DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (WO 2021/108562; hereinafter Schaer), in view of Dando et al. (US 2020/0337766; hereinafter Dando).
Regarding claim 1, Schaer discloses a cable routing and assemblies for medical device handles. Schaer shows an ultrasound imaging toot (see par. [0006]) configured with rotation (see 1003 in fig. 1A; par. [0048]) and deflection control (see 1001 in fig. 1A; par. [0048]), the tool comprising: a shaft (see fig. 1A and 2) comprising a body defining a housing (see fig. 1A and 2) comprising: a distal portion (see fig. 1A, 2 and 3Ai; par. [0056]); a first middle portion adjacent the distal portion (see fig. 1A, 2 and 3Ai; par. [0056]); a second middle portion adjacent the first middle portion (see fig. 1A, 2 and 3Ai; par. [0056]); a third middle portion adjacent the second middle portion (see fig. 1A, 2 and 3Ai; par. [0056]); and a pair of pull wires disposed in the housing (see 1104 in fig. 1B; par. [0050]), wherein the pair of pull wires comprise a bifurcation point in the third middle portion (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), wherein at least one of the pair of pull wires housing (see 1104 in fig. 1B; par. [0050]), in response to activation of the at least one of the pair of pull wires housing (see 1104 in fig. 1B; par. [0050]), is configured to: cause a first degree of deflection of the distal portion housing (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii), cause a second degree of deflection of the first middle portion (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii), wherein the second degree of deflection is less than the first degree of deflection, and cause a third degree of deflection of the second middle portion (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii, 3Diii), wherein the third degree of deflection is less than the second degree of deflection (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii, 3Diii).
Furthermore, Schaer states that the shaft may be constructed with sections of materials that vary in stiffness along the length with some portion having lower stiffness than other portion and states first middle portion is stiffer than the distal portion (see par. [0076]), but Schaer does not explicitly states wherein the second middle portion is stiffer than the first middle portion, and wherein the third middle portion is stiffer than the second middle portion, and that the third middle portion being stiffer than the distal portion, the first middle portion, and the second middle portion.
Dando discloses a device and accessories for a percutaneous endoscope access device. Dando teaches a shaft with variable stiffness along the shaft (see fig. 2B), and teaches second middle portion is stiffer than first middle portion (see par. [0042], fig. 2B), and wherein the third middle portion is stiffer than the second middle portion (see par. [0042], fig. 2B), and third middle portion is stiffer than the second middle portion, and that the third middle portion being stiffer than the first middle portion (see fig. 2B), and the second middle portion (see fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the second middle portion is stiffer than the first middle portion, and wherein the third middle portion is stiffer than the second middle portion, and third middle portion is stiffer than the second middle portion, and that the third middle portion being stiffer than the first middle portion, and the second middle portion in the invention of Schaer, as taught by Dando, to provide a variable bending stiffness to be able to provide specific bending control at different region of the shaft. The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide that the third middle portion being stiffer than the distal portion, the first middle portion, and the second middle portion.
Regarding claim 2, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows using a material for the shaft with a stiffness of 35D Pebax (see par. [0054]). The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the distal portion comprising a material with the stiffness of 35 D Pebax.
Regarding claim 3, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows using a material for the shaft with a stiffness of 40D Pebax (see par. [0054]). The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the first middle portion comprising a material with the stiffness of 40 Pebax.
Regarding claim 4, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows using a material for the shaft with a stiffness of 55D Pebax (see par. [0054]). The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the second middle portion comprising a material with the stiffness of 55 Pebax.
Regarding claim 5, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows using a material for the shaft with a stiffness of 72D Pebax (see par. [0054]). The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the third middle portion comprising a material with the stiffness of 72D Pebax.
Regarding claim 6, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein the third middle portion begins at a length from a distal end (see fig. 3Ai), but fails to explicitly that the length is 11 cm, however, it would have been obvious design choice and routine to one of ordinary skill in the art to have the length to be 11cm since it has been held that merely optimum length and change of size/length is routine to one of ordinary skill in the art.
Regarding claim 7, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein the third middle portion ends at certain length from the distal end (see fig. 3Ai), but fails to explicitly state that the certain length is 16.7 cm, however, it would have been obvious design choice and routine to one of ordinary skill in the art to have the certain length to be 16.7 since it has been held that merely optimum length and change of size/length is routine to one of ordinary skill in the art.
Regarding claim 8, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein the second middle portion begins at a certain length from the distal end (see fig. 3Ai), but fails to explicitly state that the certain length is 7.5 cm, however, it would have been obvious design choice and routine to one of ordinary skill in the art to have the length to be 7.5 cm since it has been held that merely optimum length and change of size/length is routine to one of ordinary skill in the art.
Regarding claim 9, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein the first middle portion begins at a certain length from the distal end (see fig. 3Ai), but fails to explicitly state that the certain length is 5.5 cm, however, it would have been obvious design choice and routine to one of ordinary skill in the art to have the length to be 5.5 cm since it has been held that merely optimum length and change of size/length is routine to one of ordinary skill in the art.
Regarding claim 10, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows further comprising a fourth middle portion (see fig. 1A, 2 and 3Ai; par. [0056]).
Regarding claim 11, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows a material for the shaft comprises Nylon 12. The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the fourth middle portion comprising Nylon 12.
Regarding claim 12, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows further comprising a proximal portion (see fig. 1A).
Regarding claim 13, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows using a material for the shaft with a stiffness of 72D Pebax (see par. [0054]). The examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide the proximal portion comprising a material with the stiffness of 72D Pebax.
Regarding claim 14, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein both of the pair of pull wires, in response to activation, are configured to: cause the first degree of deflection of the distal portion (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii, 3Diii), cause the second degree of deflection of the first middle portion (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii, 3Diii), and cause the third degree of deflection of the second middle portion (par. [0050]; fig. 3Bi, 3Ci, 3Di, 3Dii, 3Diii).
Regarding claim 15, Schaer and Dando disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer shows wherein the shaft comprises thermoplastic polymer (see par. [0054]).
Regarding claim 16, It is noted that the limitation “wherein the shaft is manufactured using a heat lamination fusing process” is considered as a product by process claim. It is noted that even though product by process limitation is limited by and defined by the process, determination of patentability is based on production itself. The patentability of product does not depend on its method production. Therefor, the shaft taught by Schaer is substantially same as the claimed structure. The examiner notes that Schaer does teach that the shaft is manufactured using a heat lamination fusing process (see par. [0056]).
Regarding claim 17, the claim limitation “wherein activation of the at least one of the pair of pull wires causes a parabolic deflection of the shaft distal to the bifurcation point” is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Schaer and Dando. is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments with respect to prior arts Schaer and Dando, the examiner respectfully disagrees. The examiner notes that combined invention of Schaer and Dando does disclose all the claim limitation set forth, particularly that the third portion being stiffer than the distal portion, the first middle portion, and the second middle portion. As stated above, Schaer states that the shaft may be constructed with sections of materials that vary in stiffness along the length with some portion having lower stiffness than other portion and states first middle portion is stiffer than the distal portion (see par. [0076]). The examiner maintains that prior art Dando does teach the third middle portion being stiffer than the first middle portion (see fig. 2B), and the second middle portion (see fig. 2B). Therefore, the examiner notes that upon modification of prior art Schaer to incorporate the teaching of Dando would provide that the third middle portion is stiffer than the second middle portion, and that the third middle portion being stiffer than the distal portion, the first middle portion, and the second middle portion.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mcguinn et al. (US 2023/0405270) discloses that the distal end is the most flexible compare to rest of the catheter shaft (see par. [0125])
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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