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
The amendments filed on 01/22/2026 have been entered. Claims 1-18 remain pending in the application. The amendments overcome the claim objection set forth in the previous office action dated 10/22/2025
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 01/22/2026, with respect to the rejection(s) of claim(s) 1, 9, and 14 under 35 USC 102(a)(1) in view of Plowe 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 Therefore, the rejection has been withdrawn.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 Koblish et al. (US 2004/0049182) and Kmiec (US 2021/0059736).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koblish et al. (US 2004/0049182).
Regarding claim 1, Kolbish et al. discloses a handheld medical device (40, FIG 6A-6B, [0073-0084]), comprising: a cylindrical inner drive shaft (12, FIGs 1A-1B and 6A-6B, [0073] discloses 12 is a shaft made of tubular parts. Cross section FIG 4 shows the cylindrical shape); an elongated, tubular, outer housing (42) encapsulating the inner drive shaft such that the inner drive shaft is positioned within the outer housing (FIG 6A-6B, [0074 and 0083-0084]); an implement (28 and 26, FIG 1C, [0076-0077, 0082]) at a distal end of the outer housing (FIG 6B); wherein the inner drive shaft is bendable (See change in shape between FIG 1B and 5 of 6B, [0080, 0086] disclose 18 being flexible); wherein the outer housing is bendable (FIG 6B shows 42 bending at 44, [0083] discloses 42 can be bent by hand by a surgeon and remain in the bent position); and wherein the inner drive shaft is more bendable than the outer housing ([0080] discloses 18 as being “very flexible” while [0083] discloses 42 as being malleable, which is explained to be more rigid than “somewhat flexible” because it can hold its bent shape. The “very flexible” inner shaft is therefore taught to be more bendable than the “malleable” outer member), and wherein, once bent, the inner drive shaft remains in a bent position and does not bind against the outer housing ([0083] discloses the malleable outer member is a outer member that can be readily bent by the physician to a desired shape, without springing back when released, so that it will remain in that shape during the surgical procedure. Thus, the stiffness of a malleable outer member must be low enough to allow the outer member to be bent, but high enough to resist bending when the forces associated with a surgical procedure are applied to the outer member. This bent position is shown in FIG 6B, wherein the very flexible inner shaft is also in a bent position therein. As best shown in FIG 1C, inner shaft 18 is wrapped by would coil 20, [0112], therefore preventing direct contact/binding between the outer surface of 18 and the inner surface of 42).
Regarding claim 4, Kolbish et al. discloses the inner drive shaft has a lower flexure modulus than a flexure modulus for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower flexure modulus than the outer housing based on this description of flexibilities).
Regarding claim 5, Kolbish et al. discloses the inner drive is more flexible than the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft is more flexible than the outer housing based on this description of flexibilities).
Regarding claim 6, Kolbish et al. discloses the inner drive shaft has a lower modulus of elasticity than a modulus or elasticity for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower modulus of elasticity than the outer housing based on this description of flexibilities).
Regarding claim 7, Kolbish et al. discloses the implement at the distal end of the housing comprising first and second jaws (26 and 28 are articulated relative to one another to grasp and manipulate a tissue, [0079], therefore they are interpreted as first and second jaws).
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.
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) 2, 3, 8-18 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish et al. (US 2004/0049182) in view of Kmiec (US 2021/0059736).
Regarding claims 2, 3, and 8, Kolbish et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Kolbish is silent regarding the inner drive shaft being formed from an annealed material, wherein the inner drive shaft is heated when positioned within the outer housing, and wherein the inner drive shaft is formed from the same material as a material forming the outer housing.
However, Kmiec teaches in the same field of endeavor a handheld medical device (10 and 30, FIG 1-4) having a cylindrical inner drive shaft (30) encapsulated by a tubular outer housing (10, [0021-0025]) where both the inner drive shaft and the outer housing are bendable (portion 16 of shaft 10 is bendable and rod 30 is bendable, [0025]), the inner drive shaft being formed from an annealed material ([0025] disclose the low flex strength inner shaft 30 can be formed from annealed stainless steel), wherein the inner drive shaft is heated when positioned within the outer housing (being formed of an annealed material prior to assembly is understood to comprise heating the inner shaft).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select the material of the inner drive shaft of Kolbish to be an annealed stainless steel, was taught by Kmiec, for the purpose of forming the shaft to have a desired flexibility by using a commonly known technique in the art for altering the flexibility of a material and thereby achieving the predictable result of forming a suitably flexible and biocompatible member of low flex strength. In the device as modified, the inner drive shaft is formed from the same material as a material forming the outer housing because Kolbish teaches the outer housing can be formed of stainless steel ([0083]).
