DETAILED ACTION
Claims 8-20 remain withdrawn. Claims 1 and 7 are amended. A complete action on the merits of pending claims 1-7 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/02/2026 and 02/23/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 02/03/2026. The specification objection and claim objections documented in the Non-Final Office Action sent on 11/25/2025 are overcome through Applicants amendments and are withdrawn.
Claim Rejections - 35 USC § 103
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US Patent No. 4765335).
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Regarding claim 1, Schmidt discloses, a medical clip (Figure 1, member (10); Col. 5, line 13-19) comprising:
two clamping arms (Figuresm1-2, sections (16A and 16)) that cooperate (Col. 6, line 57-68); and
a biasing element (Figures 1-2, spring portion (12); Col. 6, line 31-34 and line 47-49) having two ends (Figures 1-2, point where sections (11 and 11A) begin; Col. 6, line 60-62),
each of the two clamping arms (sections (16A and 16)) being connected to a respective one of the two ends (point where sections (11 and 11A) begin) of the biasing element (spring portion (12)) by way of a connecting portion (Figures 1-2, forearm sections (11, 11A), inwardly bent elbow portions (13, 13A), cross arm sections (17, 17A), and second inwardly bent elbow portions (14, 14A); Col. 6, line 62-Col. 7, line 6),
the two clamping arms (sections (16A and 16)) are maximally proximate to one another in a basic position of the medical clip (Figure 2; Col. 7, line 17-20) and are movable away from one another against an action of the biasing element (spring portion (12)) from the basic position into an open position (Figure 1; Col. 9, line 7-12),
the connecting portions (forearm sections (11, 11A), inwardly bent elbow portions (13, 13A), cross arm sections (17, 17A), and second inwardly bent elbow portions (14, 14A)) defining a first circular cross section having a first diameter (As clearly seen in Figures 3-4, a cross-section taken at sections (17, 17A) which is indeed circular given the disclosure of Col. 10, line 52-55, “In contrast to the prior art clip disclosed in U.S. Pat. No. 4,484,581, the cross arm sections 17 and 17A are left with their original circular cross sectional thickness…” That defines a first diameter),
the biasing element (spring portion (12)) defining a second circular cross section having a second diameter (As clearly seen in Figure 7, a cross-section taken at spring portion (12) which is indeed circular given the disclosure of Col. 6, line 32-34, “…resulted in spring coil 12 portions (sections) having a substantially flattened oval configuration as shown in FIG. 7…” That defines a second diameter),
the second diameter being smaller than the first diameter (cross arm sections (17, 17A) have a larger diameter than the spring portion (12) given that the original starting rod used to form the clip had a diameter of about 35 mils (Col. 5, line 22-27). Further, Col. 10, line 52-55, disclose, the cross-arm sections (17, 17A) maintain this "original circular cross sectional thickness." Lastly, the spring portion (12) requires significant deformation (coining), reducing the diameter of the starting rod by close to 50%, resulting in a diameter of approximately 20-25 mils in one dimension (Col. 6, line 6-15). As such the second diameter is indeed smaller than the first diameter), and
the connecting portions (forearm sections (11, 11A), inwardly bent elbow portions (13, 13A), cross arm sections (17, 17A), and second inwardly bent elbow portions (14, 14A)) tapering toward the biasing element (spring portion (12)) such that conical transition regions are formed (See annotated Figure 2 above, (Conical Transition Regions)), the conical transition regions defining a cone angle (See annotated Figure 2 below (Cone angle)).
Further, as seen above, Schmidt discloses the invention substantially as claimed, but does not explicitly disclose that the cone angle has a value of at least 10°. Nevertheless, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the transition region with a cone angle as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (e.g., of cone angle) involves only routine skill in the art. In re Aller.
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Regarding claim 2, Schmidt discloses the claimed invention except for, “the cone angle has a value of at least 15°.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the transition region with a cone angle as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (e.g., of cone angle) involve only routine skill in the art. In re Aller.
