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 . 01/06/2026
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 12/18/2025. As directed by the amendment: claims 1 and 10 has been amended, claims 3 and 15-20 have been cancelled, claim 14 remains withdrawn and new claim 26 has been added. Thus, claims 1-2, 4-13 and 21-26 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-8 and 10-12 rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Pereira et al. (2015/0374516) “Pereira”; claims 9 and 12 rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira”; claim 13 rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Porter et al. (5591199) “Porter”; claims 21-24 rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Lam et al. (2015/0088240) “Lam” and claim 25 rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Lam et al. (2015/0088240) “Lam” further in view of Porter et al. (5591199) “Porter” have been fully considered but they are not persuasive. Pinchuk may disclose different preferable materials for the breast prosthesis but it does, however, disclose peroxide cured or platinum cured silicone shells (col. 4, lin. 63-66) as possible material choices for the invention.
Regarding claim 1, the applicants argue that Pereira “appears to teach every embodiment of bonding material requiring the application of energy from an energy source in order to activate the bonding material” and therefore fails to teach that the bonding material is “pressure sensitive”. This is not found persuasive because claim 1 broadly requires the adhesive element is pressure sensitive and not “is activated by pressure”. The stent 100 (Fig. 7B and par. 0083) in Pereira has an adhesive element 120 disposed on the abluminal/outward surface of the stent where this adhesive element is placed on the stent surface in a contracted/undeployed configuration until the sheath 330 is retracted and the stent along with the adhesive element self-expands or deploys. The adhesive element is therefore “pressure sensitive” since the force of the stent expansion/deployment applies pressure on the adhesive element to also expand/deploy and contact the body lumen 200. The activation of the adhesive element in a contracted configuration would not adhere the stent to the lumen via the adhesive element, it is also the pressure sensitivity from the deployment force that allows for the adhesive element to function as intended.
Therefore, Pereira discloses all of the limitations of amended claim 1 including “wherein the adhesive structure includes an adhesive element that is activated upon deployment within the body lumen, wherein the adhesive element is either pressure sensitive or activated by moisture”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Pereira et al. (2015/0374516) “Pereira”.
Regarding claims 1, 2 and 10, Pereira discloses a system (Fig. 7B) for implantation of a stent 100 in a body lumen 200 (as shown in Fig. 7B), comprising: an elongate tubular member 330 having a lumen extending therein (stent 100 is placed within the lumen of the elongate tubular body 330; par. 0083); a stent 100 configured to shift from a delivery configuration to a deployed configuration (par. 0055 discloses an expanding device); and an adhesive structure 120 (Fig. 7B) configured to secure the stent to the body lumen in the deployed configuration (par. 0019 discloses the adhesive or bonding material upon activation attaches the stent to the body lumen); wherein the stent 100 is disposed within the lumen of the elongate tubular member 330 in the delivery configuration (par. 0083 and Fig. 7B); wherein the adhesive structure 120 is disposed within the lumen of the elongate tubular member 330 adjacent the stent 100 in a substantially inert state (par. 0083 and Fig. 7B disclose the stent along with bonding material 120 is disposed within the elongate tubular member or sheath 330 in an inert state until activated); wherein the adhesive structure includes an adhesive element that is activated upon deployment within the body lumen (Fig. 7B and pars. 0078, 0083 disclose the adhesive structure 120 including the bonding material is deposited onto the stent prior to deployment and is deployed with the body lumen 200 by retracting the sheath 330 and activated by energy emitting element 340e) wherein the adhesive element is either pressure sensitive or activated by moisture (the force of the stent expansion/deployment applies pressure on the adhesive element to also expand/deploy and contact the body lumen 200).
wherein the adhesive structure 120 is configured to adhere to the stent 100 and the body lumen 200 after the stent and the adhesive structure are deployed into the body lumen from the lumen of the elongate tubular member 330 (pars. 0019 and 0083 disclose the adhesive attaches the stent to the body lumen after the stent self expands when the elongate tubular member 330 is retracted) and wherein the adhesive structure is disposed radially outward of and in contact with the stent yet unsecured to the stent within the lumen of the elongate tubular member (the adhesive 120 is disposed radially on the abluminal/outward surface of the stent; the disclosure fails to mention the bonding material is secured to the stent within the sheath 330, therefore, the bonding material is in contact with the stent in an unsecured manner; Fig 7B).
