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 July 2nd, 2025 have been entered. Claims 1-3 and 7- 14 are pending in the application. The amendments to claim 1 overcomes the previous 35 U.S.C. 101 rejection and the restriction has been withdrawn in light of the cancelation of claims 16- 18.
Terminal Disclaimer
The terminal disclaimer filed on July 8th, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,744,591 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer overcomes the nonstatutory double patenting rejection of claims 1-3, 6- 13 over claims 1, 3, and 6- 14 of U.S. 11,744,591. The rejection is herein withdrawn.
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: The interpretation of C-ring is dependent on Applicant’s definition found on Page 7, Lines 10- 13, wherein the C-ring can be a circular or oval ring with an opening.
Claim(s) 1, 8- 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orion et al. (US 2011/0230955) in view of Goodwin et al. (US 6,808,533) and in view of Lois (US 5,851,232).
Regarding claim 1, Orion (Orion et al.) teaches a medical device (1400)(Fig. 14A)(Paragraph 0169) that is capable for anastomosis (It should be noted that Orion states within Paragraph 0069 that the device can be an intraluminal stent, which means that the device can be sized in order to perform an anastomosis and in Paragraph 0094, Orion teaches that the tubular support can be used in an anastomosis. Therefore the device is a medical anastomosis device.), the medical device comprising: a support element (vein support 1400)(Fig. 14A)(Paragraph 0169, 0170) defining a longitudinal axis (1408)(Fig. 14A), and an independent circular loop (one or more circular loops 1402A)(Paragraph 0170)(According to the Oxford Dictionary, a ring is defined as “a circular object”, therefore the circular loop is considered a ring. Furthermore, according to the Oxford Dictionary, a loop is defined as “a structure, series, or process, the end of which is connected to the beginning”, therefore Orion teaches a closed ring.) distributed (see annotated Fig. 14A below) and positioned at an acute orientation angle (the angle symbol)(Fig. 14A) relative to the longitudinal axis of the support element (Paragraph 0170 directly states that the acute orientation angle is based on the longitudinal axis.) at one end of the support element. Orion further teaches wherein the support element further comprises an end- ring (one or more circular loops 1402A)(Fig. 14A)(Examiner’s Note: For purposes of examination the circular loop that is an the end of the support element is herein considered the end- ring, since, as discussed above, the circular loops are considered rings, and this ring is at the end of the device.) attached to one end of the support element (Paragraph 0170), wherein the end- ring is aligned substantially in parallel, adjacent, yet independent to the circular loop (see annotated Fig. 14A below). Orion further teaches wherein the end-ring (one or more circular loops 1402A)(Fig. 14A) is an circular closed end- ring (As discussed above, the circular loop at the end of the device is considered the end-ring, and since, as discussed above, in Paragraph 0170 Orion teaches that 1402A is one or more circular loops, and a loop is known to be closed, Orion therefore teaches that the end-ring is a circular closed end-ring.).
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Regarding wherein at least one of the one or more independent C-rings are configured to be connected to a vessel to form an anastomosis, as this language is functional, the structure only needs to have the ability to complete the function, which, as the device taught by Orion has an independent C- ring (one or more circular loops 1402A)(Paragraph 0170), can be used during an anastomosis procedure and is able to connect a graft vessel and another vessel (Paragraph 0094, 0169, and 0170), it would accomplish this function.
Orion does not teach an inner tubular layer, outer tubular layer, or where the inner and outer tubular layers have the support element and C-ring embedded in- between them; or the ring as an open C-ring.
Regarding an inner tubular layer, outer tubular layer, or where the inner and outer tubular layers have the support element and C-ring embedded in- between them, Goodwin et al (Goodwin) teaches an intraluminal stent (covered stent 10)(Fig. 1) that has an inner tubular layer (inner cover 16)(Fig. 1) and an outer tubular layer (outer cover 18)(Fig. 1). Goodwin further teaches wherein the device has a stent (stent structure 12)(Fig. 1) covered by the outer cover and inner cover (Column 3, Lines 21- 34). The inner and outer covers are considered tubular due to how they are designed to cover a stent and are designed to extend along the entire length of the stent structure (Column 3, Lines 28- 34). Since the stent is between the outer and inner covers, and the covers are bonded to each other, the stent is considered to be embedded between the two layers. Therefore, Goodwin teaches that the stent, otherwise known as a support structure, is embedded between the inner and outer tubular layers.
Goodwin teaches that having an outer and inner cover on a stent reduces the tissue reactions that are associated with the stent coming into contact with the walls of vessels during its expansion (Column 1, Lines 17- 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the vein support element 10 as taught by Orion through covering the support structure and ring with an outer tubular layer and inner tubular layer to reduce the tissue reactions that are associated with the stent coming into contact with the walls of vessels as taught by Goodwin.
