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 .
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.
Regarding claims 1, 19, and 20, the claims recite “a self-expanding stent delivery structure”. It is unclear whether this intends to mean that a) the delivery structure is for delivering a self-expanding stent, or b) the delivery structure is made of a self-expanding stent, therefore rendering the claim indefinite. For examination purposes, it will be presumed that it means it is a delivery structure for delivering a self-expanding stent.
Claims 2-18 are indefinite by virtue of their dependency on indefinite base claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 1-10, 12, 14-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0182475 A1 to Jen et al. (hereinafter “Jen”).
Regarding claim 1, Jen discloses (see abstract; Figs. 1A-9; and [0050]-[0101]) a stent delivery apparatus (see at least [0050]-[0051]) comprising: a plurality of individual strands (at 114, see Figs. 8C-D & [0099]) braided together (see [0099]) to form a self-expanding stent (see [0051]) delivery structure (90) having a proximal end (94) and an opposing distal end (98), the delivery structure forming an elongated primary shape (see Figs. 8A/8C/9) fully capable of being inserted into a catheter (sheath 90 is a tubular elongated member and thus is fully capable of being inserted into another catheter if one desired to do so); and an at least one radiopaque marker (40 and/or 76, see Figs. 5/9 and [0064]-[0065] & [0086]-[0090])) coaxially positioned within and secured to a circumferential inner surface of the delivery structure (see Fig. 9); whereby, the delivery structure has a primary outer diameter that is substantially uniform along an entire length of the delivery structure (see Fig. 9 and [0092]-[0096]).
Jen further discloses (claim 2) wherein the distal end of the delivery structure provides an end cap (outer layer 112 present at distal end 98 of sheath 90 over layer 114) for maintaining the braided arrangement of the strands of the delivery structure (see Fig. 8C and [0098]-[0101]); (claim 3) wherein the end cap is constructed out of an at least one radiopaque material (see [0101]); (claim 4) wherein at least one of the strands of the delivery structure is comprised of an at least one radiopaque material (see [0099]/[0101]); (claim 5) further comprising a plurality of markers (40 + 76, see Fig. 9) coaxially positioned within the delivery structure and longitudinally spaced apart from one another along a length of the delivery structure (see Fig. 9 and [0086]-[0089]) (claim 6) wherein the at least one marker has an outer diameter that is relatively smaller than a primary inner diameter of the delivery structure (see Fig. 9, marker 76 is smaller than inner diameter of sheath 90 by virtue of presence of sleeve member 51); (claim 7) wherein the at least one marker has an outer diameter that approximates a primary inner diameter of the delivery structure (see Fig. 9, marker 40 abuts the inner surface of sheath 90 and thus has an outer diameter approximating the inner diameter of sheath 90); (claim 8) wherein a circumferential outer surface of the at least one marker is permanently secured to the inner surface (80) of the delivery structure (see Fig. 9 and [0087]-[0090]); (claim 9) wherein the at least one marker is substantially tubular in structure (see Fig. 5); (claim 10) wherein the at least one marker has a substantially cylindrical shape (see Fig. 5); (claim 12) further comprising an at least one elongate guide wire coaxially positioned within and extending longitudinally through the at least one marker along with the delivery structure (see Fig. 9 and [0057]/[0060]); (claim 14) further comprising an at least one substantially tubular protective outer barrier (112) circumferentially engaged about an outer surface of the delivery structure, in substantially the same position as the at least one marker, such that the at least one outer barrier, delivery structure, and at least one marker are concentrically positioned (see Figs. 8C-9 and [0098]-[0101]); (claim 15) wherein each of the at least one outer barrier has a barrier length that is greater than or equal to a marker length of the corresponding at least one marker over which said outer barrier is positioned, such that said outer barrier substantially covers said marker (see Figs. 8C-9 and [0098]-[0101]); (claim 16) wherein the at least one outer barrier is permanently secured to the outer surface of the delivery structure (see [0101]); (claim 17) wherein the at least one outer barrier is constructed out of a heat-shrink material (see [0101]); and (claim 18) wherein opposing ends of the at least one outer barrier are tapered (see [0101]).