Regarding claim 3, Schmidt further discloses, wherein the first circular cross section (cross section of sections (17, 17A)) defines a first cross sectional area (Figures 3-4), the second circular cross section (cross section of spring portion (12)) defines a second cross sectional area (Figure 7), and a ratio of the second cross sectional area and the first cross sectional area is at most 0.7 (Given the disclosures cited in the rejection of claim 1, specifically, the diameters of sections (17, 17A) being 35 mils seeing as how they are left with their original circular cross sectional thickness, and the diameter of spring portion (12) being reduced by close to 50%, resulting in a diameter of approximately 20-25 mils. Post calculation of the area (circular area) of each cross section and taking the ratio of the second cross sectional area and the first cross sectional area does indeed result in a value less than 0.7).
Regarding claim 4, Schmidt further discloses, wherein: the biasing element (spring portion (12)) is produced exclusively by reshaping (Col. 5, line 22-25, “The aneurysm clip is formed by first stamping (coining) elongated resilient member 10 shown in FIGS. 5 and 5A from a solid rod of titanium or titanium alloy...” Further, Col. 5, line 62-66, “...during the coining and coiling of the spring section 12 of an aneurysm clip such as shown in FIG. 1, where the thickness of the round starting rod must be reduced by close to 50% for proper spring action.” Also, Col. 6, line 31-33, “Combination of both heating the starting rod and use of concave coining dies resulted in spring coil 12 portions (sections)...” Lastly, Col. 7, line 14-17, “The coil 12 is formed by winding elongated member 12 about a mandrel to form the coil portion 12 at or near a central intermediate part of elongated resilient member 10.”).
Regarding claim 5, Schmidt further discloses, wherein: the biasing element (spring portion (12)) is unground (Col. 1, line 31-60, states, “In order to provide satisfactory and prolonged service when properly implanted, a cerebral aneurysm clip must satisfy the following criteria … 5. To prevent unintentional tears and pressure points, jagged edges must be absent from the exterior surface of the clip … 6. Cracks in the exterior surface of the clip, even extremely fine micro-cracks, crevices and other similar defects should be absent from the surface of the clip in order to reduce the possibility of trapping foreign matter and contamination.” These strict quality requirements for surface smoothness indicate a finished surface free of typical unground characteristics. Further, the process disclosed is designed to achieve this smooth finish without requiring post-fabrication modification: Where the use of special concave coining dies prevents the development of cracks or shears during the forming process that would otherwise require grinding is disclosed in Col. 5-Col. 6; the "further anodic oxidation of the clip after assembly further insures the existence of a smooth outer surface without surface imperfections" (Col. 4, line 30-33); and the resulting finish "provides a smooth surface for the clip which is not subject to catching and holding foreign matter in the form of blood or tissue" (Col. 10, line 35-49). Lastly, the disclosure contrasts the invention's benefits with the problems of prior art clips, specifically mentioning issues like "cracks in the exterior surface" caused by older manufacturing methods like riveting (Col. 10, line 40-48). The disclosed method eliminates the need for such operations and the defects they cause).
Regarding claim 6, Schmidt further discloses, wherein: the medical clip (member (10)) is of a one-piece monolithic construction (Col. 5, line 13-17 discloses, “The cerebral aneurysm clip (or clamp) constructed according to the invention, is formed by bending a continuous, elongated, resilient member 10... fabricated from titanium metal or a titanium alloy…” Further, Col. 5, line 22-25 discloses, “The aneurysm clip is formed by first stamping (coining) elongated resilient member 10... from a solid rod of titanium or titanium alloy...” Lastly, Col. 4, line 50-52, “FIG. 5 is a top plan view of an elongated continuous resilient member formed from titanium or titanium alloy which is compatible with human tissue prior to being bent and shaped into the aneurysm clip shown in FIG. 1 or FIG. 11”).
Regarding claim 7, Schmidt further discloses, wherein a respective clamping face (Figures 1 and 5A) of each of the two clamping arms (sections (16A and 16)) defines a respective clamping face plane (Figure 2), and the respective clamping face planes are oriented in parallel to one another in the basic position (Figure 2 shows the closed basic position with the clamping face planes indeed being oriented in parallel to one another).
Response to Arguments
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive.
With regards to claim 1, Applicant argues that Schmidt's spring portion (12) has a "substantially flattened oval configuration" (Col. 6, line 31-36; Figure 7), which cannot be considered "circular," as "circular" requires a perfectly round shape (citing dictionary definitions and Schmidt's distinction between "circular" elbow portions in Figure 6 and the oval coil). Applicant further asserts that modifying to circular would destroy Schmidt's purpose (avoiding cracks/residual stresses in titanium via concave coining dies; Col.’s 5-6).
