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 .
Status of Claims
This office action is responsive to the amendment filed on 06/25/2026. As directed by the amendment: claims 1, 4-14, 16 and 19 have been amended, no claims have been cancelled, no new claims have been added, and claim 20 remains withdrawn from consideration as being drawn to a non-elected invention. Thus, claims 1-19 are presently examined in the current Office Action.
Response to Amendment
The amendment to the drawings, dated 06/25/2026, is accepted and overcomes the previous drawing objections as set forth in the Office Action dated 03/25/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the delivery system comprising a dilator having a shaft, with a tapered distal region tapering towards a distal tip, an expander positioned on the shaft adjacent to the distal tip, wherein the expander includes a tubular portion and an expansion member, such that a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, the expansion member being rotatable with respect to the distal end of the tubular portion, and the expansion member being movable between a compressed configuration where the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further having a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms, the plurality of longitudinally extending arms structured to move away from the shaft such that a distal end of each of the plurality of longitudinally extending arms is spaced radially from the shaft and a proximal end of each of the plurality of longitudinally extending arms is aligned with a corresponding proximal end of the plurality of longitudinally extending slits (claim 6), the delivery system comprising a dilator having a shaft, with a tapered distal region tapering towards a distal tip, an expander positioned on the shaft adjacent to the distal tip, wherein the expander includes a tubular portion and an expansion member, such that a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, the expansion member being rotatable with respect to the distal end of the tubular portion, and the expansion member being movable between a compressed configuration where the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further having a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms; and wherein the plurality of longitudinally extending slits extends proximally from a distal end of the expander along a portion of a length of the expansion member (claim 7), the delivery system comprising a dilator having a shaft, with a tapered distal region tapering towards a distal tip, an expander positioned on the shaft adjacent to the distal tip, wherein the expander includes a tubular portion and an expansion member, such that a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, the expansion member being rotatable with respect to the distal end of the tubular portion, and the expansion member being movable between a compressed configuration where the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further having a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms; wherein the plurality of longitudinally extending arms that move away from the shaft upon a change in at least one of a surrounding temperature or pH (claim 8), the delivery system comprising a dilator having a shaft, with a tapered distal region tapering towards a distal tip, an expander positioned on the shaft adjacent to the distal tip, wherein the expander includes a tubular portion and an expansion member, such that a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, the expansion member being rotatable with respect to the distal end of the tubular portion, and the expansion member being movable between a compressed configuration where the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further comprises one or more folds in the compressed configuration that unfold upon a change in a set of surroundings (claim 9), and the delivery system comprising a dilator having a shaft, with a tapered distal region tapering towards a distal tip, an expander positioned on the shaft adjacent to the distal tip, wherein the expander includes a tubular portion and an expansion member, such that a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, the expansion member being rotatable with respect to the distal end of the tubular portion, and the expansion member being movable between a compressed configuration where the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further forms a funnel in the expanded configuration (claim 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: line 12 states “rotatable with respect to the tubular portion to such that the distal end…” (emphasis added); this phrase grammatically and/or confusing due to the word “to”. In order to overcome this issue, it is suggested the word “to”, between the words “portion” and “such”, be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 6, which depends from independent claim 1 which sets forth the parameter(s) of “the expander includes a tubular portion and an expansion member” and “a proximal end of the expansion member coupled to and extending from a distal end of the tubular portion, wherein the expansion member is rotatable with respect to the distal end of the tubular portion” (emphasis added); and claim 6 further sets forth the parameter of “the expansion member includes a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms…and a proximal end of each of the plurality of longitudinally extending arms is aligned with a corresponding proximal end of the plurality of longitudinally extending slits”, however this parameter/combination of parameters was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates a delivery system comprising an expander that includes a tubular portion and an expansion member, wherein a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, wherein the expansion member is rotatable with respect to the distal end of the tubular portion, and the expansion member further also includes a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms, such that a proximal end of each of the plurality of longitudinally extending arms is aligned with a corresponding proximal end of the plurality of longitudinally extending slits. It is to be noted that different parts/parameters of the above mentioned combination of parameters are disclosed in different/separate embodiments, however, the originally filed disclosure is completely silent regarding a delivery device having all the parameters disclosed above/as set forth in claim 6.
Regarding claim 7, which depends from claim 6, which has new matter issues (see details above), in addition claim 7 further sets forth the parameter of “the plurality of longitudinally extending slits extends proximally from a distal end of the expander along a portion of a length of the expansion member”; however this parameter/combination of parameters was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates a delivery system comprising an expander that includes a tubular portion and an expansion member, wherein a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, wherein the expansion member is rotatable with respect to the distal end of the tubular portion, and the expansion member further also includes a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms, such that a proximal end of each of the plurality of longitudinally extending arms is aligned with a corresponding proximal end of the plurality of longitudinally extending slits, wherein the plurality of longitudinally extending slits extends proximally from a distal end of the expander along a portion of a length of the expansion member. It is to be noted that different parts/parameters of the above mentioned combination of parameters are disclosed in different/separate embodiments, however, the originally filed disclosure is completely silent regarding a delivery device having all the parameters disclosed above/as set forth in claim 7.
