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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 11th, 2025 has been entered.
Response to Amendment
Claims filed on December 1st, 2025 have been entered. Claims 3, 30, 41, 66- 67, 69, 71, and 73- 84 are pending in the application. Claims 76- 78 are withdrawn for being drawn to an unelected invention.
Claim Rejections - 35 USC § 102 and 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.
The rejection of claims 3, 30, 41, 71, 73, 75, and 80 under 35 U.S.C. 102(a)(1) over Bolduc et al. (US 2001/0001826) has been withdrawn in light of applicant’s amendments; specifically Bolduc does not teach wherein the plurality of retainers are elastically flexible.
The rejection of claims 66 and 67 under 35 U.S.C. 103 over Bolduc et al. (US 2001/0001826) in view of Cully et al. (US 2014/0046347) has been withdrawn in light of applicant’s amendments; specifically Bolduc does not teach wherein the plurality of retainers are elastically flexible.
The rejection of claim 68 under 35 U.S.C. 103 over Bolduc et al. (US 2001/0001826) in view of Davis et al. (WO 02/098316) has been withdrawn as claim 68 has been cancelled.
The rejection of claims 69, 74 and 81 under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) has been withdrawn in light of applicant’s amendments; specifically Bolduc does not teach wherein the plurality of retainers are elastically flexible.
The rejection of claim 79 under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) in view of Yoon (WO 94/04067) has been withdrawn in light of applicant’s amendments; specifically Bolduc does not teach wherein the plurality of retainers are elastically flexible.
Claim(s) 3, 30, 41, 71, 73, 75, 80, and 82- 84 is/are rejected under 35 U.S.C. 103 over Bolduc et al. (US 2001/0001826) in view of Davis et al. (WO 02/098316).
Regarding claim 30, Bolduc (Bolduc et al.) teaches a tubular tissue transformer (10)(Figs. 1- 5)(Paragraphs 0048 and 0050) for a tubular tissue structure (abstract), the tubular tissue transformer comprising:
a plurality of retainers (tissue securing members 14) configured to retain an everted portion of the tubular tissue structure (Paragraph 0050);
a substantially longitudinal passage, the plurality of retainers being located about an opening of the passage (see annotated Fig. 3 below); and
an applier member (16)(Applicant sets forth on Page 9, Lines 4-5 that a bushing is “a member located about the inner perimeter of a passage or opening”, as the applier member is located about the inner perimeter of the passage and other applier member 18 (see Fig. 1), it is considered a bushing.) configured to couple about an outer wall of the corresponding first or second tubular tissue structure (For purposes of examination, the bushing is considered coupled about an outer wall when it surrounds the outer wall, as the bushing is required to move. Since Bolduc teaches that the applier member 16 moves around the tubular tissue structure, it is coupled about it (Paragraphs 0048 and 0049).), in situ, the bushing being movable between a first position and a second position (In Paragraph 0052, Bolduc teaches that the applier member moves from a distal position to a proximal position, for purposes of examination, the first position is the applier member at its distalmost position, and the second position is the applier member after being retracted proximally.) and having one or more support surfaces configured to support an outer wall of the everted portion of the tubular tissue structure in the second position (see annotated Fig. 4 below)(Paragraphs 0051 and 0052), wherein the bushing is movable longitudinally along the passage from the first position to the second position to cause the plurality of retainers to move radially outwardly relative to the opening of the passage and accordingly further evert the tubular tissue structure when it is retained by the plurality of retainers (Paragraph 0052, see annotated Figs. 3 and 4 below)(As the tissue tubular structure is further pulled by the plurality of retainers (14) when they move radially outwardly, the tissue tubular structure is further everted.), wherein in the second position, the one or more support surfaces of the bushing locate proximal to ends of the plurality of retainers to support the outer wall of the everted portion of the tubular tissue structure (see annotated Fig. 4 below), and wherein the TTT is configured such that the bushing cannot advance beyond the second position (As Bolduc teaches in Paragraph 0052 that after the applier member is moved into the second position and the plurality of retainers are secured to the tissue structures, the applier member 16 and the other applier 18 are removed from the body, the bushing would not advance distally beyond the second position, since it would be removed from the body.).
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Bolduc does not teach in wherein the plurality of retainers are elastically flexible.
Davis (Davis et al.) teaches a similar a tubular tissue transformer (tool 79, anastomosis ring 80)(Figs. 16-25A)(Page 20, Lines 19- 20) for a tubular tissue structure (abstract), the tubular tissue transformer comprising: a plurality of retainers (tine 80A) configured to retain an everted portion of the tubular tissue structure (Page 22, Lines 19- 22; Page 22, Line 28- Page 23, Line 2; Page 23, Lines 9- 13) that are elastically flexible (Page 20, Lines 25- 26; Page 18, Lines 8- 10); a substantially longitudinal passage, the plurality of retainers being located about an opening of the passage (see annotated Fig. 25A below); and an anvil (70A)(Applicant sets forth on Page 9, Lines 4-5 that a bushing is “a member located about the inner perimeter of a passage or opening”, as the anvil is located about the inner perimeter of the passage of the anastomosis ring 80 (see Fig. 25A), it is considered a bushing.) and wherein the bushing is movable longitudinally along the passage from the first position to the second position to cause the plurality of retainers to move radially outwardly relative to the opening of the passage and accordingly further evert the tubular tissue structure when it is retained by the plurality of retainers (Page 23, Lines 6- 13).
