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 .
Information Disclosure Statement
The information disclosure statement filed 6/4/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
Each U.S. patent listed in an information disclosure statement must be identified by inventor, patent number, and issue date; and
Each U.S. application listed in an information disclosure statement must be identified by the inventor, application number, and filing date.
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1, 4-6, 9-10, 12, and 31 are objected to because of the following informalities:
Claim 1, line 8 recites “clips jaws” which should instead recite “clip jaws”.
Claim 4, line 2 recites “yield at strength”, which should instead be “strength at yield”.
The spacing between claims 5-6 should be corrected such that there is a space between the claims.
Claim 9, line 2 recites “barbs” which should be amended to recite “the at least one barbs” instead.
Claim 10, line 2 recites “barbs” which should be amended to recite “the barbs” instead.
Claim 12, line 10 recites “a close configuration” which should be amended to recite “a closed configuration” instead.
Claim 31, line 12 recites “the clip jaw” which should be amended to recite “the clip jaws” instead.
Appropriate correction is required.
Claims 4-11, 20-26, and 30 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim:
must not reference another multiple dependent claim;
must refer to multiple claims in the alternative only; and
must be worded in line with the examples provided in MPEP 608.081 A.
See MPEP § 608.01(n). Although these claims should not be further treated on the merits, examination will continue under the assumption that these claims depend properly from their respective independent claims instead.
Applicant is advised that should claims 1-11 and 12-15 be found allowable, claims 16-26 and 27-30, respectively, will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 8-10 and 23-25 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.
Claims 8-10 and 23-25 each recite the limitation "barbs" or “the barbs”. There is insufficient antecedent basis for this limitation in the claims, since each claim depends from a claim which only introduces “at least one barb”. It is unclear whether the claims only require at least a single barb, or whether a plurality of barbs are required by the claims. It is recommended that the independent claims be amended to recite “at least one barb coupled to a distal portion of each of the clip jaws” instead to establish a plurality of barbs.
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.
Claims 1-35 are rejected under 35 U.S.C. 103 as being unpatentable over Litscher et al. (US PGPub 2005/0107809 A1).
Claims containing duplicate subject matter will be grouped together for rejection purposes.
With respect to claims 1 and 16, Litscher et al. discloses a device for treating tissue (see Fig. 1), comprising:
a capsule (200 in Fig. 1A) extending longitudinally from a proximal end to a distal end and including a channel extending therethrough (PP [0064]: “a capsule 200 which provides a structural shell for the clip assembly 106”);
clip jaws (106 in Fig. 1, see also 208 in Fig. 18), proximal ends of which are slidably received in the channel of the capsule (200 in Fig. 1A) so that the clip jaws (106 in Fig. 1) are movable between an open configuration, in which distal ends of the clip jaws extend distally past the distal ends of the capsule to be separated from one another (PP [0066]: “The open configuration is obtained when the sliding spool 110 shown in FIG. 1 is moved distally so that the ball 140 of the control wire 118 pushes the assembly containing the yoke 204 and the tension member 206 distally, sliding within the capsule 200. As will be described below, the distal ends of the clip arms 208 are biased toward the open position and revert to this position whenever they are not constrained by the capsule 200”), and a closed configuration, in which the clip jaws are restrained via an interior surface of the capsule so that distal ends of the clip jaws are drawn toward one another (PP [0065]: “The clip arms 208 in the closed configuration have a radius section 300 which is partially contained within the capsule 200 to prevent opening of the arms”); and
at least one barb (408 in Fig. 18) coupled to a distal portion of the clip jaws (208).
However, Litscher et al. is silent on a distance between distal ends of the clip jaws in the open configuration being between 15 and 20 millimeters.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that a distance between distal ends of the clip jaws in the open configuration being between 15 and 20 millimeters since doing so would simply involve a mere change in size of the clipping device and it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which is concerned with grasping tissue (PP [0049]), but would simply and predictably affect the type of tissue the device is configured to target, which Litscher et al. places no criticality on (PP [0050]: “within the GI tract, the pulmonary system, the vascular system or within other lumens and ducts”).
Regarding claims 2 and 17, Litscher et al. fails to explicitly disclose wherein the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which emphasizes the importance of maximizing spring properties in constructing the clip arms (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”).
Regarding claims 3 and 18, Litscher et al. further discloses wherein the clip jaws (106 in Fig. 1, see also 208 in Fig. 18) are formed of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”).
