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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/28/2026 has been entered.
Response to Arguments
Applicant's arguments filed 8/28/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The primary references Cully and Williams are not required to state a deficiency or need to have a retaining mechanism, as the secondary reference Levine provides the motivation for modifying Cully and/or Williams to have a retaining mechanism for the purpose of retaining a proximal anchor with a releasable wire in order to allow implant to be partially deployed and properly positioned first, before the prosthesis is anchored within the body by the anchor, and subsequently and controllably releasing the anchor to anchor the device at the desired position within the patient’s body (col 14, lines 57-65 of Levine).
Levine is considered to be analogous to Cully and Williams, because they are all directed towards delivery catheters for tubular, expandable gastrointestinal implants that function to expose the implant by retraction of an outer sheath. The proximal anchor (452) of Levine corresponds with the proximal anchor (306) of Cully and the proximal anchor (12) of Williams. All the references disclose the proximal anchors are retained within proximal capsules (see rejection below for more details). Since the references all perform the same function of delivering a gastrointestinal implant, the combination of delivery mechanisms would have been obvious to one of ordinary skill in the art and obtains predictable results. Therefore, the previous rejections have been maintained.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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.
Limitations interpreted under 112(f) include “anchor locking mechanism” and “ejection mechanism”.
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.
Claim(s) 1, 85 and 126 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2008/0255587 (Cully et al.) in view of USPAP 2016/0022461 (Errico et al.), and further in view of US 7,837,643 (Levine et al.).
Cully discloses a delivery system for placing a gastrointestinal implant in a gastrointestinal tract of a patient, the delivery system comprising:
(a) a delivery catheter (300) comprising a lumen (308) (see Figure 3; [0094]);
(b) a container assembly (307) at the distal portion of the delivery catheter, the container assembly comprising a proximal capsule (sheath 314) and a distal cap (316) [0096] removably attachable thereto; and
(c) a gastrointestinal implant comprising:
(i) a sleeve (310) configured to carry fluid from its proximal end to its distal end; and
(ii) an anchor (306) connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract (Fig. 10A-D; abstract);
wherein the gastrointestinal implant is configured to fit within the container assembly [0094-0096] such that the anchor (306) fits within the proximal capsule (114) and a portion of the sleeve (310) fits within the distal cap (316). Cully discloses the anchor is held in the proximal capsule until it is released by a push rod (see Fig. 9e-f; [0142]) (which meets the requirement of an “ejection mechanism”).
Cully discloses atraumatic materials [0052] for construction of the delivery tube but fails to specify the cap is formed of an atraumatic material. Errico discloses another delivery device for a gastrointestinal implant having an anchor and sleeve (462). Errico teaches that silicone is a suitable biocompatible material for forming a sleeve (460) of a delivery device that contains the implant (see Figure 18; [0136]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the distal cap of the Cully device from atraumatic silicone, as taught by Errico, 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. In re Leshin, 125 USPQ 416.
Cully fails to disclose an anchor locking mechanism to retain the anchor within the proximal capsule. Levine discloses another device for delivery of a gastrointestinal implant having a proximal anchor (452) and teaches that the anchor can be retained with an anchor retaining wire (440) within a proximal capsule (container 404) (Fig. 4H-J; column 14, line 57 to column 15). This locking mechanism provides additional control for release of the implant after the capsule (404) has been withdrawn. It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the anchor locking mechanism comprising a locking wire taught by Levine with the Cully device in order to enhance control over releasing the anchor from the delivery device. releasably retain the anchor of the Williams device until actuated by an operator.
Regarding claim 85: Cully discloses a method of assembling a delivery system (Fig. 3), the method comprising the steps of:
(a) providing a gastrointestinal implant comprising: (i) a sleeve (310) configured to carry fluid from its proximal end to its distal end: and (ii) an anchor (306) connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract (Abstract);
(b) inserting the anchor (306) within a proximal capsule (distal end of sheath 314), the proximal capsule connected to a distal portion of a delivery catheter (the proximal capsule being formed of a distal portion of the delivery catheter 314 meets the broad requirement; [0096]);
(c) inserting a portion of the sleeve (310) within a distal cap (316) (see Figure 3; [0076]); and
(d) attaching the proximal end of the distal cap (316) to the distal end of the proximal capsule (314) (see description of the cap being arranged over at least a portion of the sheath 314 [0096]); thereby assembling the delivery system.
Cully discloses atraumatic materials [0052] for construction of the delivery tube but fails to specify the cap is formed of an atraumatic material. Errico discloses another delivery device for a gastrointestinal implant having an anchor and sleeve (462). Errico teaches that silicone is a suitable biocompatible material for forming a sleeve (460) of a delivery device that contains the implant (see Figure 18; [0136]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the distal cap of the Cully device from atraumatic silicone, as taught by Errico, 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. In re Leshin, 125 USPQ 416.
