DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 1/12/2026. As per the amendments therein, claim 18 has been amended, claim 36 has been added, and no claims have been cancelled. Thus, claims 18-22, 25-26, and 28-36 are pending in the application.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/12/2026 has been entered.
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 18-22, 26, and 28-36 are rejected under 35 U.S.C. 103 as being obvious over Sutton et al. (US Pub. 2012/0221024) in view of Elias et al. (US Pat. 5,549,566) in view of Koch et al. (US Pub. 2009/0209914).
Regarding claim 18, Sutton discloses a method of making a vascular access hemostasis sealing device (device of Figs. 1-7) comprising: obtaining an enclosure configured to at least partially receive a medical device (enclosure 120 in Fig. 1; see also [0022]), the enclosure defining a cavity (cavity 122 in Fig. 1) and comprising a distal end (proximal end 104 in Fig. 2, where the naming of an end as “proximal” or “distal” is arbitrary) a proximal end (the end of the enclosure 120 at first seal 110 in Fig. 1) a first seal portion (first seal portion 110 in Fig. 1); a second seal portion (second seal portion 130 in Fig. 1), the cavity disposed between the first seal portion and the second seal portion (see cavity 122 between the first and second seal), wherein the second seal portion is located distal from the first seal portion (see Fig. 1 where seal 130 is distal to seal 110), wherein the enclosure is configured to receive the medical device through the second seal portion (see [0017] and Fig. 1 where devices go through seal 110 first; it is noted that it appears the Applicant is including the “guide wire” of the disclosure as at least part of the medical device. It is further noted that the claim is directed to a “method of making” and the language regarding the medical device is under the parts of the enclosure, such that the medical device is not being positively claimed and merely amounts to an intended use of the device); a barrel in structural communication with the second seal portion (Sutton; barrel 140 in Fig. 1 around the second seal 130), and a plurality of support ribs operably connected to the second seal portion (support ribs 170 in Fig. 2), where the plurality of support ribs extend axially outward (see support rubs 170 in Fig. 2, which extend axially outward and beyond barrel 140).
Sutton lacks a detailed description of the barrel defining a retaining flange around an outer perimeter of the barrel, wherein the retaining flange extends from the barrel such that adjacent portions of the barrel proximal and distal to the retaining flange have a smaller diameter than the retaining flange, disposing a constriction ring around the enclosure, the constriction ring comprising an elastomeric material, the constriction ring interfacing with the second seal portion to limit movement of the second seal portion; wherein the constriction ring is disposed around the enclosure between the plurality of support ribs and the retaining flange and between a proximal portion of the second seal portion and a distal portion of the second seal portion; wherein the retaining flange is configured to retain the constriction ring in position and the retaining flange is disposed between the constriction ring and the distal end of the enclosure, the retaining flange is disposed closer to a distal end of the plurality of support ribs than to the distal end of the enclosure, wherein the plurality of support ribs axially extend beyond the constriction ring.
