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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 9th, 2025, has been entered.
Response to Amendment
The claims filed on December 9th, 2025, have been entered. Claims 1 and 4-20 remain pending in the Application. Claims 18-20 were previously withdrawn by the Applicant. The claim amendments overcome the previous claim objections and 112(a) rejection.
Response to Arguments
Applicant's arguments filed December 9th, 2025, with regard to claims 1-14 and 16 have been fully considered but they are not persuasive.
Regarding claims 1-14, Applicant’s arguments are directed toward the product-by-process limitations made throughout the claims, and particularly in claim 1, regarding whether the medical clip, first clip portion, second clip portion, first clamping arm, and second clamping arm are made by generative manufacturing processes or by other processes. Applicant begins by citing MPEP 2113.I., which states in part that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product” (emphasis added). Since the medical clip, first and second clip portions, and first and second clamping arms can indisputably be made by other processes than those claimed, Applicant focuses on asserting that distinctive structural characteristics are made by the generative manufacturing processes or by the other processes. However, the broadness of these product-by-process limitations undermines Applicant’s arguments; unlike In re Garnero, where terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” were capable of being constructed as structural limitations, the “generative manufacturing processes” can include a number of different processes, including at least additive manufacturing, laser deposition welding, and thermal spraying, while “other processes” can include at least cold forming and coining. Applicant relies on asserted differences between particular examples, such as comparing cold forming to laser deposition welding, but MPEP 2113.I. requires that the claimed manufacturing process step imparts distinctive claimed structural characteristics to the final product, not just that some of the potential processes may differ from non-claimed processes. Both generative manufacturing processes and non-generative manufacturing processes can be used to create the medical clip, first and second clip portions, and first and second clamping arms as claimed.
Applicant also responded to previous arguments made by Examiner in the Final Rejection dated September 11th, 2025. In response to Examiner pointing out that Applicant had indicated in the Specification that the first clip portion could be formed by either generative manufacturing processes or non-generative manufacturing processes, Applicant argues that the Specification section demonstrates that the choice in process is based on the desired properties in the first clip portion. As Examiner previously pointed out, this shows that the first clip portion as claimed can be made by either process.
Regarding claim 16 in view of Schmidt et al. (U.S. Patent No. 5,758,420), Applicant argues that Schmidt et al. does not disclose the identified winding receptacle as being flat and as facing the spring. Examiner respectfully disagrees. First, claim 16 does not include a limitation where the winding receptacle is flat, so Schmidt et al. does not need to disclose that limitation to reject the claim. Second, the identified winding receptacle has a cylindrical body where at least some of the surface of the winding receptacle faces towards the spring.
Regarding claim 16, Applicant argues that McFadden (Pub. No. 2013/0267973) does not disclose the limitation “a winding receptacle is formed on the spring” because the identified winding receptacle of arms 26 and 28 is connected to plates 20 and 22 rather than spring 24. Examiner respectfully disagrees. [0022] of McFadden states that “arms 26 and 28 are adjacent to spring 24.” This disclosure is supported by [0021], where 20 and 22 are integrated with 24, and has 26 and 28 formed on 24.
The rejection of claims 15 and 17 under 102(a)(1) over Schmidt et al. and McFadden has been withdrawn in light of Applicant’s amendments made December 9th, 2025; specifically, neither reference teaches a cross-sectional area of the spring is reduced in the winding receptacle.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt et al. (U.S. Patent No. 5,758,420).
