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 .
Detailed Action
This is in response to non-provisional application filed 01/12/2026.
Allowable Subject Matter
Claims 19, 20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 19 recites allowing the distal portion of the dilator to form a loop; rotating the dilator to align the loop to engage with more than one cusp of the aortic valve, wherein the dilator comprises a reinforcement member disposed within a wall of the dilator to improve torqueability of the dilator; advancing the dilator and the sheath together past cusps of the aortic valve into the left ventricle, wherein a distal portion of the sheath and the distal portion of the dilator are disposed within the left ventricle of the heart; and removing the dilator from the sheath.
The office agrees the art of record fail to teach or suggest these features.
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, 2, 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2006/0253102 (Nance et al.)
Regarding claim 1, 21, 22 Landman et al. discloses as shown in Figure 1, a catheter delivery system, comprising: a sheath (sheath tube 46, see paragraph [0022]) comprising a sheath body comprising: a distal end; a proximal end; a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body; and a dilator (ureteral catheter 20, see paragraph [0022]) comprising a dilator body comprising: a distal end: a proximal end; and a loop portion (portion of distal tube portion 28 indicated as A, see paragraph [0023]) disposed proximal to the distal end of the dilator body, wherein the dilator body is co-axially disposable within the sheath lumen, and wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen, wherein the loop portion is capable of traversing an aortic value while engaging more than one cusp of the aortic valve (if manipulated by hand).
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Landman fails to disclose wherein the dilator body comprises a reinforcement member.
Nance et al., from the same field of endeavor teaches a similar catheter delivery system as shown in Figure 2, wherein the dilator body comprises a reinforcement member for the purpose of enhancing radiopacity, the reinforcement member capable of transmitting rotational torque proportionally from the proximal end of the dilator body to the loop portion of the dilator body. See paragraph [0021].
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 dilator disclosed by Landman to include the reinforcement member taught by Nance et al. in order to enhance radiopacity.
Regarding claim 2, Landman in view of Nance is silent regarding the reinforcement member is disposed within a wall of the dilator body.
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 dilator disclosed by Landman in view of Nance et al. such that the reinforcement member is disposed within a wall of the dilator body because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 1, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2014/0343684 (Epstein et al.)
Regarding claims 1, 3 Landman et al. discloses as shown in Figure 1, a catheter delivery system, comprising: a sheath (sheath tube 46, see paragraph [0022]) comprising a sheath body comprising: a distal end; a proximal end; a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body; and a dilator (ureteral catheter 20, see paragraph [0022]) comprising a dilator body comprising: a distal end: a proximal end; and a loop portion (portion of distal tube portion 28 indicated as A, see paragraph [0023]) disposed proximal to the distal end of the dilator body, wherein the dilator body is co-axially disposable within the sheath lumen, and wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen.
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Landman fails to disclose wherein the dilator body comprises a reinforcement member.
Epstein., from the same field of endeavor teaches a similar catheter delivery system as shown in Figure 4, wherein the dilator body comprises a reinforcement member in the form of braid for the purpose reinforcing the dilator. See paragraph [0011].
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 dilator disclosed by Landman to include the reinforcement member in the form of a braid taught by Epstein et al. in order to reinforce the dilator.
Claim(s) 1, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2006/0135981 (Lenker et al.)
Regarding claims 1, 4 Landman et al. discloses as shown in Figure 1, a catheter delivery system, comprising: a sheath (sheath tube 46, see paragraph [0022]) comprising a sheath body comprising: a distal end; a proximal end; a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body; and a dilator (ureteral catheter 20, see paragraph [0022]) comprising a dilator body comprising: a distal end: a proximal end; and a loop portion (portion of distal tube portion 28 indicated as A, see paragraph [0023]) disposed proximal to the distal end of the dilator body, wherein the dilator body is co-axially disposable within the sheath lumen, and wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen.
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Landman fails to disclose wherein the dilator body comprises a reinforcement member.
Lenker., from a related field of endeavor teaches a similar catheter delivery system as shown in Figure 1, wherein the dilator body comprises a reinforcement member in the form of coil for the purpose reinforcing the dilator. See paragraph [0052].