Regarding claims 4 and 19, Litscher et al. further discloses wherein the clip jaws (106 in Fig. 1, see also 208 in Fig. 18) are formed of an alternate material (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel”), but fails to explicitly disclose that material having a [strength at yield] equal to that of 17-7 Stainless Steel.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of an alternate material having a [strength at yield] equal to that of 17-7 Stainless Steel since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which contemplates the use of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”) and is configured to operate with a material of a similar strength at yield.
Regarding claims 5 and 20, Litscher et al. further discloses wherein the at least one barb (408 in Figs. 18-20) extends from the distal portion of the clip jaws (208) at an angle between 20 and 90 degrees (see angle beta in Fig. 20, which is 90 degrees, PP [0079]: “The teeth 408 are disposed at a nose angle beta which is preferably between approximately 90 and 135 degrees”) relative to the longitudinal axis of the clip jaws (208).
Regarding claims 6 and 21, Litscher et al. fails to disclose wherein the distance between distal ends of the clip jaws in the open position is 16 millimeters or greater.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the distance between distal ends of the clip jaws in the open position is 16 millimeters or greater since doing so would simply involve a mere change in size of the clipping device and it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which is concerned with grasping tissue (PP [0049]), but would simply and predictably affect the type of tissue the device is configured to target, which Litscher et al. places no criticality on (PP [0050]: “within the GI tract, the pulmonary system, the vascular system or within other lumens and ducts”).
Regarding claims 7 and 22, Litscher et al. further discloses wherein the distal portion of the clip jaws (208 in Figs. 18-20) includes a stamped rib feature (bend of clip body meeting wings 300 in Figs. 19-20).
Regarding claims 8 and 23, Litscher et al. further discloses wherein the barbs (408 in Figs. 18-20) are formed as wing teeth (PP [0079]: “interlocking teeth 408 disposed at their distal ends”).
Regarding claims 9 and 24, Litscher et al. further discloses wherein when the clip jaws (208 in Figs. 18-20) are in the closed configuration, [the] barbs (408) on opposing clip jaws (208) are configured to be staggered (PP [0079]: “The clip arms 208 also comprise interlocking teeth 408 disposed at their distal ends. In the exemplary embodiment, the teeth 408 are identical so that the arms may be interchangeable and will mesh smoothly with the set facing them”, barbs 408 are interlocking and mesh with one another, each set has two staggered teeth of barb 408).
Regarding claims 10 and 25, Litscher et al. further discloses wherein when the clip jaws (208 in Figs. 18-20) are in the closed configuration, [the] barbs (408) on opposing clip jaws (208) are configured to touch (PP [0079]: “The clip arms 208 also comprise interlocking teeth 408 disposed at their distal ends. In the exemplary embodiment, the teeth 408 are identical so that the arms may be interchangeable and will mesh smoothly with the set facing them”, barbs 408 are interlocking and mesh with one another, they are configured to touch each other).
Regarding claims 11 and 26, Litscher et al. fails to explicitly disclose wherein the clip jaws have a radius of curvature of 2.8 mm or less.
However, Litscher et al. recognizes curvature of the clip jaws to be a result effective variable which directly affects the engaging force between the two clip jaws (PP [0079]: “A pre-load angle a is defined between the radius section 300 and the spring section 404. The pre-load angle alpha determines how much interference (pre-load) exists between the two opposing clip arms 208 at their distal ends when closed. The greater the pre-load angle alpha, the greater the engaging force that is applied by the clip arms 208. However, this condition also causes the greatest system friction when the hemostatic clip 90 is closed”).
It would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws have a radius of curvature of 2.8 mm or less because doing so would be a matter of routine optimization, as Litscher et al. already recognizes the impact clip jaw curvature has on tissue engagement force (see PP [0079] as cited above) and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). The modification as proposed would not have altered the main operating principle of the Litscher et al. device, which already includes a clip jaw curvature (see Figs. 18-20) and contemplates the effect of curvature on engagement force, but would simply and predictably affect the force with which the clip jaws close over a target tissue.
