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 .
Specification
The content of the amended Abstract filed 125/2025 is acceptable, but the Abstract does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 6 is objected to because of the following informalities: The phrase “the unfolded state” on line 2 should be amended to recite “the expanded, unfolded state” to match the language used in claim 15. Appropriate correction is required. This objection was set forth in the last Office Action and, although the Remarks filed 12/5/2025 state that the claims were amended in accordance with the Office’s suggestions, claim 6 was not amended.
Claim 17 is objected to because of the following informalities: The phrase “proximal portion” on line 2 lacks an article preceding it and is, therefore, grammatically incorrect. The term “the” should be inserted before this phrase since a “proximal portion” has been introduced in claim 16. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: The phrase “wherein a proximal end of the dilator tip is spaced from an outer surface of the dilator shaft to form a cavity the outer surface of the dilator shaft and an inner surface of the proximal end of the dilator tip” on lines 13-15 is grammatically incorrect; it is believed that the term “between” should be inserted after the term “cavity”. The phrase “dilator tip” on lines 16-17 lacks an article preceding it and, therefore, is grammatically incorrect; the term “the” should be inserted before this phrase since a “dilator tip” has been introduced earlier in the claim. The term “configuration” has been misspelled as “configurated” on line 27. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: A comma should be inserted after the term “configuration” on line 1 in order to be grammatically correct. Appropriate correction is required.
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 3-9, 12-17 and 23-25 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.
Claim 15 recites “a distal end of the thin, flexible plastic tube” on both of lines 10 and 20. As written, it appears that these recitations require the “thin, flexible plastic tube” to have two “distal end(s)”. However, based on the specification, it appears that the “distal end” of line 20 is intended to be the same as the “distal end of line 10. Because of the contradiction in the claim language compared to the specification, it is unclear how to interpret claim 15 in light of the specification; that is, it is unclear if claim 15 was intended to include two “distal end(s)” or if the “distal end” of line 20 is intended to be the same as that of line 10. For the sake of examination, the “distal end” of line 20 is interpreted as being the same as that of line 10. Accordingly, it is suggested to amend line 20 to recite “[[a]] the distal end of the thin, flexible plastic tube”. Claims 3-9, 12-14, 16 and 17 are rejected due to their dependence on claim 15.
Claim 9 recites “a distal end of the tubular membrane” on line 2. However, claim 15 already introduces “a distal end of the tubular membrane” on line 18. As written, it appears that these recitations require the “tubular membrane” to have two “distal end(s)”. However, based on the specification, it appears that the “distal end” of claim 9 is intended to be the same as the “distal end” of claim 15. Because of the contradiction in the claim language compared to the specification, it is unclear how to interpret claim 9 in light of the specification; that is, it is unclear if claim 9 was intended to introduce an additional “distal end” or if the “distal end” of claim 9 is intended to be the same as that of claim 15. For the sake of examination, the “distal end” of claim 9 is interpreted as being the same as that of claim 15. Accordingly, it is suggested to amend claim 9 to recite “[[a]] the distal end of the tubular membrane”.
Claim 14 recites “the spine comprises two or more spines” on line 2. Applicant asserts in the Reply filed 12/5/2025 that the term “a” carries the meaning of “one or more”. In light of this, it is unclear if the phrase “the spine comprises two or more spines” is intended to require (1) the spine of claim 15 to be formed by two or more spines (for example, multiple smaller spines braided together to form a larger spine) or (2) the tubular membrane to have two or more separate spines (for example, one spine on a first side of the tubular membrane and a second spine on an opposite side of the tubular membrane). For the sake of examination, the phrase of claim 14 is interpreted as requiring two or more separate spines. Accordingly, it is suggested to amend claim 14 to recite “further comprising at least one additional spine”.
Claim 17 recites “the distal tip of the dilator” on line 3. This phrase lacks proper antecedent basis since no suction “distal tip” belonging to the “dilator” is introduced in claim 15. Claim 15 introduces “a dilator tip” and “a distal end of the dilator shaft”, but it is unclear as to which of these features the “distal tip” of claim 17 is intended to refer to. For the sake of examination, “the distal tip of the dilator” is interpreted as referring to the “dilator tip”. Accordingly, it is suggested to amend claim 17 to recite “the dilator tip This rejection was set forth in the last Office Action and, although the Remarks filed 12/5/2025 state that the claim has been amended to address the rejection, claim 17 has not been amended to address this issue.
