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 .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 30 July 2026 wherein Claims 1, 2, 4, and 11 – 15 are amended, no claims are newly added, no claims are cancelled. Therefore Claims 1 – 20 are currently pending.
The Applicant’s amendment to the Specification dated 30 July 2026 has overcome each Specification Objection set forth in the Non-Final Rejection dated 30 April 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Drawings dated 30 July 2026 has overcome each Drawing Objection set forth in the Non-Final Rejection. Therefore, each Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 30 July 2026 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 30 July 2026 has overcome each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 3 – 6, filed 30 July 2026, with respect to the rejection(s) of independent claim(s) 1 and its respective dependent claims under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shelso et al. (US 2005/0187536 A1) and Griffin et al. (US 6,652,508 B2).
The Applicant’s argument regarding Griffin et al. focuses on substituting the metallic hypotube 20 of Griffin et al. for the inner tube 112 of Shelso et al. The Examiner notes that the 35 U.S.C. § 103 rejection below does not substitute the metallic hypotube 20 of Griffin et al. for the inner tube 112 of Shelso et al. Rather, the material of the inner tube 112 of Griffin et al. is modified in view of the teaching of Shelso et al. 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 manner of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); MPEP 2144.07.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites:
A surgical introducer comprising:
an introducer shaft having a longitudinally extending rigid portion having a distal end, the rigid portion defining a lumen;
a metal tube disposed within the rigid portion and extending longitudinally through the rigid portion to a metal tube distal end, wherein the metal tube distal end defines the rigid portion distal end:
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,
wherein the second polymer is longitudinally abutted against and extends distally from the metal tube 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 fluid communication with the lumen.
Claim 1 is objected to because the claim conflicts with the disclosure of the Application. As currently claimed, the introducer shaft has a longitudinally extending rigid portion. The claim then recites that the surgical introducer comprises a flexible tip portion. However, the flexible tip portion is not claimed to be a portion of the introducer shaft. Additionally, the rigid portion is claimed as being a separate part from the metal tube. The Specification and Drawings of the current Application conflict with the current claim language. The Specification discloses that the introducer shaft comprises a rigid portion and a flexible tip portion; wherein the rigid portion comprises a metal tube. See paragraphs [0005], [0084], and [0147] of the Specification. The Examiner suggests reviewing Claim 1 and amending the claim to better reflect the current disclosure to prevent future vagueness and ambiguity.
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.
Claims 1 – 20 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 1 recites “a metal tube disposed within the rigid portion and extending longitudinally through the rigid portion to a metal tube distal end, wherein the metal tube distal end defines the tube portion distal end.” Claim 1 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 the claim scope of the phrase “disposed within the rigid portion” is unclear. Claim 1 recites:
A surgical introducer comprising:
an introducer shaft having a longitudinally extending rigid portion having a distal end, the rigid portion defining a lumen;
a metal tube disposed within the rigid portion and extending longitudinally through the rigid portion to a metal tube distal end, wherein the metal tube distal end defines the rigid portion distal end:
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,
wherein the second polymer is longitudinally abutted against and extends distally from the metal tube 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 fluid communication with the lumen.
Does “a metal tube disposed within the rigid portion” mean that the metal tube must be inside another physical structure? Alternatively, does “a metal tube disposed within the rigid portion” mean that the metal tube is a constituent part of the rigid portion wherein the rigid portion does not convey any further physical structure? The Applicant alleges that the “rigid portion” and “metal tube” are separate physical structures. See page 4 of the Applicant’s Remarks dated 30 July 2026. The Examiner respectfully disagrees with this claim interpretation. The Examiner believes that the metal tube is a constituent part or the entirety of the rigid portion rather than a separate, physical structure.
The Specification and Drawings of the Application support the Examiner’s interpretation. Figures 31 – 34A and 35 of the Drawings and their related Specification paragraphs disclose the metal tube 146 to be a constituent part or the entirety of the rigid portion 141. The Drawing figures and Specification paragraphs do not disclose that the rigid portion is itself a separate, physical structure. Furthermore, dependent Claim 10 further supports that the rigid portion comprises the metal tube. Since the claim scope of the phrase “a metal tube disposed within the rigid portion” cannot be determined, Claim 1 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.
Claims 2 – 20 are dependent upon Claim 1 and are rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 1 recites “a longitudinally extending rigid portion having a distal end…a metal tube distal end, wherein the metal tube distal end defines the rigid portion distal end; a flexible tip portion coupled to the distal end.” Claim 1 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 the claim recites the same structure using different language (i.e., distal end, rigid portion distal end). Is the tip portion coupled to the distal end of the rigid portion or the metal tube? Are these separate parts or the same part?
