DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/6/25 has been entered.
Response to Amendment
Claims 11-14 and 16-30 are pending in the application. Claims 1-10 and 15 have been canceled. Claims 11-14 and 16-30 have been amended.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “self-expanding sheath” (claims 13 and 19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12, 20, and 25-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 has been amended to recite the 3.2Fr. stent device is disposed to conform to arterial diameters in a range from 2.0 to 4.5 mm. The Applicant does not have explicit disclosure of this range. The Applicant discloses: an objective of the instant system to introduce a stent which may conform to different arterial diameters from 1.5 mm to 4 mm (see paragraphs 0112, 0135, 0167, and 0196 of the US Patent Application publication). Appropriate correction is required.
Claim 20 has been similarly amended to recite: “a stent device having a diameter of 2.5 mm to 4.5 mm…” Thus, claim 20 also fails to comply with the written description requirement. Appropriate correction is required.
Claim 25 has also been amended to recite: “the stent device is disposed to conform to arterial diameters ranging from 2.0 mm to 4.5 mm.” Thus, claim 25 also fails to comply with the written description requirement. Appropriate correction is required.
Claim 26 has been amended to recite that the support catheter “comprises a delivery catheter having a length ranging from 40 cm to 120 cm.” The Applicant does not have explicit disclosure of this range. The Applicant only has support for a catheter with a length of 120 cm (see paragraphs 0113-0116, 0200, 0201, and 0203 of the US Patent Application Publication). Appropriate correction is required.
Claim 27 has also been amended to recite “at least one support catheter having a length of between 40 cm and 120 cm). Thus, claim 27 also fails to comply with the written description requirement. Appropriate correction is required.
Claim 27 has also been amended to recite a 4 Fr. sheath. There is no explicit disclosure of a 4 Fr. sheath in the Applicant’s disclosure. The only mention of “4 Fr.” in the Applicant’s disclosure is “a 4 Fr. compatible stent” (see paragraphs 0113-0116 and 0200 of the US Patent Application Publication). There is no disclosure of a 4 Fr. sheath. Only a 7 Fr. sheath is disclosed (see paragraph 0194 of the US Patent Application Publication). Appropriate correction is required.
Claims 28-30 are dependent on claim 27, thus also fail to comply with the written description requirement. Appropriate correction is required.
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 11-14, 16-26, and 28-30 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 11 recites the limitation "the stent" in line 11. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 12-14 and 16-18 are all dependent on claim 11, thus are also rendered indefinite. Appropriate correction is required.
Claim 11 has been amended to recite a platinum to nitinol alloy with a platinum content ranging from 5 percent to less than 10 percent platinum. Claim 14 is dependent on claim 11, and has been amended to recite the stent device comprises a radiopaque alloy including platinum in an amount ranging from 2.5% to 15% relative to the total metal content. Claim 14 recites a broader range (2.5% to 15%) than claim 11 (5% to less than 10%), rendering the claim indefinite. The scope of claim 14 is unclear. Appropriate correction is required
Claim 14 also recites the limitation "the radiopaque 3.2Fr. stent" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 also recites the limitation "the total metal content" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 17 is similar to claim 14. Claim 17 has been amended to recite that the 3.2 French stent device comprises a platinum containing alloy, where platinum is present in an atomic percentage ranging from 2.5% to 15% of the alloy composition. Claim 14 recites a broader range (2.5% to 15%) than claim 11 (5% to less than 10%), rendering the claim indefinite. The scope of claim 17 is unclear. Appropriate correction is required
Claim 17 also recites the limitation "the alloy composition" in line 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 18 also recites the limitation "the at least one support PT guidewire" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 19 recites the limitation "the distal posterior tibial artery" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 20-26 are dependent on claim 19, thus are also rendered indefinite.
