DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office action is in response to the applicant’s communication filed 12/30/2025.
Status of the claims:
Claims 1 – 20 are pending in the application.
Claims 1, 2, 4, 5, 6, 11, 12, 15, and 17 are amended.
Claim Objections
The objections to claims 1, 4, 6, and 15 in the previous action dated 10/10/2025 have been withdrawn in light of the Applicant’s amendments filed 12/30/2025. Specifically, the objections to claims 1, 6, and 15 regarding the phrase “a plurality of filaments”, the objection to claim 4 regarding the phrase “an upstream side”, and the objections to claims 5, 11, and 12 regarding the phrase “formed of a plurality of braided, woven, or knitted filaments” have been withdrawn as the appropriate corrections have been made.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
the generic placeholder is “an element” in claims 2 and 17, which is coupled to the functional language “relative movement of the element…results in the shifting of the occlusion device from the expanded configuration to the collapsed configuration”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “element” will be read as a separate loop or an extension of the device (e.g., an extension of wires or filaments forming the device) (which is the disclosed corresponding structure, as described in paragraph [0058] of the instant specification) or an equivalent structure, which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claim 10 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 10/10/2025 have been withdrawn in light of the Applicant’s amendments filed 12/30/2025. Specifically, the rejection of claim 1, regarding the lack of clarity in the phrase "said occlusive covering", has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 7 and 10 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (JP 2010136734 A) (cited and translated PDF attached) (previously cited) and in view of Burnett et al (US 2005/0055039 A1) (previously cited) and Thompson et al (US 2016/0228276 A1) (previously cited).
Regarding claims 1, 3, and 5, Yoshida discloses a pyloric occlusion device (pyloric occlusion device 2) for preventing flow of materials through a pylorus between a stomach and a duodenum, said occlusion device (expandable anchor 224) (abstract, pages 4 – 5, and Figs. 1 – 8) comprising:
a first retention member (front side bag body 31a and designated in annotated Fig. 6) configured to be positioned within the stomach (page 6 lines 7 – 18 and Fig. 6);
a second retention member (back side bag body 31b and designated in annotated Fig. 6) configured to be positioned within the duodenum (page 6 paragraph [0002] and Fig. 6); and
an adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) (Examiner’s note: a saddle is defined as a structure connecting two larger structures on each end thereof; and as shown in Fig. 6 the constriction portion 31c connects the bag bodies 31a and 31b) between said first retention member and said second retention member (Fig. 6 and annotated Fig. 6) configured to be positioned through the pylorus and to prevent of materials therethrough (Examiner’s note: as stated on page 8 line 2 the diameter of the constriction part corresponds to the pyloric ring 82 (i.e., the pyloric sphincter); which means that the constriction part 31c will fill the entire space within the pylorus and thus prevent the flow of materials therethrough as desired; additionally, page 4 paragraph [0007] recites that the occlusion device occludes the pylorus from air traveling therethrough);
wherein:
the adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) is axially adjustable to adjust a distance between the first retention member and the second retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the distance between the first wall and the second changes along with the length of the saddle; therefore, because distance between the first wall and the second wall changes with the saddle length, it can be said that the saddle is adjustable to adjust the distance between the first wall and the second wall; in other words, any change in the length of the saddle will lead to a corresponding change to the distance between the first wall and second wall, thus the saddle is adjustable to adjust said distance);
at least one of said first retention member or said second retention member (front side and back side bag bodies 31b and 31a, respectively) extends radially outwardly from said saddle to define a radially extending upstream side and a radially extending downstream side (see annotated Fig. 6);
said first retention member and said second retention member are configured to engage anatomical structures on either end of the body passage to inhibit migration of said occlusion device with respect to the body passage (page 6 lines 8 – 17) (Examiner’s note: as recited in page 6 lines 8 – 17 and shown in Fig. 6 that the bag bodies come into pressure contact with their respective portions of the body; thus, the bag bodies act anchors that will inhibit movement of the overall device); and
the upstream side or the downstream side of said first retention member (upstream side of front side bag body 31b) has a side having a surface curved (curved upstream surface of front side bag body 31b facing the stomach 8 shown in Fig. 6 and designated in annotated Fig. 6) to resist inversion of said retention member to resist migration of said occlusion device with respect to the body passage (Examiner’s note: because the body’s curve is curved outward it will inherently resist the forces that would cause inversion of the retention member as well as resist the migration of the device as a whole through the passage of the pylorus);
[claim 5] wherein the first retention member (front side bag body 31b) is a double wall retention member (Fig. 6) with a first wall facing said saddle and a second wall facing away from the saddle (see annotated Fig. 6).
However, Yoshida is silent regarding (i) [claims 1 and 5] wherein the occlusive device comprises a plurality of braided filaments which form at least one of the first retention member or second retention member and (ii) [claim 3] an occlusive covering provided on at least one of said first retention member and said second retention member to occlude the flow of materials therethrough.