Claims 2 – 20 are dependent upon Claim 1 and are rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 10 recites “wherein the rigid portion is steel.” Claim 10 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 it cannot be determined if this claim limitation is limiting the rigid portion or the metal tube?
Claim 13 recites “the distal end.” It is unclear if this distal end is referring to the distal end of the metal tube or rigid portion. Claim 13 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 it cannot be determined if the distal end is referring to the metal tube distal end or the rigid portion distal end.
Claim 14 recites “the second polymer outside layer extends proximally to the proximal end.” 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 dependency on Claim 12. The Examiner believes that “the second polymer outside layer extends proximally to the proximal end” should be amended to recite “the first polymer outside layer extends proximally to the proximal end.”
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) 1 – 5, 8, 10 – 14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso et al. (US 2005/0187536 A1) (hereinafter referred to as “Shelso”) and Griffin et al. (US 6,652,508 B2) (hereinafter referred to as “Griffin”).
Shelso and Griffin are cited in the Notice of References Cited form dated 30 April 2026.
With regard to claim 1, Shelso discloses (see Figures 1 – 2) a surgical introducer (100) (see [0017]) comprising:
an introducer shaft (see at 100 in Figure 1) having a longitudinally extending rigid portion (see along 112 in Figure 2) having a distal end (see Examiner annotated Figure 2 below; hereinafter referred to as Fig. A below), the rigid portion defining a lumen (116) (see [0018]);
a tube (112) (see [0018]) disposed within the rigid portion and extending longitudinally through the rigid portion to a tube distal end (see at the annotated “Distal end” in Figure A below), wherein the tube distal end defines the rigid portion distal end (see Figure A below);
a flexible tip portion (106) (see[ 0017]) coupled to the distal end (see Figure 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 tube 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 fluid communication with the lumen.
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However, Shelso is silent with regard to the tube being metal.
Nonetheless Griffin, which is within the analogous art of catheters (see abstract and title), teaches the tube (20) is metal (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 tube of the surgical introducer of Shelso in view of a teaching of Griffin such that the tube is comprised of metal. 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 tube of the surgical introducer such that the tube 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.
The surgical introducer of Shelso modified in view of a teaching of Griffin will hereinafter be referred to as the surgical introducer of Shelso and Griffin.
With regard to claim 2, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, and Shelso further teaches wherein the distal opening is forward facing (see Fig. B above).
With regard to claim 3, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, and Shelso further teaches the surgical introducer (100) (see [0017]) further comprising 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 (see along 112 in Figure 2).
With regard to claim 4, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, however Shelso is silent with regards to the surgical introducer further comprising an inside layer of polymer on a 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 a 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 and Griffin in view of a further teaching of Griffin such that an inside layer of polymer on a 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 regard to claim 5, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, and Shelso further teaches 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 regard to claim 8, the surgical introducer of Shelso and Griffin teaches 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 and Griffin in view of a further 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 regard to claim 10, the surgical introducer of Shelso and Griffin teaches 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 and Griffin in view of a further 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 regard to claim 11, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, and Shelso further teaches wherein the second polymer (108) (see [0017] and [0024]) extends proximally from the metal tube distal end (see at the annotated “Distal end” in Fig. A above) on an outside of the rigid portion (see along 112 in Figure 2).
With regard to claim 12, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 11, and Shelso further teaches 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 is silent with regards to the first polymer further 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.”) further 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 and Griffin in view of a further teaching of Griffin such that the first polymer further 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 further 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.
With regard to claim 13, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 11, and Shelso further teaches 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 (see along 112 in Figure 2) 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 metal tube distal end for a distance less than length L2 (see Fig. 2).
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With regard to claim 14, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 12, and the surgical introducer of Shelso and Griffin further teaches wherein the rigid portion (see along 122 in Figure 2 of Shelso) has a proximal end (see left side of Fig. 2 of Shelso) and the second polymer outside layer extends proximally to the proximal end (see the 35 U.S.C. § 112(b) rejection above wherein this limitation is interpreted to be “the first polymer outside layer extends proximally to the proximal end”; see the rejection of claim 12 above where the material of tube 104 was modified to be the same as the material of the rigid annular ring 110).
With regard to claim 18, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, and Shelso further teaches the surgical introducer further comprising 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 above).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelso and Griffin as applied to claim 1 above, in further view of Hibbs et al. (US 4,950,257 A) (hereinafter referred to as “Hibbs”).
Hibbs is cited in the Notice of References Cited form dated 30 April 2026.