Claim 20 has been amended to recite that the stent device comprises “a stent device having a diameter ranging from 2.5 mm to 4.5 mm and a length ranging from 8 mm to 60 mm. Claim 20 is indefinite because claim 19 recites that the stent device is a 3.2Fr. stent device. The conversion of 3.2 French to millimeters is 1.07 mm. It is unclear how a 1.07 mm stent device can have a diameter ranging from 2.5 mm to 4.5 mm as claimed. Appropriate correction is required.
Claim 21 has been amended to recite “utilizing a standard percutaneous transluminal angioplasty (PTA) balloon catheter for vessel dilation prior to stent deployment and utilizing a PTA balloon catheter having a diameter less than the treated vessel diameter after stent deployment.” Claim 21 is indefinite because it is unclear what a “standard percutaneous transluminal angioplasty (PTA) balloon catheter” entails. Appropriate correction is required
Claim 21 recites the limitation "the treated vessel diameter" in line 6. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 24 recites the limitation “the ankle joint” in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 28 recites the limitation "the dorsalis pedis artery" in line 21. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 28 recites the limitation "the distal posterior tibial artery" in line 25. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 28 recites the limitation "the stent position" in line 29. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 28 recites the limitation "the stent" in line 30. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the posterior tibial vein" in line 20. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required
Claim 29 recites the limitation "the ankle and foot region" in line 21. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the plantar arch" in line 23. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the distal posterior tibial artery" in line 25. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the delivery" in line 26. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 has been amended to recite “using an ultrasound imaging system to assist in the delivery of a self-expanding stent.” Claim 29 is indefinite because it is unclear if “a self-expanding stent” is the “4Fr. compatible stent device” recited in claim 27, or a different stent. Appropriate correction is required.
Claim 29 recites the limitation "the stent" in line 28. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the stent’s placement" in line 30. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 29 recites the limitation "the stent" in line 31. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the anterior tibial vein" in line 20. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required
Claim 30 recites the limitation "the ankle and foot " in line 21. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the plantar arch" in line 23. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the distal anterior tibial artery" in line 25. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the delivery" in lines 26-27. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 has been amended to recite “using an ultrasound imaging system to assist in the delivery of a self-expanding stent.” Claim 29 is indefinite because it is unclear if “a self-expanding stent” is the “4Fr. compatible stent device” recited in claim 27, or a different stent. Appropriate correction is required.
Claim 30 recites the limitation "the stent" in line 28. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the stent’s placement" in line 30. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 30 recites the limitation "the stent" in line 31. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 14 and 17 recite broader ranges than claim 11, and thus fail to further limit the subject matter of the claim upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 11-12, 14, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Osbrink et al. (US 2018/0256376 A1) (“Osbrink”) in view of George et al. (US 2005/0209670 A1) (“George”) and Sullivan (US 2018/0071120 A1).
Regarding claims 11 and 12, Osbrink discloses (Figures 1-24) a system capable of treating critical limb ischemia (CLI) comprising: a 7 French sheath (50; paragraph 0044); at least one support catheter (20); at least one support percutaneous transluminal (PT) guidewire (19); and a stent device (31).
Osbrink fails to disclose that the stent device is a 3.2 French stent device comprised of radiopaque material. However, Osbrink discloses that the delivery system enables delivery of the stent to peripheral small diameter blood vessels previously unreachable with larger diameter conventional stent delivery systems (paragraph 0033). In other words, the diameter of the stent is a result effective variable, in that reducing the size of the stent allows an operator to treat peripheral smaller diameter blood vessels. Osbrink fails to explicitly disclose that the 3.2 French stent device is disposed to conform to arterial diameters in a range from 2.0 mm to 4.5 mm. Osbrink fails to disclose that the stent device comprises a platinum to nitinol alloy with a platinum content ranging from 5 percent to less than 10 percent by weight such that the stent is radiopaque throughout.