As to the above, Burnett teaches, in the same field of endeavor, a pyloric occlusion device (pyloric corking device 4) configured to prevent the flow of materials through the pylorus (intermittently obstruction) (paragraphs [0033], [0063], [0065]) comprising a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and a second/downstream retention member (framework/expandable scaffold of distal occlusion member 14) with a saddle (bridging member 10) therebetween (paragraphs [0065 – 0067]) and further comprising an occlusive covering (the polymeric material that surrounds the expandable scaffolding – discussed in paragraph [0067]) on the a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and the second/downstream retention member (framework/expandable scaffold of distal occlusion member 14). Burnett, in paragraph [0104] describes the self-expanding scaffold as supportive structures, and in paragraph [0106] states that the support portion, due to its rigidity, helps maintain the diameter of the expandable retaining member so that the device does not pass through the pylorus.
It should be understood that Yoshida and Burnett are known references that teach means for occluding the pylorus (abstract, pages 4 – 7, and Figs. 1 – 8 of Yoshida ; abstract, paragraphs [0033], [0063], [0065 – 0067] of Burnett); wherein Burnett teaches the occlusion members (i.e., the first/second retention members) can be either an inflatable member, inflated by the influx of material (i.e., water / saline) (which is similar to the occlusion members of Yoshida), or they can be a self-expandable frames/ scaffolds with a covering (paragraph [0067]). Therefore, the Examiner contends it would be obvious to one of ordinary skill in the art to substitute the gas inflatable retention members (front and back side bag bodies 31b/a) of Yoshida with self-expandable frames with a cover, and the results of the substitution would have been predictable and resulted in the modified pyloric occlusion device of Yoshida being able to function as intended to properly fully occlude the pylorus. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first/upstream and second/downstream retention members of Yoshida to be self-expandable scaffolding with a covering, based on the teachings of Burnett, because the self-expandable scaffold / support help the retention members retain their shape in the expanded state so that the device does not pass through the pylorus while the covering can contact the tissue without cause significant damage (paragraphs [0067], [0104], and [0106] – Burnett).
Additionally, Thompson teaches, a pyloric occlusion device (expandable anchor) (Fig. 90), comprising two double walled retention members (disks 561 and 560; which equate to the self-expandable scaffolds that make up the retention members of Yoshida in view of Burnett) that have a self-expandable scaffolding formed by a plurality of braided filaments (braided Nitinol wires) (paragraph [0233]). It should be understood that Yoshida in view of Burnett are known references that teach self-expanding occlusive anchoring devices for the pylorus (abstract, pages 4 – 6, Figs. 1 – 8 – Yoshida; abstract and paragraphs [0065 – 0067] – Burnett; abstract, paragraphs [0137] and [0233] – Thompson); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one self-expandable frame work for another, and the results of the substitution would have been predictable and resulted in the modified retention members of Yoshida in view of Burnett still being able to operate as intended to occlude the pylorus. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the modification is such that the retention members of Yoshida in view of Burnett and Thompson comprises the covering taught by Burnett that covers the self-expandable scaffolds that are made up of a mesh (braided) framework, as taught by Thompson. Furthermore, it should be understood that the prior art makes obvious wherein the modified occlusion device of Yoshida would maintain its same shape in the collapsed configuration and in the expanded configuration so that the device will operate as intended.
Annotated Figure 6 of Yoshida
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Regarding claim 2, as discussed above, Yoshida discloses the pyloric occlusion device of claim 1. Additionally, Yoshida discloses [a portion of claim 2] wherein said occlusion device (pyloric occlusion device 2) is shiftable between a collapsed configuration (configuration shown in Fig. 2) and an expanded configuration (configuration shown in Figs. 3 – 8), said curved surface (curved upstream surface of front side bag body 31b shown in Fig. 6 and designated in annotated Fig. 6) is a convex surface on at least one of said first retention member (front side bag body 31b) facing away from said saddle (see annotated Fig. 6).
However, Yoshida is silent regarding (i) an element associated with said convex surface of said at least one of said first retention member or said second retention member, so that relative movement of said element causes shifting of said occlusion device from an expanded configuration to a collapsed configuration when pulled in a direction away from said convex surface.