Regarding claim 16, Schmidt et al. discloses a medical clip (10; FIG. 1; C4:L12-14) comprising a first clamping arm (32), a second clamping arm (40), and a spring (22), wherein the first clamping arm is connected to a first end of the spring (FIG. 1: 32 is connected to a first end of 26), wherein the second clamping arm is connected to a second end of the spring (FIG. 1: 40 is connected to a second end of 26), and wherein the first clamping arm and the second clamping arm are maximally proximate to one another in a basic position of the clip (FIG. 1: 32 and 40 are maximally proximate to each other when the clip is closed) and are movable away from one another against the action of the spring from the basic position into an opening position (C4:L26-29: 32 and 40 are brought together in the closed position by 22, and can be moved away from each other against the force of 22), wherein the spring is configured in the form of a coil spring with at least one complete winding (FIG. 1: 22 is a coil spring with a complete winding), and wherein a winding receptacle is formed on the spring in the region of the first end and the second end (Annotated FIG. 2 below: on the ends of 22 which connect to 32 and 40, a space for part of the curve of 38 is on the axis of 24, shown in FIG. 1), and wherein the winding receptacle is formed pointing in the direction toward the adjacent winding (FIGs. 1 and 2: the space for part of the curve 38 is on axis 24 and points towards the winding on 22).
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Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFadden (Pub. No. 2013/0267973).
Regarding claim 16, McFadden discloses a medical clip (10; FIGs. 2-7; [0020]) comprising a first clamping arm (14), a second clamping arm (16), and a spring (12), wherein the first clamping arm is connected to a first end of the spring (FIG. 2: 14 is connected to a first end of 12 through 28), wherein the second clamping arm is connected to a second end of the spring (FIG. 2: 14 is connected to a second end of 12 through 26), and wherein the first clamping arm and the second clamping arm are maximally proximate to one another in a basic position of the clip (FIG. 2: 14 and 16 are maximally proximate to each other when the clip is closed) and are movable away from one another against the action of the spring from the basic position into an opening position ([0021] 14 and 16 are brought together in the closed position by 12 shown in FIG. 2, and can be moved away from each other against the force of 12 to the position shown in FIG. 7), wherein the spring is configured in the form of a coil spring with at least one complete winding (FIGs. 2 and 6: 24, which is part of 12, is a coil spring with a complete winding), and wherein a winding receptacle is formed on the spring in the region of the first end and the second end (FIG. 2: 20 and 22 are winding receptacles formed on 12 in the region of 26 and 28), and wherein the winding receptacle is formed pointing in the direction toward the adjacent winding (FIG. 2: 20 and 22 face in the direction of the windings of 24).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4-14 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schmidt et al. (U.S. Patent No. 5,758,420).
Regarding claim 1, Schmidt et al. discloses a medical clip (10; FIG. 1; C4:L12-14) comprising a first clamping arm (32), a second clamping arm (40), and a spring (22), wherein the first clamping arm is connected to a first end of the spring (FIG. 1: 32 is connected to a first end of 26), wherein the second clamping arm is connected to a second end of the spring (FIG. 1: 40 is connected to a second end of 26), and wherein the first clamping arm and the second clamping arm are maximally proximate to one another in a basic position of the clip (FIG. 1: 32 and 40 are maximally proximate to each other when the clip is closed) and are movable away from one another against the action of the spring from the basic position into an opening position (C4:L26-29: 32 and 40 are brought together in the closed position by 22, and can be moved away from each other against the force of 22), wherein the medical clip comprises at least one clip portion (FIG. 1: the first clip portion is the coil spring 22) and at least one second clip portion (FIG. 1: the second clip portion is the two arms 32 and 40), wherein the at least one first clip portion is made by a process other than a generative manufacturing process (C9:L55-67: 22 is formed by a cold forming process), and wherein the at least one second clip portion is formed directly onto the at least one first clip portion (C7:L42-48: arms of the clip are made by bending material from the newly formed coil spring 22 into straight and flat portions extending distally), wherein the spring forms the at least one first clip portion (FIG. 1: the first clip portion is the coil spring 22), and wherein the at least one of the first clamping arm and the second clamping arm forms the at least one second clip portion (FIG. 1: the second clip portion is the two arms 32 and 40).
The claimed phrases “wherein the medical clip is made partially by a generative manufacturing process,” “wherein the at least one second clip portion is formed directly onto the at least one first clip portion by a generative manufacturing process,” “wherein at least one of the first clamping arm and the second clamping arm are formed by a generative manufacturing process,” and “wherein the spring is formed by a generative manufacturing process,” are being treated as product by process limitations; that is to say, “the medical clip is formed by generative manufacturing,” “the at least one second clip portion is formed by generative manufacturing,” “the first clamping arm and the second clamping arm are formed by generative manufacturing,” and “the spring is formed by generative manufacturing.” As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Applicant responded to this by arguing that the two processes had unobvious differences, which was addressed above in the Response to Arguments section.