Regarding claims 9 and 10, Kolbish et al. discloses a method of forming handheld medical device (40, FIG 6A-6B, [0073-0084]), comprising: providing a cylindrical inner drive shaft (12, FIGs 1A-1B and 6A-6B, [0073] discloses 12 is a shaft made of tubular parts. Cross section FIG 4 shows the cylindrical shape), an elongated, tubular, outer housing (42) encapsulating the inner drive shaft such that the inner drive shaft is positioned within the outer housing (FIG 6A-6B, [0074 and 0083-0084]), an implement (28, FIG 1C, [0076-0077, 0082]) at a distal end of the outer housing (FIG 6B), wherein the inner drive shaft is bendable (See change in shape between FIG 1B and 5 of 6B, [0080, 0086] disclose 18 being flexible), wherein the outer housing is bendable (FIG 6B shows 42 bending at 44, [0083] discloses 42 can be bent by hand by a surgeon and remain in the bent position); and positioning the inner drive shaft in the outer housing (FIG 6A-6B, [0074 and 0083-0084]).It is understood that in order to form the assembled device, the inner drive is positioned in the outer housing), wherein the inner drive shaft is more bendable than the outer housing (0080] discloses 18 as being “very flexible” while [0083] discloses 42 as being malleable, which is explained to be more rigid than “somewhat flexible” because it can hold its bent shape. The “very flexible” inner shaft is therefore taught to be more bendable than the “malleable” outer member) and wherein, once bent, the inner drive shaft remains in a bent position and does not bind against the outer housing ([0083] discloses the malleable outer member is a outer member that can be readily bent by the physician to a desired shape, without springing back when released, so that it will remain in that shape during the surgical procedure. Thus, the stiffness of a malleable outer member must be low enough to allow the outer member to be bent, but high enough to resist bending when the forces associated with a surgical procedure are applied to the outer member. This bent position is shown in FIG 6B, wherein the very flexible inner shaft is also in a bent position therein. As best shown in FIG 1C, inner shaft 18 is wrapped by would coil 20, [0112], therefore preventing direct contact/binding between the outer surface of 18 and the inner surface of 42).
Kolbish is silent regarding heating the inner drive shaft, wherein heating the inner drive shaft anneals the material forming the inner drive shaft.
However, Kmiec teaches in the same field of endeavor a handheld medical device (10 and 30, FIG 1-4) having a cylindrical inner drive shaft (30) encapsulated by a tubular outer housing (10, [0021-0025]) where both the inner drive shaft and the outer housing are bendable (portion 16 of shaft 10 is bendable and rod 30 is bendable, [0025]), the inner drive shaft being heated forming an annealed inner drive shaft ([0025] disclose the low flex strength inner shaft 30 can be formed from annealed stainless steel), wherein the inner drive shaft is heated (being formed of an annealed material prior to assembly is understood to comprise heating the inner shaft).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select the material of the inner drive shaft of Kolbish to be an annealed stainless steel, was taught by Kmiec, for the purpose of forming the shaft to have a desired flexibility by using a commonly known technique in the art for altering the flexibility of a material and thereby achieving the predictable result of forming a suitably flexible and biocompatible member of low flex strength.
Regarding claim 11, Kolbish et al./Kmiec discloses the invention substantially as claimed, as set forth above for claim 9. Kolbish et al. further discloses the inner drive shaft has a lower flexure modulus than a flexure modulus for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower flexure modulus than the outer housing based on this description of flexibilities).
Regarding claim 12, Kolbish et al./Kmiec discloses the invention substantially as claimed, as set forth above for claim 9. Kolbish et al. further discloses the inner drive is more flexible than the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft is more flexible than the outer housing based on this description of flexibilities).