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 dilator disclosed by Landman to include the reinforcement member in the form of a coil taught by Lenker et al. in order to reinforce the dilator.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2006/0253102 (Nance et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2005/0203425 (Langston)
Regarding claim 5, Landman et al. fails disclose wherein dilator body comprises a proximal portion with a first diameter, the loop portion with a second diameter, the first diameter is greater than the second diameter, and a taper portion disposed between the proximal portion and the loop portion that transitions the dilator body from the first diameter to the second diameter.
Langston, from the same field of endeavor teaches a similar catheter system as shown in Figure 2 where the dilator body comprises a proximal portion (outer lumen 26, see paragraph [0016]) with a first diameter, the loop portion (pigtail 44, see paragraph [0019]) with a second diameter, the first diameter is greater than the second diameter, and a taper portion (juncture, see paragraph [00018]) disposed between the proximal portion and the loop portion that transitions the dilator body from the first diameter to the second diameter.
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 catheter delivery system disclosed by Landman by substituting the proximal portion and loop portion disclosed by Landman for the proximal portion, loop portion, and tapered portion taught by Langston such that dilator body comprises a proximal portion with a first diameter, the loop portion with a second diameter, the first diameter is greater than the second diameter, and a taper portion disposed between the proximal portion and the loop portion that transitions the dilator body from the first diameter to the second diameter because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 6, 7 Landman in view of Nance is silent regarding the reinforcement member is disposed within a wall of the dilator body in the proximal portion, wherein the reinforcement member extends from the proximal end of the dilator body toward the taper portion and terminates about 0.5 inches before the taper portion.
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 dilator disclosed by Landman in view of Nance et al. such that the reinforcement member is disposed within a wall of the dilator body in the proximal portion, wherein the reinforcement member extends from the proximal end of the dilator body toward the taper portion and terminates about 0.5 inches before the taper portion, because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2006/0253102 (Nance et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2005/0272975 (McWeeney et al.)
Regarding claim 8, Landman et al. disclose wherein the sheath is steerable. See paragraph [0022].
Landman et al. fails disclose wherein the delivery system further comprises an actuator mechanism proximally attached to the sheath.
McWeeney et al., from a related field of endeavor teaches a similar dilator with a sheath as shown in Figure 2, where sheath is steerable, and wherein the delivery system further comprises an actuator mechanism proximally attached to the sheath. See paragraphs [0087], [0088].
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 catheter delivery system disclosed by Landman et al. to include the actuator mechanism taught by McWeeney et al. proximally attached to the sheath in order to steer the sheath disclosed by Landman et al. remotely.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2006/0253102 (Nance et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2002/0169377 (Khairkhahan et al.)
Regarding claim 9, Landman et al. a proximal section, a tip section, and a mid-section disposed between the proximal section and the tip section. See Figure 1 and paragraph [0022].
Landman et al. fails disclose the proximal section is the stiffest of the three sections, the mid-section is less stiff than the proximal section and more stiff than the tip section, and the tip section is less stiff than the proximal section and the mid-section.
Khairkhahan et al. from a related field of endeavor teaches a similar sheath as shown in Figure 1, where the sheath comprises a proximal section, a tip section, and a mid-section disposed between the proximal section and the tip section, and wherein the proximal section is the stiffest of the three sections, the mid-section is less stiff than the proximal section and more stiff than the tip section, and the tip section is less stiff than the proximal section and the mid-section for the purpose of facilitating manageability and atraumaticity. See paragraph [0075].
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 catheter delivery system disclosed by Landman et al. such that the proximal section is the stiffest of the three sections, the mid-section is less stiff than the proximal section and more stiff than the tip section, and the tip section is less stiff than the proximal section and the mid-section in order to facilitate manageability and atraumaticity.
Regarding claims 10-12, Landman fails to disclose wherein the tip section is between 10 cm and 30 cm, wherein the mid-section is between 10 cm and 30 cm, wherein the proximal section is between 35 cm and 75 cm.
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 catheter delivery system disclosed by Landman et al. such that the tip section is between 10 cm and 30 cm, wherein the mid-section is between 10 cm and 30 cm, wherein the proximal section is between 35 cm and 75 cm as a matter of engineering design choice.
Applicant has not disclosed that specific lengths of the sections provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0029] of the specification. One of ordinary skill in the art, furthermore, would have expected Landman’s sections, and applicant’s invention, to perform equally well with either the lengths taught by Landman or the claimed lengths because both spacing dimensions would perform the same function of providing a length of the sheath equally well considering the relative dimensions disclosed.
