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 Arguments
Applicant’s arguments, see pages 5-7, filed 3/16/2026, with respect to the rejection(s) of claim(s) 1, 39, 41 and 85 under 102 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of combinations of Cully and Williams with Errico and Levine.
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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 and 62 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Since claim 1 now recites an ejection mechanism, claim 16 fails to further limit claim 1.
Since claim 39 now recites an ejection mechanism, claim 62 fails to further limit claim 39.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 16, and 85 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 silicone. 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 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 silicone. 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 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.
Claim(s) 1, 16, 17, 39-41, 62, 63, 122, 123 and 125 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 silicone. 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 Williams device from 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 silicone. 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 Williams device from 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 silicone. 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 Williams device from 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 62 and 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 124, Williams discloses the use of the gastrointestinal device to treat obesity (weight loss) and type 2 diabetes ([0002]).
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
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.
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
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