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 .
Election/Restrictions
Applicant’s election without traverse of Group I (a medical device delivery system) in the reply filed on 02/10/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/10/2026.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 medical delivery system comprising a dilator comprising a shaft with a tapered distal tip, an expander comprising a compressed configuration and an expanded configuration extending radially way from the shaft; and a sheath comprising a distal portion configured to expand radially outward and having two or more weakened longitudinal areas; wherein the sheath comprises a proximal portion having a first alignment indicator and the dilator comprises a proximal region having a second alignment indicator, and wherein alignment of the first alignment indicator with the second alignment indicator corresponds to alignment of the weakened areas of the distal portion of the sheath with the two or more extensions of the expander (claim 19) 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 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 5, 8, 16 and 19 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 5, which recites the limitation “the surroundings”, on line 3; there is insufficient antecedent basis for this limitation in the claim. Additionally, the parameter of the expander comprising shape memory material which is “configured to take the expanded configuration upon a change in the surroundings” (emphasis added) is found to be confusing, since it is not clear what exactly, structurally, is meant by the term “the surroundings”. Specifically, are “the surroundings” related/referring to structure of the claimed invention, i.e. the medical device delivery system, and if so, what/which structure would need to change and/or how would it need to change for the expander to take the expanded configuration; or are “the surroundings” referring to structure/locations outside of/separate from the structure of the claimed invention/medical device delivery system. 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 8, which sets forth the parameter of the longitudinally extending arms moving “away from the shaft upon a change in a set of surroundings” (emphasis added); however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “a set of surroundings”. Specifically, are the “set of surroundings” related/referring to structure of the claimed invention, i.e. the medical device delivery system, and if so, what/which structure would need to change and/or how would it need to change for the longitudinally extending arms to move away from the shaft; or are the “set of surroundings” referring to structure/locations outside of/separate from the structure of the claimed invention/medical device delivery system. 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 16, it is not clear what, if any, additional structural limitation(s) this parameter imparts on the final structure of the claimed invention. Specifically, by the stopping feature having a physical structure it would meet the limitation of being “a visual indicator”. Therefore, it is unclear if the stopping feature would need any other structural/chemical limitations to meet the claimed parameter, or if the stopping feature just existing would meet the claim (and if this is the case, then the claim would also be rejected under 35 U.S.C. 112(d)/112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends). 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 19, which recites the limitation “the two or more extensions”, on line 5; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is also unclear what exactly, structurally, is meant by the limitation of “the two or more extensions”, and/or how exactly this structure relates to the final structure of the claimed invention. Moreover, the parameter is further found to be confusing since it is not clear how exactly the first and second indicators and/or the weakened areas of the distal portion of the sheath relate to, and/or are affected by, the unknown structure of “the two or more extensions”. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-8, 11, 12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moran et al. (US PG Pub. 2018/0001003), hereinafter Moran.
Regarding claims 1-4, 14 and 15, Moran discloses a medical device delivery system (1) comprising a dilator (20), illustrated in Figures 1 and 2, the dilator (20) comprising a shaft (21) with a tapered distal region (23) which narrows distally towards a distal tip (24); an expander (25) coupled to, and extending circumferentially around, the shaft (21) positioned proximal to the tapered distal region (23) and adjacent to the distal tip (24), the expander (25) comprising a compressed configuration wherein the expander is compressed against the shaft and an expanded configuration wherein the expander extends radially away from the shaft in multiple radial directions; and a proximal region comprising a stopping feature (SF), having a larger diameter than the shaft (21), and positioned a fixed distance from the expander (25), illustrated in Figures 2, 3 and modified figure 3, below ([0041] & [0042]).
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Regarding claims 6-8, Moran discloses the medical device delivery system of claim 1, wherein the expander, illustrated in Figures 10a-11c, comprises a plurality of longitudinally extending slits (225), extending proximally from a distal end of the expander, dividing the expander into longitudinally extending arms (226) that move away from the shaft upon a change in a set of surroundings ([0047] – to clarify, screw mechanism 223 changes the set of surroundings 222 to extend arms 226).
