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
Claims 3-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/19/2026.
Applicant’s election without traverse of Group I in the reply filed on 3/19/2026 is acknowledged.
Drawings
The drawings were received on 3/19/2026. These drawings are acceptable.
Response to Arguments
Applicant's arguments filed 3/19/2026 have been fully considered but they are not persuasive.
With respect to claim 1, applicant argues that if the needle of Racz (US 5,810,788) was modified by Miura (US 2006/0193742), the resulting modified needle may be too sharp and rigid due to hardness, which may shave the plastic tubing inserted through the needle of Racz.
The examiner respectfully disagrees. Instead, it is the improved point, i.e. the shape of the point along with the angled surfaces of the point 42 which helps minimize the cutting of longitudinal fibers of the dura and the plastic tubing therein (column 2, lines 22-31; column 3, lines 42-51). Racz discloses the point 42 is formed without any portion thereof being smaller in diameter than the internal diameter of the cannula 32 to prevent the point from shearing or cutting any plastic tubing or catheter inserted therethrough (column 4, lines 6-11). Further, all the edges of the point 42 have been buffed or abrasion blasted to remove any sharp cutting edges. Modifying the material of the cannula 32 of Racz with that of Miura would not change the shape of the device of Racz nor would it result in a point that hasn’t been buffed to remove sharp cutting edges.
Miura teaches a non-magnetic, nano-crystal austenite stainless steel material ([0073]) is a known material used for medical mechanical tools such as injection needles ([0069]) for the purpose of forming a super hard, strength and tough material having an improved corrosion resistance ([0073]). Changing the material of the cannula of Racz would not result in a different device that would become sharp and cut the tubing. The same buffed edges would remain on the point 42 of Racz, the point would just be made of known material of Miura.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, motivation to combine the references can be explicitly found in Miura.
Miura teaches materials for “medical mechanical tools such as injection needles” ([0069]) and the cannula 32 of Racz is an injection needle as it is a “needle for use in administering anesthetics, medication, and the like into the spinal canal” (abstract). Miura further teaches “the synergistic effects of the solid-solution strengthening by nitrogen and the enhanced crystal grain reduction are combined with the toughness inherent in the austenite phase to make it easy to prepare a super hard, strength and tough, non-magnetic, high-nitrogen nano-crystal austenite steel (nano-crystal austenite stainless steel) material having an improved corrosion resistance (pitting corrosion resistance)” ([0073]). Thus, Miura teaches an easy to prepare material for an injection needle having improved corrosion resistance. While the challenge specifically described in Racz would not be improved by Miura’s materials, the combination would result in an improved corrosion resistance injection needle/cannula based on the teachings of Miura.
Applicant’s arguments over the manufacturing methos of the present application and the cited references are moot as the method of manufacturing is not present in the elected claims. Instead, the claims are directed to a product, which is taught by Racz and Miura, as discussed above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., maintaining non-magnetic properties throughout processing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues that Racz and Miura are directed to different technical fields with different technical problems as Racz’s needle is designed to minimize dural trauma and to prevent cerebrospinal fluid leakage while the present application describes example embodiments directed to fine medical instruments with the technical problems of improving grindability and preventing burr generation at the tip end portion. However, both Racz and Miura are found to be in the field of the inventor’s endeavor. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Racz and Miura are both found to be in the field of the inventor’s endeavor of “medical instruments such as injection needles” ([0045] of applicant’s invention). As discussed above, Racz discloses an injection needle i.e., a “needle for use in administering anesthetics, medication, and the like into the spinal canal” (abstract) and Miura teaches materials for “medical mechanical tools such as injection needles” ([0069]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., burr generation during trimming and grinding, excellent grindability, and maintained non-magnetic properties throughout the processing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Accordingly, applicant’s arguments with respect to claim 1 are not found persuasive and the rejection over Racz in view of Miura has been maintained.
The rejection of claim 2 under 35 U.S.C. 103 as being obvious over Racz in view of Miura has been withdrawn in light of applicant’s amendment made 3/19/2026. Specifically, Racz does not teach the inclination angle of the tapered inclined portion is 9 degrees or more and 30 degrees or less, and an inclination angle of a tapered pointed end portion is 2 degrees or more to less than 9 degrees.
Applicant’s arguments with respect to claim 2 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Spaide (US 2008/0021399 A1) teaches said limitation.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “a tapered slope circumferentially in contact with the body part and formed at a predetermined inclination angle ϴ” in lines 4-5, “a tapered tip circumferentially in contact with the tapered slope and formed at a predetermined inclination angle Ф” in lines 5-7 and “an inclination angle φ of a tapered pointed end portion” in line 13. While applicant has support for two tapered surfaces (Fig. 1B; [0048]), a third inclination angle φ of a tapered pointed end portion is not described in the original specification.
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.
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.
Claim 2 recites the limitation "the tapered inclined portion" in line 12. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the limitation has been interpreted to read “the tapered slope”.
Claim 2 recites the limitation “a tapered tip circumferentially in contact with the tapered slope and formed at a predetermined inclination angle Ф with respect to the axis of the body part…the tapered tip is formed of a stainless crystal structure having a crystal grain size of 1 µm or less…an inclination angle φ of a tapered pointed end portion is 2 degrees or more to less than 9 degrees…the tapered pointed end portion is formed of a stainless crystal structure having a crystal grain size of 1 µm or less” in lines 5-16. The difference between the tapered tip and the tapered pointed end portion along with the inclination angles Ф and φ is unclear. Figure 1B and paragraph [0048] support a tapered slope 2 having an inclination angle ϴ and a tapered tip 1 having an inclination angle Ф. However, a tapered pointed end portion having an inclination angle φ is not shown in the Figures or specification. Accordingly, it is unclear if the tapered pointed end portion and the inclination angle φ are intended to be the same or in addition to the tapered tip and the inclination angle Ф. For the purposes of examination, the tapered pointed end portion and the inclination angle φ are interpreted to be the same as the tapered tip and the inclination angle Ф.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz (US 5,810,788) in view of Miura et al. (US 2006/0193742 A1).
