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 .
Response to Amendment
Claims filed on February 12th, 2026 have been entered. Claims 1-19 are pending in the application. The amendment to claims 3 and 7 overcome the previous claim objections and the amendments to claims 5, 10, 12, 17, and 18 overcome the previous 35 U.S.C 112(b) rejections.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “retraction element” in claims 1-12 and “deployment assembly” in claims 17 and 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“Deployment assembly” is being interpreted as “a release component 22 that restrains the footplate 40, a delivery component 26 that contains at least a portion of the footplate 40 and a suture 44 of the sealing unit 18 and one or more actuators, such as deployment actuator 38” (Paragraphs 0033 and 0034 of Applicant’s specification), or equivalents thereof.
“Retraction element” is being interpreted as an element having a first portion, a second portion, a distal wall and a side wall (Paragraphs 0050 and 0054) or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Examiner’s note: Deployment assembly is herein interpreted as “a release component 22 that restrains the footplate 40, a delivery component 26 that contains at least a portion of the footplate 40 and a suture 44 of the sealing unit 18 and one or more actuators, such as deployment actuator 38” (Paragraphs 0033 and 0034 of Applicant’s specification.), or equivalents thereof. “Retraction element” is being interpreted as an element having a first portion, a second portion, a distal wall and a side wall (Paragraphs 0050 and 0054) or equivalents thereof.
Claim(s) 1-5, 7, 12- 14, and 17- 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huss (WO 98/31286) in view of Redmond et al. (US 2002/0006429), as evidenced by Kaplan (JP 2011517605 English Machine Translation).
Regarding claim 1, Huss teaches a vascular closure device (Figs. 13- 17) configured to seal a puncture in an artery or vein (abstract, Page 1, Lines 4- 8), the vascular closure device comprising: a suture (positioning member 34), a footplate (anchor member 32) coupled to the suture (Page 10, Lines 9- 13), wherein the footplate is configured for deployment in a lumen of the artery or vein (see Fig. 14)(Page 25, Lines 3- 6), a sealing plug (tamping member 150)(On Page 23, Lines 13- 16 and 25- 30, Huss teaches that the tamping member has clotting agents which promotes the formation of a clot, thus plugging up an opening within a vessel and “preventing oozing or bleeding” from the puncture site.) movably coupled to the suture (Page 23, Lines 1- 5), the sealing plug having a forward end, a trailing end, and sides that extend from the forward end toward the trailing end, and an element (sealing member 30) positioned at the sealing plug (see annotated Fig. 14 below).
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Regarding the element being a retraction element, as the element is positioned underneath the sealing plug (see Fig. 14), when the suture (34) is pulled upward before the footplate is fully deployed within the vessel, the element would also move upward through being pushed by the footplate, and therefore push the sealing plug upward and out of the opening, acting as a retraction element.
Regarding wherein the sealing plug is configured for placement against an outer surface of the artery or vein to seal the puncture, as this language is functional, the structure of the combination merely needs to be capable of accomplishing the function. Since Huss teaches a sealing plug (tamping member 150) that occupies a puncture on the outer surface of a vessel (Page 23, Lines 25- 30) and comprises clotting factors which seals the puncture (Page 23, Lines 13- 16), Huss teaches a structure capable of accomplishing the function and therefore teaches the limitation.
Regarding wherein the sealing plug comprises a compressible material, as Huss teaches that the sealing plug (tamping member 150) can be made of polyglycolic acid (Page 23, Lines 5- 10) and Kaplan teaches that polyglycolic acid is known in the art to be compressible (Paragraph 0012 of Kaplan), then Huss teaches that the sealing plug comprises a compressible material.
Huss does not teach a tether coupled to the retraction element.
Redmond (Redmond et al.) teaches a similar vascular closure device (Figs. 18A- 20) comprising: a suture (230), a footplate (208), a retraction element that is a tether (232) coupled to the footplate (Paragraph 0070).
It would have been obvious to one of ordinary skill in the art to modify the vascular closure device as taught by Huss to have a tether coupled to the footplate, since Redmond teaches that the tether can pivot the footplate as need during use, thereby enabling the device to be retracted from the vessel for repositioning (Paragraph 0070).
Regarding the tether coupled to the retraction element, as the tether of the combination is coupled to the footplate, which is coupled to the retraction element through the suture (see Figs. 13 and 15)(Page 24, Lines 4- 5), it is indirectly coupled to the retraction element.