As to the above, Thompson, additionally, teaches another embodiment of a pyloric occlusive device (expandable anchor of Fig. 40; which equates to the pyloric occlusion device 2 of Yoshida modified with the self-expandable scaffolding of Burnett) inserted within the pylorus comprising an element (drawstring 347) so that relative movement of said element causes shifting the occlusion device (expandable anchor of Fig. 40) from the expanded state to the collapsed state for purpose of being able to remove the anchor and/or load the anchor onto a delivery catheter (abstract, paragraph [0185], and Fig. 40) (Examiner’s note: as discussed above, the removal element is being interpreted under 112(f) as a separate loop or an extension of the device (e.g., an extension of wires or filaments forming the device) or an equivalent structure, capable shifting the occlusion device from the expanded configuration to the collapsed configuration as disclosed by Applicant. Thompson, in paragraph [0185], teaches wherein the drawstring 347 is used to collapse the expandable anchor, therefore the drawstring is considered an equivalent structure to the claimed element).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first retention member of Yoshida in view of Burnett and Thompson to incorporate a removal element on the surface thereof, based on the teachings of Thompson, for the purpose of being able to load the anchor onto the delivery device in the collapsed state and for the purpose of providing a means of withdrawing the anchor into the catheter such that the anchor is removable in a more compact state, which reduces the chances of damaging the inner tissue walls during the retrieval process. Thus, the combination of Yoshida, Burnett, and Thompson makes obvious the limitations of claim 2.
Regarding claim 4, as discussed above, it would have been obvious to modify the occlusion device of Yoshida to comprise the plurality of filaments based on the teachings of Burnett and Thompson. Additionally, Yoshida further discloses wherein:
said at least one of said first retention member or said second retention member is said first retention member (Examiner’s note: the first retention member is the said at least one first retention member), said curved surface (curved upstream surface of front side bag body 31b facing the stomach 8 shown in Fig. 6 and designated in annotated Fig. 6) being a convex surface on an upstream side of said first retention member, facing away from said saddle and toward said stomach, curved to resist to inversion and migration through the pylorus (Fig. 6 and designated in annotated Fig. 6)).
Regarding claims 6, 10, 11, and 12, discloses a pyloric occlusion device (pyloric occlusion device 2) for preventing flow of materials through a pylorus (abstract, page 4 – 5, and Figs. 5 – 8) having an inlet at a stomach at an upstream side (stomach 8) and an outlet at a duodenum at a downstream side (duodenal 83), said occlusion device (expandable anchor 224) comprising:
an upstream retention member (front side bag body 31a and designated in annotated Fig. 6) configured to be positioned within the stomach and to occlude the pylorus (pylorus 82) (page 6 lines 7 – 18 and Fig. 6) and having an upstream side and a downstream side (see annotated Fig. 6);
a downstream retention member (back side bag body 31b and designated in annotated Fig. 6) configured to be positioned within the duodenum and occlude the pylorus (page 6 lines 7 – 18 and Fig. 6) and having an upstream side and a downstream side (see annotated Fig. 6); and
an adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) (Examiner’s note: a saddle is defined as a structure connecting two larger structures on each end thereof; and as shown in Fig. 6 the constriction portion 31c connects the bag bodies 31a and 31b) between said upstream retention member and said downstream retention member (Fig. 6 and annotated Fig. 6) configured to be positioned through the pylorus and to prevent of materials therethrough (Examiner’s note: as stated on page 8 line 2 the diameter of the constriction part corresponds to the pyloric ring 82 (i.e., the pyloric sphincter); which means that the constriction part 31c will fill the entire space within the pylorus and thus prevent the flow of materials therethrough as desired; additionally, page 4 paragraph [0007] recites that the occlusion device occludes the pylorus from air traveling therethrough);
wherein:
the adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) is axially adjustable to adjust a distance between the upstream retention member and the downstream retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the distance between the first wall and the second changes along with the length of the saddle; therefore, because distance between the first wall and the second wall changes with the saddle length, it can be said that the saddle is adjustable to adjust the distance between the first wall and the second wall; in other words, any change in the length of the saddle will lead to a corresponding change to the distance between the first wall and second wall, thus the saddle is adjustable to adjust said distance);
said upstream side of said upstream retention member (right side of front side bag 31b and designated in annotated Fig. 6) has a convex surface with a convex curvature sufficient to cause said upstream retention member to resist inversion to inhibit downstream migration of said occlusion device through the body passage (Examiner’s note: as shown in annotated Fig. 6 the upstream side of the front side bag 31b has a convex curvature and because the curve is curved outward it will inherently resist the forces that would cause inversion of the retention member as well as resist the migration of the device as a whole through the passage of the pylorus); and
said downstream side of said downstream retention member (left side of back side bag 31a and designated in annotated Fig. 6) has a curvature different from the convex curvature of said upstream side of said upstream retention member (Examiner’s note: as shown in annotated Fig. 6, the downstream side of the back side bag 31a is larger and thus has a different curvature from the smaller curvature of the upstream side of the front side bag 31b);
[claim 12] wherein the upstream retention member (front side bag body 31b) is a double wall retention member (Fig. 6) with a first wall facing said saddle and a second wall facing away from the saddle (see annotated Fig. 6).
However, Yoshida is silent regarding (i) [claims 6, 11, and 12] wherein the occlusive device comprises a plurality of braided filaments which form at least one of the first retention member or second retention member and (ii) [claims 10 and 11] an occlusive covering the plurality of filaments.
