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
In light of Applicant’s amendment, claim(s) 1, 6, 15, 17, and 52 is/are amended and claim(s) 4-5 is/are canceled. Claims 18-51 were previously canceled. Claims 55-56 are added. Claims 1-3, 6-17, 52-56 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 15-17 is/are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments, filed 5/11/2026, with respect to the rejection(s) of claim(s) 1 and 52 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the references do not explicitly disclose the amended limitations “wherein the outer tubular body is configured to deform from a first, straightened configuration wherein the superelastic material is relatively tensioned due to being stretched into a superelastic state into a second, curved configuration wherein the superelastic material is shortened and relatively relaxed” and “wherein the first body deforms from a first configuration wherein the at least one elongate body is in a superelastic state due to being stretched longitudinally into a second configuration wherein the at least one elongate body has contracted longitudinally at least partially out of the superelastic state” in claims 1 and 52 respectively. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lombardo in view of Poncet.
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) 1-3, 6-17 and 52-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardo (US 20190110788 A1) (previously of record) in view of Poncet e al. (US 5254130 A).
Regarding claim 1, Lombardo discloses a suturing needle comprising a needle body (10) having a leading end (14) and a trailing end (12) (Figure 1; Paragraph 0023), the needle body comprising an outer tubular body (28) having a proximal end (proximal end of 28) and a distal end (32) configured to pierce tissue (Figure 3-4; Paragraph 0003; 0025), and at least one elongate inner body (30) disposed within and operably coupled to the outer tubular body (Figure 5-7; Paragraph 0030), wherein the outer tubular body deforms from a first configuration (Figure 1) into a second configuration (Figure 6) in response to the application of force by the at least one elongate inner body on the outer tubular body (Figure 1, 6-7; Paragraph 0007; 0031).
Lombardo fails to explicitly disclose the at least one elongate inner body made of superelastic material and wherein the outer tubular body is configured to deform from a first, straightened configuration wherein the superelastic material is relatively tensioned due to being stretched into a superelastic state into a second, curved configuration wherein the superelastic material is shortened and relatively relaxed.
Further, Poncet teaches bending member (17), serving as an elongate inner body, wherein the distal portion of the bending member (17') comprises a superelastic memory metal alloy that changes its shape from a stressed straight shape to an unstressed curved shape when deployed from the constraining housing (3) (Col 9, line 46-50). Essentially, as a result of the combination, the outer tubular body of Lombardo would be fully capable of being configured to deform from a first, straightened configuration wherein the superelastic material is relatively tensioned due to being stretched into a superelastic state into a second, curved configuration wherein the superelastic material is shortened and relatively relaxed, as the superelastic inner member would be fully capable of deforming from a stretched state to a relaxed state, as Lombardo teaches deforming the outer tubular body based on compressive force from the inner member (Lombardo Paragraph 0030).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo such that the at least one elongate inner body made of superelastic material and the outer tubular body is configured to deform from a first, straightened configuration wherein the superelastic material is relatively tensioned due to being stretched into a superelastic state into a second, curved configuration wherein the superelastic material is shortened and relatively relaxed, as taught by Poncet, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo with the teachings of Poncet by incorporating the at least one elongate inner body made of superelastic material and the outer tubular body is configured to deform from a first, straightened configuration wherein the superelastic material is relatively tensioned due to being stretched into a superelastic state into a second, curved configuration wherein the superelastic material is shortened and relatively relaxed as superelastic materials are useful in that they exhibit pseudoelasticity allowing for high levels of deformation (Poncet Col 4, line 60-66).
Regarding claim 2, Lombardo further discloses wherein the outer tubular body defines at least one opening (40) therethrough when the outer tubular body is in the first configuration that decreases in spatial extent when the outer tubular body deforms from the first configuration into the second configuration (Figure 3-4, 6; Paragraph 0026).
Regarding claim 3, Lombardo further discloses wherein the at least one opening comprises a plurality of openings (40) defined along a length of the outer tubular body (Figure 3-4; Paragraph 0026).
Regarding claim 4, Lombardo further discloses wherein the first configuration is a generally linear configuration (Figure 1; Paragraph 0003).
Regarding claim 5, Lombardo further discloses wherein the second configuration is a curved configuration (Figure 6-7; Paragraph 0003).
Regarding claim 6, Lombardo further discloses wherein the second configuration is an arcuate configuration (Figure 6-7; Paragraph 0030).
Regarding claim 7, Lombardo further discloses wherein the second configuration defines a splined shape (Figure 6-7).
Regarding claim 8, Lombardo further discloses wherein the second configuration defines an out of plane shape (Figure 6-7).