Regarding claim 4, Schmidt et al. further discloses the first clamping arm comprises an end pointing toward the spring (FIG. 1: the proximal end of 32), wherein the second clamping arm comprises an end pointing toward the spring (FIG. 1: the proximal end of 40), wherein the end of the first clamping arm pointing toward the spring is connected to the first end of the spring by way of a first connecting portion (FIG. 1: the connecting portion between 22 and 32 is where 32 and 40 cross), and wherein the end of the second clamping arm pointing toward the spring is connected to the second end of the spring by way of a second connecting portion (FIG. 1: the connecting portion between 22 and 40 is where 32 and 40 cross).
Regarding claim 5, Schmidt et al. further discloses the first connecting portion and the second connecting portion intersect in a connection region of the clip (FIG. 1: 32 and 40 intersect, and the connecting portions are located at the intersection).
Regarding claim 6, the claimed phrase “wherein the first connecting portion and the second connecting portion are formed by a generative manufacturing process” is being treated as a product by process limitation; that is to say, “the first connecting portion and the second connecting portion are formed by the generative manufacturing”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, using a known technique of coining as disclosed by Schmidt et al. in place of generative manufacturing would have been obvious since the structure of the medical clip in the prior art is the same structure as that which is claimed.
Applicant responded to this by arguing that the two processes had unobvious differences, which was addressed above in the Response to Arguments section.
Regarding claim 7, Schmidt et al. further discloses the first clamping arm comprises a first clamping face (FIG. 1: the downward-facing surface of 32), wherein the second clamping arm comprises a second clamping face (FIG. 1: the upward-facing surface of 40), and wherein the first clamping face and the second clamping face abut against one another in the basic position (FIG. 1: in the depicted basic position, the downward-facing surface of 32 and the upward-facing surface of 40 rest against each other).
Regarding claim 8, Schmidt et al. further discloses the first clamping arm and the second clamping arm are biased against one another in the basic position (C4:L26-29: 32 and 40 are brought together in the closed position by 22 and push against each other), and the spring is formed by a cold forming process (C9:L55-67: 22 is formed by a cold forming process).
Regarding claim 9, Schmidt et al. further discloses the clip is made of at least one biocompatible material (C5:L57-66: the clip is made of a biocompatible titanium rod), and the at least one first clip portion is formed by a cold forming process (FIG. 1: the first clip portion is formed by 22, and C9:L55-67: 22 is formed by a cold forming process).
Regarding claim 10, Schmidt et al. further discloses a transition of the at least one first clip portion to the at least one second clip portion defines a transition region (Annotated FIG. 1 below: the transition region consists of the intersection of arms 32 and 40).
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Regarding claim 11, Schmidt et al. further discloses the transition region defines a transition region longitudinal axis (Annotated FIG. 1 above: longitudinal axis 24 goes through the transition region) and extends between a first transition region end (Annotated FIG. 1) and a second transition region end (Annotated FIG. 1), wherein between the first transition region end and the second transition region end a cross section transverse to the transition region longitudinal axis is defined partially by the at least one first clip portion (Annotated FIG. 1: part of the transition region is defined by the second clip portion, where 40 curves upward around 38 in a direction transverse to 24) and partially by the at least one second clip portion (Annotated FIG. 1: part of the transition region is defined by the first clip portion, where the biasing member connects with 40 and curves upward in a direction transverse to 24).
Regarding claim 12, Schmidt et al. further discloses the transition region defines a contact face between the at least one first clip portion and the at least one second clip portion (Annotated FIG. 1: the transition point between the arm 40 and the end of the biasing member 22 connected to 40 creates a contact face within the upward curve of 38) and wherein the contact face corresponds at least to a cross sectional area of the medical clip in the transition region transverse to a transition region longitudinal axis (Annotated FIG. 1: the contact face at the upward curve of 38 is straight down the center of 38, making the surface transverse to 24).