As to the above, Burnett teaches, in the same field of endeavor, a pyloric occlusion device (pyloric corking device 4) configured to prevent the flow of materials through the pylorus (intermittently obstruction) (paragraphs [0033], [0063], [0065]) comprising a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and a second/downstream retention member (framework/expandable scaffold of distal occlusion member 14) with a saddle (bridging member 10) therebetween (paragraphs [0065 – 0067]) and further comprising an occlusive covering (the polymeric material that surrounds the expandable scaffolding – discussed in paragraph [0067]) on the a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and the second/downstream retention member (framework/expandable scaffold of distal occlusion member 14). Burnett, in paragraph [0104] describes the self-expanding scaffold as supportive structures, and in paragraph [0106] states that the support portion, due to its rigidity, helps maintain the diameter of the expandable retaining member so that the device does not pass through the pylorus.
It should be understood that Yoshida and Burnett are known references that teach means for occluding the pylorus (abstract, pages 4 – 7, and Figs. 1 – 8 of Yoshida ; abstract, paragraphs [0033], [0063], [0065 – 0067] of Burnett); wherein Burnett teaches the occlusion members (i.e., the first/second retention members) can be either an inflatable member, inflated by the influx of material (i.e., water / saline) (which is similar to the occlusion members of Yoshida), or they can be a self-expandable frames/ scaffolds with a covering (paragraph [0067]). Therefore, the Examiner contends it would be obvious to one of ordinary skill in the art to substitute the gas inflatable retention members (front and back side bag bodies 31b/a) of Yoshida with self-expandable frames with a cover, and the results of the substitution would have been predictable and resulted in the modified pyloric occlusion device of Yoshida being able to function as intended to properly fully occlude the pylorus. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first/upstream and second/downstream retention members of Yoshida to be self-expandable scaffolding with a covering, based on the teachings of Burnett, because the self-expandable scaffold / support help the retention members retain their shape in the expanded state so that the device does not pass through the pylorus while the covering can contact the tissue without cause significant damage (paragraphs [0067], [0104], and [0106] – Burnett).
Additionally, Thompson teaches, a pyloric occlusion device (expandable anchor) (Fig. 90), comprising two double walled retention members (disks 561 and 560; which equate to the self-expandable scaffolds that make up the retention members of Yoshida in view of Burnett) that have a self-expandable scaffolding formed by a plurality of braided filaments (braided Nitinol wires) (paragraph [0233]). It should be understood that Yoshida in view of Burnett are known references that teach self-expanding occlusive anchoring devices for the pylorus (abstract, pages 4 – 6, Figs. 1 – 8 – Yoshida; abstract and paragraphs [0065 – 0067] – Burnett; abstract, paragraphs [0137] and [0233] – Thompson); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one self-expandable frame work for another, and the results of the substitution would have been predictable and resulted in the modified retention members of Yoshida in view of Burnett still being able to operate as intended to occlude the pylorus. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the modification is such that the retention members of Yoshida in view of Burnett and Thompson comprises the covering taught by Burnett that covers the self-expandable scaffolds that are made up of a mesh (braided) framework, as taught by Thompson. Furthermore, it should be understood that the prior art makes obvious wherein the modified occlusion device of Yoshida would maintain its same shape in the collapsed configuration and in the expanded configuration so that the device will operate as intended.
Annotated Figure 6 of Yoshida
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Regarding claim 7, as discussed above, the combination of Yoshida, Burnett, and Thompson makes obvious the device of claim 6. Additionally, Yoshida discloses wherein said downstream side of said downstream retention member is substantially convex with a convex curvature (see annotated Fig. 6).
However, the combination of Yoshida, Burnett, and Thompson is silent regarding (i) [claim 7] wherein said downstream side of said downstream retention member is substantially convex with a convex curvature less than the convex curvature of said convex surface of said upstream side of said upstream retention member.
As to the above, Burnett further teaches, in the same field of endeavor, in paragraph [0073], wherein the proximal and distal occlusion members (upstream and downstream retention members) can have any shape so long as the retention members prevent the passage of the device therethrough, which includes having the upstream retention member (i.e., the proximal occlusion member) having a larger diameter than the downstream retention member (i.e., the distal occlusion member). Furthermore, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of sizes that the upstream retention member can be in relation to the downstream retention member, the upstream retention member can be either: (i) larger than the downstream retention member, the same size as the downstream retention member, or smaller than the upstream edge of the downstream retention member. Therefore, it would have been obvious to one of ordinary skill in the art to modify the upstream retention member to be larger than the downstream retention member since there are a limited number of possible relative sizes for the upstream retention member to be relative to the downstream retention member and having the upstream retention member being larger than the downstream retention member is well within the purview of one of ordinary skill in the art and would have yielded, with a reasonable expectation of success, a retention member configured to block flow of material through the pylorus. Furthermore, it would have been prima facie obvious to a person of ordinary skill in the art to modify the upstream retention member to be larger, so that the upstream retention member can resist the forces pushing the upstream retention member downstream. “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, 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 the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Therefore, it would have been obvious to try having a larger the upstream retention member than the downstream retention member. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rationale E, outlined in MPEP 2143.