These arguments are not persuasive for the following reasons:
The broadest reasonable interpretation (BRI) of "circular cross section" — Under MPEP § 2111, claim terms are given their ordinary and customary meaning as understood by one of ordinary skill in the art, consistent with the specification. While Applicant cites general dictionary definitions of "circle" as perfectly round, the specification does not require mathematical perfection or exclude minor deviations. The disclosure describes the biasing element (coil spring (54)) as formed by winding an intermediate portion reshaped to a smaller "second circular cross section" (e.g., Page 13, line 26-28 and Page 14, line 28-30), but acknowledges prior art rotary swaging of wire blanks that inherently produce near-circular (round) sections post-reduction, with possible minor ovality from processing. A "substantially flattened oval" in Schmidt is the result of specific coining for titanium to prevent cracking (Col. 6, line 6-36), but the underlying wire starts round (35 mils diameter rod; Col. 5, line. 22-27), and the coil is wound from that reshaped material. One of ordinary skill would recognize that the coil cross-section remains effectively circular/round for functional purposes (providing uniform spring properties), especially since Schmidt contrasts it with explicitly circular sections elsewhere but does not describe the oval as deviating so far as to lose round character. The term "circular" in patent claims for wire/coil elements often encompasses minor processing-induced ovality (see analogous cases like In re Wertheim (541 F. 2d 257 - CCPA 1976), where slight variations do not distinguish over prior art). Thus, Schmidt's coil reasonably meets the BRI of "circular cross section."
Schmidt explicitly teaches a reduced-diameter round starting material for the coil — The starting rod is round (circular cross-section; Col. 5, line 22-27), coined primarily in one dimension to oval for coiling benefits, but the disclosure emphasizes maintaining cross-sectional area uniformity (Col. 10, line. 64-66) and round origins. The coil is formed by winding the reshaped member (Col. 7, line 14-17). The transition regions taper conically toward the coil (annotated FIG. 2), inherently connecting larger round connecting portions to the smaller coil section. The ovality is a material-specific optimization (titanium alpha-beta alloys prone to cracking; Col. 6), not a requirement for all aneurysm clips. For general materials (as in many prior art clips using stainless steel or Phynox), round reduction via swaging/reshaping is standard (Applicant's own background Page 2, line 15-Page 3, line 2, admits rotary swaging of wire blanks for biasing elements). Thus, Schmidt teaches the structural limitation, and any minor ovality does not negate anticipation or obviousness.
No destruction of purpose in viewing as circular — Schmidt's oval is to enable approximately 50% reduction without cracks in titanium (Col. 6). But the claim is not limited to titanium; the invention uses biocompatible metal wire (e.g., instrument steel or titanium; Page 16, line 9-10). For non-titanium materials, round coining/swaging is predictable and preserves purpose (enhanced elasticity via cold working; Schmidt Col.’s 5-6). Modifying to fully round (if needed) is obvious optimization of shape for equivalent spring function (MPEP § 2144.04(IV)(B), changes in shape/form obvious absent criticality). Applicant has not shown criticality for perfectly round vs. slightly oval (no unexpected results over oval coils).
Further, with regards to claim 3, Applicant argues Schmidt maintains "essentially uniform" cross-sectional area (Col. 10, line 64-66), so no reduction, only flattening (conservation of mass, no stretching/compaction).
This is not persuasive:
Schmidt explicitly reduces diameter "close to 50%" via coining (Col. 5, line 61-68; Col. 6, line 6-15), from 35 mils to 20-25 mils in one dimension, yielding approximately 0.5 ratio if approximating circular equivalent. While area is "essentially uniform" overall (due to volume conservation in plastic deformation without significant axial stretch), the effective load-bearing cross-section for spring constant is reduced in the thinned direction. The claim recites "cross sectional area" based on circular diameters, and Schmidt's reduction achieves equivalent functional area reduction for elasticity (yield strength increase via work hardening; analogous to Applicant's Page 4, line 7-17). Even if area conserved, the ratio falls within the claimed range under reasonable calculation of equivalent circular area post-reduction. Optimization of reduction ratio (for elasticity/force) is routine (In re Aller; MPEP § 2144.05).
Thus, Applicant's arguments fail to overcome the rejection. The prior art teaches or renders obvious all limitations. The rejection are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771