Regarding claim 4, Pereira discloses wherein the adhesive element is pressure sensitive (the adhesive attaches the stent to the lumen from the pressure applied by the stent’s expansion; pars. 0078 and 0083).
Regarding claim 5, Pereira discloses wherein the adhesive structure 120 is disposed radially outward of the stent within the lumen of the elongate tubular member (as shown in Fig. 7B, adhesive 120 is disposed on the outer surface of the stent 100 within lumen of sheath 330).
Regarding claims 6-7, Pereira discloses wherein after the stent 100 and the adhesive structure 120 are deployed into the body lumen 200, the stent exerts a radially outward force against the adhesive structure and the body lumen (par. 0078); and wherein the radially outward force increases adhesion between the stent and the adhesive structure and between the adhesive structure and the body lumen (the force from stent expansion would inherently increase the adhesion between the stent, adhesive structure and the lumen; par. 0078).
Regarding claim 8, Pereira discloses wherein the adhesive structure 120 extends circumferentially around a majority of a circumference of the stent in the delivery configuration (Fig. 2 discloses the stent 100 with adhesive structure extending on the majority of its circumference and Fig. 7B discloses the adhesive structure wrapped around the full circumference of the stent).
Regarding claim 11, Pereira discloses wherein after the stent 100 and the adhesive structure 120 are deployed into the body lumen 200 from the lumen of the elongate tubular member 330, the adhesive structure is configured to adhere to an inner outer surface of the stent and the adhesive structure is configured to adhere to the body lumen through interstices 110 formed in the stent (Fig. 7B; pars. 0071 and 0078).
Regarding claim 12, Pereira discloses wherein the adhesive structure 120 includes a cross-linked polymer (polyethylene glycol; par. 0048).
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 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira”.
Regarding claim 9, Pereira discloses the claimed invention of claim 1; except for wherein in the substantially inert state the adhesive structure has a thickness between about 0.254 mm and about 2.032 mm. However, Pereira does disclose an adhesive structure is a coating applied to the stent in the inert state which would obviously have a certain coating thickness (par. 0063). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the adhesive structure coating to have a thickness between about 0.254 mm and about 2.032 mm, since these are result effective variables that contribute to the adhesion of the adhesive structure to the stent and the lumen, 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 and modifying Pereira as suggested would allow for the adhesive structure to provide an optimal adhesion capability. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality that in the substantially inert state the adhesive structure has a thickness between about 0.254 mm and about 2.032 mm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 12, Pereira discloses the claimed invention of claim 10 including an adhesive structure 120 made of polymers (par. 0048); except for explicitly disclosing the adhesive structure includes a cross-linked polymer. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the polymers in Pereira to be cross-linked, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.05.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Porter et al. (5591199) “Porter”.
Pereira discloses the claimed invention of claim 1 including the adhesive structure is a patch (par. 0078); except for wherein the adhesive structure includes a plurality of interwoven fibers defining a patch. However, Porter teaches a similar stent having an adhesive patch (col. 2, lin. 5-10 disclose tightly engaging the lumen wall) comprising a plurality of interwoven fibers (claim 1 and abstract disclose fibers that are curable to form a rigid support structure and col. 4, lin. 46-51 disclose fabrics or interwoven fibers). 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 adhesive structure in Pereira to include a plurality of interwoven fibers defining a patch, as taught and suggested by Porter, for allowing the stent to be flexible and tightly engaging the surrounding lumen wall (col. 2, lin. 5-10).
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Lam et al. (2015/0088240) “Lam”.
