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 .
Specification
The disclosure is objected to because of the following informalities:
[0017] recites “Fig. 6 is an illustration of detail A of Fig. 4.” However no detail A is shown in Figure 4 of the Drawings.
[0066] recites “of marker 17.” The Examiner believes this is the incorrect reference numeral for the marker. Rather the correct reference numeral is “117.”
[0067] recites ‘Fig. 3 illustrates detail C of Fig. 2.” However no detail C is shown in Fig. 3.
[0073] recites “Fig. 6 is an illustration of detail A of Fig. 4.” However no detail A is shown in Figure 4 of the Drawings.
[0074] recites “and position of the distal tip of a elongate puncture device.” The Examiner suggests this to recite “and position of the distal tip of an elongate puncture device” to improve the grammar of the language.
[0078] recites “> 0.04 Nm2 and for a shaft 12 cm a stiffness > .03Nm2.” The Examiner suggests amending these to recite “Nm2” to provide the proper units.
[0087] recites “Figs. 32 to 35.” There is no Figure 32 in the Drawings.
[0088] recites “Figs. 32 to 35.” There is no Figure 32 in the Drawings.
[0089] recites “Figs. 32 to 35.” There is no Figure 32 in the Drawings.
[0094] recites “proximal end 241can be located.” The Examiner suggests adding a space between reference numeral 241 and the word “can.”
[0113] recites “while the tip of the tip of the elongate puncture device” twice. The Examiner believes the words “the tip of” have been inadvertently repeated for each recitation.
Appropriate correction is required.
Drawings
The drawings are objected to because of the following:
Figure 21B contains reference numeral 228 twice. The Examiner believes the left 228 should be amended to be reference numeral 236.
Figure 34B contains reference numeral 203. The Examiner believes this reference numeral is an error and should be amended to recite reference numeral 200. Reference numeral 203 refers to the first polymer outside layer proximal end. While reference numeral 200 refers to the second polymer outside layer proximal end. According to paragraph [0101], Figure 34B is depicting the second polymer outside layer 200 but this is not what is shown in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1 recites “fluide.” The Examiner believes this is a misspelling of the word “fluid.” Appropriate correction is required to fix the spelling of the word.
Claim 4 recites “further comprising an inside layer of polymer on portion of an inside of the rigid portion.” The Examiner suggests amending this to recite “further comprising an inside layer of polymer on a portion of an inside of the rigid portion” to clarify the claim language.
Appropriate correction is required.
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.
Claim(s) 2, 12, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “the distal end opening.” This limitation lacks antecedent basis within the claim language. Therefore, Claim 2 is rejected.
Claim 12 recites “the first polymer extends proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer.” This claim limitation conflicts with the following claim limitation from Claim 1: “the first polymer longitudinally abutted against and extending distally from the second polymer flexible tip segment end to define a flexible tip portion cap.” How can the first polymer extend proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer and longitudinally abut against and extend distally from the second flexible tip segment end to define a flexible tip portion cap? Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because of the aforementioned conflicting claim limitations of Claim 1 and 12.
Claim 14 recites “wherein the rigid portion has a proximal end and the second polymer outside layer extends proximally to the proximal end.” This claim limitation conflicts with the following claim limitation from Claim 13: “wherein the second polymer flexible tip segment has a second polymer flexible tip segment length of length L2 and the second polymer extends proximally from the distal end on the outside of the rigid portion to define a second polymer outside layer which extends longitudinally and proximally from the distal end for a distance less than length L2.” How can the second polymer outside layer extend proximally from the distal end of the rigid portion to the proximal end of the rigid portion and still be less than length L2? Figures 32A – 32B and paragraph [0091] appear to teach the limitation of Claim 13. Figures 34A – 34B and paragraph [0101] appear to teach the limitation of Claim 14 but does not show how the limitation of Claim 13 is possible? Claim 14 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because of the aforementioned conflicting claim limitations of Claim 1 and 14.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 3, 5, 11, 13, 14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelso et al. (US 2005/0187536 A1; hereinafter referred to as “Shelso”).