Claim 23 recites “the distal tip” on lines 26 and 27. This phrase lacks proper antecedent basis since no suction “distal tip” is introduced earlier in claim 23. Claim 23 introduces “a dilator tip” and “a distal end of the dilator shaft”, but it is unclear as to which of these features the “distal tip” of lines 26 and 27 is intended to refer to. For the sake of examination, “the distal tip” is interpreted as being “the dilator tip”. Accordingly, it is suggested to amend each of lines 26 and 27 to recite “the dilator tip”. Claims 24 and 25 are rejected due to their dependence on claim 23.
Claim 25 recites “the removable clip is removed from the assembly” on lines 1-2. Since claim 24 sets forth that the removable clip is a part of the assembly (“The assembly of claim 23, further comprising a removable clip”), it is unclear how the can be removed from the thing that it forms. For the sake of examination, this limitation is interpreted as referring to when the clip is removed from the rest of the assembly. Accordingly, it is suggested to amend claim 25 to recite “the removable clip is removed from the rest of the assembly”.
Claim 25 recites “the distal tip of the dilator” on line 3. This phrase lacks proper antecedent basis since no suction “distal tip” belonging to the “dilator” is introduced in claim 23. Claim 23 introduces “a dilator tip” and “a distal end of the dilator shaft”, but it is unclear as to which of these features the “distal tip” of claim 25 is intended to refer to. For the sake of examination, “the distal tip of the dilator” is interpreted as referring to the “dilator tip”. Accordingly, it is suggested to amend claim 25 to recite “the dilator tip
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.
Claim 3, 4, 7-9 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ginn et al. (PG PUB 2016/0128723).
Re claim 15, Ginn discloses an introducer dilator assembly 300 (Fig 13; it is noted that all reference characters cited below refer to Fig 13 unless otherwise noted) comprising: an introducer 301 including: an introducer hub 302+303; a tubular membrane 304, the tubular membrane being a thin, flexible plastic tube (Para 6), a proximal end of the thin, flexible plastic tube being coupled to the introducer hub and extending distally from the introducer hub (as seen in Fig 13), the tubular membrane having a folded state 322 and an expanded, unfolded state 321 (as seen in Fig 16D) (Para 59); and a spine (364 of Fig 30B, for all claims except claim 14; any of the elongated fibers seen in Fig 18F except radiopaque strand 328, for claims 13 and 14) attached to, partially attached to, extending through, or incorporated into the tubular membrane (as seen in Fig 30B/18F), the spine extending from adjacent the introducer hub to adjacent a distal end of the thin, flexible plastic tube (Para 70/6); and a dilator 305 including: a dilator hub (seen in Fig 13 proximal to shaft 306, but not labeled); a dilator shaft 306 coupled to the dilator hub and extending distally therefrom (as seen in Fig 13); and a dilator tip 308 coupled to a distal end of the dilator shaft (as seen in Fig 13); wherein in an assembled configuration (seen in Fig 14B), the dilator shaft extends through the introducer hub and the tubular membrane such that the dilator hub is proximal of the introducer hub, the distal end of the dilator shaft is distal of a distal end of the tubular membrane, and the dilator tip extends proximally from the distal end of the dilator shaft and houses the distal end of the thin, flexible plastic tube therewithin (as seen in Fig 14B,16E).
Re claim 3, Ginn discloses that the tubular membrane is mechanically expandable (Para 65).
Re claim 4, Ginn discloses that the tubular membrane comprises a polymer or nylon material or any combination thereof (Para 6).
Re claim 13, Ginn (under the interpretation where the spine is 364) discloses that the spine is a single spine (as seen in Fig 30B) attached to, partially attached to, extending through, or incorporated into the tubular membrane (Para 70).
Re claim 13, Ginn (under the interpretation where the spine is an of the elongated fibers seen in Fig 18F except radiopaque strand 328) discloses that the spine is a single spine attached to, partially attached to, extending through, or incorporated into the tubular membrane (as seen in Fig 18F).