However, Elias teaches a valve system for a medical device, having the barrel (see Figs. 1-2 head portion 50, which includes circumferential lip 60 and annular recess 58) defining a retaining flange around an outer perimeter of the barrel (see Figs. 1-2 ring 20), wherein the retaining flange extends from the barrel such that adjacent portions of the barrel proximal and distal to the retaining flange have a smaller diameter than the retaining flange (see Figs. 1-2 where the radial extend of circumferential lip 60 is a larger diameter than the section of head portion 50 that is distal to it, and has a larger diameter than the annular recess 58 that is proximal to it), disposing a constriction ring around the enclosure (see Figs. 1-2 where the ring 20 fits radially around the annular recess 58 of the head portion 50), the constriction ring comprising an elastomeric material, the constriction ring interfacing with the seal portion to limit movement of the seal portion (see Col. 5 lines 60-65); wherein the constriction ring is disposed around the enclosure (see Figs. 1-2 where the ring 20 fits around the body of head portion 50) between the plurality of support ribs and the retaining flange (see Figs. 1-2 where the ring 20 is placed between the ribs 56 and the circumferential lip 60) and between a proximal portion of the seal portion and a distal portion of the seal portion (see Figs. 1-2 where the ring 20 is placed between the first end 46 and second end 48 of the valve 16); wherein the retaining flange is configured to retain the constriction ring in position (see Figs. 1-2 where the circumferential lip 60 extends so as to block axial movement of the ring 20, thus helping hold it in place) and the retaining flange is disposed between the constriction ring and the distal end of the enclosure (see Figs. 1-2 where the circumferential lip 60 is between the first end 46 and the ring 20), the retaining flange is disposed closer to a distal end of the plurality of support ribs than to the distal end of the enclosure (see Figs. 1-2 where one end of the ring 20 is directly adjacent to the ribs 56, and another end of the ring 20 is closer to first end 46 but has the length of circumferential lip 60 between the end of the ring and first end 46, thus making the ring 20 closer to ribs 56 than first end 46), wherein the plurality of support ribs axially extend beyond the constriction ring (see Figs. 1-2 where the ribs 56 closer to second end 48 are radially extended further outward than ring 20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel and seal of Sutton to have a compressive ring placed around it and held by a retaining flange as taught by Elias as it would ensure that the bore of the seal maintains a liquid-tightness to better prevent leakage and contamination (Elias; see Col. 4 lines 12-17). It is understood that in the modified Sutton device, the second seal of the modified device of Sutton Fig. 1 has the constriction ring (Elias; ring 20 in Figs. 1-2) around it, and it is placed around the seal area 130 such that it is between the very proximal end of seal 130 (which interfaces directly with cavity 122) and the distal end of barrel opening 142. Further, the ring as taught by Elias is placed around the barrel of Sutton, such that it is able to compress the second sealing portion 330, and thus the ring is placed at the bottom of the barrel so as to be in-line with and compress the seal. Hence, the support ribs (Sutton; 170 in Fig. 2) extend axially beyond both the barrel (140) and the ring placed around the barrel as taught by Elias.
The modified Sutton device lacks a detailed description of the constriction ring comprising an elastomeric material. It is noted that the compression ring of Elias is designed to deliver a lateral compression while being able to be opened wider upon receiving a sufficient opening force, and that such materials would be generally understood to be elastomeric.
However, in the alternative that the modified Sutton device lacks the constriction ring comprising an elastomeric material, then it is taught by Koch. Koch teaches a medical sealing valve system, having a barrel (see Fig. 2 sealing member 50 (unlabeled), which is understood to be the barrel part of the seal through which aperture 62 runs, containing circular flange 58, and notch 60), disposing a constriction ring around the barrel (see Fig. 2 washer 66 that is placed around the barrel of the sealing member), the constriction ring comprising an elastomeric material (see [0023]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constriction ring of the modified Sutton device to be an elastomeric constriction ring as taught by Koch as it would be a simple substitution of one material of constriction ring for another material of constriction ring, to yield the predictable result of providing a ring that provides compressive forces.
Regarding claim 19, the modified Sutton device has the support ribs configured for compressive interfacing with a housing (Sutton; see [0018]).
Regarding claim 20, the modified Sutton device has the second seal portion comprising a split, septum seal (Sutton; see [0006]).
Regarding claim 21, the modified Sutton device has wherein the constriction ring is disposed around the barrel (Sutton; see barrel 140 in Fig. 1, which defines the second seal, and in the modified device has the ring of Elias placed around it to compress the seal aperture).
Regarding claim 22, the modified Sutton device has the barrel defining a notch around the outer perimeter of the barrel, wherein the notch is defined between the proximal end of the enclosure and the retaining flange, the notch configured to receive the constriction ring (Elias; see Figs. 1-2 where circumferential lip 60 leads into annular recess 58, such that the annular recess is a notch that goes around the circumference of the modified Sutton barrel to receive the ring of Elias, and is placed between a proximal end of the enclosure and the circumferential lip).
Regarding claim 26, the modified Sutton device has the constriction ring comprising a non-polygonal shaped cross-section (Elias; see Figs. 1-2 where ring 20 is annular, thus having a circular, disc-shaped cross-section).
