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 Arguments
Regarding claims 7 and its dependents, it is noted that the foil is not part of the claimed invention as confirmed by Applicant in Remarks filed on 06/12/2026.
Applicant’s arguments with respect to claim(s) 1 - 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim(s) 24 - 28 have been considered but are moot because the new ground of rejection does not rely on any current interpretation of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the retractor head portion is newly defined based upon the most recent claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 - 18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites “the retractor head includes a first blade”. It is unclear if the first blade is the same or different than the blade-shaped member of claim 1. For purposes of examination, they are assumed to be the same.
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 – 13, 19, 20 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baril et al. (US 2022/0096071 A1).
Regarding claim 1, Baril discloses a surgical retractor (Abstract), comprising:
a handle (Fig. 1, refs. 10, 20) having a distal end portion (ref. 20) defining a distal end axis (Fig. 2); and
a retractor head (Fig. 2, ref. 310) including a blade-shaped member (ref. 310) defining a retractor surface portion (considered to be the surface area of ref. 310) on the distal end portion of the handle (Fig. 2), wherein the retractor surface portion includes a fixed perimeter (component ref. 310 does not retract or expand and is therefore considered to have a fixed perimeter), is configured to engage tissue of a patient (Abstract), and forms an acute angle that is substantially less than 900 with respect to the distal end axis (because the retractor surface portion is able to articulate relative to the axis via pin ref. 70a, it is fully capable of forming an angle less than 90 degrees, see remarked Fig. 11 below for one example of an angle).
PNG
media_image1.png
479
874
media_image1.png
Greyscale
Regarding claim 2, Baril discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 300 with respect to the distal end axis (as explained above, the retractor surface portion can form an angle from 0 degrees to over 90 degrees, thus if fully capable of an angle of 30 degrees).
Regarding claim 3, Baril discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 150 with respect to the distal end axis (the retractor surface portion is fully capable of forming such an angle as explained above).
Regarding claim 4, Baril discloses the surgical retractor of claim 1, wherein the retractor surface portion forms an angle that is less than 5° with respect to the distal end axis (the retractor surface portion is fully capable of forming such an angle as explained above).
Regarding claim 5, Baril discloses the surgical retractor of claim 1, wherein the retractor surface portion is parallel to the distal end axis (Fig. 7 shows such a configuration).
Regarding claim 6, Baril discloses the surgical retractor of claim 1, wherein the retractor surface portion is configured at an angle sufficiently close to parallel with respect to the distal end axis to facilitate insertion of the distal end portion of the handle into a heart chamber of a patient, optionally a left atrium or right atrium of the patient, from a side of the patient in a medial direction aligned with the distal end axis of the handle (this is considered an intended use limitation in which the retractor surface portion is fully capable of a plurality of different angles, such as parallel as shown in Fig. 7, to be inserted in such a manner).
Regarding claim 7, Baril discloses the surgical retractor of claim 1, further comprising an attachment structure on the distal end portion of the handle configured to releasably attach a foil to the retractor head (the attachment structure is considered to comprise the slots, pins and shelves as shown in Fig. 3, refs. 252, 70a, 80a), wherein the attachment structure is configured such that a surface portion of the foil, when attached to the retractor head by the attachment structure, forms an acute angle that is substantially less than 900 with respect to the distal end axis (the foil is not part of the claimed invention, however any of refs. 310 other than the retractor surface portion may be considered the foil which are fully capable of a plurality of different angles relative to the distal end axis when engaged with the attachment structure).
Regarding claim 8, Baril discloses the surgical retractor of claim 7, wherein the attachment structure is configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 30° with respect to the distal end axis (the foil is not part of the claimed invention, thus this limitation is treated as an intended use limitation in which the components are fully capable of functioning in such a manner as described above).
Regarding claim 9, Baril discloses the surgical retractor of claim 7, the attachment structure is configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 15° with respect to the distal end axis (the foil is not part of the claimed invention, thus this limitation is treated as an intended use limitation in which the components are fully capable of functioning in such a manner as described above).
Regarding claim 10, Baril discloses the surgical retractor of claim 7, wherein the attachment structure is configured such that a surface portion of the foil, when attached to the retractor head, forms an angle that is less than 5° with respect to the distal end axis (the foil is not part of the claimed invention, thus this limitation is treated as an intended use limitation in which the components are fully capable of functioning in such a manner as described above).
Regarding claim 11, Baril discloses the surgical retractor of claim 7, wherein the attachment structure is configured such that a surface portion of the foil, when attached to the retractor head, is parallel to the distal end axis (the foil is not part of the claimed invention, thus this limitation is treated as an intended use limitation in which the components are fully capable of functioning in such a manner as described above).
Regarding claim 12, Baril discloses the surgical retractor of claim 7, wherein the attachment structure is configured such that the surface portion of the foil, when attached to the retractor head, is at an angle sufficiently close to parallel with respect to the distal end axis to facilitate insertion of the distal end portion of the handle and the foil into a heart chamber of a patient, optionally a left atrium or right atrium of the patient, from a side of the patient in a medial direction aligned with the distal end axis of the handle (the foil is not part of the claimed invention, thus this limitation is treated as
an intended use limitation in which the components are fully capable of functioning in such a manner as described above).