The combination (Orion as modified by Goodwin) does not teach one or more independent open C-rings.
Regarding the ring as an open C-ring, Lois teaches an intraluminal stent (10)(Fig. 1)(Column 4, Lines 10- 12) that has cut coils (16)(Fig. 1)(It is understood by the figures given by Lois that the cut coils are open C-rings, with a circular shape and opening.) embedded (Column 4, Line 12- 16) within an outer cylindrical shell (14)(Fig. 1)(Column 4, Lines 44- 51). Since the coils, otherwise known as C-rings, have a cut through them, they are therefore not fully closed, meeting the definition of C-rings as set forth by applicant (Applicant’s specification: Page 7, Lines 10- 12). Therefore, Lois teaches one or more independent open C-rings.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rings as taught by Orion to be the cut coils, i.e. C-rings with an opening, as taught by Lois, since Lois teaches that the cut coils allow for the stent to be further compressed which allows for easy insertion (Column 5, Lines 37 – 48).
Regarding claim 8, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion is silent to wherein the distance between the end- ring attached to the support element and the first independent C-ring is in the range of 0.5 to 1.5 mm.
Lois teaches an intraluminal stent (10)(Fig. 1) that has cut coils (16)(Fig. 1)(As discussed above, since Lois teaches that the coils are cut and are rings (Column 4, Lines 12- 17), Lois therefore teaches open C-rings.) embedded (Column 4, Line 12- 16) within an outer cylindrical shell (14)(Fig. 1). Lois further teaches wherein the C-rings are distanced from the edge of the device by 1 mm (Column 4, Lines 47- 51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the disclosed invention as taught by Orion, Goodwin, and Lois to have the distance between the one C-ring and the edge of the device, where the end-ring is located, be 1 mm, since this is a known value for a distance between a C-ring and the edge to achieve the predictable result of providing adequate support to the end of the stent.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the disclosed invention as taught by Orion, Goodwin and Lois to the claimed range of 0.5 mm to 1.5 mm as both Orion and Lois are directed to an intraluminal stent, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
As discussed above, the limitation of claim 9 is optional for when there are two or more C-rings within the device. Orion teaches of “one or more” rings (Paragraph 0170), which encompasses only one C ring and one end ring, and additionally that Figure 14A shows only one C ring with one end ring. Thus, since Orion only teaches one C-ring, this limitation is not required.
Regarding claims 10 and 11, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion further discloses wherein the acute orientation angle (the angle symbol)(Fig. 14A) is between the range of 20 – 80 degrees (In Paragraph 0170, Orion provides more specificity within this range, such as 20- 65 degrees and specifically 60 degrees. Therefore, Orion gives sufficient examples within the claimed range of 30- 60 degrees as recited in claim 10. Likewise, Orion gives sufficient examples within the claimed range of 15- 90 degrees as recited in claim 11 and sufficiently teaches this range as well.).
Regarding claim 12, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion further teaches wherein the support element is a braided tubular body (In Paragraph 0169, Orion discloses that the vein support may be the same as vein support 100 which is described in Paragraph 0123 as a braided tubular body.). As Orion teaches a vein support (Paragraph 0123), which is understood as a cardiovascular implant, Orion therefore discloses a support structure that is used in cardiovascular implants, therefore substantially disclosing what is claimed within Claim 12.
Regarding claim 14, Orion, Goodwin, and Lois make obvious the device and the use of the open C-rings as recited in claim 1.
Regarding wherein the one or more independent open C-rings prevent radial deformation, since the combination of Orion, Goodwin, and Lois teach open C-rings (Lois, 16)(Fig. 1) with the same structure as set forth by applicant, it would have been obvious to one of ordinary skill in the art that the open C-rings of the combination are able to accomplish the function of preventing radial deformation. Furthermore, Applicant discloses that “a ring-based support element can effectively prevent radial deformation” (Applicant’s specification, Page 10, Lines 12- 14), therefore, since the combination of Orion, Goodwin, and Lois teach a ring-based support element (Lois, 16)(Fig. 1), it would be obvious to one of ordinary skill in the art that the device of the combination would effectively prevent radial deformation.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orion in view of Goodwin in further view of Lois, as applied to claim 1 above, and in further view of Sostek et al. (US 2014/0141152).
Regarding claims 2 and 3, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion, Goodwin, and Lois do not teach wherein the inner tubular layer or the outer tubular layer are electrospun layers.
