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
Claims 2 and 12 are canceled. Claims 17-20 are withdrawn. Currently, claims 1, 3-11, 13-16 are pending for examination.
Response to Arguments
Applicant’s arguments, see Pre-Appeal Brief Conference Request, filed January 20, 2026, with respect to the rejection(s) of claim(s) 1, 3-11, 13-16 under 35 U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 an alternative interpretation of Siess et al. (US 6,007,478) as discussed during the pre-appeal brief conference, and Gerber (US 2008/0132933).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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(s) 1, 4, 8-9, 11, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933).
Regarding claims 1 and 16, Siess et al. discloses a percutaneous pump system 14, the system comprising: a cannula (fig. 4) having a proximal opening, a proximal section, a first distal section, a second distal section between the first distal section and a distal end of the cannula, a distal opening, and a lumen extending between the distal and proximal openings (see figure below);
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and an impeller (col. 2, line 43) configured to pump blood through the lumen of the cannula when the impeller is disposed in a vasculature of a patient (col. 4, lines 48-50); wherein the proximal section of the cannula has a first flexural modulus that is constant along its length, and the first distal section of the cannula has a second flexural modulus that is constant along its length and which is smaller than the first flexural modulus (“at the proximal end of the cannula body, its composition comprises substantially 100% of the stiffer material while at the distal end, the composition comprises substantially 100% of the more flexible material” col. 5, lines 13-18; the stepped composition of the first distal section includes a portion of the stiffer and a portion of the more flexible material, therefore yielding a smaller second flexural modulus as compared to the first flexural modulus of the 100% of the stiffer material in the proximal section), and the second distal section has a third flexural modulus that is smaller than the first flexural modulus and the second flexural modulus (col; 5, lines 13-18; the third flexural modulus of the 100% of the more flexible material in the second distal section is smaller than the first and second flexural moduli), the cannula further comprising a first transition region joining the proximal section to the first distal section and a second transition region joining the first distal section to the second distal section (see figure above), the first transition region having a variable flexural modulus (the first transition region comprises portions of 100% material 28b and portions of combined materials 28b and 30b, thus a “variable flexural modulus”); wherein the first flexural modulus is configured to increase a buckling resistance of the cannula (“stiff proximal end of the cannula” col. 2, line 40; “stiffer material may consist of any number of materials including but not limited to a polyurethane or resin impregnated fibers” col. 5, lines 18-20; “resistance to radial deformation” col. 5, line 39); and a reinforced coil 29 disposed in the proximal section of the cannula in a proximal outer wall (fig. 2-3; “The presence of the spring imparts significant resistance to radial deformation while the particular alloy employed allows the spring to regain its original shape even after a substantial deformation that it may be subjected to during placement or manipulation of the heart” col. 5, lines 29-34).
Siess et al. does not expressly disclose wherein the proximal section of the cannula includes a proximal inner wall made of a first material different from the proximal outer wall made of a second material, the reinforced coil disposed between the proximal inner wall and the proximal outer wall. Ju et al. teaches a catheter device, analogous in the art for implanting in the body and being exposed to fluids, where a Nylon-12 material inner wall layer 28 (fig. 4) is provided in tubular body 12, because Nylon-12 is “inherently lubricous” and found “not to absorb moisture and, hence, will not change in dimension when immersed in saline, body fluids” (col. 4, lines 26-28). This inner layer 28 is provided throughout the tubular body, including a proximal section (fig. 1), in addition to a reinforced coil 30 embedded in an outer wall layer 32 of a different material (“polymers such as a blend of polyether block amides”) selected to provide a desired flexural modulus (“desired stiffness characteristic” col. 5, lines 15-20), much like Siess et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least the proximal section of the cannula of Siess et al. to include the Nylon-12 inner wall layer 28 as taught by Ju et al. as it is a known material selected based on its suitability for its intended purpose of providing a lubricous surface to assist the insertion of the guide wire disclosed in Siess et al. (col. 5, line 67 to col. 6, line 1; fig. 7-8) and that is more resistant to absorbing moisture when immersed in body fluids (col. 4, lines 26-28).