Regarding claims 13 and 14, as discussed above, the combination of Yoshida, Burnett, and Thompson makes obvious the device of claim 12. Additionally, the combination makes obvious wherein said saddle (constricted portion 31c; designated in annotated Fig. 6 – Yoshida) [claim 13] is adjustable to adjust the distance between the first wall of said double wall retention member and the second wall of said double wall retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the distance between the first wall and the second changes along with the length of the saddle; therefore, because distance between the first wall and the second wall changes with the saddle length, it can be said that the saddle is adjustable to adjust the distance between the first wall and the second wall; in other words, any change in the length of the saddle will lead to a corresponding change to the distance between the first wall and second wall, thus the saddle is adjustable to adjust said distance) and [claim 14] is adjustable in length to adjust the distance between said first retention member and said second retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the adjusted length adjusts the distance between the first retention member (i.e., the front side bag 31b) and the second retention member (i.e., the back side bag 31a) changes; in other words the process of expanding the saddle changes the length of the saddle region which results in the distance between the retention members changing as required by the claim). As stated above, the prior art makes obvious wherein the modified occlusion device of Yoshida would maintain its same shape in the collapsed configuration and in the expanded configuration so that the device will operate as intended; therefore, the combination is said to encompass the limitations of claims 13 and 14 in the manner discussed above.
Regarding claims 15 and 16, Yoshida discloses a pyloric occlusion device (pyloric occlusion device 2) (abstract, page 4 – 5, and Figs. 5 – 8) shiftable between a collapsed configuration (configuration shown in Fig. 2) to an expandable configuration (configuration shown in Figs. 4 – 8), said pyloric occlusion device comprising:
an adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) (Examiner’s note: a saddle is defined as a structure connecting two larger structures on each end thereof; and as shown in Fig. 6 the constriction portion 31c connects the bag bodies 31a and 31b) configured to be positioned through the pylorus between a stomach and duodenum and to occlude flow of materials therethrough (Examiner’s note: as stated on page 8 line 2 the diameter of the constriction part corresponds to the pyloric ring 82 (i.e., the pyloric sphincter); which means that the constriction part 31c will fill the entire space within the pylorus and thus prevent the flow of materials therethrough as desired; additionally, page 4 paragraph [0007] recites that the occlusion device occludes the pylorus from air traveling therethrough);
an upstream retention member (front side bag body 31a and designated in annotated Fig. 6) configured to be positioned within the stomach upstream of the pylorus to hold the pyloric occlusion device from migrating through the pylorus and into the duodenum (page 6 lines 7 – 18 and Fig. 6) (Examiner’s note: as recited in page 6 lines 8 – 17 and shown in Fig. 6 the bag bodies come into pressure contact with their respective portions of the body; thus, the bag bodies act anchors that will inhibit movement of the overall device);
a downstream retention member (back side bag body 31b and designated in annotated Fig. 6) configured to be positioned within the duodenum downstream of the pylorus to hold said pyloric occlusion device from migrating through the pylorus and into the stomach (page 6 lines 7 – 18 and Fig. 6) (Examiner’s note: as recited in page 6 lines 8 – 17 and shown in Fig. 6 the bag bodies come into pressure contact with their respective portions of the body; thus, the bag bodies act anchors that will inhibit movement of the overall device); and
wherein:
the adjustable saddle (constriction portion 31c and designated in annotated Fig. 6) is axially adjustable to adjust a distance between the upstream retention member and the downstream retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the distance between the first wall and the second changes along with the length of the saddle; therefore, because distance between the first wall and the second wall changes with the saddle length, it can be said that the saddle is adjustable to adjust the distance between the first wall and the second wall; in other words, any change in the length of the saddle will lead to a corresponding change to the distance between the first wall and second wall, thus the saddle is adjustable to adjust said distance);
said upstream retention member has an upstream side, facing away from said saddle and toward said stomach, having a convex surface (see annotated Fig. 6) to resist inversion of said retention member to resist migration of said occlusion device with respect to the body passage (Examiner’s note: because the body’s curve is curved outward it will inherently resist the forces that would cause inversion of the retention member as well as resist the migration of the device as a whole through the passage of the pylorus).
However, Yoshida is silent regarding (i) [claim 15] wherein the occlusive device comprises a plurality of filaments which form at least one of the first retention member or second retention member and (ii) [claims 15 and 16] wherein the an occlusive covering is provided over the upstream retention member and said downstream retention member.