George teaches that the smallest known balloon-expandable stent delivery systems are in the size range of about 3 to about 4 FR (paragraph 0069). George teaches treating of vessels with diameters in a range of 2.0 mm to 4.5 mm (paragraphs 0053, 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stent device to be a 3.2 French stent device sized to conform to arterial diameters in a range from 2.0 mm to 4.5 mm, as taught by George, because the diameter of the stent is disclosed to be a result effective variable, in that reducing the diameter of the stent allows the stent to treat smaller peripheral blood vessels. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of the success in modifying the diameter of the stent device to be 3.2 French, as it involves only adjusting a dimension of the stent device, and George teaches that stents of this size are known in the art to treat small diameter vessels. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the stent device to be a 3.2 French stent device sized to conform to arterial diameters in a range from 2.0 mm to 4.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Sullivan teaches (Figures 1 and 2) a stent delivery system comprising: a stent device (10) comprised of radiopaque material (18, paragraph 0050) and further comprising a 5% to 50% platinum to nitinol ratio (paragraph 0054) such that the stent is radiopaque throughout.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the 3.2 French stent device taught by Osbrink in view of George to be comprised of a platinum to nitinol alloy with a platinum content ranging from 5 percent to less than 10 percent by weight such that the stent is radiopaque throughout, as taught by Sullivan.
This modification would provide a stent device formed of a material that allows sufficient degree of radiopacity while also ensuring that the super elastic properties of the stent stay true (Sullivan, paragraph 0028). A stent formed of this material is biocompatible, radiopaque, and MRI compatible (Sullivan, paragraph 0030). Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQd 1934 (Fed. Cir. 1990). Additionally, Applicant appears to have placed no criticality on the claimed range. In paragraph 0188 of the US Patent Application Publication, the Applicant discloses “a range of rations of platinum to nitinol may be employed, including rations of 5% to 50%. However, the utilization of 10% Platinum to Nitinol ration represents an optimum compromise between visualization and mechanical performances as every increase in platinum, the wire becomes more visible but the material properties diminish, which makes the stent weaker and less flexible.” A 10% ratio of platinum to nitinol represents an “optimum compromise between visualization and mechanical performances.” This value falls outside of the recited range in claim 11. Thus, the claimed range is not critical.
Regarding claim 14, Osbrink in view of George and Sullivan above teaches the invention substantially as claimed. However, the combined teaching fails to teach that the 3.2Fr. stent device includes platinum in an amount ranging from 2.5% to 15% atomic percent relative to the total metal content.
Sullivan teaches (Figures 1 and 2) a stent delivery system comprising: a stent device (10) comprised of radiopaque material (18, paragraph 0050) and further comprising a 5% to 50% platinum to nitinol ratio (paragraph 0054) such that the stent is radiopaque throughout.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the 3.2 French stent device taught by Osbrink in view of George and Sullivan above to include platinum in an amount ranging from 2.5% to 15% atomic percent relative to the total metal content, as taught by Sullivan. This modification would provide a stent device formed of a material that allows sufficient degree of radiopacity while also ensuring that the super elastic properties of the stent stay true (Sullivan, paragraph 0028). A stent formed of this material is biocompatible, radiopaque, and MRI compatible (Sullivan, paragraph 0030). Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQd 1934 (Fed. Cir. 1990). Additionally, Applicant appears to have placed no criticality on the claimed range. In paragraph 0188 of the US Patent Application Publication, the Applicant discloses “a range of rations of platinum to nitinol may be employed, including rations of 5% to 50%.” Thus the claimed range is not critical
Regarding claim 17, Osbrink in view of George and Sullivan above teaches the invention substantially as claimed. However, the combined teaching fails to teach that the 3.2Fr. stent device comprises platinum present in an atomic percentage ranging from 2.5% to 15% of the alloy composition.