Regarding claim 9, Lombardo further discloses wherein each opening in the plurality of openings is defined along a first lateral side (labeled in Annotated Figure 3) of the outer tubular body (Figure 3; Paragraph 0026).
PNG
media_image1.png
375
549
media_image1.png
Greyscale
Regarding claim 10, Lombardo further discloses wherein no openings are defined along a second lateral side (labeled in Annotated Figure 3) of the outer tubular body opposite the first lateral side of the outer tubular body (Figure 3).
Regarding claim 11, Lombardo further discloses wherein a second lateral side (labeled in Annotated Figure 3) of the outer tubular body opposite the first lateral side of the outer tubular body is defined by a continuous surface free from openings (Annotated Figure 3).
Regarding claim 12, Lombardo further discloses wherein the outer tubular body is not diametrically expandable (Lombardo does not teach diametric expansion, thus the tubular body is not diametrically expandable).
Regarding claim 13, Lombardo further discloses wherein the outer tubular body is not diametrically contractable (Lombardo does not teach diametric contraction, thus the tubular body is not diametrically contractable).
Regarding claim 14, Lombardo further discloses wherein a cross-sectional height of the outer tubular body does not change when the outer tubular body deforms from the first configuration into the second configuration, as Lombardo does not teach any change in the cross-sectional height of the outer tubular body.
Regarding claim 15, Lombardo further discloses wherein the outer tubular body is configured to possess sufficient column strength when in the second configuration to be advanced through tissue to suture the tissue without deformation of the suturing needle (Lombardo does not teach deformation of the needle during insertion, thus the outer tubular body is seen to have sufficient column strength.).
Regarding claim 16, Lombardo further discloses wherein the outer tubular body is generally toroidally shaped when in the second configuration (Figure 6-7) (the outer tubular body is curved, which is seen as “generally toroidally shaped”.).
Regarding claim 17, Lombardo further discloses wherein the outer tubular body is configured to resist deformation when advanced through tissue in the second configuration during a suturing operation (Lombardo does not teach deformation when the tubular body is advanced, thus Lombardo discloses wherein the outer tubular body resists deformation when advanced through tissue.).
Regarding claim 52, Lombardo discloses a suturing needle (10) comprising a needle body (10) having a leading end (14) and a trailing end (12) (Figure 1; Paragraph 0023), the needle body comprising a first body (28) having a proximal end (proximal end of 28) and a distal end (32) configured to pierce tissue (Figure 3-4; Paragraph 0003; 0025), and at least one elongate body (30) operably coupled to the first body (Figure 5-7; Paragraph 0030), wherein the first body deforms from a first configuration (Figure 1) into a second configuration (Figure 6) in response to the application of force by the at least one elongate body on the first body (Figure 1, 6-7; Paragraph 0007; 0031).
Lombardo fails to explicitly disclose the at least one elongate inner body made of superelastic material, wherein the first body deforms from a first configuration wherein the at least one elongate body is in a superelastic state due to being stretched longitudinally into a second configuration wherein the at least one elongate body has contracted longitudinally at least partially out of the superelastic state.
However, Poncet teaches bending member (17), serving as an elongate inner body, wherein the distal portion of the bending member (17') comprises a superelastic memory metal alloy that changes its shape from a stressed straight shape to an unstressed curved shape when deployed from the constraining housing (3) (Col 9, line 46-50). Essentially, as a result of the combination, the first body deforms from a first configuration wherein the at least one elongate body is in a superelastic state due to being stretched longitudinally into a second configuration wherein the at least one elongate body has contracted longitudinally at least partially out of the superelastic stat, as the superelastic first body would be fully capable of deforming from a stretched state to a relaxed state, as Lombardo teaches deforming the outer tubular body based on compressive force from the inner member (Lombardo Paragraph 0030).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo such that the at least one elongate inner body made of superelastic material, wherein the first body deforms from a first configuration wherein the at least one elongate body is in a superelastic state due to being stretched longitudinally into a second configuration wherein the at least one elongate body has contracted longitudinally at least partially out of the superelastic state, as taught by Poncet, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo with the teachings of Poncet by incorporating the at least one elongate inner body made of superelastic material, wherein the first body deforms from a first configuration wherein the at least one elongate body is in a superelastic state due to being stretched longitudinally into a second configuration wherein the at least one elongate body has contracted longitudinally at least partially out of the superelastic state as superelastic materials are useful in that they exhibit pseudoelasticity allowing for high levels of deformation (Poncet Col 4, line 60-66).
Regarding claim 53, Lombardo further discloses wherein the at least one elongate body is disposed parallel to the first body (Figure 2; Paragraph 0025) (Lombardo states “The inner tube 30 is positioned slidably within the outer tube 28”, thus the elongate body is parallel to the first body.).