With respect to claims 12 and 27, Litscher et al. discloses a clipping device (see Fig. 1), comprising:
a proximal portion (152);
a distal portion (see Fig. 1A including 106 and 108, see also 208 in Figs. 18-20) releasably coupled to the proximal portion (152, see capsule 200 uncoupled to 152) so that the distal portion is deployable therefrom (106 and 108 are deployable, see Fig. 42 for example), the distal portion (106 and 108 in Fig. 1A, see also 208 in Figs. 18-20) including:
a capsule (200 in Fig. 1A) extending longitudinally from a proximal end to a distal end and including a channel extending therethrough (PP [0064]: “a capsule 200 which provides a structural shell for the clip assembly 106”);
clip jaws (106 in Fig. 1, see also 208 in Fig. 18), proximal ends of which are slidably received in the channel of the capsule (200 in Fig. 1A) so that the clip jaws (208) are movable between an open configuration, in which distal ends of the clip jaws extend distally past the distal ends of the capsule to be separated from one another (PP [0066]: “The open configuration is obtained when the sliding spool 110 shown in FIG. 1 is moved distally so that the ball 140 of the control wire 118 pushes the assembly containing the yoke 204 and the tension member 206 distally, sliding within the capsule 200. As will be described below, the distal ends of the clip arms 208 are biased toward the open position and revert to this position whenever they are not constrained by the capsule 200”), and a closed configuration, in which the clip jaws are restrained via an interior surface of the capsule so that distal ends of the clip jaws are drawn toward one another (PP [0065]: “The clip arms 208 in the closed configuration have a radius section 300 which is partially contained within the capsule 200 to prevent opening of the arms”); and
at least one barb (408 in Fig. 18) coupled to a distal portion of the clip jaws (208); and
a control member (118 in Fig. 1A) extending from a proximal end to a distal end, the distal end coupled to proximal ends of the clip jaws (118 couples to 208 via 204 and 206, PP [0068]: “the control cable 118 pulls the yoke 204 proximally, away from the tension member 206. The tension member 206 is firmly attached to the clip arms 208”).
However, Litscher et al. fails to disclose a distance between distal ends of the clip jaws in the open configuration being between 15 and 20 millimeters (claim 12), or between 15 and 18 millimeters (claim 27).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that a distance between distal ends of the clip jaws in the open configuration being between 15 and 20 millimeters or between 15 and 18 millimeters since doing so would simply involve a mere change in size of the clipping device and it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which is concerned with grasping tissue (PP [0049]), but would simply and predictably affect the type of tissue the device is configured to target, which Litscher et al. places no criticality on (PP [0050]: “within the GI tract, the pulmonary system, the vascular system or within other lumens and ducts”).
Regarding claims 13 and 28, Litscher et al. discloses wherein the clip jaws are formed of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”) for claim 28, but fails to explicitly disclose wherein the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 2144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which emphasizes the importance of maximizing spring properties in constructing the clip arms (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”).
Regarding claims 14 and 29, Litscher et al. further discloses wherein the clip jaws (208 in Figs. 18-20) are formed of an alternate material (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel”), but fails to explicitly disclose that material having a [strength at yield] equal to that of 17-7 Stainless Steel.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of an alternate material having a [strength at yield] equal to that of 17-7 Stainless Steel since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 2144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which contemplates the use of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”) and is configured to operate with a material of a similar strength at yield.
Regarding claims 15 and 30, Litscher et al. further discloses wherein the at least one barb (408 in Figs. 18-20) extends from the distal portion of the clip jaws (208) at an angle between 20 and 90 degrees (see angle beta in Fig. 20, which is 90 degrees, PP [0079]: “The teeth 408 are disposed at a nose angle beta which is preferably between approximately 90 and 135 degrees”) relative to the longitudinal axis of the clip jaws (208).
With respect to claim 31, Litscher et al. discloses a method for treating a target tissue (PP [0005]: “an apparatus for applying clips to tissue”), comprising:
inserting a distal portion of a clipping device (see Fig. 1) to a target area within a living body (PP [0006]: “a method of deploying hemostatic clips, comprising inserting to a target site in a body a magazine including a plurality of hemostatic clips connected in a clip chain”), the distal portion including a capsule (200) and clip jaws (208) slidably received within the capsule (200) to be movable between an open configuration, in which distal ends of the clip jaws are separated from one another (PP [0066]: “The open configuration is obtained when the sliding spool 110 shown in FIG. 1 is moved distally so that the ball 140 of the control wire 118 pushes the assembly containing the yoke 204 and the tension member 206 distally, sliding within the capsule 200. As will be described below, the distal ends of the clip arms 208 are biased toward the open position and revert to this position whenever they are not constrained by the capsule 200”), and a closed configuration, in which the distal ends of the clip jaws are drawn toward one another (PP [0065]: “The clip arms 208 in the closed configuration have a radius section 300 which is partially contained within the capsule 200 to prevent opening of the arms”), the clip jaws (208 in Figs. 18-20) including:
at least one barb (408) coupled to a distal portion of the clip jaws (208);
positioning the clip jaws (208) in contact with a target tissue (PP [0006]: “extend a distal-most one of the clips out of a distal end of the magazine to open clip arms of the distal-most clip into a tissue receiving configuration and positioning the distal-most clip to receive a first target portion of tissue between the clip arms thereof”); and
clipping a target portion of tissue by positioning the target portion of tissue between the clip jaws in the open configuration (see PP [0006] as cited above) and drawing the clip jaw[s] toward the closed configuration to grip the target portion of tissue (PP [0006]: “translating the clip chain proximally to draw the distal-most clip back into the magazine and close the clip arms of the distal-most clip over the first target portion of tissue and translating the clip chain further proximally to detach the distal-most clip from a next most distal clip of the clip chain”).