Siess et al. does not expressly disclose the proximal section of the cannula is provided with a first curve in a first plane, the first distal section of the cannula is provided with a second curve in a second plane different from the first plane. Gerber teaches it is known in the art for a cannula configured for positioning with a patient to comprise a proximal section 72, 78 that is provided with a first curve in a first plane, and a more distal section 70, 76 provided with a second curve in a second plane different from the first plane (fig. 8-9), in the form of an ‘S’ shape (fig. 9), in order to “allow a clinician to more accurately position” the cannula within the patient when the need arises and “to help reduce the likelihood of trauma to surrounding tissue, particularly with respect to an anatomical structure having an irregular shape or a shape that varies between patients” ([0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to provide a first curve in a first plane in the proximal section of the cannula and a second curve in a second plane different from the first plane in the first distal section of the cannula such that the first and second curves form an ‘S’ shape as taught by Gerber as it is a known technique in the art of cannulas implanted within the body, and would allow the clinician to more accurately position the device within the patient and help reduce the likelihood of trauma to surrounding tissue ([0056]).
Regarding claim 4, Siess et al. discloses the distal opening is capable of being inserted into a left ventricle (col. 4, lines 40-55). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that the distal opening of the cannula would also be capable of being inserted into the right ventricle of the heart given the dimensions of the cannula and the similar anatomical structures between the left and right ventricle.
Regarding claim 8, Siess et al. discloses the first distal section comprises a first distal outer wall made of a third material that is different from the second material (“a layered composite of two materials, one relatively stiff 28, the other relatively more flexible 30.” col. 4, lines 62-65), but does not expressly disclose the first distal section of the cannula includes a first distal inner wall made of the first material. However, similarly to what is reasoned for claim 1, Ju et al. teaches a catheter device, analogous in the art for implanting in the body and being exposed to fluids, where a Nylon-12 material inner wall layer 28 (fig. 4) is provided in tubular body 12, because Nylon-12 is “inherently lubricous” and found “not to absorb moisture and, hence, will not change in dimension when immersed in saline, body fluids” (col. 4, lines 26-28). This inner layer 28 is provided throughout the tubular body, including a distal section (fig. 1), in addition to a reinforced coil 30 embedded in an outer wall layer 32 of a different material (“polymers such as a blend of polyether block amides”) selected to provide a desired flexural modulus (“desired stiffness characteristic” col. 5, lines 15-20), much like Siess et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first distal section of the cannula of Siess et al. to include the Nylon-12 inner wall layer 28 as taught by Ju et al. as it is a known material selected based on its suitability for its intended purpose of providing a lubricous surface to assist the insertion of the guide wire disclosed in Siess et al. (col. 5, line 67 to col. 6, line 1; fig. 7-8) and that is more resistant to absorbing moisture when immersed in body fluids (col. 4, lines 26-28).
Regarding claim 9, see the rejection of claim 8, and furthermore, Siess et al. discloses the reinforced coil 30 is disposed between the first distal inner wall and the first distal outer wall (fig. 2-3).
Regarding claim 11, Siess et al. does not expressly disclose wherein a length of the proximal section is between 10%-50% of a length of the cannula. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a section 10%-50% of a length of the cannula to designate as the proximal section, with all the corresponding characteristics, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 15, Siess et al. does not expressly disclose wherein a length of the second distal section is between 10-40% of a length of the cannula. However it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a section 10%-50% of a length of the cannula to designate as the second distal section, with all the corresponding characteristics, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 3, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933) and further in view of Pravongviengkham et al. (US Pat 2015/0141938) and Wilson et al. (US PG Pub 2014/0277405).
Regarding claims 3, 6-7, Siess et al. discloses the use of a guidewire (col. 3, lines 17-19) but does not expressly disclose the guidewire having a fourth flexural modulus along at least a portion of its length, and the second flexural modulus is less than or equal to the fourth flexural modulus. Siess et al. also does not expressly disclose the first flexural modulus is equal to or greater than 23,000 psi, and the second flexural modulus is smaller than 10,000 psi. Pravongviengkham et al. teaches a it is known in the art for cannulas to comprise flexural modulus values for proximal and distal sections where the proximal section of the cannula has a first flexural modulus of greater than 100,000 psi and a distal section 7 of the cannula has a second flexural modulus of 1,500 psi ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to select a first flexural modulus for the proximal section at greater than 100,000 psi and a second flexural modulus for the distal section at 1,500 psi as taught by Pravongviengkham et al. as a matter of routine optimization since it has been held that “where the general working 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). It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Siess et al. cannula to have flexural moduli for the proximal section and the first distal section within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment and doing so would not appear to alter the operation of the device and the results of such a rearrangement would be reasonably predictable. Wilson et al. teaches it is known in the art for guide wires to comprise a sufficiently stiff flexural modulus of approximately 19,900,000 psi in order to resist undesirable bending and/or kinking ([0062]), thus the second flexural modulus of the distal section of the cannula being less than the fourth flexural modulus of the guidewire. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to try using the guidewire as taught by Wilson et al. in order to provide a guiding device for the percutaneous pump system that resists undesirable bending and/or kinking ([0062]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933) and further in view of Corl et al. (US 2014/0187964).