Regarding claim 13, Schmidt et al. further discloses formed on one of the clip portions is a connecting projection pointing in the direction toward the at least one other clip portion (Annotated FIG. 1: the contact face of 38 would have a connecting projection from 40 which faces 22) and wherein formed on the at least one other clip portion is a connecting projection receptacle (Annotated FIG. 1: the contact face from the perspective of 22 would receive the contact face from the perspective of 40), which accommodates the connecting projection in a materially bonded manner (Annotated FIG. 1: the contact faces of 22 and 40 are materially bonded together as part of a single wire).
Regarding claim 14, Schmidt et al. further discloses the spring is configured in the form of a coil spring with at least one complete winding (FIG. 1: 22 is a coil spring with a complete winding), and wherein a winding receptacle is formed on the spring in the region of the first end and the second end (Annotated FIG. 2 below: on the ends of 22 which connect to 32 and 40, a space for part of the curve of 38 is on the axis of 24, shown in FIG. 1), and wherein the winding receptacle is formed pointing in the direction toward the adjacent winding (FIGs. 1 and 2: the space for part of the curve 38 is on axis 24 and points towards the winding on 22).
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Claim(s) 1, 4-9, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McFadden (Pub. No. 2013/0267973).
Regarding claim 1, McFadden discloses a medical clip (10; FIGs. 2-7; [0020]) comprising a first clamping arm (14), a second clamping arm (16), and a spring (12), wherein the first clamping arm is connected to a first end of the spring (FIG. 2: 14 is connected to a first end of 12 through 28), wherein the second clamping arm is connected to a second end of the spring (FIG. 2: 14 is connected to a second end of 12 through 26), and wherein the first clamping arm and the second clamping arm are maximally proximate to one another in a basic position of the clip (FIG. 2: 14 and 16 are maximally proximate to each other when the clip is closed) and are movable away from one another against the action of the spring from the basic position into an opening position ([0021] 14 and 16 are brought together in the closed position by 12 shown in FIG. 2, and can be moved away from each other against the force of 12 to the position shown in FIG. 7), the medical clip comprises at least one clip portion (FIG. 2: 12 forms the first clip portion) and at least one second clip portion (FIG. 2: the second clip portion is the two arms 14 and 16), and wherein the at least one second clip portion is formed directly onto the at least one first clip portion ([0019]: arms of the clip are made by bending material from the newly formed coil spring 12 into straight and flat portions extending distally), wherein the spring forms the at least one first clip portion (FIG. 2: 12 forms the first clip portion) and wherein at least one of the first clamping arm and the second clamping arm forms the at least one second clip portion (FIG. 2: the second clip portion is the two arms 14 and 16).
The claimed phrases “wherein the medical clip is made partially by a generative manufacturing process,” “wherein the at least one first clip portion is made by a process other than a generative manufacturing process,” “wherein the at least one second clip portion is formed directly onto the at least one first clip portion by a generative manufacturing process,” “wherein at least one of the first clamping arm and the second clamping arm are formed by a generative manufacturing process,” and “wherein the spring is formed by a generative manufacturing process,” are being treated as product by process limitations; that is to say, “the medical clip is formed by generative manufacturing,” “the at least one second clip portion is formed by generative manufacturing,” “the first clamping arm and the second clamping arm are formed by generative manufacturing,” and “the spring is formed by generative manufacturing.” As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Applicant responded to this by arguing that the two processes had unobvious differences, which was addressed above in the Response to Arguments section.
Regarding claim 4, McFadden further discloses the first clamping arm comprises an end pointing toward the spring (FIG. 2: the proximal end of 14), wherein the second clamping arm comprises an end pointing toward the spring (FIG. 2: the proximal end of 16), wherein the end of the first clamping arm pointing toward the spring is connected to the first end of the spring by way of a first connecting portion (28), and wherein the end of the second clamping arm pointing toward the spring is connected to the second end of the spring by way of a second connecting portion (26).