Regarding claims 11 and 12, Moran discloses the medical device delivery system of claim 1, wherein the expander, illustrated in Figures 12a-13c, comprises two or more extensions (325) pointing toward the proximal region of the dilator and biased toward the expanded configuration, wherein the two or more extensions (325) extend radially away from the shaft ([0048]).
Regarding claim 16, Moran discloses the medical device delivery system of claim 1, wherein the stopping feature (SF) is a visual indicator, illustrated in Figures 2, 3 and modified figure 3, above (to clarify, since the stopping feature has a larger diameter than the shaft, it can be considered a visual indictor since it would be visually larger than the shaft).
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.
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Moran, or in the alternative, under 35 U.S.C. 103 as obvious over Moran in view of Georgilis et al. (US PG Pub. 2017/0367718), hereinafter Georgilis.
Regarding claim 5, Moran discloses the medical device delivery system of claim 1, wherein the expander (25) comprises a shape memory material ([0042], Last 2 Lines); to clarify, it is well-known in the art, and iterated by Georgilis, that Nylon is a shape memory material/polymer (Georgilis: [0039], Last 3 Lines), and further also well-known in the art that a shape memory material is configured to take an expanded configuration upon a change in the surroundings.
Claims 9, 10, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Moran as applied to claim 1 above, and in view of Leschinsky (US Patent No. 6,346,092), as disclosed in the IDS dated 10/30/2024.
Regarding claims 9 and 10, Moran discloses the medical device delivery system of claim 1, wherein the expander (25) comprises the compressed configuration that expands upon a change in a set of surroundings ([0042], Last 2 Lines - to clarify, as detailed above in the rejection of claim 5, the expander comprises Nylon which is known in the art to be a shape memory material/polymer, and is also known in the art that a shape memory material is configured to change shape/expand upon a change in the surroundings); but does not specifically disclose the expander comprises one or more folds in the compressed configuration, and forms a funnel in the expanded configuration.
However, Leschinsky teaches a medical device delivery system (1), in the same filed of endeavor, comprising an expander/balloon (8) having one or more folds (11) to attain a compressed configuration, and forming a funnel shape in an expanded configuration, illustrated in Figure 1 (Column 4, Lines 19-22 – to clarify, expander/balloon 8 is considered to form a funnel in the expanded configuration due to its funnel shape, i.e. wider in one portion/middle portion and narrower in another portion/end portion, as illustrated in Figure 1).
In view of the teachings of Leschinsky, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the expander, of the medical device delivery system of Moran, to comprise one or more folds in order to achieve the compressed configuration, and form a funnel in the expanded configuration, as taught by Leschinsky; and a change in shape/form, of the expander in the expanded configuration, is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claims 17 and 18, Moran discloses the medical device delivery system of claim 1, further comprising a sheath (11) comprising a distal portion (13), illustrated in Figures 1 and 2 ([0041]); but does not specifically disclose the sheath comprises two or more weakened longitudinal areas and the distal portion, of the sheath, is configured to expand radially outward.
However, Leschinsky teaches a medical device delivery system (1), in the same filed of endeavor, comprising a sheath (20) having a distal portion configured to expand radially outward, wherein the sheath comprises (20) has two or more weakened longitudinal areas (80), illustrated in Figures 3-3B, aiding in inserting of an unfurled/non-compressed expander/balloon into the sheath (Column 4, Lines 50-54 & Column 5, Lines 34-50).
In view of the teachings of Leschinsky, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sheath, of the medical device delivery system of Moran, to have two or more weakened longitudinal areas and for the distal portion to be able to expand radially outward, in order to aid with inserting the expander, in an unfurled/non-compressed configuration, into the sheath for delivery, as taught by Leschinsky.
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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