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 § 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.
Claim 15 is 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 15 recites “a securement ring” in Line 2. It is unclear from the claim whether this securement feature refers back to the “one or more securement features” of Claim 1 or is a separate securement feature distinct from Claim 1. Examiner is treating “a securement ring” in Claim 15 as further limiting the “one or more securement features” of Claim 1. Appropriate correction and/or clarification is required.
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 1-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al. (USPGPub 2004/0019348) in view of Yamazaki (USPGPub 2020/0060819).
Re Claim 1, Stevens teaches a viewer (121) comprising; a body (22, 127, 129) having a first end (Stevens Fig. 8B - end with eyepiece 129) and a second end (125) opposite the first end (Stevens ¶ 0103), the first end being closed and having a transparent viewing window (129), the second end arranged to be attached to an aorta or a pulmonary artery (Stevens ¶ 0097, 0147), wherein an outer diameter of the first end (end with eyepiece 129) of the body (22, 127, 129) is larger than an outer diameter of the second end (125) of the body (Stevens Fig. 8B); and one or more ports (137) arranged to provide fluid access to an internal portion of the viewer (121) (Stevens ¶ 0103). However, Stevens fails to teach wherein the body includes one or more securement features including a rim extending outwardly from a portion of the body adjacent to the second end, and wherein the rim is arranged to permit attachment of the body to the aorta or the pulmonary artery.
Yamazaki teaches a viewer (2) comprising a body (100a) (Yamazaki Figs. 2A-2B), wherein the body (100a) includes one or more securement features (110a, 230) (Yamazaki ¶ 0070) including a rim (230) extending outwardly from a portion (216) of the body (100a) adjacent to a second end (distal end of body 100a), and wherein the rim (230) is arranged to permit attachment of the body (100a) to the aorta or the pulmonary artery (Yamazaki ¶ 0070-0075), the one or more securement features providing ease of connection and disconnection of the body to the aorta or the pulmonary artery during a medical procedure (Yamazaki ¶ 0022, 0070).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the body of Stevens one or more securement features, said one or more securement features including a rim extending outwardly from a portion of the body adjacent to the second end, and wherein the rim is arranged to permit attachment of the body to the aorta or the pulmonary artery, the configuration as disclosed by Yamazaki for providing ease of connection and disconnection of the body to the aorta or the pulmonary artery during a medical procedure (Yamazaki ¶ 0022, 0070).
Re Claim 2, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the body includes a tubular body (as seen in Stevens Fig. 8B).
Re Claims 3-4, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein a first outer diameter of a first portion of the body (outer diameter of eyepiece 129) is greater than a second outer diameter of a second portion of the body (outer diameter of distal end 125), the first portion of the body being closer to the first end than the second portion of the body is to the first end (as seen in Stevens Fig. 8B); and wherein the body includes a tapered portion (Stevens Fig. 8B - wherein eyepiece 129 is tapered).
Re Claim 5, Stevens in view of Yamazaki teach all of the limitations of Claim 4. Stevens teaches wherein the tapered portion is positioned in between the first portion of the body and the second portion of the body (as seen in Stevens Fig. 8B).
Re Claim 6, Stevens in view of Yamazaki teach all of the limitations of Claim 5. Stevens teaches wherein a first outer diameter of a first end of the tapered portion is the same as the first outer diameter of the first portion of the body (as seen in Stevens Fig. 8B). Stevens further teaches a second outer diameter of a second end of the tapered portion is the same as the second outer diameter of the second portion of the body. With regard to this limitation, examiner is interpreting a second outer diameter of a second end of the tapered portion as whichever diameter of the tapered portion that has the same diameter as the second outer diameter of the second portion of the body (Stevens Fig. 8B).
Furthermore, it would have been an obvious matter of design choice to modify the first and second ends such that a first outer diameter of a first end of the tapered portion is the same as the first outer diameter of the first portion of the body and a second outer diameter of a second end of the tapered portion is the same as the second outer diameter of the second portion of the body since applicant has not disclosed that having a first outer diameter of a first end of the tapered portion is the same as the first outer diameter of the first portion of the body and a second outer diameter of a second end of the tapered portion is the same as the second outer diameter of the second portion of the body solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of a first outer diameter of a first end of the tapered portion is the same as the first outer diameter of the first portion of the body and a second outer diameter of a second end of the tapered portion is the same as the second outer diameter of the second portion of the body, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Re Claims 7-8, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the body (22, 127, 129) includes a tapered portion (Stevens Fig. 8B - wherein eyepiece 129 is tapered), wherein an outer diameter of the tapered portion decreases in a direction from the first end of the body towards the second end of the body (as seen in Stevens Fig. 8B); and wherein the outer diameter of the tapered portion decreases from the first end to a portion in between the first and second ends (as seen in Stevens Fig. 8B).