Regarding claim 2, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches wherein the retraction element (sealing member 30) is porous such that blood and other fluids can pass therethrough (Page 10, Lines 21- 25, one of ordinary skill in the art would recognize that foam is porous.).
Regarding claims 3 and 4, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches wherein the retraction element (sealing member 30) includes a retraction body having a forward surface and a trailing surface opposite the forward surface, wherein the trailing surface is opposite the forward end of the sealing plug (see annotated Fig. 14 below) and wherein the retraction body has a plurality of apertures configured to allow blood or fluid to pass through the retraction element (Page 10, Line 33- Page 11, Line 6).
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Regarding claim 5, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches wherein the retraction element (sealing member 30) is bioabsorbable (Page 9, Lines 30- 32).
Regarding claim 7, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss wherein the retraction element (sealing member 30) has a first portion positioned at the forward end of the sealing plug and a second portion adjacent to the sides of the sealing plug (see annotated Fig. 15 below).
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Regarding claim 12, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches wherein the retraction element is a first retraction element (sealing member 30) and the vascular closure device further comprises a second retraction element (instrument 20)(As the deployment system is taught to be able to move the vascular closure device (Page 12, Lines 25- 32), it can retract the device and therefore act as a second retraction element. Furthermore, the instrument is considered a retraction element as it has a first portion, a second portion, a distal end, and a sidewall (see annotated Fig. 13 below), which is the structure required by the retraction element.).
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Regarding claims 13 and 14, Huss and Redmond make obvious the vascular closure device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the vascular closure device as taught by Huss to have a tether coupled to the footplate, since Redmond teaches that the tether can pivot the footplate as need during use, thereby enabling the device to be retracted from the vessel for repositioning (Redmond, Paragraph 0070).
The combination further teaches wherein the tether comprises a suture and is a filament (Redmond, Paragraph 0070).
Regarding claim 17, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches a deployment assembly (instrument 20)(Page 12, Lines 25- 32, this instrument is an equivalent of the deployment assembly), wherein the tether extends through a deployment assembly (see Fig. 13).
Regarding claim 18, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches a deployment assembly (20)(Page 12, Lines 25- 32, this instrument is an equivalent of the deployment assembly).
Huss does not teach wherein the tether extends alongside the deployment assembly.
However, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the tether to extend alongside the deployment assembly. Huss teaches that the tether extends through the deployment assembly (see Fig. 13), and therefore one of ordinary skill in the art would have two options, to have the tether extend alongside the deployment assembly or have the tether extend within the deployment assembly. Thus, the tether extending alongside the deployment assembly would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 19, Huss and Redmond make obvious the vascular closure device as discussed above.
Huss further teaches the device further comprising a movable lock (locking disk 152) positioned along the suture (Page 23, Lines 1- 5), and a tamper (154) slidable along the suture (Page 23, Lines 1- 5), the tamper configured to slide the movable lock into engagement with the sealing plug (Page 23, Line 34- Page 24, Line 6).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huss (WO 98/31286) in view of Redmond et al. (US 2002/0006429) as evidenced by Kaplan (JP 2011517605 English Machine Translation), as applied to claim 1 above, in further view of Hill et al. (US 2012/0143243).
Regarding claim 6, Huss and Redmond make obvious the vascular closure device as discussed above.
The combination does not teach wherein the retraction element comprises a mesh structure.
Hill (Hill et al.) teaches a similar vascular closure device (abstract, Figs. 3A- 3C) comprising a suture (308), a footplate (306), and with a collagen element (312) that comprises a mesh structure (322)(Paragraphs 0049- 0051).
It would have been obvious to one of ordinary skill in the art to modify the retraction element of the combination to comprise a mesh structure as taught by Hill, since Hill teaches that the mesh “surrounds and supports the portion of the first plug segment” (Hill, Paragraph 0006) and the first plug segment is made of a collagen foam (Hill, Paragraphs 0049- 0051), which Huss also teaches is the same material as that of the retraction element (Huss, Page 21- 25).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huss (WO 98/31286) in view of Redmond et al. (US 2002/0006429) as evidenced by Kaplan (JP 2011517605 English Machine Translation), as applied to claim 1 above, as evidenced by Dictionary.com.