Re claim 14, Ginn (under the interpretation where the spine is an of the elongated fibers seen in Fig 18F except radiopaque strand 328) discloses that the spine comprises two or more spines (“fibers”, Para 36; Fig 18F) attached to, partially attached to, extending through, or incorporated into the tubular membrane (as seen in Fig 18F).
Re claim 16, Ginn discloses a removable clip 309, wherein in the assembled configuration, the removable clip is coupled to a proximal portion of the dilator shaft between the introducer hub and the dilator hub, and prevents distal advancement of the dilator relative to the introducer (as seen in Fig 14B; Para 64).
Re claim 17, Ginn discloses that, with the removable clip removed from the proximal portion of the dilator shaft, the dilator may be advanced distally relative to the introducer such that the distal tip of the dilator releases the distal end of the tubular membrane (Para 65).
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 5 and 6 are rejected under 35 U.S.C. 103 as being obvious over Ginn et al. (PG PUB 2016/0128723).
Re claims 5 and 6, Ginn discloses that the tubular membrane has a first diameter in the folded state and a second diameter in the unfolded state that is larger than the first diameter (as seen in comparison of Fig 16D and Fig 16E, Para 59), but does not explicitly disclose that the first diameter is 1-3 mm (as required by claim 5) and that the second diameter is 10 mm to 12 mm (as required by claim 6). However, it would have been an obvious matter of design choice to modify the tubular membrane such that its first diameter is 1-3 mm and its second diameter is 10-12 mm since applicant has not disclosed that having these diameter measurements solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of these diameter measurements, 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. Additionally, it would have been an obvious matter of design choice to provide the tubular membrane such that its first diameter is 1-3 mm and its second diameter is 10-12 mm since such a modification would have involved a mere change in the form or shape of a component.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ginn et al. (PG PUB 2016/0128723) in view of Kick (PG PUB 2005/0124937).
Re claims 5 and 6, Ginn discloses that the tubular membrane has a first diameter in the folded state and a second diameter in the unfolded state that is larger than the first diameter (as seen in comparison of Fig 16D and Fig 16E, Para 59), but does not explicitly disclose that the first diameter is 1-3 mm (as required by claim 5) and that the second diameter is 10 mm to 12 mm (as required by claim 6). Kick, however, teaches an introducer dilator assembly (Fig 7) comprising a dilator 300 and an introducer 100 comprising a tubular membrane having a folded state and an expanded, unfolded state (Para 42,47-48), wherein a first diameter of the tubular membrane in the folded state is 1-3 mm and a second diameter of the tubular membrane in the unfolded state is 10-12 mm (Para 56,57) for the purpose of using the introducer in urological, gastrointestinal, cardiovascular, vascular, or gynecologic applications (Para 56,57). Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify Ginn to include the first diameter as 1-3 mm and the second diameter as 10-12 mm, as taught by Kick, for the purpose of using the introducer in urological, gastrointestinal, cardiovascular, vascular, or gynecologic applications (Para 56,57).
Claims 7, 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ginn et al. (PG PUB 2016/0128723) in view of Zhou et al. (PG PUB 2016/0296730).
Re claim 7, Ginn discloses that the spine is a thin, rigid element configured to support the tubular membrane (Para 70) but does not explicitly disclose that it is a wire that extends longitudinally through the membrane. Zhou, however, teaches an introducer (Fig 5) comprising a tubular membrane 40 (Fig 5) having a collapsed state and an expanded state (Para 69) and a spine 60 (Fig 5) in the form of a thin, rigid wire configured to support the tubular membrane and extending longitudinally through the membrane (as seen in Fig 6; Para 70) for the purpose of providing a bearing surface to facilitate the movement of instruments through the tubular membrane (Para 70). Therefore, it would have been obvious to one of ordinary skill in the art to modify Ginn to include a spine in the form of a thin, rigid wire extending longitudinally through the membrane, as taught by Zhou, for the purpose of providing a bearing surface to facilitate the movement of instruments through the tubular membrane (Para 70).
