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 with traverse of Species II (Claim 5 embodiment) in the reply filed on 06/01/2026 is acknowledged. The traversal is on the grounds that Claim 5 (Species II) depends from Claim 1 (Species I). This is not found persuasive because the restriction is directed to a specific limitation of Claim 1, not Claim 1 as a whole. Applicant has provided two distinct product-by-process limitations in the present case. Examiner has restricted the present case between the two. Applicant has elected the product-by-process limitation of Species II (Claim 5) and thus, the product-by-process limitation of Species I (Claim 1) will not be considered. No claims in the present case are being viewed as withdrawn as non-elected.
The requirement is still deemed proper and is therefore made FINAL.
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 1-6 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. Line 10 recites the limitation “the distal shaft includes a distal end tip that is provided on the distal end side.” It is unclear from this limitation whether applicant is referring back to “a distal end side of the proximal shaft” first recited in Line 3 of Claim 1, or some different distal end side. For purposes of examination, the “distal end side” in Line 10 is being treated as a different “distal end side” than that recited in Line 3. Claims 2-6 are rejected by virtue of their dependence on Claim 1. Appropriate correction and/or clarification is required.
Claim 2 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. Line 3 recites the limitation “a distal end toward a proximal end of the distal shaft.” It is unclear from this limitation whether applicant is referring back to “the distal shaft includes […] on the distal end side.” first recited in Line 10 of Claim 1, or some different distal end. It would appear applicant is referring to the same structure with different names. For purposes of examination, the “distal end” in Line 3 of Claim 2 is being treated as the same structure as the “distal end side” first recited in Line 10 of Claim 1. Appropriate correction and/or clarification is required.
Claim 3 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. Line 2 recites the limitation “a proximal end portion of the distal shaft.” However, Claim 2 recites in Line 3 “a proximal end of the distal shaft.” It is unclear from the claims whether these are different or the same structures. Applicant is required to use consistent language in the claims for purposes of clarity. For purposes of examination, “a proximal end portion of the distal shaft” in Line 2 of Claim 3 is being treated as the same structure as “a proximal end of the distal shaft” in Line 3 of Claim 2. Appropriate correction and/or clarification is required.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cottone et al. (EP3849648).
Re Claims 1 and 5, Cottone teaches a guide extension catheter (1000) (Cottone Fig. 1A) comprising: a proximal shaft (1001); and a distal shaft (1005) of tubular shape provided on a distal end side of the proximal shaft (1001) (Cottone ¶ 0038; Fig. 1A), wherein regarding a main body (1007) of the distal shaft (1005), a maximum load value acting on the main body is not smaller than 4.0 N (Cottone ¶ 0019, 0046, 0074, 0111), the distal shaft (1005) includes a distal end tip (1011) that is provided on a distal end side (1013) with respect to the main body (1007) and is more flexible than the main body (1007) (Cottone ¶ 0018, 0039, 0051), and the distal end tip (1011) includes a marker part (1023) in which a powder comprising a radiopaque material is mixed (Cottone ¶ 0020, 0115).
Cottone fails to explicitly teach a length dimension of the distal end tip (1011) is not smaller than 2.5 mm. However, the length of the distal end tip may vary depending upon the particular procedure or application being performed and/or a vasculature access point being utilized (e.g., whether introduced via a radial artery, femoral artery, contralateral access, or the like) (Cottone ¶ 0046). The limitation reading “the maximum load value being measured when the main body is clamped radially between a support surface and a crushing jig while being subjected to a load of 0.5 N and then the crushing jig is further moved 0.5 mm in a direction of approach to the support surface” is being viewed as a product-by-process limitation. As per MPEP §2113, product-by-process claims are limited by the product itself, not the process of making them.
Re Claim 2, Cottone teaches wherein on an outer circumferential surface of the distal shaft (1005), a coating layer of hydrophilic polymer is provided from a distal end (1013) toward a proximal end (1012) of the distal shaft (1005) over a region having a length that does not reach the proximal end (1012) of the distal shaft (1005) (Cottone ¶ 0041, 0110, 0119-0121).
Re Claim 3, Cottone teaches wherein an anti-slip part (1018) is provided on an outer circumferential surface of a proximal end portion (1012) of the distal shaft (1005) (Cottone ¶ 0091-0093).
Re Claim 4, Cottone teaches all of the limitations of Claim 1. The limitation “wherein when kinking occurs in the main body of the distal shaft by the main body being wound around a kink test jig having an outer circumferential surface of round tubular shape, an outer diameter dimension of the kink test jig is not greater than 3 mm” is being viewed as a product-by-process limitation. As per MPEP §2113, product-by-process claims are limited by the product itself, not the process of making them.
Re Claim 6, Cottone teaches wherein regarding the distal end tip, a maximum load value is at least 0.5 N and not greater than 1.5 N (Cottone ¶ 0019, 0046, 0074, 0111). The limitation “the maximum load value being measured when the distal shaft connected to the distal end tip is restrained by a holding jig at a location shifted to a proximal end side from a portion extending for 5 mm from a distal end of the distal shaft while a distal end face of the distal end tip is in contact with a pressing jig and then the holding jig is moved closer to the pressing jig at a speed of 10 mm/min to compress the distal end tip by 1 mm in a length direction” is being viewed as a product-by-process limitation. As per MPEP §2113, product-by-process claims are limited by the product itself, not the process of making them.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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