Regarding claim 20, Jen discloses (see abstract; Figs. 1A-9; and [0050]-[0101]) a stent delivery apparatus (see at least [0050]-[0051]) comprising: a plurality of individual strands (at 114, see Figs. 8C-D & [0099]) braided together (see [0099]) to form a self-expanding stent (see [0051]) delivery structure (90) having a proximal end (94) and an opposing distal end (98), the delivery structure forming an elongated primary shape (see Figs. 8A/8C/9) fully capable of being inserted into a catheter (sheath 90 is a tubular elongated member and thus is fully capable of being inserted into another catheter if one desired to do so); an at least one radiopaque marker (40 and/or 76, see Figs. 5/9 and [0064]-[0065] & [0086]-[0090])) coaxially positioned within and secured to a circumferential inner surface of the delivery structure (see Fig. 9); an at least one substantially tubular protective outer barrier (112) circumferentially engaged about an outer surface of the delivery structure, in substantially the same position as the at least one marker, such that the at least one outer barrier, delivery structure, and at least one marker are concentrically positioned (see Figs. 8C-9 and [0098]-[0101]); whereby, the delivery structure has a primary outer diameter that is substantially uniform along an entire length of the delivery structure (see Fig. 9 and [0092]-[0096]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11, 13, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jens in view of US 2023/0293295 A1 to Neumann et al. (hereinafter “Neumann”).
Jen discloses the invention substantially as claimed as discussed above, however, with respect to claim 11, Jens fails to specifically disclose wherein the least one marker has a substantially coil shape, and with respect to claim 13, wherein the at least one marker is not tubular in structure, but Jens does disclose the marker is a tube (see Figs. 5/9). Neumann discloses, in the same field of endeavor of radiopaque features for delivery devices (see abstract), the known interchangeability of a radiopaque marker to be shaped as either a tube or a coil (where the coil is interpreted as "not tubular in structure" since it is distinguished by Neumann as compared to the tube) (see Figs. 58/61 and [0213]/[0214]/[0227]), where the shape does not change the purpose or function of the marker as being radiopaque to improve visualization (see [0006]). Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a radiopaque marker for visualization which could be shaped either as a tube or as a coil since the change in shape is known in the art to not affect the radiopaqueness of the marker and still predictably allows for visualization.
Regarding claim 19, Jen discloses (see abstract; Figs. 1A-9; and [0050]-[0101]) a stent delivery apparatus (see at least [0050]-[0051]) comprising: a plurality of individual strands (at 114, see Figs. 8C-D & [0099]) braided together (see [0099]) to form a self-expanding stent (see [0051]) delivery structure (90) having a proximal end (94) and an opposing distal end (98), the delivery structure forming an elongated primary shape (see Figs. 8A/8C/9) fully capable of being inserted into a catheter (sheath 90 is a tubular elongated member and thus is fully capable of being inserted into another catheter if one desired to do so); and an at least one radiopaque marker (40 and/or 76, see Figs. 5/9 and [0064]-[0065] & [0086]-[0090])) coaxially positioned within the delivery structure (see Fig. 9); the at least one marker having a circumferential outer surface that is permanently secured to a circumferential inner surface (80) of the delivery structure (see Fig. 9 and [0087]-[0090]) whereby, the delivery structure has a primary outer diameter that is substantially uniform along an entire length of the delivery structure (see Fig. 9 and [0092]-[0096]).
Jen discloses the invention substantially as claimed as discussed above, however, with respect to claim 19, Jens fails to specifically disclose wherein the least one marker has a substantially coil shape, but Jens does disclose the marker is a tube (see Figs. 5/9). Neumann discloses, in the same field of endeavor of radiopaque features for delivery devices (see abstract), the known interchangeability of a radiopaque marker to be shaped as either a tube or a coil (see Figs. 58/61 and [0213]/[0214]/[0227]), where the shape does not change the purpose or function of the marker as being radiopaque to improve visualization (see [0006]). Therefore it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a radiopaque marker for visualization which could be shaped either as a tube or as a coil since the change in shape is known in the art to not affect the radiopaqueness of the marker and still predictably allows for visualization.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing stent delivery devices having radiopaque marker bands.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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