Regarding claim 54, Lombardo further discloses wherein the least one elongate body is operably coupled to the first body at a plurality of locations along a length of the first body (the elongate body is welded to the first body at 32, as disclosed in Paragraph 0025, then is further coupled to the first body as both the inner tube 30 and outer tube 28 are bent, thus creating points of connection along the length of the first body.) (Figure 2, 6-7; Paragraph 0025).
Claim(s) 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lombardo in view of Poncet and further in view of Meade (US 20180242967 A1).
Regarding claim 55-56, Lombardo discloses a suturing device (10), comprising:
a drive (18+20) to advance the suturing needle along a needle track and through a tissue segment, the drive being configured to engage and disengage from the suturing needle to advance the needle through the tissue segment (Figure 1; Paragraph 0023); and
a needle delivery catheter, comprising:
an elongate main body portion (22) (Figure 1; Paragraph 0023); and
a suturing needle comprising a needle body (28+30) having a leading end (14) and a trailing end (connection between 28 and 22) (Figure 1; Paragraph 0023), the needle body comprising an outer tubular body (28) having a proximal end (proximal end of 28) and a distal end (32) configured to pierce tissue (Figure 3-4; Paragraph 0003; 0025), and at least one elongate inner body (inner surface of 28) disposed within and operably coupled to the outer tubular body (Figure 3-4; Paragraph 0025);
a removable restraining wire (30) disposed within the outer tubular body of the suturing needle (Figure 5-6; Paragraph 0025);
and wherein the first configuration of the outer tubular body is non-arcuate (Figure 6; Paragraph 0031) and wherein the second configuration of the outer tubular body is arcuate (Figure 7; Paragraph 0030).
Lombardo fails to explicitly disclose a housing defining a needle track therein to slidably receive a suturing needle therein; the at least one elongate inner body made of superelastic material; wherein the outer tubular body is configured to deform from a first configuration wherein the at least one elongate inner body is in a tensioned, relatively elongated, superelastic condition into a second, relatively shorter, less superelastic configuration in response to removal of the restraining wire from the outer tubular body of the suturing needle; wherein the needle track is arcuate, wherein the outer tubular body is configured to be received by the arcuate needle track when the outer tubular body is in the second configuration.
However, Poncet teaches bending member (17), serving as an elongate inner body, wherein the distal portion of the bending member (17') comprises a superelastic memory metal alloy that changes its shape from a stressed straight shape to an unstressed curved shape when deployed from the constraining housing (3) (Col 9, line 46-50). Essentially, as a result of the combination, the at least one elongate inner body made of superelastic material; wherein the outer tubular body is configured to deform from a first configuration wherein the at least one elongate inner body is in a tensioned, relatively elongated, superelastic condition into a second, relatively shorter, less superelastic configuration in response to removal of the restraining wire from the outer tubular body of the suturing needle, and Lombardo teaches deforming the outer tubular body based on compressive force from the inner member (Lombardo Paragraph 0030).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo such that the at least one elongate inner body made of superelastic material; wherein the outer tubular body is configured to deform from a first configuration wherein the at least one elongate inner body is in a tensioned, relatively elongated, superelastic condition into a second, relatively shorter, less superelastic configuration in response to removal of the restraining wire from the outer tubular body of the suturing needle, as taught by Poncet, as both references and the claimed invention are directed to surgical instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo with the teachings of Poncet by incorporating the at least one elongate inner body made of superelastic material; wherein the outer tubular body is configured to deform from a first configuration wherein the at least one elongate inner body is in a tensioned, relatively elongated, superelastic condition into a second, relatively shorter, less superelastic configuration in response to removal of the restraining wire from the outer tubular body of the suturing needle as superelastic materials are useful in that they exhibit pseudoelasticity allowing for high levels of deformation (Poncet Col 4, line 60-66).
Further, Meade is directed to a suturing device and teaches a housing (88) defining a needle track (92) therein to slidably receive a suturing needle (120) therein (Figure 2B; Paragraph 0017; 0103); wherein the needle track is arcuate (Figure 2B; Paragraph 0103).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lombardo as modified by Poncet such that a housing defining a needle track therein to slidably receive a suturing needle therein, wherein the needle track is arcuate, as taught by Meade, as both references and the claimed invention are directed to suturing devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lombardo as modified by Poncet with the teachings of Meade by incorporating a housing defining a needle track therein to slidably receive a suturing needle therein, wherein the needle track is arcuate in order to prevent the needle from inadvertently penetrating the patient (Meade Paragraph 0017; 0103).
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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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, DARWIN EREZO can be reached at (571) 272-4695. 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.
/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
Prosecution Insights