Regarding claim 21, Pereira discloses a system (Fig. 7B) for implantation of a stent 100 in a body lumen 200 (as shown in Fig. 7B), comprising: an elongate tubular member 330 having a lumen extending therein (stent 100 is placed within the lumen of the elongate tubular body 330; par. 0083); a stent 100 configured to shift from a delivery configuration to a deployed configuration (par. 0055 discloses an expanding device); and an adhesive structure 120 (Fig. 7B) configured to secure the stent to the body lumen in the deployed configuration (par. 0019 discloses the adhesive or bonding material upon activation attaches the stent to the body lumen); wherein the stent 100 is disposed within the lumen of the elongate tubular member 330 in the delivery configuration (par. 0083 and Fig. 7B); wherein the adhesive structure 120 is disposed within the lumen of the elongate tubular member 330 adjacent the stent 100 in a substantially inert state (par. 0083 and Fig. 7B disclose the stent along with bonding material 120 is disposed within the elongate tubular member or sheath 330 in an inert state until activated by energy emitting element 340e); wherein the adhesive structure 120 is configured to adhere to the stent 100 and the body lumen 200 after the stent and the adhesive structure are deployed into the body lumen from the lumen of the elongate tubular member 330 (pars. 0019 and 0083 disclose the adhesive attaches the stent to the body lumen after the stent self expands when the elongate tubular member 330 is retracted); except for wherein the adhesive structure includes a longitudinal gap extending along a length of the adhesive structure.
However, Lam teaches a similar stent implantation system (Fig. 1A) comprising a structure 30 including a longitudinal gap extending along a length of the structure (Fig. 1A and par. 0080 disclose a structure 30 comprising a longitudinal opening 50). 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 adhesive structure in Pereira to include a longitudinal gap extending along a length of the adhesive structure, as taught and suggested by Lam, for providing accessibility to the adhesive structure for intuitive manipulation (par. 0080).
Regarding claim 22, Pereira discloses wherein the adhesive structure includes an adhesive element that is activated upon deployment within the body lumen (par. 0083 discloses the adhesive 120 is activated by energy emitting 340e).
Regarding claim 23, Pereira discloses wherein the adhesive element is pressure sensitive (the adhesive attaches the stent to the lumen from the pressure applied by the stent’s expansion; par. 0078).
Regarding claim 24, Pereira discloses wherein the adhesive structure 120 extends circumferentially around a majority of a circumference of the stent in the delivery configuration (Fig. 2 discloses the stent 100 with adhesive structure extending on the majority of its circumference and Fig. 7B discloses the adhesive structure wrapped around the full circumference of the stent).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Lam et al. (2015/0088240) “Lam” further in view of Porter et al. (5591199) “Porter”.
Pereira in view of Lam discloses the claimed invention of claim 21 including the adhesive 26. structure is a patch (par. 0078 of Pereira); except for wherein the adhesive structure includes a plurality of interwoven fibers defining a patch. However, Porter teaches a similar stent having an adhesive patch (col. 2, lin. 5-10 disclose tightly engaging the lumen wall) comprising a plurality of interwoven fibers (claim 1 and abstract disclose fibers that are curable to form a rigid support structure and col. 4, lin. 46-51 disclose fabrics or interwoven fibers). 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 adhesive structure in Pereira in view of Lam to include a plurality of interwoven fibers defining a patch, as taught and suggested by Porter, for allowing the stent to be flexible and tightly engaging the surrounding lumen wall (col. 2, lin. 5-10).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira et al. (2015/0374516) “Pereira” in view of Lam et al. (2015/0088240) “Lam” further in view of Kleshinski (5755778).
Pereira in view of Lam discloses the claimed invention of claims 21 and 22; except for the adhesive element is activated by moisture. However, Kleshinski teaches a similar system comprising a stent having an adhesive element activated by moisture (Figs. 1-2 and col. 3, lin. 19-33 disclose an adhesive activated by fluids and with light energy activation which requires pressure/rupture activation). 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 one known adhesive structure in Pereira in view of Lam to include another known adhesive element activated by moisture, as taught and suggested by Kleshinki, for providing a known adhesive activation method for a secured attachment (col. 3, lin. 19-33).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
Prosecution Insights