Re claim 8, Ginn as modified by Zhou in the rejection of claim 7 about discloses all the claimed features with Zhou teaching that the spine 60 is attached to, partially attached to, or incorporated into an inner surface of the tubular membrane (as seen in Fig 6). The motivation applied to claim 7 also applies to claim 8.
Re claim 12, Ginn as modified by Zhou in the rejection of claim 7 above discloses all the claimed features but does not explicitly disclose that the spine comprises stainless steel, nitinol and/or a rigid polymer. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spine to comprise stainless steel, nitinol, and/or a rigid polymer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Claim 12 has additionally been rejected with art below.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn et al. (PG PUB 2016/0128723)/Zhou et al. (PG PUB 2016/0296730) in view of Furnish (PG PUB 2016/0074067).
Re claim 9, Ginn as modified by Zhou in the rejection of claim 7 above discloses all the claimed features except explicitly disclosing that a distal end of the spine terminates proximal to a distal end of the tubular membrane. Furnish, however, teaches providing an introducer 10 (Fig 7A) comprising a tubular membrane 22+24 (Fig 7A) with a spine 38 (Fig 7A) whose distal end terminates proximal to a distal end of the tubular membrane (as seen in Fig 7A), wherein the spine allows tubular membrane to expand and contract (Para 29,30) as does the tubular membrane of Ginn/Zhou. Since Furnish teaches that a tubular membrane having a spine whose distal end terminates proximal to a distal end of the tubular membrane functions in the same manner as one that has a spine that extends to the distal end of the tubular membrane achieves the same result, these configurations were art-recognized equivalents at the time the invention was made. Therefore, it would have been obvious to one of ordinary skill in the art to modify Ginn/Zhou to include the spine such that it terminates proximal to a distal end of the tubular membrane, as taught by Furnish, since it has been held that substituting parts of an invention involves only routine skill in the art.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ginn et al. (PG PUB 2016/0128723) in view of Lenker et al. (PG PUB 2006/0135981).
Re claim 12, Ginn as modified by Zhou in the rejection of claim 7 above discloses all the claimed features but does not explicitly disclose that the spine comprises stainless steel, nitinol and/or a rigid polymer. Lenker, however, teaches using stainless steel, nitinol and a rigid polymer in a spine 506 (Fig 5B; Para 82) of a flexible membrane 510 (Fig 5B) for the purpose of providing strength to the flexible membrane and reducing friction track for the passage of an instrument within the flexible membrane (Para 19,82). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Ginn/Zhou to include the spine such that it is made of stainless steel, nitinol or rigid polymer, as taught by Lenker, for the purpose of providing strength to the flexible membrane and reducing friction track for the passage of an instrument within the flexible membrane (Para 19,82).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham et al. (PG PUB 2014/0236123) in view of Ginn et al. (PG PUB 2016/0128723).
Re claim 23, Birmingham discloses an introducer dilator assembly 1010+1402 (Fig 43,44; it is noted that all reference characters cited below refer to Fig 43,44 unless otherwise noted; it also noted that membrane 1010 of Fig 43 is the same as membrane 10 of Fig 15) comprising: an introducer 1010+15 (wherein hub 15 is shown in Fig 15 and membrane 1010 is denoted as 10 in Fig 15) including: an introducer hub 15 (Fig 15); a tubular membrane 200+300 (Fig 8,9) coupled to the introducer hub and extending distally from the introducer hub (as seen in Fig 15), the tubular membrane having a folded state 40 (Fig 8; “collapsed state 40”, Para 79; “collapsed or closed state”, Para 104) and an expanded, unfolded state 50 (Fig 9; “expanded state 50”, Para 80); and a spine 100 (Fig 8), attached to, partially attached to, extending through, or incorporated into the tubular membrane (as seen in Fig 8); and a dilator 1402 including: a dilator shaft (the shaft of dilator 1402 from which diameter retention element 1404 directly extends in Fig 43, labeled in Fig A below) and a dilator tip 1404 coupled to a distal end of the dilator shaft (as seen in Fig 43), the dilator tip having a radially expanded configuration (seen in Fig 43) wherein a proximal end of the dilator tip is spaced from an outer surface of the dilator shaft to form a cavity between the outer surface of the dilator shaft and an inner surface of the proximal end of the dilator tip (as seen in Fig 43; Para 104) and a radially collapsed configuration (seen in Fig 44) wherein the inner surface of the proximal end of dilator tip is in contact with the outer surface of the dilator shaft (not shown but described in Para 104 which states “diameter retention element 1404 can be elastic and can collapse against dilator 1402”); wherein in an assembled configuration (seen in Fig 43), the dilator shaft extends through the introducer hub and the tubular membrane such that the dilator hub is proximal of the introducer hub, the distal end of the dilator shaft is distal of a distal end of the tubular membrane, and the dilator tip extends proximally from the distal end of the dilator shaft and houses the distal end of the tubular membrane therewithin (as seen in Fig 43; Para 104), wherein in a disengaged configuration (seen in Fig 44), the dilator shaft is disposed distally relative to the assembled configuration such that the proximal end of the dilator tip is distal of the distal end of the tubular membrane, thereby disengaging the distal tip from the distal end of the tubular member, wherein in the disengaged configurated the distal tip is in the radially collapsed configuration (as seen in Fig 44; Para 104). Birmingham does not explicitly disclose a dilator hub coupled to the dilator shaft from which the dilator shaft extends distally therefrom.