As to the above, Burnett teaches, in the same field of endeavor, a pyloric occlusion device (pyloric corking device 4) configured to prevent the flow of materials through the pylorus (intermittently obstruction) (paragraphs [0033], [0063], [0065]) comprising a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and a second/downstream retention member (framework/expandable scaffold of distal occlusion member 14) with a saddle (bridging member 10) therebetween (paragraphs [0065 – 0067]) and further comprising an occlusive covering (the polymeric material that surrounds the expandable scaffolding – discussed in paragraph [0067]) on the a first/upstream retention member (framework/expandable scaffold of proximal occlusion member 16) and the second/downstream retention member (framework/expandable scaffold of distal occlusion member 14). Burnett, in paragraph [0104] describes the self-expanding scaffold as supportive structures, and in paragraph [0106] states that the support portion, due to its rigidity, helps maintain the diameter of the expandable retaining member so that the device does not pass through the pylorus.
It should be understood that Yoshida and Burnett are known references that teach means for occluding the pylorus (abstract, pages 4 – 7, and Figs. 1 – 8 of Yoshida ; abstract, paragraphs [0033], [0063], [0065 – 0067] of Burnett); wherein Burnett teaches the occlusion members (i.e., the first/second retention members) can be either an inflatable member, inflated by the influx of material (i.e., water / saline) (which is similar to the occlusion members of Yoshida), or they can be a self-expandable frames/ scaffolds with a covering (paragraph [0067]). Therefore, the Examiner contends it would be obvious to one of ordinary skill in the art to substitute the gas inflatable retention members (front and back side bag bodies 31b/a) of Yoshida with self-expandable frames with a cover, and the results of the substitution would have been predictable and resulted in the modified pyloric occlusion device of Yoshida being able to function as intended to properly fully occlude the pylorus. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first/upstream and second/downstream retention members of Yoshida to be self-expandable scaffolding with a covering, based on the teachings of Burnett, because the self-expandable scaffold / support help the retention members retain their shape in the expanded state so that the device does not pass through the pylorus while the covering can contact the tissue without cause significant damage (paragraphs [0067], [0104], and [0106] – Burnett).
Additionally, Thompson teaches, a pyloric occlusion device (expandable anchor) (Fig. 90), comprising two double walled retention members (disks 561 and 560; which equate to the self-expandable scaffolds that make up the retention members of Yoshida in view of Burnett) that have a self-expandable scaffolding formed by a plurality of braided filaments (braided Nitinol wires) (paragraph [0233]). It should be understood that Yoshida in view of Burnett are known references that teach self-expanding occlusive anchoring devices for the pylorus (abstract, pages 4 – 6, Figs. 1 – 8 – Yoshida; abstract and paragraphs [0065 – 0067] – Burnett; abstract, paragraphs [0137] and [0233] – Thompson); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one self-expandable frame work for another, and the results of the substitution would have been predictable and resulted in the modified retention members of Yoshida in view of Burnett still being able to operate as intended to occlude the pylorus. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the modification is such that the retention members of Yoshida in view of Burnett and Thompson comprises the covering taught by Burnett that covers the self-expandable scaffolds that are made up of a mesh (braided) framework, as taught by Thompson. Furthermore, it should be understood that the prior art makes obvious wherein the modified occlusion device of Yoshida would maintain its same shape in the collapsed configuration and in the expanded configuration so that the device will operate as intended.
Annotated Figure 6 of Yoshida
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Regarding claim 17, as discussed above, it would be obvious to modify the retention members of Yoshida to be self-expandable scaffolds comprised of filaments within a covering, based on the teachings of Burnett and Thompson. Additionally, the combination teaches [a portion of claim 17] wherein said occlusion device (pyloric occlusion device 2 of Yoshida) is shiftable between a collapsed configuration (configuration shown in Fig. 2 of Yoshida) and an expanded configuration (configuration shown in Figs. 3 – 8 of Yoshida), said curved surface (curved upstream surface of front side bag body 31b shown in Fig. 6 and designated in annotated Fig. 6 of Yoshida) is a convex surface on at least one of said first retention member (front side bag body 31b of Yoshida) facing away from said saddle (see annotated Fig. 6) (Examiner’s note: it should be understood that the modification made is such that the side bag bodies of Yoshida are modified to incorporate a self-expandable frame, but maintain the same desired shape and function as taught by Yoshida. Therefore, for the sake of simplicity the Examiner has still cited to Yoshida to show the claimed shape and function).
However, the combination below is silent regarding (i) an element associated with said convex surface of said at least one of said first retention member or said second retention member and said element so that relative movement of said element causes shifting of said occlusion device from an expanded configuration to a collapsed configuration when pulled in a direction away from said convex surface.