Sullivan teaches (Figures 1 and 2) a stent delivery system comprising: a stent device (10) comprised of radiopaque material (18, paragraph 0050) and further comprising a 5% to 50% platinum to nitinol ratio (paragraph 0054) such that the stent is radiopaque throughout.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the 3.2 French stent device taught by Osbrink in view of George and Sullivan above to comprises platinum present in an atomic percentage ranging from 2.5% to 15% of the alloy composition, as taught by Sullivan. This modification would provide a stent device formed of a material that allows sufficient degree of radiopacity while also ensuring that the super elastic properties of the stent stay true (Sullivan, paragraph 0028). A stent formed of this material is biocompatible, radiopaque, and MRI compatible (Sullivan, paragraph 0030). Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQd 1934 (Fed. Cir. 1990). Additionally, Applicant appears to have placed no criticality on the claimed range. In paragraph 0188 of the US Patent Application Publication, the Applicant discloses “a range of rations of platinum to nitinol may be employed, including rations of 5% to 50%.” Thus, the claimed range is not critical.
Regarding claim 18, the at least one support PT guidewire taught by Osbrink as modified by George and Sullivan is capable of being inserted into a left posterior descending artery and a left posterior tibial artery (Osbrink, paragraph 0044).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Osbrink et al. (US 2018/0256376 A1) (“Osbrink”) in view of George et al. (US 2005/0209670 A1) (“George”) and Sullivan (US 2018/0071120 A1) as applied to claim 11 above, and further in view of Campbell (US 2015/0265816 A1).
Regarding claim 16, Osbrink as modified by George and Sullivan teaches the invention substantially as claimed. The combined teaching teaches a support PT guidewire configured to facilitate navigation through occluded peripheral arteries associated with CLI. However, the combined teaching fails to teach that the support PT guidewire comprises a core wire and a hydrophilic polymer coating.
Campbell teaches (Figure 1) an intravascular catheter (11) and a guidewire (14). Campbell teaches that the guidewire comprises a core wire coated with a hydrophilic material to facilitate movement within the patient’s vasculature system (paragraph 0020).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one support PT guidewire to comprise a core wire and a hydrophilic polymer coating, as taught by Campbell. This modification would provide a guidewire that facilitates movement within the patient’s vasculature system (Campbell, paragraph 0020).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Osbrink et al. (US 2018/0256376 A1) (“Osbrink”) in view of George et al. (US 2005/0209670 A1) (“George”), Sullivan (US 2018/0071120 A1), and Dickinson et al. (US 2015/0374486 A1) (“Dickinson”).
Regarding claim 27, Osbrink discloses (Figures 1-24) a stent delivery system comprising: a 7 French (or less) sheath (50; paragraph 0044); at least one support catheter (20); at least one support percutaneous transluminal (PT) guidewire (19); and a stent device (31).
Osbrink fails to explicitly disclose a 4Fr. sheath. Osbrink fails to disclose the catheter having a length of between 40 cm and 120 cm. Osbrink fails to disclose the stent device comprises a 4Fr. compatible stent device comprising radiopaque material and having a platinum to nitinol ratio ranging from five percent to less than 10%.
However, Osbrink discloses that the delivery system enables delivery of the stent to peripheral small diameter blood vessels previously unreachable with larger diameter conventional stent delivery systems (paragraph 0033). In other words, the diameter of the sheath and the diameter of the stent are result effective variables, in that reducing the size of the sheath and stent allows an operator to treat peripheral smaller diameter blood vessels.