With regards to claim 1, Shelso discloses (see Figs. 1 – 2) discloses a surgical introducer (100) (see [0017]) comprising:
an introducer shaft (112) (see [0018]) having a longitudinally extending rigid portion (see at 112 in Fig. 2) having a distal end (see Examiner annotated Fig. A below), the rigid portion defining a lumen (116) (see [0018]);
a flexible tip portion (106) (see [0017]) coupled to the distal end (see Fig. 2), the flexible tip portion including a first polymer (110) (see [0018] “Ring 110 is radially relatively non-extensible. ‘Radially non-extensible’ is intended to be broader than completely rigid and is intended to mean relatively non-compliant in the radial direction. Of course, if a ring is completely rigid, it is also radially non-extensible” and [0023] “A ring may also be made from a suitable polymer such as a thermoplastic or resin”) and a second polymer (108) (see [0017] “a generally soft body portion 108” and [0024] “The soft body portion of the several embodiments may be made from any suitably soft and elastic material such as certain polymers.”), the second polymer being more flexible than the first polymer (see [0017] – [0018], [0023], and [0024] which describes the second polymer being more flexible than the first polymer),
wherein the second polymer is longitudinally abutted against and extends distally from the distal end to define a second polymer flexible tip segment (see Examiner annotated Fig. 2 below; hereinafter referred to as Fig. B) having a second polymer flexible tip segment end (see Fig. B below) and the first polymer longitudinally abutted against and extending distally from the second polymer flexible tip segment end to define a flexible tip portion cap (see Fig. B below), the tip portion cap defining a distal opening (see Fig. B below) in fluide communication with the lumen.
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With regards to claim 2, Shelso discloses the claimed invention of claim 1, and Shelso further discloses (see Figs. 1 – 2) wherein the distal end opening is forward facing (see Fig. B above).
With regards to claim 3, Shelso discloses the claimed invention of claim 1, and Shelso further discloses (see Figs. 1 – 2) an outside layer of a polymer (104) (see [0017] “tubular member 104 and distal tip 106 may be integral, or one or both may be formed separately and then attached” and [0024] which describes the types of polymers that the tubular member 104 may be) on an outside of the rigid portion (112) (see [0018] and Fig. 2).
With regards to claim 5, Shelso discloses the claimed invention of claim 1, and Shelso further discloses (see Figs. 1 – 2) wherein the second polymer flexible tip segment (see Fig. B above) has a length of length L2 (see Fig. B above and the length annotated) and the flexible tip portion cap has a length of length L1 (see Fig. B at the annotated flexible tip portion cap), such that the length L2 is greater than the length L1 (see Fig. B which shows L2 being greater than L1).
With regards to claim 11, Shelso discloses the claimed invention of claim 1, and Shelso further discloses (see Figs. 1 – 2) wherein the second polymer (108) (see [0017] and [0024]) extends proximally from on an outside of the rigid portion (112) (see [0018] and Fig. B).
With regards to claim 13, Shelso discloses the claimed invention of claim 11, and Shelso further discloses (see Figs. 1 – 2) wherein the second polymer flexible tip segment has a second polymer flexible tip segment length of length L2 (see Fig. B above and the length annotated) and the second polymer (108) (see [0017] and [0024]) extends proximally from the distal end (see Fig. A above) on the outside of the rigid portion (112) (see [0018]) to define a second polymer outside layer (see Examiner annotated Fig. 2 below; hereinafter referred to as Fig. C) which extends longitudinally and proximally from the distal end for a distance less than length L2 (see Fig. 2).
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With regards to claim 14, Shelso discloses the claimed invention of claim 13, and further discloses (see Figs. 1 – 2) wherein the rigid portion (112) has a proximal end (see Fig. 2) and the second polymer outside layer (104, 108) (see [0017] where the tubular member 104 and the soft body portion are described as being made integral wherein the second polymer outside layer now extends from the annotation in Fig. C through tube 104) extends proximally to the proximal end (see Fig. 2).
With regards to claim 18, Shelso discloses the claimed invention of claim 1, and Shelso further discloses the first polymer (110) (see [0018] “Ring 110 is radially relatively non-extensible. ‘Radially non-extensible’ is intended to be broader than completely rigid and is intended to mean relatively non-compliant in the radial direction. Of course, if a ring is completely rigid, it is also radially non-extensible” and [0023] “A ring may also be made from a suitable polymer such as a thermoplastic or resin”) extending proximally from the flexible tip portion cap (see Fig. B above) to form a first polymer inside layer (see the inner layer of the annotated flexible tip portion cap), the first polymer inside layer defining at least a portion of the lumen (see Fig. B).
Claim Rejections - 35 USC § 103
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) 4, 8, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso and Griffin et al. (US 6,652,508 B2; hereinafter referred to as “Griffin”).