Regarding claim 8, which depends from claim 6, which has new matter issues (see details above), in addition claim 8 further sets forth the parameter of “the plurality of longitudinally extending arms that move away from the shaft upon a change in at least one of a surrounding temperature or surrounding pH”; however this parameter/combination of parameters was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates a delivery system comprising an expander that includes a tubular portion and an expansion member, wherein a proximal end of the expansion member is coupled to, and extends from, a distal end of the tubular portion, wherein the expansion member is rotatable with respect to the distal end of the tubular portion, and the expansion member further also includes a plurality of longitudinally extending slits separating the expansion member to form a plurality of longitudinally extending arms, such that a proximal end of each of the plurality of longitudinally extending arms is aligned with a corresponding proximal end of the plurality of longitudinally extending slits, and that the longitudinally extending arms move away from the shaft upon a change in surrounding temperature or pH. It is to be noted that different parts/parameters of the above mentioned combination of parameters are disclosed in different/separate embodiments, however, the originally filed disclosure is completely silent regarding a delivery device having all the parameters disclosed above/as set forth in claim 8.
Regarding claim 9, which depends from independent claim 1 which sets forth the parameter(s) of “the expander includes a tubular portion and an expansion member”, that “the expansion member is rotatable with respect to the distal end of the tubular portion” (emphasis added), and that in a compressed configuration “the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and an expanded configuration where the expansion member is rotatable with respect to the tubular portion to such that the distal end of the expansion member extends radially away from the shaft” (emphasis added); and claim 9 further sets forth the parameter of “the expansion member comprises one or more folds in the compressed configuration that unfold upon a change in a set of surroundings”, however this parameter/combination of parameters was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates a delivery system comprising an expander that includes a tubular portion and an expansion member, wherein the expansion member is rotatable with respect to the distal end of the tubular portion, wherein in a compressed configuration the expansion member is compressed against the shaft and a distal end of the expansion member is directed toward the tapered distal region of the shaft, and in an expanded configuration the expansion member is rotatable with respect to the tubular portion to such that the distal end of the expansion member extends radially away from the shaft; and the expansion member further comprises one or more folds in the compressed configuration that unfold upon a change in a set of surroundings. It is to be noted that different parts/parameters of the above mentioned combination of parameters are disclosed in different/separate embodiments, however, the originally filed disclosure is completely silent regarding a delivery device having all the parameters disclosed above/as set forth in claim 9.
Regarding claim 10, which depends from claim 9, which has new matter issues (see details above), in addition claim 10 further sets forth the parameter of “the expansion member forms a funnel in the expanded configuration”; however this parameter/combination of parameters was never mentioned or suggested in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests, or illustrates a delivery system comprising an expander that includes a tubular portion and an expansion member, wherein the expansion member is rotatable with respect to the distal end of the tubular portion, wherein in an expanded configuration the expansion member is rotatable with respect to the tubular portion to such that the distal end of the expansion member extends radially away from the shaft, wherein the expansion member further comprises one or more folds in the compressed configuration that unfold upon a change in a set of surroundings, and the expansion member forms a funnel in the expanded configuration. It is to be noted that different parts/parameters of the above mentioned combination of parameters are disclosed in different/separate embodiments, however, the originally filed disclosure is completely silent regarding a delivery device having all the parameters disclosed above/as set forth in claim 10.
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 11-13 are 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.
Regarding claim 11, which depends from claim 1 which sets forth the parameter of, in a compressed configuration “a distal end of the expansion member is directed toward the tapered distal region of the shaft”, and claim 11 further sets forth the parameter of “the expansion member comprises two or more extensions pointing toward the proximal region of the dilator” (emphasis added); however, this parameter is found to be confusing since it is not clear how the distal end of the expansion member is directed toward the tapered distal region of the shaft and the extensions, which the expansion member comprises, can also be pointing toward the proximal region of the dilator. Specifically, are different portions/areas of the expansion member/extensions, i.e. a proximal end and a distal end, pointing/directed towards the opposite directions of distal and proximal regions, or is the expansion member/extensions pointing/directed towards the opposite directions of distal and proximal regions in different configurations, i.e. compressed versus expanded, or is there some other configuration/structure in which the expansion member/extensions are pointing/directed towards the opposite directions of distal and proximal regions. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 13, which depends from claim 11 which sets forth the parameter of “the expansion member comprises two or more extensions pointing toward the proximal region of the dilator”, and further depends from claim 1 which sets forth the parameter of, in a compressed configuration “a distal end of the expansion member is directed toward the tapered distal region of the shaft”, and claim 13 further sets forth the parameter of “each of the two or more extensions is rotatable around a hinge to point at a proximal end of the two or more extensions toward the tapered distal region of the dilator”; however, this parameter is found to be confusing for a few reasons. Firstly, it is unclear what exactly is meant by the extensions being rotatable around a hinge “to point at a proximal end of the two or more extensions toward the tapered distal region of the dilator”; does this mean the proximal end of the extensions point/extend toward the distal region of the dilator, or does it mean something else completely different. Furthermore, if the above mentioned interpretation, i.e. that the proximal end of the extensions point/extend toward the distal region of the dilator, is correct, then it is further unclear/confusing how the extensions further point toward the proximal region of the dilator, as set forth in claim 11, and/or how, in a compressed configuration, the distal end of the expansion member, which comprise the extensions, is directed toward the tapered distal region of the shaft, as set forth in claim 1. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Allowable Subject Matter
Claims 1-5 and 14-19 are allowed.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/18/2026
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