However, Litscher et al. fails to explicitly disclose a distance between distal ends of the clip jaws in the open configuration between 15 and 20 millimeters.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that a distance between distal ends of the clip jaws in the open configuration being between 15 and 20 millimeters since doing so would simply involve a mere change in size of the clipping device and it has been held that a change in size is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), see MPEP 2144.04). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which is concerned with grasping tissue (PP [0049]), but would simply and predictably affect the type of tissue the device is configured to target, which Litscher et al. places no criticality on (PP [0050]: “within the GI tract, the pulmonary system, the vascular system or within other lumens and ducts”).
Regarding claim 32, Litscher et al. further discloses wherein positioning the clip jaws in contact with the target tissue (PP [0006]: “translating the clip chain proximally to draw the distal-most clip back into the magazine and close the clip arms of the distal-most clip over the first target portion of tissue and translating the clip chain further proximally to detach the distal-most clip from a next most distal clip of the clip chain”) includes gripping the target tissue with the at least one barb (408 in Figs. 18-20, PP [0079]: “The clip arms 208 also comprise interlocking teeth 408 disposed at their distal ends”, the entirety of clip jaws 208 are in contact with the target tissue including barbs 408).
Regarding claim 33, Litscher et al. discloses wherein the clip jaws are formed of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”) for claim 28, but fails to explicitly disclose wherein the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of a material having a yield strength between 200 and 260 ksi or an equivalent strain at yield since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 2144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which emphasizes the importance of maximizing spring properties in constructing the clip arms (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”).
Regarding claim 34, Litscher et al. further discloses wherein the clip jaws (106 in Fig. 1, see also 208 in Fig. 18) are formed of an alternate material (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel”), but fails to explicitly disclose that material having a [strength at yield] equal to that of 17-7 Stainless Steel.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Litscher et al. device such that the clip jaws are formed of an alternate material having a [strength at yield] equal to that of 17-7 Stainless Steel since it has been held that it is generally within the skill of one of ordinary skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), see MPEP 144.07). The modification as proposed would not alter the main operating principle of the Litscher et al. device, which contemplates the use of 17-7 Stainless Steel (PP [0078]: “The clip arms 208 are preferably formed of a biocompatible material such as Nitinol, Titanium or stainless steel. Maximum spring properties may be obtained by using materials such as 400 series stainless or 17-7 PH”) and is configured to operate with a material of a similar strength at yield.
Regarding claim 35, Litscher et al. further discloses wherein the at least one barb (408 in Figs. 18-20) extends from the distal portion of the clip jaws (208) at an angle between 20 and 90 degrees (see angle beta in Fig. 20, which is 90 degrees, PP [0079]: “The teeth 408 are disposed at a nose angle beta which is preferably between approximately 90 and 135 degrees”) relative to the longitudinal axis of the clip jaws (208).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-15 of U.S. Patent No. 10,588,635 B2 (hereinafter known as the ‘635 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘635 patent anticipate the claims of the present disclosure.
Claims
Present
1, 16
2, 17
3, 18
4, 19
5, 20
6, 21
7, 22
8, 23
9, 24
10, 25
11, 26
12, 27
13, 28
14, 29
15, 30
31
32
33
34
35
‘635
1
2
3
2
1
1
5
6
7
8
9
10
11
11
11
12
13
14
14
15
The following table maps the claims as rejected:
Claims 1, 8-9, 12-14, 16, 23-24, 27-29, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 13-14, and 15 of U.S. Patent No. 11,253,259 B2 (hereinafter known as the ‘259 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘635 patent anticipate the claims of the present disclosure.
The following table maps the claims as rejected:
Claims
Present
1, 16
8, 23
9, 24
12, 27
13, 28
14, 29
31
32
‘259
1, 11
1
1
13
14
14
15
15
Claims 1, 6, 8, 12, 16, 21, 23, 27, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 17, and 19 of U.S. Patent No. 12,336,711 B2 (hereinafter known as the ‘711 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘635 patent anticipate the claims of the present disclosure.
The following table maps the claims as rejected:
Claims
Present
1, 16
6, 21
8, 23
12, 27
31
32
‘711
1, 7
1, 7
1
1, 7
17, 19
17
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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