Regarding claim 5, McFadden further discloses the first connecting portion and the second connecting portion intersect in a connection region of the clip (FIG. 2: 26 and 28 cross over each other).
Regarding claim 6, the claimed phrase “wherein the first connecting portion and the second connecting portion are formed by a generative manufacturing process” is being treated as a product by process limitation; that is to say, “the first connecting portion and the second connecting portion are formed by the generative manufacturing”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In this case, using a known technique of bending as disclosed by McFadden in place of generative manufacturing would have been obvious since the structure of the medical clip in the prior art is the same structure as that which is claimed. Applicant responded to this by arguing that the two processes had unobvious differences, which was addressed above in the Response to Arguments section.
Regarding claim 7, McFadden further discloses the first clamping arm comprises a first clamping face (FIG. 3: the downward-facing surface of 14), wherein the second clamping arm comprises a second clamping face (FIG. 3: the upward-facing surface of 16), and wherein the first clamping face and the second clamping face abut against one another in the basic position (FIG. 3 and [0020]: in the depicted basic position, the downward-facing surface of 14 and the upward-facing surface of 16 are planar).
Regarding claim 8, McFadden further discloses the first clamping arm and the second clamping arm are biased against one another in the basic position ([0020] 14 and 16 are biased to each other).
Regarding claim 9, McFadden further discloses the clip is made of at least one biocompatible material ([0019] the clip 10 can be made of titanium, which the present Spec on Page 11, lines 7-8, states is a biocompatible material).
Regarding claim 14, McFadden further discloses the spring is configured in the form of a coil spring with at least one complete winding (FIGs. 2 and 6: 24, which is part of 12, is a coil spring with a complete winding), and wherein a winding receptacle is formed on the spring in the region of the first end and the second end (FIG. 2: 20 and 22 are winding receptacles formed on 12 in the region of 26 and 28), and wherein the winding receptacle is formed pointing in the direction toward the adjacent winding (FIG. 2: 20 and 22 face in the direction of the windings of 24).
Allowable Subject Matter
Claims 15 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 15 and 17, the prior art does not suggest, in combination with the remaining claim limitations, the spring is configured in a form of a coil spring with at least one complete winding, a winding receptacle is formed on the spring, the winding receptacle is formed pointing in a direction toward an adjacent winding, the winding receptacle is formed by a flattened portion or a flat recess on the spring, and a cross-sectional area of the spring is reduced in the winding receptacle.
Two close prior art references, Viola (Pub. No. 2003/0229368) and Khan (Pub. No. 2017/0086824), do not disclose a complete winding. Instead, as shown in FIGs. 5 and 24, respectively, the potentially flat portion of the winding receptacle is part of a spring that does not coil in a complete winding.
Another two close prior art references, Hart et al. (Pub. No. 2006/0100646) and Steinhilper et al. (Pub. No. 2011/0288571), do not explicitly disclose the winding receptacle is formed by a flattened portion or a flat recess on the spring. Instead, while FIGs. 1-3 and 5, respectively, appear to show a flat recess to receive part of the winding, neither reference states that the winding receptacle is flat, and the winding receptacle could be curved for both references.
Another two close prior art references, Goradia (U.S. Patent No. 6,179,850) and Perlin (U.S. Patent No. 4,777,949), may disclose the flattened winding receptacle with a complete winding, but do not disclose the winding receptacle faces the adjacent winding. Instead, in FIGs. 2 and 0B, respectively, the flat sections at 58/60 and 72/71, respectively, do not face the windings at 23 and 11, respectively.
Finally, a close prior art reference, Frantzen et al. (U.S. Patent No. 6,193,732), does not disclose a cross-sectional area of the spring is reduced in the winding receptacle. While FIGs. 14A-16B illustrate a coil spring with flat portions in the adjacent coils, none of the figures show the cross-sectional area of the spring being reduced in these flattened areas, nor does the Specification disclose any such reduction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771