With regards to claim 4, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to an inside layer of polymer on portion of an inside of the rigid portion.
Nonetheless Griffin, which is within the analogous art of catheters (see abstract and title), teaches an inside layer of polymer (32, 34) on portion of an inside of the rigid portion (20) (see Col. 2, lines 28 – 32 and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the surgical introducer of Shelso in view of a teaching of Griffin such that an inside layer of polymer on portion of an inside of the rigid portion. One of ordinary skill in the art would have been motivated to make this modification because including a lubricious polymer reduces friction and facilitates the infusion process (see Col. 2, lines 56 – 67 of Griffin). Devices threaded through the lumen of the introducer would face reduced friction thanks to the lubricious polymer. A lubricious layer also prevents the formation of biofilm within the introducer.
With regards to claim 8, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to wherein the first polymer is HDPE.
Nonetheless Griffin, which is within the analogous art of catheters (see abstract and title), teaches the first polymer is HDPE (see Col. 2, lines 56 – 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the first polymer of the surgical introducer of Shelso in view of a teaching of Griffin such that the first polymer is HDPE. One of ordinary skill in the art would have been motivated to make this modification because HDPE is a lubricious polymer that would prevent the formation of biofilm within the surgical introducer (see Col. 2, lines 56 – 67 of Griffin). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the first polymer of the surgical introducer such that the first polymer is HDPE since it has been held to be within the general skill of a worker 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); MPEP 2144.07.
With regards to claim 10, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to wherein the rigid portion is steel.
Nonetheless Griffin, which is within the analogous art of catheters (see abstract and title), teaches the rigid portion is steel (20) (see Col. 2, lines 28 – 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the rigid portion of the surgical introducer of Shelso in view of a teaching of Griffin such that the rigid portion is steel. One of ordinary skill in the art would have been motivated to make this modification because stainless steel is biocompatible and widely used in implants and surgical devices (see Col. 2, lines 28 – 32 of Griffin). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the rigid portion of the surgical introducer such that the rigid portion is steel since it has been held to be within the general skill of a worker 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); MPEP 2144.07.
With regards to claim 12, Shelso discloses the claimed invention of claim 11, and Shelso further discloses (see Figs. 1 – 2) wherein the second polymer (108) (see [0017] “a generally soft body portion 108” and [0024] “The soft body portion of the several embodiments may be made from any suitably soft and elastic material such as certain polymers.”) defines a second polymer outside layer (see Examiner annotated Fig. 2 below; hereinafter referred to as Fig. D) which has a second polymer outside layer proximal end (see Fig. D below).
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However, Shelso does not discloses that the first polymer extends proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer.
Nonetheless Griffin, which is within the analogous art of catheters (see abstract and title), the first polymer (38) (see Col. 3, lines 55 – 58 “the outer layer 38 may comprise a polymer tube having a continuous durometer, or a series of connected polymer tubes having different durometers.”) extends proximally from the second polymer (see Col. 3, lines 55 – 58 wherein when the outer layer comprises the series of connected polymer tubes the alternate polymer tube would be the second polymer) outside layer proximal end on an outside of the rigid portion (20) (see Fig. 2 and Col. 2, lines 29 – 48) to define a first polymer outside layer (see Col. 3, lines 55 – 58 wherein when the outer layer comprises the series of connected polymer tubes the length of the alternate polymer tube would be the first polymer outside layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the tube 104 of the surgical introducer of Shelso in view of a teaching of Griffin such that the first polymer extends proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer. One of ordinary skill in the art would have been motivated to make this modification because Griffin teaches that the introducer may be a series of connected polymer tubes having different durometers to adjust the flexibility and navigability of the introducer (see Col. 3, lines 55 – 58 of Griffin).
Here modifying the tube 104 to be the same polymer material of the rigid annular ring 110 of Shelso in view of the teaching from Griffin would result in the introducer of Shelso and Griffin to read upon the claim language the first polymer extends proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer. The first polymer, tube 104 comprising the same material as rigid annular ring 110, extends proximally from the second polymer outside layer proximal end, the proximal end of the soft body portion 108, on an outside of the rigid portion, the inner tube 112, to define a first polymer outside layer, the length of the tube 104.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso in view of Hibbs et al. (US 4,950,257 A; hereinafter referred to as “Hibbs”).
With regards to claim 6, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to wherein the flexible tip portion has a length of about 1 to 3 cm.
