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
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 2 and 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.
Claim 2 recites “the tapered surface is constituted by the inner circumferential surface at the distal and the proximal end.” As claimed and described in the specification, the stepped part appears to be referring to the outer stepped portion of the needle, so it is unclear how it is being “constituted” by at least the inner surface of the distal end. Furthermore, regarding the proximal end, it is unclear if the inner or outer surface of the proximal end is being referred to. In any case, it is unclear why inner surface of the proximal end is being used to describe an outer stepped portion. For examination purposes, such a limitation will be interpreted as “the tapered surface is formed between the outer surface of the distal end and the proximal end” until the limitation is clarified.
Regarding claim 6, it is unclear what statutory class the claim is directed towards. The claim appears to be directed to process of manufacturing, but include the limitations of claim 1, which is a product. Each claim must only be directed to one statutory class, clarification is required.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2016/0243305 to NAKAMURA et al. (“Nakamura”).
Regarding claim 1, Nakamura teaches a medical hollow needle (6, Fig. 5) having an inner lumen (60) penetrating it in a direction of a needle axis (central axis of 6), comprising a needle tube (65), wherein an inner circumferential surface of the needle tube has a tapered surface (Fig. 5) with a diameter becoming smaller toward a needle tip (Fig. 5), formed by deep drawing, and an arithmetic mean roughness Ra of the inner circumferential surface in the direction of the needle axis is set as Ra≤1.0µm ([0038]).
Regarding the deep drawing, such a recitation is considered to be a product by process limitation. MPEP 2113 clearly states “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes.” In this instance, the product taught by Nakamura is the same as the product claimed thereby meeting the limitation of the claim.
Regarding claim 3, Nakamura teaches the medical hollow needle according to claim 1 as shown above, Nakamura further teaching the inner circumferential surface of the needle tube is the tapered surface with an approximately constant inclination angle relative to the needle axis over an entire length thereof in the direction of the needle axis ([0044]).
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of U.S. Patent Publication No. 2003/0127149 to Ooyauchi et al. (“Ooyauchi”).
Regarding claim 2, Nakamura teaches the medical hollow needle according to claim 1 as shown above, Nakamura further teaching an inner diameter of a distal end of the needle tube on a needle tip side is smaller than an inner diameter of a proximal end of the needle tube on an opposite side to the needle tip (Fig. 5, the diameter at the tip is smaller than the proximal side), but does not show the stepped part.
Ooyauchi teaches a distal end and a proximal end of a needle tube being connected by a stepped part (Figs. 1B, 1C, 2A-2E) whose diameter decreases toward the needle tip side (Figs. 1B, 1C, 2A-2E), and the inner circumferential surface of the needle tube has a greater inclination angle relative to the needle axis at the stepped part than at the distal end and at the proximal end (given a uniform thickness, the inclination angle of the tapered portion is greater than the distal end in all the embodiments), and the tapered surface is above for interpretation) formed between the outer surface of the distal end and the proximal end (Figs. 1B, 1C, 2A-2E). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nakamura to include a stepped part as taught by Ooyauchi, as such stepped parts may function as an indicator for the location of the needle tip, thereby preventing accidental damage if the needle is inserted too far ([0031]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of U.S. Patent Publication No. U.S. 2005/0234386 to Nishikawa et al. (“Nishikawa”).
Regarding claim 5, Nakamura teaches the medical hollow needle according to claim 1 as shown above, but does not mention the inclination angle.
Nishikawa teaches a medical hollow needle having an inclination angle of the tapered surface relative to the needle axis is greater than 0 degrees and not greater than 5 degrees ([0039]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nakamura to have an inclination angle of less than 5 degrees as taught by Nishikawa to yield the predictable result of providing a smooth transition angle to ease insertion of the needle into the patient to avoid patient pain and injury (abstract).
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. U.S. 2015/0283369 to Brouwers et al. (“Brouwers”) in view of Nakamura.
Regarding claim 1, Brouwers teaches a medical hollow needle (Fig. A1 & 1B) having an inner lumen (3) penetrating it in a direction of a needle axis (A in Fig. 1A), comprising a needle tube (2), wherein an inner circumferential surface of the needle tube has a tapered surface (Fig. 1B) with a diameter becoming smaller toward a needle tip (Fig. 1B), formed by deep drawing ([0014], although Brouwers teaches deep drawing, as set forth above in the rejection of claim 1 by Nakamura, such a limitation is considered as product-by-process limitation and patentability is based on the product, not how it is made), but does not teach the claimed roughness.
Nakamura teaches an arithmetic mean roughness Ra of the inner circumferential surface in the direction of the needle axis is set as Ra≤1.0µm ([0038]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Brouwers to have a Ra≤1.0µm as taught by Nakamura to yield the predictable result of providing a smooth inner surface such that fluids may flow through the needle efficiently and with minimal impediments.
Regarding claim 6, Brouwers teaches a method for manufacturing the medical hollow needle according to claim 1, Brouwers further teaching a pressing process of performing a multi-step deep drawing on a blank metal plate to form a bottomed tube ([0038], deep-drawing starting with a flat material which would form the bottomed tube prior to cutting as understood in the art), and a needle tip forming process of cutting the tube at a side of a deep-drawn bottom thereof to form the needle tip ([0039]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Brouwers in view of Nakamura as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2023/0182370 to Chi et al. (“Chi”) as evidenced by U.S. Patent Publication No. 2019/0127739 to Guo et al. (“Guo”).
Regarding claim 4, Brouwers and Nakamura teach the medical hollow needle according to claim 1 as shown above, but do not teach the molding trace.
Chi teaches molding trace extending in the direction of the needle axis is present on the inner circumferential surface of the needle tube in a micrograph ([0013], Chi describes marks that are made as a punch presses against a target material, the direction of which would be same as the direction of the needle axis). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have seen molding traces on items manufactured by presses and dies as such markings are a normal part of the manufacturing process. Chi measures marks using a CCD camera and does not explicitly mention a micrograph. However, Guo as been cited to as an evidentiary reference to show that micrographs are taken by CCD cameras ([0505]).
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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