm, the courts have stated changes in size/proportion are not sufficient to patentably distinguish over prior art. See MPEP 2144.04 IV. A., and the change in length would be contemplated by one of ordinary skill as a matter of routine optimization through experimentation See MPEP 2144.05 II. A.
Regarding Claim 2, Abner discloses the guide wire according to claim 1, Abner further discloses wherein the outer diameter of the main body part is 0.58 mm or more and 0.71 mm or less (Abner: Para. [0028]).
Regarding Claim 3, Abner discloses the guide wire according to claim 1, Abner further discloses wherein the core shaft further includes:
a small diameter portion having a smaller outer diameter than the main body part (Abner: Fig. 1, items 18 & 20), and
a large diameter portion having a larger outer diameter than the main body part (Abner: Fig. 1, items 26 & 24), and
the main body part is provided on a rear end side of the small diameter portion, and the large diameter portion is provided on a rear end side of the main body part (Abner: Fig. 1, D3; Para. [0028]).
Regarding Claim 4, Abner discloses the guide wire according to claim 3, Abner further discloses wherein the small diameter portion includes a straight portion and a tapered portion that is provided on a rear end side of the straight portion (Abner: Fig. 1, items 18 & 20),
an outer diameter of the straight portion is substantially constant along the longitudinal axis of the core shaft (Abner: Fig. 1, item 18; Para. [0023]), and
an outer diameter of the tapered portion gradually increases in size in a direction extending along the longitudinal axis toward the rear end of the core shaft (Abner: Fig. 1, item 20; Para. [0023], [0029]).
Regarding Claim 5, Abner discloses the guide wire according to claim 3, Abner further discloses wherein the large diameter portion includes a straight portion and a tapered portion that is provided on a distal end side of the straight portion (Abner: Fig. 1, items 26 & 24),
an outer diameter of the straight portion is substantially constant along the longitudinal axis of the core shaft (Abner: Fig. 1, item 26; Para. [0026]), and
an outer diameter of the tapered portion gradually increases in size in a direction extending along the longitudinal axis toward the rear end of the core shaft (Abner: Fig. 1, item 24; Para. [0027]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20150148706 A1 to Abner in view of US 20130226033 A1 to Eskuri.
Regarding Claim 6, Abner discloses the guide wire according to claim 3, While Abner discloses attaching coils onto the distal tip of the guidewire as optional radiopaque markers (Abner: Para. [0046]), Abner is silent on the specifics regarding the coils and their positions.
However, Eskuri teaches further comprising a coil covering an outer periphery of the small diameter portion, wherein a distal end portion of the coil is joined to a distal end portion of the small diameter portion by a distal end side fixing portion (Eskuri: Para. [0034-0036]; Figs. 2 & 3).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the guidewire of Abner to specify comprising a coil covering an outer periphery of the small diameter portion, a distal end portion of the coil joined to a distal end portion of the small diameter portion as taught by Eskuri to assist in placement of the guidewire distal tip within vasculature through the use of imaging means, e.g., fluoroscopically during the interventional procedure (Eskuri: Para. [0036]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20150148706 A1 to Abner in view of US 20150174379 A1 to Bagaoisan et al. (hereinafter, Bagaoisan).
Regarding Claim 7, Abner discloses the guide wire according to claim 1, Abner is silent on insertion percutaneously into a blood vessel, and advanced toward a constricted part occurring in a blood vessel of a leg of a human body.
However, Bagaoisan teaches wherein the guide wire is configured to be: inserted percutaneously into a blood vessel, and advanced toward a constricted part occurring in a blood vessel of a leg of a human body (Bagaoisan: Para. [0035], [0007], [0029]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the guidewire of Abner to be configured to be inserted into a blood vessel and advanced toward a constricted part occurring in a blood vessel of a leg of a human body as taught by Bagaoisan because the tapered sections enable easier insertion and passage through constricted body lumens (Bagaoisan: Para. [0035]).
Regarding Claim 8, Abner in view of Bagaoisan discloses the guide wire according to claim 7, Abner is silent on wherein the guide wire is configured to: be inserted from a blood vessel of another leg of the human body in which the constricted part has not occurred, pass through a common iliac artery, and be advanced toward the constricted part.
However, Bagaoisan teaches wherein the guide wire is configured to: be inserted from a blood vessel of another leg of the human body in which the constricted part has not occurred, pass through a common iliac artery, and be advanced toward the constricted part (Bagaoisan: Para. [0007], [0029]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the guidewire of Abner to be configured to be inserted into a blood vessel and advanced toward a constricted part occurring in a blood vessel of a leg of a human body as taught by Bagaoisan because the tapered sections enable easier insertion and passage through constricted body lumens (Bagaoisan: Para. [0035]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over to Abner in view of to Bagaoisan et al. (hereinafter, Bagaoisan) in view of US 20140142677 A1 to Heuser et al. (hereinafter, Heuser).
Regarding Claim 9, Abner in view of Bagaoisan discloses the guide wire according to claim 7, Abner is silent on wherein the guide wire is configured to be advanced toward the constricted part occurring in a region below a knee of the human body when a distal end portion of the guide wire is positioned in the region below the knee of the human body, the main body part is configured to be positioned in a common iliac artery.
However, Bagaoisan teaches wherein the guide wire is configured to be advanced toward the constricted part occurring in a region below a knee of the human body (Bagaoisan: Para. [0007], [0029]), and
when a distal end portion of the guide wire is positioned in the region below the knee of the human body (Bagaoisan: Para. [0007], [0029]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the guidewire of Abner to be configured to be inserted into a blood vessel and advanced toward a constricted part occurring in a blood vessel of a leg of a human body as taught by Bagaoisan because the tapered sections enable easier insertion and passage through constricted body lumens (Bagaoisan: Para. [0035]).
Abner in view of Bagaoisan does not explicitly disclose on the main body part is configured to be positioned in a common iliac artery.
However, Heuser teaches the guidewire is configured to be positioned in a common iliac artery (Heuser: Para. [0010], [0042]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the guidewire Abner in view of Bagaoisan with Heuser to specify configuring the guidewire by positioning the main body part in a common iliac artery for contralateral advancement and catheter guidance through the vasculature, including tibial arteries (Heuser: Para. [0010], [0042])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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