Nonetheless Hibbs, which is within the analogous art of catheter introducer with flexible tip (see abstract and title)¸teaches the flexible tip portion has a length of about 1 to 3 cm (see Col. 4, line 50 – Col. 5, line 5 “a short tip portion 26 having a length from 0.5 inches (1.2 cm) to 1 inch (2.5 cm)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the length of the flexible tip portion of the surgical introducer of Shelso in view of a teaching of Hibbs such that the flexible tip portion has a length of about 1 to 3 cm. One of ordinary skill in the art would have been motivated to make this modification because Hibbs teaches that this length is closely follow a curvature of a guide wire while preventing snagging, buckling, or splitting of the tip (see Col. 4, line 50 – Col. 5, line 5 of Hibbs).
With regards to claim 7, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to wherein the flexible tip portion has a length of 2 to 3 cm.
Nonetheless Hibbs, which is within the analogous art of catheter introducer with flexible tip (see abstract and title)¸ wherein the flexible tip portion has a length of 2 to 3 cm (see Col. 4, line 50 – Col. 5, line 5 “a short tip portion 26 having a length from 0.5 inches (1.2 cm) to 1 inch (2.5 cm)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the length of the flexible tip portion of the surgical introducer of Shelso in view of a teaching of Hibbs such the flexible tip portion has a length of 2 to 3 cm. One of ordinary skill in the art would have been motivated to make this modification because Hibbs teaches that this length is closely follow a curvature of a guide wire while preventing snagging, buckling, or splitting of the tip (see Col. 4, line 50 – Col. 5, line 5 of Hibbs).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso in view of Grace et al. (US 2017/0333132 A1; hereinafter referred to as “Grace”).
With regards to claim 9, Shelso discloses the claimed invention of claim 1, however Shelso is silent with regards to wherein the second polymer is LDPE.
Nonetheless Grace, which is within the analogous art of catheter sheathes (see abstract and title), teaches the second polymer is LDPE (see [0491]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the second polymer of the surgical introducer of Shelso in view of a teaching of Grace such that the second polymer is LDPE. One of ordinary skill in the art would have been motivated to make this modification because LDPE is a commonly used material within medical devices based on its desirable characteristics of biocompatibility, flexibility, and durability. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the material of the first polymer of the surgical introducer such that the first polymer is HDPE since it has been held to be within the general skill of a worker 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); MPEP 2144.07.
Claim(s) 15 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso in view of Watanabe et al. (US 2015/0273182 A1; hereinafter referred to as “Watanabe”).
With regards to claim 15, Shelso discloses the claimed invention of claim 1, and Shelso further discloses the second polymer extending proximally from the distal end on the inside of the rigid portion to define a second polymer inside layer having a second polymer inside layer proximal end.
Nonetheless Watanabe, which is within the analogous art of catheters (see abstract), teaches the second polymer (50) (see [0016]) extending proximally from the distal end (32) (see [0024]) on the inside of the rigid portion (30) (see [0017]) to define a second polymer inside layer (see at 52b in Fig. 2) having a second polymer inside layer proximal end (see at 50a in Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second polymer of the surgical introducer of Shelso in view of a teaching of Watanabe such that the second polymer extending proximally from the distal end on the inside of the rigid portion to define a second polymer inside layer having a second polymer inside layer proximal end. One of ordinary skill in the art would have been motivated to make this modification because Watanabe teaches that this configuration reduces the risk that the tip itself will break off from the surgical introducer (see [0008], [0025], and [0026] of Watanabe). Here the distal tip 106 of Shelso will be modified such that a portion of the distal tip is inside the inner tube 112. This coupling will reduce the risk that the tip 106 will break off from the inner tube as taught by Watanabe.
The surgical introducer of Shelso modified in view of a teaching of Watanabe will hereinafter be referred to as the surgical introducer of Shelso and Watanabe.
With regards to claim 16, the surgical introducer of Shelso and Watanabe teaches the claimed invention of claim 15, however, Shelso is silent with regards to wherein the rigid portion has a proximal end and the second polymer inside layer proximal end is distal of the rigid portion proximal end.