Ginn, however, teaches an introducer dilator assembly 300 (Fig 13; it is noted that all reference characters cited below refer to Fig 13 unless otherwise noted) comprising: an introducer 301 including an introducer hub 302+303 and a tubular membrane 304 that is coupled to the introducer hub and extends distally therefrom (as seen in Fig 13) – wherein the tubular membrane has a folded state 322 and an expanded, unfolded state 321 (as seen in Fig 16D; Para 59) – and a dilator 305 including a dilator hub 312 (seen in Fig 13 but not labeled; labeled in Fig 15A) and a dilator shaft 306 coupled to the dilator hub and extending distally therefrom (as seen in Fig 13), wherein the dilator extends through the introducer hub, the dilator hub is proximal of the introducer hub, a distal end of the dilator shaft is distal a distal end of the tubular membrane, and a dilator tip 308 houses the distal end of the tubular membrane in an assembled configuration (as seen in Fig 14A,16E) and wherein the dilator shaft is disposed distally relative to the assembled configuration such that the dilator tip disengages from the distal end of the tubular member by extending (Para 65). Ginn teaches that providing the dilator with a dilator hub allows for a retention clip 309 (Fig 14A) to hold the dilator in position relative to the introducer until the desired location in the vasculature is reached (Para 72). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Birmingham to include a dilator hub, as taught by Ginn, for the purpose of allowing for a retention clip to hold the dilator in position relative to the introducer during insertion into the vasculature (Para 72).
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Re claim 24, Birmingham as modified by Ginn in the rejection of claim 23 above discloses all the claimed features with Ginn teaching that the assembly further comprises a removable clip 309 (Fig 14A), wherein in the assembled configuration, the removable clip is coupled to a proximal portion of the dilator shaft between the introducer hub and the dilator hub (as seen in Fig 14A) and prevents distal advancement of the dilator relative to the introducer (Para 62). Ginn teaches that providing a removable clip ensures that the dilator is held in position relative to the introducer until the desired location in the vasculature is reached (Para 72). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Birmingham to include a removable clip, as taught by Ginn, for the purpose of ensuring that the dilator is held in position relative to the introducer until the desired location in the vasculature is reached (Para 72).
Re claim 25, Birmingham as modified by Ginn in the rejection of claim 23 above discloses all the claimed features with Ginn teaching that, in the disengaged configuration, the removable clip is removed from the assembly such that the dilator may be advanced distally relative to the introducer such that the distal tip of the dilator releases the distal end of the tubular membrane (Para 72) for the purpose of allowing the dilator to be removed from the introducer when the desired location in the vasculature is reached (Para 72). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Birmingham to include the assembly such that the disengaged configuration comprises the removable clip being removed, as taught by Ginn, for the purpose of allowing the dilator to be removed from the introducer when the desired location in the vasculature is reached (Para 72).
Response to Arguments
Applicant’s arguments filed 12/5/2025 have been fully considered but are moot in view of the present Office Action using an interpretation of Ginn that differs from that used in the last Office Action.
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783