As to the above, Thompson, additionally, teaches another embodiment of a pyloric occlusive device (expandable anchor of Fig. 40; which equates to the pyloric occlusion device 2 of Yoshida modified with the self-expandable scaffolding of Burnett) inserted within the pylorus comprising an element (drawstring 347) so that relative movement of said element causes shifting the occlusion device (expandable anchor of Fig. 40) from the expanded state to the collapsed state for purpose of being able to remove the anchor and/or load the anchor onto a delivery catheter (abstract, paragraph [0185], and Fig. 40) (Examiner’s note: as discussed above, the removal element is being interpreted under 112(f) as a separate loop or an extension of the device (e.g., an extension of wires or filaments forming the device) or an equivalent structure, capable shifting the occlusion device from the expanded configuration to the collapsed configuration as disclosed by Applicant. Thompson, in paragraph [0185], teaches wherein the drawstring 347 is used to collapse the expandable anchor, therefore the drawstring is considered an equivalent structure to the claimed element).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first retention member of Yoshida in view of Burnett and Thompson to incorporate a removal element on the surface thereof, based on the teachings of Thompson, for the purpose of being able to load the anchor onto the delivery device in the collapsed state and for the purpose of providing a means of withdrawing the anchor into the catheter such that the anchor is removable in a more compact state, which reduces the chances of damaging the inner tissue walls during the retrieval process. Thus, the combination of Yoshida, Burnett, and Thompson makes obvious the limitations of claim 17.
Regarding claim 18, as discussed above, it would be obvious to modify the retention members of Yoshida to be self-expandable scaffolds comprised of filaments within a covering, based on the teachings of Burnett and Thompson.
However, the combination below is silent regarding (i) the downstream side of said upstream retention member having a concave surface with a concave curvature sufficient to cause said upstream retention member to resist inversion to inhibit downstream migration of said occlusion device through the pylorus.
As to the above, Thompson further teaches, in a different embodiment a self-expandable pyloric occlusion device (gastrointestinal device within a pylorus – expandable anchor 397) (abstract, paragraphs [0007] and [0197], and Figs. 51 – 52) comprising an upstream retention member (disk 381) (paragraph [0197] and Figs. 51 – 52) having an upstream side and a downstream side (right side and left side of disk 381, respectively, when looking at Fig. 52B), a downstream retention member (disk 380) having an upstream side and a downstream side (right side and left side of disk 380, respectively, when looking at Fig. 52B), and a saddle (central cylinder 382) extending therebetween. Thompson, in the embodiment of Fig. 51 – 52, further teaches, in paragraphs [0197 – 0198], wherein said downstream side of said upstream retention member has a concave surface such that said upstream retention member to resistant to inversion and migration through the pylorus (Examiner’s note: as shown in Fig. 51 the downstream side of the upstream disk 381 has a concave curvature, and because the rings / struts of the disk 381 are curved inward they will inherently resist compression and inversion as well as migration of the device as a whole).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the upstream retention member of Yoshida in view of Burnett (i.e., the self-expandable scaffold with a cover) to have the concave curvature at the downstream side, as taught by Thompson, for the purpose of allowing the radial ends of the anchor to generate a greater clamping pressure on the adjacent tissue, thereby providing enhanced migration resistance.
Regarding claim 19, as discussed above, it would be obvious to modify the retention members of Yoshida to be self-expandable scaffolds comprised of filaments within a covering, based on the teachings of Burnett and Thompson. Additionally, the combination teaches wherein said saddle (constricted portion 31c; designated in annotated Fig. 6 of Yoshida) is adjustable in length to adjust the distance between said upstream retention member and said downstream retention member (Examiner’s note: as shown in Fig. 3 of Yoshida (where the medical device is being expanded in stages) the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the adjusted length adjusts the distance between the upstream retention member (i.e., the front side bag 31b) and the downstream retention member (i.e., the back side bag 31a) changes; in other words the process of expanding the saddle changes the length of the saddle region which results in the distance between the retention members changing as required by the claim). As stated above, the prior art makes obvious wherein the modified occlusion device of Yoshida would maintain its same shape in the collapsed configuration and in the expanded configuration so that the device will operate as intended; therefore, the combination is said to encompass the limitations of claim 19 in the manner described above.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (JP 2010136734 A) (cited and translated PDF attached) (previously cited) in view of Burnett et al (US 2005/0055039 A1) (previously cited) and Thompson et al (US 2016/0228276 A1) (previously cited), as applied to claim 6 above, and further in view of Lottick (US 4,686,985) (previously cited).
Regarding claim 8, as discussed above, the combination of Yoshida, Burnett, and Thompson teaches the device of claim 6.
However, the combination of Yoshida, Burnett, and Thompson is silent regarding (i) wherein said upstream retention member has a downstream side, facing said saddle, having a concave surface such that said upstream retention member is resistant to inversion and migration through the pylorus.
As to the above, Lottick teaches an inflatable occlusion device for occluding an anal sphincter (which is similar to the pyloric sphincter), wherein the device comprises an upstream retention member (third chamber 22; which equates to the front side bag body 31b of Yoshida) and a downstream retention member (first chamber 14; which equates to the backside bag body 31a of Yoshida) with a saddle (second chamber 18; which equates to the constriction portion 31c of Yoshida) therebetween (abstract, col. 4 lines 20 – 53, and Figs. 1 – 4), wherein the upstream retention member has a downstream side (side pressed against the body) having a concave surface such that the upstream retention member (third chamber 22) is resistant to inversion and migration through the anal sphincter (which equates to the pyloric sphincter) (col. 8 lines 10 – 19) (Examiner’s note: as stated in col. 8 lines 10 – 19, the banana shape of the inflatable chamber prevents the device from being drawn or pushed into the anus (i.e., further downstream)).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the shape of the upstream retention member of Yoshida in view of Burnett and Thompson to have the banana shape (i.e., a concave downstream side), based on the teachings of Lottick, for the purpose of providing additional resistant to the occluder to prevent the device from traveling downstream (col. 8 lines 10 – 19 of Lottick).
