DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 55-67, 69-70, and 73-76 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Yassinzadeh et al. (2010/0168767).
Yassinzadeh discloses the following claimed limitations:
Claim 55: An apparatus for deploying a sealant in a puncture through a patient's tissue adjacent a blood vessel (Fig. 9a-c), comprising: a tubular member (152) (Fig. 9a-c and [0047]) comprising a proximal end (Fig. 9a-c), a distal end (Fig. 9a-c) and a lumen (Fig. 9a-c) extending from the proximal end to the distal end (Fig. 9a-c), wherein the distal end of the tubular member includes a slitted distal tip (158) (Fig. 9a-c and [0047]); a sealant (121) (Fig. 9a-c, [0041], and [0047]) disposed within the lumen of the tubular member near the slitted distal tip (Fig. 9a-c, [0041], and [0047]), wherein the slitted distal tip is configured to open upon expansion of the sealant (Fig. 9a-c, [0041], and [0047]); and an advancer member (127) disposed within the lumen of the tubular member adjacent the sealant for exposing the sealant distally from the lumen of the tubular member when the tubular member is retracted proximally relative to the advancer member (Fig. 9a-c, [0044], and [0047]); and, a sleeve (40) (Fig. 8a and [0045]) slidably disposed over the slitted distal tip of the tubular member (Fig. 8a-i), wherein the sleeve comprises a proximal diameter (diameter at the proximal end in Fig. 8a) and a distal diameter (diameter at the distal end in Fig. 8a) and wherein the proximal diameter of the sleeve is configured to have a larger diameter than the distal diameter (Fig. 8a).
Claim 56: wherein expansion of the sealant occurs upon hydration of the sealant ([0041]).
Claim 57: wherein the advancer member is disposed within the lumen of the tubular member adjacent the sealant to maintain the sealant in the puncture adjacent the blood vessel and to expose the sealant distally from the lumen of the tubular member when the tubular member is retracted proximally relative to the advancer member (Fig. 9a-c, [0044], and [0047]).
Claim 59: a positioning element (90), wherein the sealant is compressed between against the positioning element when the advancer member is advanced distally (Fig. 8a-h and 10a-c )
Claim 60: wherein the slitted distal tip comprises a slit having a length longer than a length of the sealant to facilitate opening the slitted distal tip upon expansion of the sealant (Fig. 9c).
Claim 61: wherein the slitted distal tip is configured to reduce the sealant from binding up within the lumen of the tubular member near the slitted distal tip (Fig. 9a-c where it is capable of performing this function).
Claim 63: wherein the slitted distal tip is configured to accommodate expansion of the sealant prior to exposing the sealant from the tubular member (Fig. 9a-c where it is capable of performing this function).
Claim 64: wherein the slitted distal tip comprises a single longitudinal slit (Fig. 9a-c and [0047]).
Claim 65: wherein the single longitudinal slit extends proximally from the distal tip (Fig. 9a-c and [0047])
Claim 66: wherein the slitted distal tip is configured to provide flexibility to the distal end of the tubular member to facilitate retraction of the tubular member relative to the sealant (Fig. 9a-c and [0047] where it is capable of performing this function).
Claim 67: wherein the slitted distal tip is configured to pre-hydrate the sealant ([0041] where it is capable of performing this function)
Claim 69: wherein the sleeve is a cover (Fig. 9a-c and [0047]).
Claim 70: wherein the sleeve is configured to prevent the slitted distal tip from opening before the slitted distal end is exposed from the sleeve (Fig. 9a-c and [0047]).
Claim 73: wherein the sleeve is configured to provide a different frictional interference with an outer surface of the tubular member ([0047]).
Claim 74: wherein the sleeve further comprises a lumen which is configured to allow the sleeve to slide over the tubular member (Fig. 9a-c and [0047]).
Claims 75 and 76: See rejections above specifically the rejection of claim 55 and 59
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 55-58, 61-67, and 72 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rudnick (5,320,639) in view of Pai et al. (2006/0100664).
Rudnick discloses the following claimed limitations:
Claim 55:
Rudnik discloses an apparatus for deploying a sealant in a puncture through a patient's tissue adjacent a blood vessel (Abstract and Fig. 5-8), comprising: a tubular member (20) (Fig. 1-3 and Col. 3 Lines 60-67) comprising a proximal end (Fig. 3), a distal end (Fig. 3) and a lumen (lumen where all the parts enter as seen in Fig. 1-3) extending from the proximal end to the distal end (Fig. 3), wherein the distal end of the tubular member includes a slitted distal tip (26) (Fig. 1 and 3 and Col. 4 Lines 14-35); a sealant (18) (Fig. 1-3 and Col. 4 Lines 3-14) disposed within the lumen of the tubular member near the slitted distal tip (Fig. 1-3), wherein the slitted distal tip is configured to open upon expansion of the sealant (Fig. 5-8 where the slitted distal tip is capable of opening if the sealant is expanded); and an advancer member (22) (Fig. 1-3) disposed within the lumen of the tubular member adjacent the sealant for exposing the sealant distally from the lumen of the tubular member when the tubular member is retracted proximally relative to the advancer member (Fig. 1-8).
Rudnik teaches all the claimed limitations discussed above however, Rudnik does not disclose the sleeve as claimed.