Regarding claim 28, the modified Sutton device has the first seal portion comprises a hole seal (Sutton; see [0006]).
Regarding claim 29, the modified Sutton device has the first seal portion comprises a ring seal (Sutton; see claim 3).
Regarding claim 30, the modified Sutton device has the second seal portion is configured to be held in compression by a mating housing (Sutton; see end of [0025]).
Regarding claim 31, the modified Sutton device has the second seal portion defines a single axial split 45 degrees offset from the support ribs (Sutton; see [0006] and claim 8).
Regarding claim 32, the modified Sutton device has the second seal portion defines a split (Sutton; see [0006]), and wherein the support ribs are offset from the split by about 45 degrees (Sutton; see end of [0035]).
Regarding claim 33, the modified Sutton device has the second seal portion defines a split (Sutton; see [0006]), and wherein the support ribs are substantially symmetrical relative to the split (Sutton; see [0032]).
Regarding claim 34, the modified Sutton device has the constriction ring is restricted between the plurality of support ribs and the retaining flange (Sutton; see Figs. 1-2 where the ring taught by Elias aligns at the bottom of barrel 140 so as to compress seal portion 130, with the support ribs 170 below and proximal to the ring, and the retaining flange taught by Elias is aligned above and distal to the ring so as to hold it in place, thus having the ring in the modified device between the support ribs and retaining flange).
Regarding claim 35, the modified Sutton device has wherein the retaining flange comprises a symmetric cross-section (Elias; see Figs. 1-2 where a plane can vertically cut through the middle of the circumferential lip 60, forming a symmetric cross-section).
Regarding claim 36, the modified Sutton device has wherein the constriction ring comprises: a first surface defining an inner portion of the constriction ring (Elias; see Figs. 1-2 an inner surface of ring 20 that is radially inward and abuts the surface of the recess 58), a second surface defining a top portion of the constriction ring (Elias; see Figs. 1-2 a top surface of ring 20 that abuts the flange formed by circumferential lip 60), a third surface defining an outer portion of the constriction ring (Elias; see Figs. 1-2 the outer surface that is radially outward and opposite the inner surface), and a fourth surface defining a bottom portion of the constriction ring (Elias; see Figs. 1-2 a bottom surface closest to second ribs 56 and opposite to the top end), wherein the first surface is larger than the second surface (Elias; see Figs. 1-2 where the inner surface is a longer side surface, which is larger than the smaller top surface), wherein the first surface is adjacent to the barrel of the enclosure (Elias; see Figs. 1-2 where the inner surface of the ring 20 is adjacent to and abuts the barrel of the enclosure in the modified Sutton device) and the fourth surface is adjacent to a top portion of the plurality of support ribs (Elias; see Figs. 1-2 where the fourth surface is the bottom surface of ring 20 closest to the proximal end, such that in the modified Sutton device it is adjacent to the support ribs).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Sutton in view of Elias in view of Koch as applied to claim 18 above, and further in view of Kurth (US Pub. 2005/0020981).
Regarding claim 25, the modified Sutton device has the constriction ring comprising a cross-section.
The modified Sutton device lacks a detailed description of the constriction ring comprising a polygonal shaped cross-section.
However, Kurth teaches a similar seal device, where a constriction ring comprises a polygonal shaped cross-section (see Fig. 9A and [0049] where the housing which forms the constriction ring can be rectangular in shape, thus having a polygonal cross-section).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the constriction ring of the modified Sutton device to have a rectangular cross-section as taught by Kurth, as it would be a simple matter of design choice for one of ordinary skill in the art to choose different shaped constriction rings, to provide the same constriction force on the barrel of the seal.
Response to Arguments
Applicant’s arguments filed 1/12/2026 with respect to claims 18-22, 25-26, and 28-36 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. Specifically, the newly applied Elias teaching reference is relied upon to teach the limitations regarding the retaining flange and constriction ring, which modify the Sutton reference.
For the reasons above, the rejections hold.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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