Regarding claim 13, Kolbish et al./Kmiec discloses the invention substantially as claimed, as set forth above for claim 9. Kolbish et al. further discloses the inner drive shaft has a lower modulus of elasticity than a modulus or elasticity for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower modulus of elasticity than the outer housing based on this description of flexibilities).
Regarding claims 14-15 and 18, Kolbish et al. discloses a handheld medical device (40, FIG 6A-6B, [0073-0084]), comprising: a cylindrical inner drive shaft (12, FIGs 1A-1B and 6A-6B, [0073] discloses 12 is a shaft made of tubular parts. Cross section FIG 4 shows the cylindrical shape); an elongated, tubular, outer housing (42) encapsulating the inner drive shaft such that the inner drive shaft is positioned within the outer housing (FIG 6A-6B, [0074 and 0083-0084]); an implement (28, FIG 1C, [0076-0077, 0082]) at a distal end of the outer housing (FIG 6B); wherein the inner drive shaft is bendable (See change in shape between FIG 1B and 5 of 6B, [0080, 0086] disclose 18 being flexible); wherein the outer housing is bendable (FIG 6B shows 42 bending at 44, [0083] discloses 42 can be bent by hand by a surgeon and remain in the bent position); and wherein the inner drive shaft is more flexible than the outer housing ([0080] discloses 18 as being “very flexible” while [0083] discloses 42 as being malleable, which is explained to be more rigid than “somewhat flexible” because it can hold its bent shape. The “very flexible” inner shaft is therefore taught to be more flexible than the “malleable” outer member), and wherein, once bent, the inner drive shaft remains in a bent position and does not bind against the outer housing ([0083] discloses the malleable outer member is a outer member that can be readily bent by the physician to a desired shape, without springing back when released, so that it will remain in that shape during the surgical procedure. Thus, the stiffness of a malleable outer member must be low enough to allow the outer member to be bent, but high enough to resist bending when the forces associated with a surgical procedure are applied to the outer member. This bent position is shown in FIG 6B, wherein the very flexible inner shaft is also in a bent position therein. As best shown in FIG 1C, inner shaft 18 is wrapped by would coil 20, [0112], therefore preventing direct contact/binding between the outer surface of 18 and the inner surface of 42).
Kolbish is silent regarding the inner drive shaft being heated forming an annealed inner drive shaft and wherein the inner drive shaft has been heated when positioned within the outer housing, and wherein the inner drive shaft is formed from the same material as a material forming the outer housing.
However, Kmiec teaches in the same field of endeavor a handheld medical device (10 and 30, FIG 1-4) having a cylindrical inner drive shaft (30) encapsulated by a tubular outer housing (10, [0021-0025]) where both the inner drive shaft and the outer housing are bendable (portion 16 of shaft 10 is bendable and rod 30 is bendable, [0025]), the inner drive shaft being heated forming an annealed inner drive shaft ([0025] disclose the low flex strength inner shaft 30 can be formed from annealed stainless steel), wherein the inner drive shaft is heated when positioned within the outer housing (being formed of an annealed material prior to assembly is understood to comprise heating the inner shaft).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select the material of the inner drive shaft of Kolbish to be an annealed stainless steel, was taught by Kmiec, for the purpose of forming the shaft to have a desired flexibility by using a commonly known technique in the art for altering the flexibility of a material and thereby achieving the predictable result of forming a suitably flexible and biocompatible member of low flex strength. In the device as modified, the inner drive shaft is formed from the same material as a material forming the outer housing because Kolbish teaches the outer housing can be formed of stainless steel ([0083]).
Regarding claim 16, Kolbish et al./Kmiec discloses the invention substantially as claimed, as set forth above for claim 14. Kolbish et al. further discloses the inner drive shaft has a lower flexure modulus than a flexure modulus for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower flexure modulus than the outer housing based on this description of flexibilities).
Regarding claim 17, Kolbish et al./Kmiec discloses the invention substantially as claimed, as set forth above for claim 14. Kolbish et al. further discloses the inner drive shaft has a lower modulus of elasticity than a modulus or elasticity for the outer housing ([0073 and 0080] disclose the ‘very flexible” properties of 18 while 42 is described as “relatively stiff” such as malleable. It is understood that the inner drive shaft has a lower modulus of elasticity than the outer housing based on this description of flexibilities).
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 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771