Regarding claim 15, Huss and Redmond make obvious the vascular closure device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the vascular closure device as taught by Huss to have a tether coupled to the footplate, since Redmond teaches that the tether can pivot the footplate as need during use, thereby enabling the device to be retracted from the vessel for repositioning (Redmond, Paragraph 0070).
Regarding wherein the tether comprises a wire, according to dictionary.com, a wire is defined as “a slender, stringlike piece or filament of a relatively rigid or flexible metal, usual circular in section, manufactured in a great variety of diameters and metals depending on its application”, as Redmond teaches that the tether is a filament and is slender and stringlike (see Fig. 18B of Redmond)(Paragraph 0070), Redmond teaches that the tether comprises a wire.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huss (WO 98/31286) in view of Redmond et al. (US 2002/0006429) as evidenced by Kaplan (JP 2011517605 English Machine Translation), as applied to claim 1 above, as evidenced by the Merriam-Webster Dictionary.
Regarding claim 16, Huss and Redmond make obvious the vascular closure device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the vascular closure device as taught by Huss to have a tether coupled to the footplate, since Redmond teaches that the tether can pivot the footplate as need during use, thereby enabling the device to be retracted from the vessel for repositioning (Redmond, Paragraph 0070).
Regarding wherein the tether comprises an elongated shaft, according to the Merriam-Webster Dictionary, a shaft is defined as “something suggestive of the shaft of a spear or arrow especially in long slender cylindrical form”, as the filament of Redmond is cylindrical, long, and slender (see Fig. 18B)(Paragraph 0070), it resembles the shaft of a spear and therefore is an elongate shaft.
Allowable Subject Matter
Claims 8- 11 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Huss (WO 9831286) and Redmond et al. (US 20020006429).
Huss teaches a vascular closure device (Figs. 13- 17) configured to seal a puncture in an artery or vein (abstract, Page 1, Lines 4- 8), the vascular closure device comprising: a suture (positioning member 34), a footplate (anchor member 32) coupled to the suture (Page 10, Lines 9- 13)(Page 25, Lines 3- 6), a sealing plug (tamping member 150)(On Page 23, Lines 13- 16 and 25- 30, Huss teaches that the tamping member has clotting agents which promotes the formation of a clot, thus plugging up an opening within a vessel and “preventing oozing or bleeding” from the puncture site.) movably coupled to the suture (Page 23, Lines 1- 5).
Redmond (Redmond et al.) teaches a vascular closure device (Figs. 18A- 20) comprising: a suture (230), a footplate (208), a retraction element that is a tether (232) coupled to the footplate (Paragraph 0070).
However, the prior art does not teach or suggest (claim 8) wherein the retraction element has a distal wall and a sidewall that extends in a proximal direction relative to the distal end, wherein the distal wall and the sidewall define an internal space that includes the forward end of the sealing plug. Furthermore, there is no motivation to modify Huss or Redmond to have the missing limitations.
Response to Arguments
Applicant's arguments filed on February 12th, 2026 have been fully considered but they are not persuasive.
Applicant’s argument, see Page 6, regarding that Huss does not teach the limitation of the sealing plug comprising a compressible material, this argument has been fully considered but is not persuasive. As discussed above, as Huss teaches that the sealing plug (tamping member 150) can be made of polyglycolic acid (Page 23, Lines 5- 10) and Kaplan teaches that polyglycolic acid is known in the art to be compressible (Paragraph 0012 of Kaplan), then Huss teaches that the sealing plug is can comprise a compressible material. Furthermore, as Huss teaches that the sealing plug (tamping member 150) softens when introduced into the body, then the material of the sealing plug is not so rigid to be unable to be compressed (Page 22, Lines 7- 11).
Applicant’s argument, see Page 7, regarding that Huss does not teach a retracting member has been fully considered but is not persuasive. As discussed above, as the element is positioned underneath the sealing plug (see Fig. 14), when the suture (34) is pulled upward before the footplate is fully deployed within the vessel, the element would also move upward through being pushed by the footplate, and therefore push the sealing plug upward and out of the opening, acting as a retraction element.
Applicant’s argument, see Page 7, regarding that the tamping member of Huss is not a sealing plug, this argument has been fully considered but is not persuasive. As discussed above, Huss teaches that the tamping member 150 occupies a puncture on the outer surface of a vessel (Page 23, Lines 25- 30) and comprises clotting factors which seals the puncture (Page 23, Lines 13- 16), and therefore acts as a sealing plug.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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