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It would have been obvious to one of ordinary skill in the art to modify the plurality retainers as taught by Bolduc to be the malleable plurality of retainers as taught by Davis for the purpose of retaining everted tissue (Bolduc, Paragraph 0050 ; Davis, Page 22, Lines 19- 22; Page 22, Line 28- Page 23, Line 2; Page 23, Lines 9- 13). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one plurality of retainers for another because both are disclosed as equivalent structures for retaining the everted tissue of a tubular tissue structure (Bolduc, Paragraph 0050 ; Davis, Page 22, Lines 19- 22; Page 22, Line 28- Page 23, Line 2; Page 23, Lines 9- 13) and substitution of one for the other would have resulted in the predictable result of having a malleable structure that retains tissue. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the plurality of retainers are elastically flexible
It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the plurality of leaves as taught by the combination to be elastically flexible, since Davis teaches that a flexible element can be “elastic or malleable” (Page 10, Lines 25- 29) and that the plurality of leaves is malleable, and therefore a flexible element (Page 20, Lines 25- 26; Page 18, Lines 8- 10). One of ordinary skill in the art would recognize that one has two options for the plurality of leaves, to have them be malleable, or have them be elastic, and therefore elastically flexible. Thus, having the plurality of leaves be elastically flexible 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 3, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc further teaches wherein one or more of the retainers curve or angle away from a longitudinal axis of the tubular tissue transformer (see annotated Fig. 5 below).
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Regarding claim 41, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc further teaches the tubular tissue transformer being configured such that each of the plurality of retainers has a radially contracted configuration when the bushing is in the first position and a radially expanded configuration when the bushing is in the second position (see annotated Figs. 3 and 4 below)(Paragraphs 0051 and 0052).
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Regarding claim 71, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc further teaches wherein the one or more support surfaces are formed from a widened portion of the bushing (bell-shaped end 20)(see Fig. 1 and see annotated Fig. 3 below)(Paragraph 0052).
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Regarding claim 73, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Regarding wherein in the second position of the bushing, the TTT is configured to evert the tubular tissue structure with a radius of curvature greater than 0.2 mm, as this language is functional, the structure only needs to have the ability to complete the function, since Bolduc teaches that the applier member is capable of everting tissue (Paragraphs 0050- 0052)(see Figs. 3 and 4), it would be able to evert a tubular tissue structure with a radius of curvature.
Regarding claim 75, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc further teaches wherein when the plurality of retainers are in the radially contracted configuration, the plurality of retainers are configured to retain the tubular tissue structure in a less everted state than when the plurality of retainers are in the radially expanded configuration (see annotated Figs. 3 and 4 below)(Paragraphs 0050- 0052).
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Regarding claim 80, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc teaches wherein an end of each of the retainers locates near, and extends at an angle relative to an adjacent support surface of the one or more support surfaces of the bushing, when the bushing is in the second position (see Fig. 1, each retainers is located near the end of the bushing, denoted by the bell-shaped end 20, which forms the support surface.)(annotated Fig. 4 below).
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Regarding claim 82, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Regarding wherein, in the second position, the bushing is configured to engage with the retainers to resist retraction away from the second position towards the first position, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore since Bolduc teaches that the bushing contacts the retainer (Paragraph 0052)(see Fig. 4 of Bolduc) it is in frictional engagement with the retainer and therefore capable of resisting retraction away from the second position towards the first position.
Regarding claim 83, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc further teaches wherein each of the one or more support surfaces of the bushing curves outwardly away from a center of the everted portion to support an outer surface of the everted portion in an outwardly- curved configuration (see annotated Fig. 4 below).
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Regarding claim 84, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Regarding wherein, in the second position, the bushing resists movement away from the second position, since Bolduc teaches that the bushing contacts the retainer (Paragraph 0052)(see Fig. 4 of Bolduc) it is in frictional engagement with the retainer and therefore capable of resisting movement away from the second position. Furthermore, the bushing is not required to lock to the retainer or lock into the second position, so it is only required to resist movement, which can be done through frictional engagement with the retainer.
Claim(s) 66- 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) in view of Davis (WO 02/098316), as applied to claim 30 above, in further view of Cully et al. (US 2014/0046347).
Regarding claims 66 and 67, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc does not teach (claim 66) wherein the plurality of retainers are grouped together into two or more groups of retainers about the opening of the passage or (claim 67) wherein the plurality of retainers are grouped in pairs.