Regarding claim 9, as discussed above, it would have been obvious to modify retention member of Yoshida in view of Burnett and Thompson with the concave shape of the downstream side of the upstream retention member based on the teachings of Lottick. Additionally, the combination teaches wherein the upstream side of said downstream retention member has a convex surface (see annotated Fig. 6 of Yoshida) configured to seat around the outlet of the pylorus (Fig. 6 of Yoshida) (Examiner’s note: it should be understood that the modification of claim 8 above is such that only the shape of the front side bag body 31b was modified to be shaped as claimed; thus, the back side bag body 31a (i.e., the downstream retention member) has the same shape as disclosed by Yoshida, and as shown in the annotated Fig. 6 the back side bag body 31a (i.e., the downstream retention member) is shaped as claimed).
Annotated Figure 6 of Yoshida
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Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (JP 2010136734 A) (cited and translated PDF attached) in view of Burnett et al (US 2005/0055039 A1) (previously cited) and Thompson et al (US 2016/0228276 A1) (previously cited), as applied to claim 15 above, and further in view of Todd et al (US 2018/0250009 A1) (previously cited).
Regarding claim 20, as discussed previously, the combination of the Yoshida, Burnett, and Thompson makes obvious the device of claim 15.
However, the current combination of Yoshida, Burnett, and Thompson is silent regarding (i) a barrier between the pylorus and said upstream side of said downstream retention member to cushion the pylorus.
As to the above, Todd teaches, in a field reasonably pertinent to the particular problem in which the applicant is concerned with, namely a device for closing a passage within the body (200), wherein the device comprises a covering (covering material 112; which equates to the covering of Burnett) and a barrier (coating) (paragraphs [0068 – 0069]) placed over the covering for the purpose of improving wettability (which helps the implantation and removal of the implant) and echo translucency of the covering (which helps the operator to visually see the implant) (paragraph [0069]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device Yoshida in view of Burnett and Thompson, to incorporate the coating / barrier, as taught by Todd, for the purpose of improving wettability (which helps the implantation and removal of the implant) and echo translucency of the covering (which helps the operator to visually see the implant) (paragraph [0069] – Todd).
Additionally, it should be understood that the coating is applied to the entire bag body 31, which includes over the upstream side of the downstream retention member (the side facing the saddle of the back side bag body 31a), and the coating provides some degree of cushion between the pylorus and said upstream side. Therefore, the combination makes obvious the limitation above.
Response to Arguments
Applicant's arguments filed 12/30/2025, have been fully considered but they are not persuasive. More specially:
With respect to Applicant’s argument, on pages 7 and 8 of the remarks, regarding the 112(f) interpretation of the “element”, the Examiner acknowledges the Applicant’s position, however, the term “means” does not need to be present in order for a claimed element to be treated under 112(f). see MPEP § 2181. Furthermore, the term “element” is followed by the functional language “so that relative movement of said element and said at least on of said first / upper retention member or said second / downstream retention member results in shifting of said pyloric occlusion device”, the function being “resulting in the shifting of the occlusion device”; additionally, Applicant has not added any additional structure to further limit what the “element” is, thus the Examiner is using the structure in Applicant’s disclosure to provide the needed structure to the claims in order to apply prior art appropriately. Therefore, the 112(f) interpretation has been maintained. If Applicant does not wish for the limitation to be treated under 112(f), the Examiner suggests the claims be amended to include corresponding structure.
With respect to Applicant’s argument that “none of Yoshida, Burnett, or Thompson shows or suggests an axially adjustable saddle, independent claims 1, 6, and 15”, although the Examiner acknowledges that the saddle of prior art is not adjustable in same manner as that of the Instant Device, the Examiner notes that the saddle of the prior is still an adjustable saddle which is axially adjustable to adjust a distance between the upstream retention member and the downstream retention member, as stated in the rejection above, the length of the constricted portion 31c (i.e., the saddle) increases when expanded and the distance between the first wall and the second changes along with the length of the saddle; therefore, because distance between the first wall and the second wall changes with the saddle length, it can be said that the saddle is adjustable to adjust the distance between the first wall and the second wall; in other words, any change in the length of the saddle will lead to a corresponding change to the distance between the first wall and second wall, thus the saddle is adjustable to adjust said distance. Therefore, the argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Andrew Restaino/Primary Examiner, Art Unit 3771