Sostek et al. (Sostek) teaches a device (abstract) which can be used intraluminally (Paragraph 0009), that has an inner tubular layer (11)(Fig. 1A) and an outer tubular layer (13)(Fig. 1A), since Sostek teaches that the inner layer is a tubular shape (Paragraph 0050), it would be obvious that the outer tubular layer, which is distributed on top of the inner tubular layer and a support structure, would also be tubular. Sostek also teaches that there is a support structure (14, 15)(Fig. 1B) in- between the two layers (Paragraph 0050). Sostek further teaches wherein the inner layer and the outer layer are made of an electrospun material (Paragraph 0006).
Sostek teaches that having an inner and outer layer made of electrospun material is useful for strengthening tissue scaffolds in order to prevent or reduce damage during implantation (Paragraph 0004). Since the device of Orion and the device of Lois can be intraluminal (Orion, Paragraph 0069; Lois, Column 1, Lines 5- 8), and Goodwin states that the inner and outer tubular layers can be made from the same or different biocompatible materials (Column 1, Lines 37 – 41), and Sostek states that the scaffold can be made of a biocompatible material (Paragraph 0114, it should be noted that the scaffold includes the electrospun layers and support element, therefore the electrospun layers are biocompatible.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the disclosed invention as taught by Orion, Goodwin, and Lois to have the tubular layers be the electrospun layers as taught by Sostek for the advantage of strengthening the device and to prevent or reduce damage during implantation.
Claim(s) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orion in view of Goodwin et al. in further view of Lois, as applied to claim 1 above, and in further view of Ferrera (US 2004/0193246).
Regarding claim 7, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion teaches that the C- ring (one or more circular loops 1402A)(Fig. 14) is made of a non- plastic deformable fiber (Paragraph 0170).
The combination fails to disclose the material of the one or more C- rings as being nitinol.
Ferrera teaches connected rings made of a non- plastic deformable fiber, nitinol (Paragraph 0014 that make up a support structure (see annotated Fig. 1A below) for an intraluminal device (Paragraph 0001).
Ferrera mentions that using nitinol is preferable, since a stent made of nitinol can “be cooled and loaded within the delivery catheter in a low- stress martensitic condition” and, after being introduced in the body, the stent can then assume a pre-determined configuration (Paragraph 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use nitinol as the non- plastic deformable material of the combination for the advantage of effectively loading the device within a catheter and then having the device resume a pre-determined configuration.
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Regarding claim 13, Orion, Goodwin, and Lois make obvious the device as recited in claim 1.
Orion teaches that the C- ring (one or more circular loops 1402A)(Fig. 14) is made of a non- plastic deformable fiber (Paragraph 0170).
The combination fails to disclose that the one or more independent C- rings are under pre- load.
Ferrera teaches an intraluminal device (Paragraph 0001) that has a self- expanding support structure (In Paragraph 0052, Ferrera teaches that the stent is preferably made of nitinol and is expandable without the need for a balloon catheter, due to its spring resilience) made of connected rings (see annotated Fig. 1A above). Pre- load is defined as “to load in advance and especially at a time removed from that of use” (Merriam- Webster Dictionary). It is understood that spring resilience, or self- expansion, is possible through an internal force enacting on the rings. Since the rings are compressed before being inserted into the body, as the device is inserted into a catheter (In the abstract of Ferrera, the device being loaded into a catheter by being rolled tightly is mentioned), there is a force, otherwise known as a load, applied to the device before the device is put into use. Therefore, Ferrera teaches a device that has a support structure made up of connected rings that are under pre- load.
Ferrera teaches that nitinol is a preferable material for this device (Paragraph 0014). Since Ferrera teaches that nitinol has a spring resilience and shape- memory, it is obvious that using nitinol for the C-ring would also mean having the C-ring be under pre- load. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the disclosed invention as taught by Orion, Goodwin, and Lois to have the C-ring be under pre- load as taught by Ferrera because of how nitinol is stated as a preferable material and due to how nitinol has a spring resilience and is a shape- memory material.
Response to Arguments
Applicant's arguments filed July 2nd, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Orion,are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, as Orion teaches a device that supports vein and can be used during an anastomosis (Paragraph 0094, 0169, and 0170), Goodwin teaches a support that can be used in a vascular system (abstract), and Lois teaches a support that can be used in a vascular system (abstract), they teach are that is within the inventor’s field of endeavor.
Applicant’s arguments, see Pages 5- 8, that the device as taught by Orion would not teach the limitation of “wherein at least one of the one or more independent, open C-rings are configured to be connected to a vessel to form an anastomosis” in claim 1 is not persuasive. As discussed above, as this language is functional, the structure only needs to have the ability to complete the function, which, as the device taught by Orion has an independent C- ring (one or more circular loops 1402A)(Paragraph 0170), can be used during an anastomosis procedure and is able to connect a graft vessel and another vessel (Paragraph 0094, 0169, and 0170), it would accomplish this function.
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