Claim(s) 13, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2002/0169377 (Khairkhahan et al.)
Regarding claim 13, Landman fails to disclose a catheter delivery system kit, comprising: a sheath comprising a sheath (sheath tube 46, see paragraph [0022]) body comprising: a sheath lumen extending through the sheath body from a distal end to a proximal end of the sheath body; a first, proximal section comprising a first stiffness; a second section, distal to the first, proximal section comprising a second stiffness; and a third section, distal to the second section comprising a third stiffness, and a first dilator (ureteral catheter 20, see paragraph [0022]) comprising a first dilator body comprising: a loop portion (portion of distal tube portion 28 indicated as A, see paragraph [0023]) disposed proximal to a distal end of the first dilator body, wherein the dilator body is co-axially disposable within the sheath lumen, and wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen.
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Khairkhahan et al. from a related field of endeavor teaches a similar sheath as shown in Figure 1, where the sheath comprises a proximal section, a tip section, and a mid-section disposed between the proximal section and the tip section, and wherein the proximal section is the stiffest of the three sections, the mid-section is less stiff than the proximal section and more stiff than the tip section, and the tip section is less stiff than the proximal section and the mid-section for the purpose of facilitating manageability and atraumaticity. See paragraph [0075].
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 catheter delivery system disclosed by Landman et al. such that the proximal section is the stiffest of the three sections, the mid-section is less stiff than the proximal section and more stiff than the tip section, and the tip section is less stiff than the proximal section and the mid-section in order to facilitate manageability and atraumaticity.
Regarding claim 18, Landman et al. fails to disclose a second dilator comprising: a second dilator body comprising a straight portion disposed proximal to a distal end, wherein the second dilator body is co-axially disposable within the sheath lumen, and wherein the straight portion extends from the distal end of the sheath body when the second dilator body is disposed within the sheath lumen.
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 catheter delivery system to include a second dilator as recited because it would only require a duplication of parts without changing how the device operates. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2002/0169377 (Khairkhahan et al.) as applied to claim 13 above, and further in view of U.S. Patent Publication Number 2014/0343684 (Epstein et al.)
Regarding claims 14, 15 Landman et al. fails to disclose wherein the first dilator comprises a reinforcement member is disposed within a wall of the first dilator body, wherein the reinforcement member is a braid.
Epstein., from the same field of endeavor teaches a similar catheter delivery system as shown in Figure 4, wherein the dilator body comprises a reinforcement member in the form of braid for the purpose reinforcing the dilator. See paragraph [0011].
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 dilator disclosed by Landman to include the reinforcement member in the form of a braid taught by Epstein et al. in within a wall of the first dilator body in order to reinforce the wall of the dilator.
Claim(s) 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0107736 (Landman et al.) in view of U.S. Patent Publication Number 2002/0169377 (Khairkhahan et al.), U.S. Patent Publication Number 2014/0343684 (Epstein et al.) as applied to claim 14 above, and further in view of U.S. Patent Publication Number 2005/0203425 (Langston)
Regarding claim 16, Landman et al. fails to disclose wherein the first dilator body comprises a proximal portion with a first diameter, the loop portion with a second diameter, the first diameter being greater than the second diameter, and a taper portion disposed between the proximal portion and the loop portion that transitions the first dilator body from the first diameter to the second diameter.
Langston, from the same field of endeavor teaches a similar catheter system as shown in Figure 2 where the dilator body comprises a proximal portion (outer lumen 26, see paragraph [0016]) with a first diameter, the loop portion (pigtail 44, see paragraph [0019]) with a second diameter, the first diameter is greater than the second diameter, and a taper portion (juncture, see paragraph [00018]) disposed between the proximal portion and the loop portion that transitions the dilator body from the first diameter to the second diameter.
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 catheter delivery system disclosed by Landman by substituting the proximal portion and loop portion disclosed by Landman for the proximal portion, loop portion, and tapered portion taught by Langston such that dilator body comprises a proximal portion with a first diameter, the loop portion with a second diameter, the first diameter is greater than the second diameter, and a taper portion disposed between the proximal portion and the loop portion that transitions the dilator body from the first diameter to the second diameter because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 17 Landman in view of Nance is silent regarding the reinforcement member is disposed within a wall of the first dilator body in the proximal portion.