Regarding claim 1, Racz discloses a product (needle 30 comprising cannula 32; Figs. 3-4) having a tapered tip (formed by second angled surface 50; Fig. 4) at an end part of a body part (end of the end shape or point 42; Fig. 4) having a fine shape that is cylindrical hollow (Figs. 3-4, 6), with a sectional area of 5 mm2 or less (as the cannula outer diameter may be 0.0725 in (Fig. 5) and the cross-section of the cannula is circular due to the hollow cylindrical body of the cannula; therefore, the area (
A
=
π
r
2
)
of the cross-section of the cannula 32 is 2.66 mm2, which is less than 5 mm2).
Racz discloses that the product (cannula 32) may be formed of any suitable material (column 3, lines 41-42) but fails to disclose the product is a non-magnetic fine stainless steel processed product formed of stainless steel characterized in that the tapered tip is formed of a stainless crystal structure having a crystal grain size of 1 µm or less.
However, Miura teaches a non-magnetic fine stainless steel processed product (non-magnetic, nano-crystal austenite stainless steel material ([0073]) used for medical mechanical tools such as injection needles; [0069]) formed of stainless steel ([0073]) characterized in that the stainless crystal structure has a crystal grain size of 1 µm or less (as the nano-crystal grains have a crystal grain diameter of preferably 50 nm to 1,000 nm or 50 nm to 1 µm; [0040]) for the purpose of forming a super hard, strength and tough material having an improved corrosion resistance ([0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle/cannula and tapered tip thereof of Racz to be a non-magnetic fine stainless steel processed product formed of stainless steel characterized in that the tapered tip is formed of a stainless crystal structure having a crystal grain size of 1 µm or less as taught by Miura in order to improve the strength and corrosion resistance of the needle.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spaide (US 2008/0021399 A1) in view of Kurose (US 2016/0206832 A1) in view of Miura et al. (US 2006/0193742 A1).
Regarding claim 2, Spaide discloses a product comprising a body part (trochar 301 or 701; Figs. 3, 7) formed of stainless steel (as the trochar is made of stainless steel; [0030]) having a fine shape that is either polygonal or cylindrical stainless steel (cylindrical stainless steel; Figs. 3, 7), or polygonal or cylindrical hollow stainless steel, a tapered slope (102 or 702p) circumferentially in contact with the body part and formed at a predetermined inclination angle ϴ with respect to an axis of the body part (Figs. 3, 7), and a tapered tip (306, 702d) circumferentially in contact with the tapered slope (Figs. 3, 7) and formed at a predetermined inclination angle Ф with respect to the axis of the body part (Figs. 3, 7), characterized in that: the inclination angle ϴ of the tapered slope is larger than the inclination angle Ф of the tapered tip (Figs. 3, 7), the inclination angle Ф of the tapered tip is 2 degrees or more to less than 9 degrees (about 5 degrees or less; [0043]).
Spaide fails to explicitly disclose the inclination angle ϴ of the tapered inclined portion is 9 degrees or more and 30 degrees or less. However, the inclination angle ϴ of the tapered inclined portion/slope (102, 702p) appears to be about 30 degrees or less (Figs. 3, 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inclination angle ϴ of the tapered inclined portion/slope to be 9 degrees or more and 30 degrees or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the trochar is being used within an eye and would function appropriately having the claimed angle. Further, Applicant places no criticality on the range claimed, indicating simply the tapered slope is “preferably” within the claimed range (specification para. [0048]).
Spaide fails to explicitly disclose the product having a sectional area of 5 mm2 or less.
However, Kurose teaches an injection needle (abstract) having a body part (needle tube 12) and a tapered distal tip (Figs. 1A-1C), with a sectional area of 5 mm2 or less (as the outside diameter of the needle tube 12 is 0.6 mm ([0018]) and the cross-section of the needle is circular due to the hollow cylindrical body of the needle; therefore, the area (A=πr^2) of the cross-section of the needle tube 12 is 0.28 mm2, which is less than 5 mm2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sectional area of the trochar of Spaide to be 5 mm2 or less as taught by Kurose as applicant appears to have placed no criticality on the claimed range ([0045] indicating the area may be “less”, which is open ended) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Spaide modified fails to disclose the product is a non-magnetic fine stainless steel processed product formed of stainless steel characterized in that the tapered tip is formed of a stainless crystal structure having a crystal grain size of 1 µm or less.
However, Miura teaches a non-magnetic fine stainless steel processed product (non-magnetic, nano-crystal austenite stainless steel material ([0073]) used for medical mechanical tools such as injection needles; [0069]) formed of stainless steel ([0073]) characterized in that the stainless crystal structure has a crystal grain size of 1 µm or less (as the nano-crystal grains have a crystal grain diameter of preferably 50 nm to 1,000 nm or 50 nm to 1 µm; [0040]) for the purpose of forming a super hard, strength and tough material having an improved corrosion resistance ([0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the trochar and tapered tip thereof of modified Spaide to be a non-magnetic fine stainless steel processed product formed of stainless steel characterized in that the tapered tip is formed of a stainless crystal structure having a crystal grain size of 1 µm or less as taught by Miura in order to improve the strength and corrosion resistance of the needle.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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