Cully fails to disclose an anchor locking mechanism to retain the anchor within the proximal capsule. Levine discloses another device for delivery of a gastrointestinal implant having a proximal anchor (452) and teaches that the anchor can be retained with an anchor retaining wire (440) within a proximal capsule (container 404) (Fig. 4H-J; column 14, line 57 to column 15). This locking mechanism provides additional control for release of the implant after the capsule (404) has been withdrawn, therefore allowing the operator to ensure proper placement of the implant before anchoring it within the body lumen. It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the anchor locking mechanism comprising a locking wire taught by Levine with the Cully device in order to enhance control over releasing the anchor from the delivery device.
Regarding claim 126, the modification results in release of the anchor of modified Cully upon release of the anchor locking mechanism taught by Levine and actuation of the ejection mechanism (Cully’s push rod).
Claim(s) 1, 17, 39-41, 63, 122, 123, 125 and 126 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2012/0116286 (Williams et al.) in view of US Patent 7,837,643 (Levine et al.), and further in view of USPAP 2016/0022461 (Errico et al.).
Regarding claim 1: Williams discloses a delivery system (see Fig. 14A) for placing a gastrointestinal implant in a gastrointestinal tract of a patient, the delivery system comprising:
(a) a delivery catheter comprising a lumen (66) (see Figure 14A);
(b) a container assembly at the distal portion of the delivery catheter, the container assembly comprising a proximal capsule (distal end of the catheter 66) and a distal cap (70) removably attachable thereto; and
(c) a gastrointestinal implant (10) comprising: (i) a sleeve (14) configured to carry fluid from its proximal end to its distal end; and (ii) an anchor (12) connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract [0050];
wherein the gastrointestinal implant is configured to fit within the container assembly such that the anchor (12) fits within the proximal capsule (distal end of 66) and a portion of the sleeve (14) fits within the distal cap (70) ([0076]). Williams further discloses the catheter comprises a plunger (push rod 58) to aid in ejecting the implant (Fig. 10; [0071]), which meets the requirement of an “ejection mechanism”).
Williams fails to disclose an anchor locking mechanism to retain the anchor within the proximal capsule. Levine discloses another device for delivery of a gastrointestinal implant having a proximal anchor (452) and teaches that the anchor can be retained with an anchor retaining wire (440) within a proximal capsule (container 404) (Fig. 4H-J; column 14, line 57 to column 15). This locking mechanism provides additional control for release of the implant after the capsule (404) has been withdrawn. It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the anchor locking mechanism comprising a locking wire taught by Levine with the Williams device in order to enhance control over releasing the anchor from the delivery device. releasably retain the anchor of the Williams device until actuated by an operator.
Williams fails to specify the cap is formed of an atraumatic material. Errico discloses another delivery device for a gastrointestinal implant having an anchor and sleeve (462). Errico teaches that silicone is a suitable biocompatible (atraumatic) material for forming a sleeve (460) of a delivery device that contains the implant (see Figure 18; [0136]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the distal cap of the Williams device from atraumatic silicone, as taught by Errico, 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. In re Leshin, 125 USPQ 416.
Regarding claim 39: Williams discloses a method of positioning a gastrointestinal implant in a patient, the method comprising the steps of:
(a) providing a container assembly containing a gastrointestinal implant (see Figure 14A; [0076]), the gastrointestinal implant comprising a proximal anchor (12) and an elongate distal portion (sleeve 14) [0050], wherein the container assembly comprises: (i) a proximal capsule (distal end of 66) containing the proximal portion (anchor 12) of the gastrointestinal implant, and (ii) a distal cap (70) containing all or part of the elongate distal portion (sleeve 14);
(b) directing the container assembly into the patient's gastrointestinal tract [0054];
(c) securing the proximal anchor to a luminal wall of the gastrointestinal tract (see for example Figure 1B, 10D; and 11B; see description of self-expansion of anchor at [0050]; deploying the anchor either prior to or after deployment of the sleeve at [0067]); and
(d) allowing peristalsis to extend the elongate distal portion; thereby positioning the gastrointestinal implant [0076].
Williams further discloses the catheter comprises a plunger (push rod 58) to aid in ejecting the implant (Fig. 10; [0071]), which meets the requirement of an “ejection mechanism”).