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 dilator disclosed by Landman in view of Nance et al. such that the reinforcement member is disposed within a wall of the first dilator body in the proximal portion because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive.
The applicant argues Landman teaches away from further reinforcement. The applicant notes in paragraph [0023] Landman discloses the catheter may have different configurations and that it in paragraph [0033] it discloses the catheter need not meet the same performance requirements with regards to column strength and kink resistances as conventiona’ catheters because portion 82 is protected by a sheath.
In response, the Office respectfully disagrees for several reasons. First, The Federal Circuit's discussion in ICON also makes clear that if the reference does not teach that a combination is undesirable, then it cannot be said to teach away. See In re ICON Health & Fitness, Inc., 496 F.3d 1374,1382 (Fed. Cir. 2007). Landmans disclosure that the catheter may have different configurations and that a portion of the catheter “need not” have the same column strength or kink resistance as conventional catheters is not the same as teaching having a reinforcement is undesirable or having reinforcement.
"Although statements limiting the function or capability of a prior art device require fair consideration, simplicity of the prior art is rarely a characteristic that weighs against obviousness of a more complicated device with added function." In re Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635, 1638 (Fed. Cir. 1998).
In this, including a reinforcement member in the dilator body disclosed by Landman would provide the added function of additional structural support with the sheath.
Second, Landman’s disclosure that portion 82 of the catheter need convention column or kink resistance is not a teach away of incorporating reinforcement anywhere else on the dilator body.
The applicant further argues the secondary references do not cure the deficiencies of Landman. In particular the applicant argues Nance does not cure the deficiencies Landman the reinforcement is focused on increasing radiopaqcity. In response, the Office respectfully disagrees that this means Nance does not cure the deficiencies Landman. The applicant has not disputed that Nance teaches a reinforcement member or the reason the Office gave that it would be obvious to combine with Landman (enhancing radiopacity). Thus, the applicant’s remarks in regards to Nance are unpersuasive in that they do not actually address the grounds of rejection. The stated reason of enhancing radiopacity has nothing to do with Landman’s disclosure relating portion 82. Thus, the applicant cannot rely on it for arguing Landman teaches away from combing with Nance. In the combination Nance the benefit of radiopacity is the suggestion. The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regrading claim 13, the applicant argues Khairkhahan discloses a catheter configuration having specific bends and stiffness profiles tailored to the highly specialized application of facilitating access to the fossa ovalis and the left atrial appendage. One of ordinary skill in the art would not reasonably be motivated to combine the teachings of Khairkhahan with Landman, given the fundamentally distinct objectives, anatomies, and procedures addressed by each reference.
In response, the Office respectfully disagrees. The specific bends and stiffness profiles disclosed by Khairkhahan are in no way described as limited to the embodiments disclosed. Khairkhahan explicitly excludes such a limiting interpretation of the disclosure in paragraph [0094]. The applicant speculates (but does not explain why) the fundamentally distinct objectives, anatomies, and procedures addressed by each reference would not reasonably motivate one of ordinary skill in the art to combine the teachings of Khairkhahan with Landman.
It is the position of the Office that Khairkhahan is from a related field of endeavor and would have "logically [] have commended itself to an inventor's attention in considering" the problem of advancing a sheath through the body, considering it teaches a similar sheath used for the same purpose of directing a instrument through the body. see In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007). It remains the position of the Office that the recognized benefit facilitating manageability and atraumaticity would be present if the delivery system disclosed by Landman were modified by Khairkhahan given the similarity of structure and purpose of the two sheaths.
The structure of the sheaths are similar (tubular) and their functions are the same (advancing a tool through the body). The applicant’s remarks do not address these similarities.
The applicant’s arguments with respect to the rejections of claims 21, 22 have been considered but are not persuasive.
The applicant argues the art of record fails to teach those limitations. In response, the office respectfully disagrees. Claims 21, 22 recite functional limitations. Function follows structure. Since the structural limitations (i.e., an reinforcement member capable of transmitting rotational torque and a loop portion capable of traversing an aortic valve) are met by the reference, then it may be reasonably concluded that the functional limitations are also met.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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