George teaches that the smallest known balloon-expandable stent delivery systems are in the size range of about 3 to about 4 FR (paragraph 0069). George teaches treating of vessels with diameters in a range of 1.5 mm to 3 mm (paragraphs 0053, 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath to be a 4Fr. sheath and the stent device to be a 4 Fr. compatible stent device, as taught by George, because the diameter of the sheath and the diameter of the stent are disclosed to be result effective variables, in that reducing the diameter of the sheath and the diameter of the stent allows treatment of smaller peripheral blood vessels. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of the success in modifying the diameter of the sheath to be 4Fr. and the diameter of the stent device to be 4 Fr. compatible, as it involves only adjusting a dimension of the sheath and the stent device, and George teaches that delivery systems of this size are known in the art to treat small diameter vessels. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath to be a 4Fr. sheath and the stent device to be a 4 French compatible stent device as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Sullivan teaches (Figures 1 and 2) a stent delivery system comprising: a stent device (10) comprising an entirely radiopaque material (18; paragraph 0050) and having a platinum to nitinol ratio ranging from 5% to 50% (paragraph 0058). Sullivan further teaches the platinum additional element's atomic percent is greater than or equal to 2.5 and less than or equal to 15 (paragraph 0028). With these characteristics, the platinum still comprises high radiopacity but does not inhibit the flexibility and elastic qualities of the nitinol (paragraph 0028).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the 4r. French compatible stent device taught by Osbrink in view of George to have a platinum to nitinol ratio ranging from five percent to less than 10%, as taught by Sullivan. This modification would provide a stent device formed of a material that allows sufficient degree of radiopacity while also ensuring that the super elastic properties of the stent stay true (Sullivan, paragraph 0028). A stent formed of this material is biocompatible, radiopaque, and MRI compatible (Sullivan, paragraph 0030).
Further, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally, Applicant appears to have placed no criticality on the claimed range. In paragraph 0188 of the US Patent Application Publication, the Applicant discloses “a range of rations of platinum to nitinol may be employed, including rations of 5% to 50%. However, the utilization of 10% Platinum to Nitinol ration represents an optimum compromise between visualization and mechanical performances as every increase in platinum, the wire becomes more visible but the material properties diminish, which makes the stent weaker and less flexible.” A 10% ratio of platinum to nitinol represents an “optimum compromise between visualization and mechanical performances.” This value falls outside of the recited range in claim 27. Thus, the claimed range is not critical.
Dickinson teaches (Figures 17-20H) a stent delivery system comprising a stent device (200/340); a sheath (paragraphs 0216 and 0223); at least one support catheter having a length of between 40 cm and 120 cm (330; paragraphs 0217, 0246); and at least one support PT guidewire (paragraphs 0216, 0223, 0246).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one support catheter taught by Osbrink in view of George and Sullivan to have a length of between 40 cm and 120 cm, as taught by Dickinson. This modification would provide a system sized for insertion into a lower limb artery using the Seldinger technique and to guide the stent device to a diseased lower limb artery, such as a distal portion of the posterior or anterior tibial artery (Dickinson, paragraph 0223).
Regarding claim 28, Osbrink as modified by George, Sullivan, and Dickinson teaches the stent delivery system of claim 27 as claimed (see rejection of claim 27 above). However, the combined teaching fails to teach the steps recited in claim 28.
Sullivan further teaches (Figures 1-4) performing a below-the-knee revascularization method to gain vascular access to treat CLI (paragraph 0052); obtaining retrograde access via a pedal or plantar arch into a dorsalis pedis artery (Sullivan, paragraph 0035); advancing at least one support PT guidewire retrograde into a parallel artery; deploying the stent device from a lateral access point to a position within the distal posterior tibial artery (Sullivan, paragraph 0060); using an ultrasound imaging system (130) to guide stent delivery (Sullivan, paragraph 0052); delivering and positioning the stent (10) at a target location, wherein the ultrasound imaging system provides real-time visualization of the stent position; (Sullivan, paragraph 0052); and allowing the stent to self-expand (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to perform the steps of claim 28, as further taught by Sullivan. These modifications would provide a method to utilize the stent delivery system taught by Osbrink in view of George, Sullivan, and Dickinson to treat critical limb ischemia for cross ankle stenting (Sullivan, abstract). This would allow for delivery of the stent to wrap around the ankle while using ultrasound for detection and positioning (Sullivan, paragraph 0035).