With regard to claim 6, the surgical introducer of Shelso and Griffin teaches 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 and Griffin 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 regard to claim 7, the surgical introducer of Shelso and Griffin teaches 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 and Griffin 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 and Griffin as applied to claim 1 above, and in further view of Grace et al. (US 2017/0333132 A1) (hereinafter referred to as “Grace”).
Grace is cited within the Notice of References Cited form dated 30 April 2026.
With regard to claim 9, the surgical introducer of Shelso and Griffin teaches 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 and Griffin 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 and Griffin as applied to Claim 1 above, and in further view of Watanabe et al. (US 2015/0273182 A1) (hereinafter referred to as “Watanabe”).
Watanabe is cited within the Notice of References Cited form dated 30 April 2026.
With regard to claim 15, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 1, however, Shelso is silent with regards to the surgical introducer further comprising the second polymer extending proximally from the metal tube 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 metal tube 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 and Griffin in view of a teaching of Watanabe such that the second polymer extending proximally from the metal tube 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 and Griffin modified in view of a teaching of Watanabe will hereinafter be referred to as the surgical introducer of Shelso, Griffin, and Watanabe.
With regard to claim 16, the surgical introducer of Shelso, Griffin, 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, Griffin, 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 regard to claim 17, the surgical introducer of Shelso, Griffin, 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, Griffin, 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 and Griffin as applied to Claim 18 above, and in further view of Cope et al. (US 5,499,975 A) (hereinafter referred to as “Cope”).
Cope is cited within the Notice of References Cited form dated 30 April 2026.
With regard to claim 19, the surgical introducer of Shelso and Griffin teaches the claimed invention of claim 18, however, Shelso is silent with regards to 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 and Griffin 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 and Griffin modified in view of a teaching of Cope will hereinafter be referred to as the surgical introducer of Shelso, Griffin, and Cope.
With regard to claim 20, the surgical introducer of Shelso, Griffin, and Cope teaches the claimed invention of claim 19, and Shelso further teaches (see Figures 1 – 2) wherein a diameter of the lumen (116) which is defined by the rigid portion (see along 112 in Figure 2) is substantially equal to the diameter of the lumen which is defined by the flexible tip portion (106) (see Figure 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.
Claims 1 – 13 and 15 – 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 13 and 15 – 20 of U.S. Patent No. 11,801,087 B2 (hereinafter referred to as “Patent ’087”) (Patent ’087 is cited in the Notice of References Cited form dated 30 April 2026). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
With regard 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 metal tube disposed within the rigid portion and extending longitudinally through the rigid portion to a metal tube distal end, wherein the metal tube distal end defines the rigid portion distal end (see Col. 26, lines 40 – 43);
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 metal tube 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 fluid communication with the lumen (see Col. 26, lines 43 – 58).
With regard 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 opening is forward facing (see Col. 26, lines 59 – 60).
With regard to claim 3, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 3 of Patent ’087 further recites further comprising an outside layer of a polymer on an outside of the rigid portion (see Col. 26, lines 61 – 62).
With regard to claim 4, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 4 of Patent ’087 further recites further comprising an inside layer of polymer on a portion of an inside of the rigid portion (see Col. 26, lines 63 – 65).
With regard 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 regard 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 regard 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 regard 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 regard 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 regard 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 regard 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 the metal tube distal end on an outside of the rigid portion (see Col. 27, lines 13 – 15).
With regard 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 further 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 regard 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 metal tube distal end for a distance less than length L2 (see Col. 27, lines 23 – 30).
With regard to claim 15, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 15 of Patent ’087 further comprising the second polymer extending proximally from the metal tube 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 regard 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 regard 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 regard to claim 18, Claim 1 of Patent ’087 recites the claimed invention of claim 1, and Claim 18 of Patent ’087 further recites further comprising 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 regard 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 regard 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).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 12 of Patent ’087 in view of Shelso.
With regard to claim 14, Claims 1, 11, and 12 of Patent ’087 recites the claimed invention of claim 12, however, the claims of Patent ’087 is silent with regards to wherein the rigid portion has a proximal end and the second polymer outside layer extends proximally to the proximal end.
Nonetheless Shelso, which is within the analogous art of catheter (see abstract and title), teaches wherein the rigid portion (see along 112 in Figure 2) has a proximal end (see lefthand side in Figure 2) and the second polymer outside layer (104) extends proximally to the proximal end (see Figure 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 recited surgical introducer of the claims of Patent ’087 in view of a teaching of Shelso such that wherein the rigid portion has a proximal end and the second polymer outside layer extends proximally to the proximal end. One of ordinary skill in the art would have been motivated to make this modification because a polymer tubular member being included over a rigid tube provides for flexibility and patient comfort. Furthermore, polymer tubular members are low friction, smooth, and biocompatible for use within a patient’s vasculature.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/14/2026
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