Re Claims 9-10, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the one or more ports (137) extend outwardly from a side of the body (as seen in Stevens Fig. 8B); and wherein the one or more ports (137) extends substantially perpendicular to, substantially parallel to, or angled relative to a plane of the viewing window (as seen in Stevens Fig. 8B).
Re Claim 11, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the one or more ports (137) are located at or near the first end of the body (as seen in Stevens Fig. 8B).
Re Claim 12, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the one or more ports (137) are fixedly attached at the first end of the body (as seen in Stevens Fig. 8B).
Re Claims 13-14, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the second end is arranged to be attachable to the aorta or the pulmonary artery via one or more securement features (Stevens ¶ 0097 - grasping instrument, ¶ 0098 - thoracoscopic cinching devices); and wherein the one or more securement feature includes barbs, elastic bands, clips, collets, or clamps (Stevens ¶ 0097 - grasping instrument, ¶ 0098 - thoracoscopic cinching devices).
Re Claim 15, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens fails to teach wherein the body is attachable to the aorta or pulmonary artery via the one or more securement features, the one or more securement features comprising a securement ring, wherein the body is threadably attached to or press fit to the securement ring. Yamazaki teaches the one or more securement features (110a, 230) comprising a securement ring (110a) (Yamazaki ¶ 0070), wherein a catheter (20) having a body configured to be attachable to the aorta or pulmonary artery via the securement ring (100a), wherein the body is threadably attached to or press fit to the securement ring (100a) (Yamazaki ¶ 0075-0078), the securement ring (100a) for assisting in evaluation during a medical procedure (Yamazaki ¶ 0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the body of Stevens attachable to the aorta or pulmonary artery via a securement ring, wherein the body is threadably attached to or press fit to the securement ring as disclosed by Yamazaki for assisting in evaluation during a medical procedure (Yamazaki ¶ 0022).
Re Claims 16-17, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the outer diameter of the second end is between about 9 mm and about 35 mm; and wherein the outer diameter of the second end is between about 9 mm and about 19 mm (Stevens ¶ 0083).
Re Claim 18, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches one or more extensions extending outwardly from the viewing window for engaging with a camera or scope (Stevens ¶ 0104).
Re Claim 19, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein the outer diameter of the first end is greater than the outer diameter of the second end. However, Stevens does not teach wherein the outer diameter of the first end is two times greater than the outer diameter of the second end. However, it would have been an obvious matter of design choice to modify the first and second ends such that the outer diameter of the first end is two times greater than the outer diameter of the second end since applicant has not disclosed that having the outer diameter of the first end is two times greater than the outer diameter of the second end solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the outer diameter of the first end is two times greater than the outer diameter of the second end, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Re Claim 20, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens fails to teach wherein a diameter of the viewing window is greater than the outer diameter of the second end. It would have been an obvious matter of design choice to modify the viewing window such that the viewing window is greater than the outer diameter of the second end since applicant has not disclosed that having the viewing window is greater than the outer diameter of the second end solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the viewing window is greater than the outer diameter of the second end, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Re Claim 22, Stevens in view of Yamazaki teach all of the limitations of Claim 1. Stevens teaches wherein an inner diameter of the first end of the body is greater than an inner diameter of the second end of the body. It would have been an obvious matter of design choice to modify the first and second body such that an inner diameter of the first end of the body is greater than an inner diameter of the second end of the body since applicant has not disclosed that having an inner diameter of the first end of the body is greater than an inner diameter of the second end of the body solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of an inner diameter of the first end of the body is greater than an inner diameter of the second end of the body, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens et al. (USPGPub 2004/0019348) in view of in view of Yamazaki (USPGPub 2020/0060819) as applied to Claim 1 above and further in view of Katballe et al. (USPGPub 2019/0282072).
Re Claim 23, Stevens teaches all of the limitations of Claim 1. Stevens fails to teach wherein the body is collapsible. Katballe teaches a viewer (Katballe Fig. 7) comprising a body (128) that is collapsible, wherein the collapsible section acts as a support for the proximal end of a scope (Katballe ¶ 0091, 0121-0122). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the body of Stevens in view of Yamazaki be collapsible as disclosed by Katballe to act as a support for the proximal end of a scope (Katballe ¶ 0091, 0121-0122).
Response to Arguments
Applicant’s arguments filed 03/31/2026 with respect to claim objection of Claim 13 have been fully considered and are persuasive. Claim objection of Claim 13 is hereinafter withdrawn due to clarifying amendments to Claim 13.
Applicant’s arguments with respect to Claim 1 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. Examiner concedes prior art Stevens fails to teach “a rim extending outward from a portion of a body for attachment to an aorta or a pulmonary artery of the heart” (first paragraph, Page 9 applicant’s response). Examiner now relies upon Yamazaki to make obvious said limitation.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /NILAY J SHAH/Primary Examiner, Art Unit 3783
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