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Osbrink et al. (US 2018/0256376 A1) (“Osbrink”) in view of George et al. (US 2005/0209670 A1) (“George”), Sullivan (US 2018/0071120 A1), and Dickinson et al. (US 2015/0374486 A1) (“Dickinson”) as applied to claim 27 above, and further in view of Mauch (US 2011/0264128 A1) and Palena et al. (“Critical Limb Ischemia in Association with Charcot Neuroarthropathy: Complex Endovascular Therapy for Limb Salvage”, cited in previous Office Actions).
Regarding claim 29, Osbrink as modified by George, Sullivan, and Dickinson teaches the stent delivery system of claim 27 as claimed (see rejection of claim 27 above). However, the combined teaching fails to teach the steps recited in claim 29.
Sullivan further teaches (Sullivan, Figures 1-4) performing below-the-knee revascularization to gain vascular access for CLI treatment (paragraph 0052); deploying the stent device from a lateral access point to a position within the distal posterior tibial artery (Sullivan, paragraph 0060) using an ultrasound imaging system (130) to assist in the delivery of a self-expanding stent (Sullivan, paragraph 0052); delivering and positioning the stent (10) at a target location, wherein the ultrasound imaging system provides real-time visualization to a surgeon of the stent’s placement (Sullivan, paragraph 0052); and allowing the stent to self-expand (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to perform the steps above, as further taught by Sullivan. These modifications would provide a method to utilize the stent delivery system taught by Osbrink in view of George, Sullivan, and Dickinson to treat critical limb ischemia for cross ankle stenting (Sullivan, abstract). This would allow for delivery of the stent to wrap around the ankle while using ultrasound for detection and positioning (Sullivan, paragraph 0035).
The combined teaching above fails to teach obtaining antegrade access via the posterior tibial vein into the ankle and foot region and advancing the at least one support percutaneous transluminal (PT) guidewire antegrade into the plantar arch.
Mauch teaches that it is known in the art to access the vasculature in the lower limbs via an antegrade access through the tibial veins (paragraph 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method taught by Osbrink, George, Sullivan, and Dickinson to utilize an antegrade access via the posterior tibial vein, as taught by Mauch, in order to access the target location in the lower limb vasculature of the ankle/foot (Mauch, paragraph 0053).
Palena et al. teach (Figures 3A-3C) that it is known in the art to advance a 0.014 inch support PT guidewire antegrade into the plantar arch in procedures to restore patency of all of the tibial and foot arteries (page 260).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Osbrink, George, Sullivan, Dickinson, and Mauch to advance the at least one support PT guidewire antegrade into a planar arch in a pedal-plantar loop technique, as taught by Palena et al. This modification would aid in accessing the complex vasculature of the foot and ankle, to restore patency of the arteries in the ankle/foot (Palena et al., page 60).
Regarding claim 30, Osbrink as modified by George, Sullivan, and Dickinson teaches the stent delivery system of claim 27 as claimed (see rejection of claim 27 above). However, the combined teaching fails to teach the steps recited in claim 30.
Sullivan further teaches (Sullivan, Figures 1-4) performing below-the-knee revascularization to gain vascular access for CLI treatment (paragraph 0052); deploying the stent device from a lateral access point to a position within the distal anterior tibial artery (Sullivan, paragraph 0060); using an ultrasound imaging system (130) to assist in the delivery of a self-expanding stent (Sullivan, paragraph 0052); delivering and positioning the stent (10) at a target location, wherein the ultrasound imaging system provides real-time visualization to a surgeon of the stent’s placement (Sullivan, paragraph 0052); and allowing the stent to self-expand (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to perform the steps above, as further taught by Sullivan. These modifications would provide a method to utilize the stent delivery system taught by Osbrink in view of George, Sullivan, and Dickinson to treat critical limb ischemia for cross ankle stenting (Sullivan, abstract). This would allow for delivery of the stent to wrap around the ankle while using ultrasound for detection and positioning (Sullivan, paragraph 0035).
The combined teaching above fails to teach obtaining antegrade access via the anterior tibial vein into the ankle or foot and advancing at least one support percutaneous transluminal (PT) guidewire antegrade into the plantar arch.