Regarding claim 5, Siess et al. does not expressly disclose the first distal section of the cannula includes a first distal inner wall made of a third material that is different than the first material, and a first distal outer wall made of a fourth material that is different than the second material and the third material. Corl et al. teaches it is known in the art for a cannula to comprise a proximal inner wall comprising a first material ([0039]), a proximal outer wall comprising a second material ([0037]), a distal inner wall comprising a third material ([(0040]), and a distal outer wall comprising a fourth material ([0037]) that is different than the second material and the third material ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to select these materials for the cannula proximal inner, outer and distal inner and outer walls in order to facilitate coupling of additional coatings or couplings between materials ([0037]) and 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. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), and such a modification would not appear to alter the operation of the device and the results of such a modification would be reasonably predictable.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933) and further in view of Aboul-Hosn et al. (US 2006/0063965).
Regarding claim 10, Siess et al. does not expressly disclose at least a portion of the reinforced coil has a variable pitch length. Aboul-Hosn et al. teaches a cannula comprising a reinforced spiraling wire molded into the wall 218 to provide stiffness, where the pitch may be adjusted for the desired stiffness ([0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to include the variable pitch length in the spiraling wire as taught by Aboul-Hosn et al. to provide a variable stiffness in the cannula since such a modification would have involved a mere change in the form or shape of a component and such a rearrangement would be reasonably predictable.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933) and further in view of Aggerholm et al. (US PG Pub 2015/0367098).
Regarding claim 13, Siess et al. does not expressly disclose the second distal section includes a second distal inner wall made of a third material and a second distal outer wall made of a fourth material, wherein a flexural modulus of the fourth material is greater than a flexural modulus of the third material. Aggerholm et al. teaches a cannula comprising an inner wall 28 comprising a third material ([0036]) and an outer wall 30 made of a fourth material ([0042]), the inner wall 28 provided to increase kink resistance by minimizing the material having greater compressibility ([0016]), the flexural modulus of the fourth material being greater than a flexural modulus of the third material ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to include the second distal inner wall of the flexural modulus properties as taught by Aggerholm et al. in order to increase the kink resistance of the cannula ([0016]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US 6,007,478) in view of Ju et al. (US 5,725,513) and Gerber (US 2008/0132933) and further in view of Pravongviengkham et al. (US Pat 2015/0141938) and as evidenced by MatWeb (“Overview of materials for Nylon 12”).
Regarding claim 14, Siess et al. does not expressly disclose wherein the second distal section includes a second distal inner wall made of the first material and a second distal outer wall made of a fourth material, wherein a flexural modulus of the fourth material is greater than a flexural modulus of the first material. As stated above for claim 1, Ju et al. teaches a catheter device, analogous in the art for implanting in the body and being exposed to fluids, where a Nylon-12 material inner wall layer 28 (fig. 4) is provided in tubular body 12, because Nylon-12 is “inherently lubricous” and found “not to absorb moisture and, hence, will not change in dimension when immersed in saline, body fluids” (col. 4, lines 26-28). This inner layer 28 is provided throughout the tubular body, including a distal section (fig. 1), in addition to an outer wall layer 32 of a different material (“polymers such as a blend of polyether block amides”) selected to provide a desired flexural modulus (“desired stiffness characteristic” col. 5, lines 15-20), much like Siess et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least the second distal section of the cannula of Siess et al. to include the Nylon-12 inner wall layer 28 as taught by Ju et al. as it is a known material selected based on its suitability for its intended purpose of providing a lubricous surface to assist the insertion of the guide wire disclosed in Siess et al. (col. 5, line 67 to col. 6, line 1; fig. 7-8) and that is more resistant to absorbing moisture when immersed in body fluids (col. 4, lines 26-28). Regarding the limitation “wherein a flexural modulus of the fourth material is greater than a flexural modulus of the first material”, Pravongviengkham et al. teaches a it is known in the art for distal portions of cannulas to comprise flexural modulus of 15,000 psi ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Siess et al. to select a flexural modulus for the second distal outer wall at 15,000 psi as taught by Pravongviengkham et al. as a matter of routine optimization since it has been held that “where the general working 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). MatWeb states it is known for Nylon-12 to exhibit a flexural modulus of 13.1 ksi (13,100 psi). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the flexural modulus of the second distal outer wall made of a fourth material of a flexural modulus of 15,000 psi would be greater than the flexural modulus of the second distal inner wall of Nylon-12 of a flexural modulus of 13,100 psi given the known material properties of Nylon-12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796