Nonetheless Watanabe, which is within the analogous art of catheters (see abstract), teaches wherein the rigid portion (30) (see [0017]) has a proximal end (see the proximal most portion of the coil body in Fig. 2) and the second polymer inside layer proximal end (see at 52b in Fig. 2) is distal of the rigid portion proximal end (see Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second polymer inside layer and the rigid portion of the surgical introducer of Shelso and Watanabe in view of a further teaching of Watanabe such that the rigid portion has a proximal end and the second polymer inside layer proximal end is distal of the rigid portion proximal end. One of ordinary skill in the art would have been motivated to make this modification because Watanabe teaches that this configuration reduces the risk that the tip itself will break off from the surgical introducer (see [0008], [0025], and [0026] of Watanabe).
With regards to claim 17, the surgical introducer of Shelso and Watanabe teaches the claimed invention of claim 16, however, Shelso is silent with regards to wherein a diameter of the lumen proximal of the second polymer inside layer is greater than the diameter of the lumen defined by the flexible tip portion
Nonetheless Watanabe, which is within the analogous art of catheters (see abstract), teaches wherein a diameter of the lumen (see at 20, 22 in Fig. 2) proximal of the second polymer inside layer (see at 52b in Fig. 2) is greater than the diameter of the lumen defined by the flexible tip portion (see at 52a) (see [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the diameter of the lumen proximal of the second polymer inside layer of the surgical introducer of Shelso and Watanabe in view of a further teaching of Watanabe such that a diameter of the lumen proximal of the second polymer inside layer is greater than the diameter of the lumen defined by the flexible tip portion. One of ordinary skill in the art would have been motivated to make this modification because Watanabe teaches that this change in diameter allows for a guidewire or another catheter to be inserted therethrough where this diameter change serves as a guide (see [0021] of Watanabe).
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso in view of Cope et al. (US 5,499,975 A; hereinafter referred to as “Cope”).
With regards to claim 19, Shelso discloses the claimed invention of claim 18, however Shelso is silent wherein the rigid portion has a rigid portion proximal end and the first polymer inside layer extends proximally to the rigid portion proximal end.
Nonetheless Cope, which is within the analogous art of sheath assemblies (see abstract and title), teaches the rigid portion (21) has a rigid portion proximal end (see at 23 in Fig. 2) and the first polymer inside layer (33) extends proximally to the rigid portion proximal end (see Figs. 2 – 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the rigid portion and the first polymer inside layer of Shelso in view of a teaching of Cope such that the rigid portion has a rigid portion proximal end and the first polymer inside layer extends proximally to the rigid portion proximal end. One of ordinary skill in the art would have been motivated to make this modification because Cope teaches that extending the first polymer inside layer to the rigid portion proximal end would create a uniform internal diameter which would allow for smooth threading of medical devices through the surgical introducer (see Col. 3, lines 20 – 45 of Cope). Extending the first polymer inside layer to the rigid portion proximal end would hold the rigid portion in place. Furthermore, extending the first polymer inside layer to the rigid portion proximal end allows for the first polymer’s characteristics to be extended along the entirety of the lumen of the surgical introducer.
The surgical introducer of Shelso modified in view of a teaching of Cope will hereinafter be referred to as the surgical introducer of Shelso and Cope.
With regards to claim 20, the surgical introducer of Shelso and Cope teaches the claimed invention of claim 19, and the surgical introducer of Shelso further teaches (see Figs. 1 – 2) wherein a diameter of the lumen (116) which is defined by the rigid portion (112) is substantially equal to the diameter of the lumen which is defined by the flexible tip portion (106) (see Fig. 2).
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.
Claim(s) 1 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 – 20 of U.S. Patent No. 11,801,087 B2 (hereinafter referred to as “Patent ’087”). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
With regards to claim 1, Claim 1 of Patent ’087 recites a surgical introducer (see Col. 26, line 37) comprising:
an introducer shaft having a longitudinally extending rigid portion having a distal end, the rigid portion defining a lumen (see Col. 26, lines 38 – 39 and 54 – 55);
a flexible tip portion coupled to the distal end, the flexible tip portion including a first polymer and a second polymer, the second polymer being more flexible than the first polymer (see Col. 26, lines 38 – 39 and 43 – 46),
wherein the second polymer is longitudinally abutted against and extends distally from the distal end to define a second polymer flexible tip segment having a second polymer flexible tip segment end and the first polymer longitudinally abutted against and extending distally from the second polymer flexible tip segment end to define a flexible tip portion cap, the tip portion cap defining a distal opening in fluide communication with the lumen (see Col. 26, lines 43 – 58).
With regards to claim 2, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 2 of Patent ’087 further recites wherein the distal end opening is forward facing (see Col. 26, lines 59 – 60).