Mauch teaches that it is known in the art to access the vasculature in the lower limbs via an antegrade access through the tibial veins (paragraph 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method taught by Osbrink, George, Sullivan, and Dickinson to obtain antegrade access via the anterior tibial vein into the ankle or foot, as taught by Mauch, in order to access the target location in the lower limb vasculature of the ankle/foot (Mauch, paragraph 0053).
Palena et al. teach (Figures 3A-3C) that it is known in the art to advance a 0.014 inch support PT guidewire antegrade into the plantar arch in procedures to restore patency of all of the tibial and foot arteries (page 260).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Osbrink, George, Sullivan, Dickinson, and Mauch to advance the at least one support PT guidewire antegrade into a planar arch in a pedal-plantar loop technique, as taught by Palena et al. This modification would aid in accessing the complex vasculature of the foot and ankle, to restore patency of the arteries in the ankle/foot (Palena et al., page 60).
Allowable Subject Matter
Claim 19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13 and 20-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 13 has been amended to recite that the 3.2Fr. stent device is configured for insertion into a left popliteal artery, and wherein the system includes a self-expanding sheath deployable in a distal posterior tibial artery. The stent device taught by Osbrink in view of George and Sullivan is capable of being inserted into a left popliteal artery. However, the combined teaching fails to teach or suggest that the system includes a self-expanding sheath deployable in a distal posterior tibial artery.
Claim 19 has been amended to require a method of treating critical limb ischemia (CLI), comprising the steps of:
obtaining entry into a leg below an ankle;
obtaining antegrade access in a left popliteal artery with a 7Fr. sheath;
inserting a support catheter;
inserting a set of PT guidewires into a left posterior descending (LPDA) artery and a left posterior tibial (LPTA) artery;
inserting a 3.2Fr. stent device comprising a platinum to nitinol ratio ranging from 5 percent to less than 10 percent platinum into the left popliteal artery;
deploying a self-expanding sheath in the distal posterior tibial artery;
performing a set of functional tests including dorsal and plantar flexion to verify stent integrity.
A method containing this combination of structural features and steps is not disclosed or suggested in the prior art of record. Claims 20-26 are dependent on claim 19, thus would also be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 10/6/25 have been fully considered but they are not persuasive.
Regarding the rejection of claim 11, the Applicant has argued that the Osbrink reference is a balloon-expandable stent and the George et al. reference teaches that a balloon is not used to deploy a self-expanding stent. The Applicant has argued that the George et al. reference teaches away from Osbrink, and a person of ordinary skill in the art would have no motivation to combine these references. The Examiner respectfully disagrees.
The George et al. reference teaches an invention that is “advantageously employed with self-expanding stents.” However, the George et al. reference also teaches that “the teachings may be adapted for application in the context of balloon-expandable stents” (paragraph 0054). Further, the George et al. reference teaches that the smallest known balloon-expandable stent delivery systems are in the size range of about 3 to about 4 FR (paragraph 0069). Claim 11 recites a 7 French (7Fr.) sheath and a 3.2Fr. stent device. One having ordinary skill in the art would recognize that the teachings of the George et al. reference do not teach away from the Osbrink reference. The Osbrink reference teaches treating peripheral small diameter blood vessels (paragraph 0033). One having ordinary skill in the art would look to the teachings of the George et al. reference, which teaches a delivery system in the size range of about 3 to about 4 Fr. to treat smaller diameter blood vessels.
The rejection also establishes that the size of the stent device is a result-effective variable. The smaller the diameter of the stent, the smaller the diameter vessel that it can treat. Based on this analysis, it would have been obvious to modify the stent device of Osbrink to be a 3.2Fr. stent device as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of the success in modifying the diameter of the stent device to be 3.2 French, as it involves only adjusting a dimension of the stent device, and the George et al. reference teaches that stents of this size are known in the art to treat small diameter vessels.
For these reasons, claim 11 does not distinguish over the prior art of record.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771