Cully (Cully et al.) teaches an anchor (110)(Fig. 4A) for retaining tissue (abstract), the anchor have a plurality of leaves (218) with a plurality of retainers (219) on each of the plurality of leaves (see annotated Fig. 4A below). Cully further teaches wherein the plurality of retainers associated with each leaf are closely grouped and each leaf comprises a pair of retainers (see annotated Fig. 4A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of retainers to have a shape that has the retainers grouped together into two or more groups as taught by Cully, since Cully teaches that the shape of the retainers is capable of “penetrating tissue and securing anchor 110 to the anatomy of the patient” (Paragraph 0035).
Claim(s) 69, 74 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) in view of Davis (WO 02/098316), as applied to claim 30 above.
Regarding claim 69, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc teaches wherein each of the one or more support surfaces curve outwardly (see annotated Fig. 4 below).
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Bolduc does not teach wherein each of the one or more support faces curves outwardly by between 30 degrees and 90 degrees.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of the support faces to curve outwardly between 30 degrees and 90 degrees, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaming from having the claimed shape.
Regarding claim 74, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
Bolduc does not teach wherein a wall of the bushing comprises one or more gaps at an end of the bushing.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wall of the bushing to comprise one or more gaps, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaming from having the claimed shape.
Regarding claim 81, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the angle between the support face of the bushing and each of the retainers of the plurality of leaves to be less than 45 degrees, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaming from having the claimed shape.
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) in view of Davis (WO 02/098316), as applied to claim 30 above, in further view of Luan (CN 207429093 English Machine Translation).
Regarding claim 79, Bolduc and Davis make obvious the tubular tissue transformer as discussed above.
As discussed above, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the plurality of leaves as taught by the combination to be elastically flexible, since Davis teaches that a flexible element can be “elastic or malleable” (Page 10, Lines 25- 29) and that the plurality of leaves is malleable, and therefore a flexible element (Page 20, Lines 25- 26; Page 18, Lines 8- 10). One of ordinary skill in the art would recognize that one has two options for the plurality of leaves, to have them be malleable, or have them be elastic, and therefore elastically flexible. Thus, having the plurality of leaves be elastically flexible 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.
The combination does not teach wherein one or more of the leaves and/or the bushing is(are) transparent.
Luan teaches of a transparent and elastic material (Paragraphs 0007 and 0024) that is used in surgery (Paragraphs 0001and 0003).
It would have been obvious to one of ordinary skill in the art to modify the plurality of leaves as taught by the combination to be made of a transparent and elastic material as taught by Luan, since the combination makes obvious a flexible, elastic material (see claim 30 and obviousness statement above), and the transparent material as taught by Luan is elastic and is known in the art to be used in devices meant for surgery (Luan, Paragraphs 0003 and 0024).
Response to Arguments
Applicant’s arguments, see Pages 10- 20, filed June 9th, 2025 with respect to the rejection of claims 3, 30, 41, 71, 73, 75, and 80 under 35 U.S.C. 102(a)(1) over Bolduc et al. (US 2001/0001826), the rejection of claims 66 and 67 under 35 U.S.C. 103 over Bolduc et al. (US 2001/0001826) in view of Cully et al. (US 2014/0046347), the rejection of claim 68 under 35 U.S.C. 103 over Bolduc et al. (US 2001/0001826) in view of Davis et al. (WO 02/098316), the rejection of claims 69, 74 and 81 under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826), the rejection of claim 79 under 35 U.S.C. 103 as being unpatentable over Bolduc et al. (US 2001/0001826) in view of Yoon (WO 94/04067) have been considered but are moot as the previous rejections have been withdrawn in light of the amendments as discussed above. It is noted that Bolduc, Davis, Cully, and Yoon are still relied upon in the rejection above.
Regarding applicant’s arguments, see Pages 8- 12, that Davis does not make obvious the plurality of retainers being elastically flexible has been considered but is not persuasive. As discussed above, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the plurality of leaves as taught by the combination to be elastically flexible, since Davis teaches that a flexible element can be “elastic or malleable” (Page 10, Lines 25- 29) and that the plurality of leaves is malleable, and therefore a flexible element (Page 20, Lines 25- 26; Page 18, Lines 8- 10). One of ordinary skill in the art would recognize that one has two options for the plurality of leaves, to have them be malleable, or have them be elastic and therefore elastically flexible. Thus, having the plurality of leaves be elastically flexible 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. Furthermore, Davis teaches that the fastener elements can be malleable elements, spring elements or both (Page 4, Lines 12- 14).
Regarding the idea that Davis teaches away from an elastic material, see Page 11, this argument is not persuasive, merely stating a preferred embodiment is not teaching away (MPEP 2123: "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004))– the reference needs to discredit, discourage, or otherwise discuss the negatives of something in order to teach away from making the combination.
Conclusion
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771