Williams fails to disclose an anchor locking mechanism to retain the anchor within the proximal capsule. Levine discloses another device for delivery of a gastrointestinal implant having a proximal anchor (452) and teaches that the anchor can be retained with an anchor retaining wire (440) within a proximal capsule (container 404) (Fig. 4H-J; column 14, line 57 to column 15). This locking mechanism provides additional control for release of the implant after the capsule (404) has been withdrawn. It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the anchor locking mechanism comprising a locking wire taught by Levine with the Williams device in order to enhance control over releasing the anchor from the delivery device. releasably retain the anchor of the Williams device until actuated by an operator.
Williams fails to specify the cap is formed of an atraumatic material. Errico discloses another delivery device for a gastrointestinal implant having an anchor and sleeve (462). Errico teaches that silicone is a suitable biocompatible (atraumatic) material for forming a sleeve (460) of a delivery device that contains the implant (see Figure 18; [0136]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the distal cap of the Williams device from atraumatic silicone, as taught by Errico, 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. In re Leshin, 125 USPQ 416.
Regarding claim 40, Williams further discloses the catheter comprises a push rod (58) that aids in ejecting the implant, including the anchor, from the proximal capsule (66) (Fig. 10; [0071]).
Regarding claim 41: Williams discloses a method of positioning a gastrointestinal implant in a patient, the method comprising the steps of: (a) providing a container assembly containing a gastrointestinal implant, the gastrointestinal implant (10) comprising a proximal anchor (12) and an elongate distal portion (sleeve 14) [0050], wherein the container assembly comprises: (i) a proximal capsule (distal end of sheath 66) containing the proximal portion (anchor 12) of the gastrointestinal implant (see Figure 14A), and (ii) a distal cap (70) containing all or part of the elongate distal portion (14) [0076];
(b) directing the container assembly into the patient's gastrointestinal tract;
(c) ejecting the proximal anchor (!2) from the proximal capsule (66) while the elongate distal portion (14) is retained within the distal cap (70) (See description of deploying the anchor either prior to or after deployment of the sleeve 14 at [0067]); and
(d) allowing: (i) the proximal anchor (12) to secure to a luminal wall of the gastrointestinal tract (see for example Figure 1B, 10D; and 11B; see description of self-expansion of anchor at [0050]; wherein self-expansion is allowing the stent to assume its biased configuration);
and (ii) peristalsis to extend the elongate distal portion [0076]; thereby positioning the gastrointestinal implant in the patient.
Williams further discloses the catheter comprises a plunger (push rod 58) to aid in ejecting the implant (Fig. 10; [0071]), which meets the requirement of an “ejection mechanism”).
Williams fails to disclose an anchor locking mechanism to retain the anchor within the proximal capsule. Levine discloses another device for delivery of a gastrointestinal implant having a proximal anchor (452) and teaches that the anchor can be retained with an anchor retaining wire (440) within a proximal capsule (container 404) (Fig. 4H-J; column 14, line 57 to column 15). This locking mechanism provides additional control for release of the implant after the capsule (404) has been withdrawn. It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the anchor locking mechanism comprising a locking wire taught by Levine with the Williams device in order to enhance control over releasing the anchor from the delivery device. releasably retain the anchor of the Williams device until actuated by an operator.
Williams fails to specify the cap is formed of an atraumatic material. Errico discloses another delivery device for a gastrointestinal implant having an anchor and sleeve (462). Errico teaches that silicone is a suitable biocompatible (atraumatic) material for forming a sleeve (460) of a delivery device that contains the implant (see Figure 18; [0136]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the distal cap of the Williams device from atraumatic silicone, as taught by Errico, 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. In re Leshin, 125 USPQ 416.
Regarding claim 63, Williams further discloses the catheter comprises a push rod (58) that aids in ejecting the implant, including the anchor, from the proximal capsule (66) (Fig. 10; [0071]).
Regarding claims 122, 123 and 125, Williams discloses the use of the gastrointestinal device to treat obesity (weight loss) and type 2 diabetes ([0002]).
Regarding claim 126, the modification results in release of the anchor of modified Williams upon release of the anchor locking mechanism taught by Levine and actuation of the ejection mechanism (William’s push rod).
Claim(s) 124 is rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. in view of Levine and Errico et al., as applied above, and further in view of USPAP 2007/0282453 (Weitzner et al.).
Williams discloses the use of the gastrointestinal device to treat various medical issues, such as obesity (weight loss) and type 2 diabetes ([0002]), but fails to disclose treating non-alcoholic steatohepatitis (NASH). Weitzner teaches it was known in the art to use the implantation of a gastrointestinal implant with a sleeve and anchor to treat non-alcoholic steatohepatitis (NASH) [0002]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Williams to treat non-alcoholic steatohepatitis (NASH), as taught by Weitzner, as the modification merely involves the application of known surgical procedure to treat a different type of medical condition related to obesity.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