Regarding claim 13, Baril discloses the surgical retractor of claim 7, wherein the attachment structure comprises a tab (best shown in Fig. 3, wherein refs. 252 are considered tabs).
Regarding claim 19, Baril discloses the surgical retractor of claim 7, further comprising a foil attached to the distal end portion of the handle by the attachment structure (any of the other ref. 310 may be considered the foil).
Regarding claim 20, Baril discloses the surgical retractor of claim 19, wherein the foil comprises a resilient member configured to extend between a closed or reduced diameter delivery configuration and an increased diameter open configuration (when the foil is aligned with the axis of the hand it is considered closed, then when angled otherwise is considered open).
Regarding claim 23, Baril discloses the surgical retractor of claim 1, wherein: the distal end portion of the handle is linear; and the linear distal end portion of the handle has a length that is sufficiently long that the linear distal end portion can extend outside of the patient after the distal end portion and the retractor head are inserted into the patient's heart chamber (this is considered an intended use or functional limitation in which the linear handle is fully capable of functioning in such a manner due to its substantially straight configuration).
Claim(s) 24 - 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrison et al. (US 5, 613,937).
Regarding claim 24, Garrison discloses a method for providing surgical access to a heart chamber of a patient (Abstract), optionally a right atrium or a left atrium, by the retractor of claim 1 (claim 1 is reproduced below in italics),
a handle (Fig. 15, refs. 166, 178, 188, 186) having a distal end portion (ref. 166) defining a distal end axis (longitudinal axis of ref. 166); and
a retractor head (one of ref. 192 as shown in Fig. 15) including a blade-shaped member defining a retractor surface portion on the distal end portion of the handle (the retractor surface portion is considered to be the surface area of ref. 192 which is shaped as a retractor blade), wherein the retractor surface portion includes a fixed perimeter (the single blade ref. 192 neither contracts nor expands and is therefore considered to have a fixed perimeter), and forms an angle that is substantially less than 900 with respect to the distal end axis (because the blade can pivot relative to the axis, it is capable of a plurality of different angles including less than 90 degrees),
comprising inserting the retractor head into the heart chamber of the patient from a side of the patient at least substantially in a medial direction aligned (e.g., colinear) with the distal end axis of the distal end portion of the handle (Fig. 2 and 5, shows a medial direction for accessing the heart chamber with the retractor ref. 40, note that “a side” may be any side of the body).
Regarding claim 25, Garrison discloses the method of claim 24, wherein the retractor includes a foil attached to the retractor head (any of the other ref. 192), and inserting the retractor head into the heart chamber includes inserting the retractor head with the foil in a delivery configuration (the foil and retractor head are able to be aligned to a lower profile/delivery configuration then expand together to create a larger profile).
Regarding claim 26, Garrison discloses the method of claim 25, further comprising causing the foil to open to an operative position in the heart chamber and retract tissue in the heart (the foil/rake arms 192 “they may be expanded by pulling thumb ring 186 relative to finger rings 174”).
Regarding claim 27, Garrison discloses the method of claim 24, wherein inserting the retractor head includes moving the distal end portion of the handle in a direction parallel to the distal end axis (because the retractor is substantially linear and elongated along the distal end axis, see Fig. 15, any movement of the distal end portion would be parallel to the distal end axis).
Regarding claim 28, Garrison discloses the method of claim 27, wherein inserting the retractor head includes inserting a linear portion of the handle including the distal end portion into the patient and positioning the retractor head in the heart chamber while the linear portion of the handle extends outside of the side of the patient (Fig. 9), and wherein the retractor head optionally includes a foil attached to the retractor head when inserting the retractor head (Fig. 9 shows the foil as part of the retractor).
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) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baril et al. (US 2022/0096071 A1) in view of Mirza et al. (US 2019/0029497 A1).
Regarding claim 21, Baril discloses the surgical retractor of claim 1, except for further comprising a light or imaging device on the distal end portion of the handle.
Mirza teaches a medical device for use in heart surgical procedures (paragraph [0050]) comprising a handle (ref. 110, Fig. 1), wherein the handle comprises a light (paragraph [0098], ref. 170) or imaging device (paragraph [0090], ref. 130). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Baril to include the light and camera, as taught by Mirza, for the purpose of sufficient resolution for imaging with sufficient clarity in order to observe performance of the surgical procedure (Mirza, paragraph [0091]).
Regarding claim 22, Baril in view of Mirza discloses the surgical retractor of claim 21, wherein the light or imaging device define an optical axis that extends at a non-zero acute angle with respect to the distal end axis (Baril, paragraph [0094] discloses a movable camera, thus having a plurality of optical axes that would be non-zero acute angles).
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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, Eduardo Robert can be reached at (571) 272-4719. 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.
/TESSA M MATTHEWS/Examiner, Art Unit 3773
Prosecution Insights