With regards to claim 3, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 3 of Patent ’087 further recites an outside layer of a polymer on an outside of the rigid portion (see Col. 26, lines 61 – 62).
With regards to claim 4, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 4 of Patent ’087 further recites comprising an inside layer of polymer on portion of an inside of the rigid portion (see Col. 26, lines 63 – 65).
With regards to claim 5, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 5 of Patent ’087 further recites wherein the second polymer flexible tip segment has a length of length L2 and the flexible tip portion cap has a length of length L1, such that the length L2 is greater than the length L1 (see Col. 26, line 66 – Col. 27, line 2).
With regards to claim 6, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 6 of Patent ’087 further recites wherein the flexible tip portion has a length of about 1 to 3 cm (see Col. 27, lines 3 – 4).
With regards to claim 7, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 7 of Patent ’087 further recites wherein the flexible tip portion has a length of 2 to 3 cm (see Col. 27, lines 5 – 6).
With regards to claim 8, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 8 of Patent ’087 further recites wherein the first polymer is HDPE (see Col. 27, lines 7 – 8).
With regards to claim 9, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 9 of Patent ’087 further recites wherein the second polymer is LDPE (see Col. 27, lines 9 – 10).
With regards to claim 10, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 10 of Patent ’087 further recites wherein the rigid portion is steel (see Col. 27, lines 11 – 12).
With regards to claim 11, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 11 of Patent ’087 further recites wherein the second polymer extends proximally from on an outside of the rigid portion (see Col. 27, lines 13 – 15).
With regards to claim 12, Claims 1 and 11 of Patent ’087 recites the claimed invention of claim 11, and Claim 12 of Patent ’087 further recites wherein the second polymer defines a second polymer outside layer which has a second polymer outside layer proximal end, and the first polymer extends proximally from the second polymer outside layer proximal end on an outside of the rigid portion to define a first polymer outside layer (see Col. 27, lines 16 – 22).
With regards to claim 13, Claims 1 and 11 of Patent ’087 recites the claimed invention of claim 11, and Claim 13 of Patent ’087 further recites wherein the second polymer flexible tip segment has a second polymer flexible tip segment length of length L2 and the second polymer extends proximally from the distal end on the outside of the rigid portion to define a second polymer outside layer which extends longitudinally and proximally from the distal end for a distance less than length L2 (see Col. 27, lines 23 – 30).
With regards to claim 14, Claims 1, 11, and 13 of Patent ’087 recites the claimed invention of claim 13, and Claim 14 of Patent ’087 further recites wherein the rigid portion has a proximal end and the second polymer outside layer extends proximally to the proximal end (see Col. 28, lines 1 – 4).
With regards to claim 15, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 15 of Patent ’087 further recites the second polymer extending proximally from the distal end on the inside of the rigid portion to define a second polymer inside layer having a second polymer inside layer proximal end (see Col. 28, lines 5 – 9).
With regards to claim 16, Claims 1 and 15 of Patent ’087 recites the claimed invention of claim 15, and Claim 16 of Patent ’087 further recites wherein the rigid portion has a proximal end and the second polymer inside layer proximal end is distal of the rigid portion proximal end (see Col. 28, lines 10 – 13).
With regards to claim 17, Claims 1, 15, and 16 of Patent ’087 recites the claimed invention of claim 16, and Claim 17 of Patent ’087 further recites wherein a diameter of the lumen proximal of the second polymer inside layer is greater than the diameter of the lumen defined by the flexible tip portion (see Col. 28, lines 14 – 17).
With regards to claim 18, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 18 of Patent ’087 further recites the first polymer extending proximally from the flexible tip portion cap to form a first polymer inside layer, the first polymer inside layer defining at least a portion of the lumen (see Col. 28, lines 18 – 21).
With regards to claim 19, Claims 1 and 18 of Patent ’087 recites the claimed invention of claim 18, and Claim 19 of Patent ’087 further recites wherein the rigid portion has a rigid portion proximal end and the first polymer inside layer extends proximally to the rigid portion proximal end (see Col. 27, lines 21 – 24).
With regards to claim 20, Claims 1, 18, and 19 of Patent ’087 recites the claimed invention of claim 19, and Claim 20 of Patent ’087 further recites wherein a diameter of the lumen which is defined by the rigid portion is substantially equal to the diameter of the lumen which is defined by the flexible tip portion (see Col. 28, lines 25 – 28).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 04/28/2026
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