Pai discloses an apparatus for deploying a sealant (2) comprising a tubular member (120) (Fig. 1); a sealant (2) (Fig. 1) disposed within the lumen of the tubular member near the distal tip (Fig. 1), and an advancer member (130) (Fig. 1) disposed within the lumen of the tubular member adjacent the sealant for exposing the sealant distally from the lumen of the tubular member (Fig. 1 and 5a-f); and, a sleeve (20) (Fig. 1) slidably disposed over the distal tip of the tubular member (Fig. 1 and 5a-f), wherein the sleeve comprises a proximal diameter (diameter at 23 in Fig. 1 or diameter at 24 in Fig. 1) and a distal diameter (diameter at 25 in Fig. 1) and wherein the proximal diameter of the sleeve is configured to have a larger diameter than the distal diameter (Fig. 1 and [0027]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Rudnik with a sleeve as claimed in view of the teachings of Pai, in order to provide an introducer sleeve that can facilitate advancement through a puncture as well as providing hemostatic seals that prevent proximal flow of blood or other fluids but allows insertion of one or more instruments such as the tubular member ([0027]). The sleeve will provide access into the vessel for one or more instruments, and/or allow one or more diagnostic and/or interventional procedures to be performed via the vessel ([0060]).
Rudnick further discloses the following claimed limitations:
Claim 56: wherein expansion of the sealant occurs upon hydration of the sealant (Col. 4 Lines 6-8).
Claim 57: wherein the advancer member is disposed within the lumen of the tubular member adjacent the sealant to maintain the sealant in the puncture adjacent the blood vessel and to expose the sealant distally from the lumen of the tubular member when the tubular member is retracted proximally relative to the advancer member (Fig. 1-8 and Col. 4 Lines 36-46).
Claim 58: wherein the advancer member tamps the sealant against the blood vessel when the advancer member is advanced distally (Fig. 5-8 and Col. 5 Line 60 – Col. 6 Line 19).
Claim 61: wherein the slitted distal tip is configured to reduce the sealant from binding up within the lumen of the tubular member near the slitted distal tip (Fig. 5-8 where it is capable of performing this function).
Claim 62: wherein the slitted distal tip comprises one or more slits (Fig. 1-3).
Claim 63: wherein the slitted distal tip is configured to accommodate expansion of the sealant prior to exposing the sealant from the tubular member (Fig. 5-8 where it is capable of performing this function).
Claim 64: wherein the slitted distal tip comprises a single longitudinal slit (one of the slits in Fig. 1-3).
Claim 65: wherein the single longitudinal slit extends proximally from the distal tip (Fig. 1-3).
Claim 66: wherein the slitted distal tip is configured to provide flexibility to the distal end of the tubular member to facilitate retraction of the tubular member relative to the sealant (Fig. 5-8 where it is capable of performing this function).
Claim 67: wherein the slitted distal tip is configured to pre-hydrate the sealant (Col. 4 Lines 6-8 where it is capable of performing this function)
Claim 72: wherein the sleeve is configured to have a length which is shorter than a length of the tubular member (Fig. 5d where the tubular member extends past the larger diameter area 23 of the sleeve)
Response to Arguments
Applicant's arguments filed 5/18/26 have been fully considered but they are not persuasive.
Applicant argues that Yassinzadeh was known to the examiner in the previous non-final office action dated 3/28/25 which indicated claim 71 as allowable. Therefore, applicant amended on 9/29/25 to add the limitations of claim 71 into claim 55 and therefore should be allowable in view of it being on record.
The examiner agrees that the claim was previously stated as being allowable subject matter, however after further review of the reference, it appears to the examiner that the claimed limitations on now pending claim 55 is found in Yassinzadeh and therefore the examiner issued a second non-final on 11/18/25 to correct the issue.
It appears to the examiner, as seen in the rejection above, that Yassinzadeh teaches the claimed limitations of claims 55-67, 69-70, and 73-76 and since applicant has not explained how the claims avoid the references or distinguish from them, the rejection was maintained.
Applicant further argues that the Present Office Action characterizes Pai in a manner disclosing certain aspects of the claimed apparatus but fails to point to where Pai teaches the aspects of the claimed invention not otherwise taught by Rudnick.
The examiner disagrees, as seen in the rejection above, Pai discloses a sleeve (20) (Fig. 1) slidably disposed over the distal tip of the tubular member (Fig. 1 and 5a-f), wherein the sleeve comprises a proximal diameter (diameter at 23 in Fig. 1 or diameter at 24 in Fig. 1) and a distal diameter (diameter at 25 in Fig. 1) and wherein the proximal diameter of the sleeve is configured to have a larger diameter than the distal diameter (Fig. 1 and [0027]).
Applicant further states that Rudnick fails to teach a vascular closure apparatus in which a sleeve is provided "slidably disposed over [a] slitted distal tip of [a] tubular member" (emphasis added).
As seen in the rejection above, the examiner states that Rudnik does not teach the sleeve as claimed, however this is taught by Pai which is used to teach the sleeve which would be use din combination with the device of Rudnik which would end up having the sleeve of Pai slidable disposed over the slitted distal tip of the tubular member of Rudnik.
Applicant further states that Pai, too, fails to teach a vascular closure apparatus comprising, among other things, a tubular member with a slitted distal tip.
As stated above, Pai is merely used to teach the sleeve which when used in combination with the slitted distal tip of Rudnik (26) (Fig. 1 and 3 and Col. 4 Lines 14-35) would meet the claimed limitations since it would have been obvious to a person having ordinary skill in the art at the time the invention was made to provide Rudnik with a sleeve as claimed in view of the teachings of Pai, in order to provide an introducer sleeve that can facilitate advancement through a puncture as well as providing hemostatic seals that prevent proximal flow of blood or other fluids but allows insertion of one or more instruments such as the tubular member ([0027] of Pai). The sleeve will provide access into the vessel for one or more instruments, and/or allow one or more diagnostic and/or interventional procedures to be performed via the vessel ([0060] of Pai).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
THIS ACTION IS MADE FINAL. 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 DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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