CTNF 19/171,918 CTNF 81513 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Benefit The application claims benefit as a Continuation to US 17/732,106, issued as 12,290,460 Applicant’s claim of benefit to 63181618 (29 April 2021) is acknowledged. Formal Matters Claims 1-20 are pending and under examination. Information Disclosure Statement The information disclosure statement (IDS) submitted on 8/5/2025 has been considered by the examiner. A signed copy is attached. 07-30-03-h AIA Claim Interpretation 07-30-05 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. Claim Objections 07-29-01 AIA Claim s 1-20 are objected to because of the following informalities: some elements are referred to as “said mesh element” (claims 1-3, 5-20) and “the mesh element” (claims 6 and 19) or “said support structure” (claims 1, 2, 4, 5, 7, 8, 10-20) and “the support structure” (claims 13, 17, 18. 20) . Consistency with the word “the” is suggested, especially because claim 12 separates “said mesh element” into a “first mesh element” and a “second mesh element”. Consistency promotes clarity and avoids confusion . Appropriate correction is required. 07-29-01 AIA Claim 3 is objected to because of the following informalities: the word “element” is misspelled “elelment” . Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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. 07-34-01 Claims 7 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 7 is unclear and confusing. Line 1 recites “wherein said mesh element is in the general shape of a disk”. It is unclear what is meant by “in the general shape of a disk”. The recitation of “the general” is vague and ambiguous such that one of ordinary skill in the art would not be reasonably apprised of the meets and bounds of what that generality was supposed to be. Claim 11 is unclear and confusing. Line 1 recites “The device of claim 1, wherein a plurality of fasteners are provided…”. The claim is awkwardly constructed and is missing a transitional phase or alternatively lacks antecedent basis for the “a plurality of fasteners” in line 1. It is unclear whether Applicant intends to convey “The device of claim, further comprising a plurality of fasteners, wherein the plurality of fasteners …” or alternatively, “The device of claim 1, further comprising a plurality of fasteners on a base that is separately formed from said mesh element …” 07-34-01 Claims 9 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 9 recites the limitation "said at least one fastener" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 9 is dependent on claim 1, which does not recite “at least one fasteners”. Claims 10 recite the limitation "said plurality of fasteners" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 10 is dependent on claim 1, which does not recite “a plurality of fasteners”. Non-Statutory Obviousness-Type Double Patenting Rejections 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto- processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-34 AIA Claim s 1, 2, 4-6, 8-12, 14-16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-6, 8, 11-14, and 18-20 of U.S. Patent No. 12,290,460 (6 May 2025) . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain the same subject matter in overlapping claims. The claims of the ‘460 patent anticipate the claims of the application. A table is provided below to show a claim-by-claim comparison. Differences in spacing or combinational language is shown in italics. The comparative analysis has been done on the structure/function of the apparatus and components thereof. The “intended use” and “capability” has been interpreted as having no patentable weight. Additionally, the functional language of apparatus claims are interpreted under MPEP 2114(IV). A terminal disclaimer, as set forth above, is required in order to overcome this rejection . Application 19/171,918 US Patent 12,290,460 1 . A device for regulating flow of materials through a body passage, said device comprising: a support structure having an open proximal end and an open distal end, wherein a lumen is defined through said support structure extending between said open proximal end and said open distal end; and a mesh element formed separately from said support structure and configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen, wherein flow of materials through said device is controlled by the size of the openings through said mesh element. 1. A device for regulating flow of materials through a body passage, said device comprising: a support structure having an open proximal end and an open distal end, wherein a lumen is defined through said support structure extending between said open proximal end and said open distal end ; a mesh element extending across the open proximal end of said support structure and having openings therethrough selected to control flow of materials through said lumen; and a plurality of fasteners coupling a periphery of said mesh element to the open proximal end of said support structure. 8. The device of claim 1, wherein said mesh element is formed separately from said support structure. 14. A device for controlling flow of materials through a body passage, said device comprising: a mesh element having a perimeter around a concave upstream surface and a convex downstream surface; and a plurality of fasteners coupled about the perimeter of said mesh element and configured to engage tissue adjacent or surrounding the body passage to secure the perimeter of said mesh element to the tissue; wherein the mesh element defines openings therethrough extending from the concave upstream surface to the convex downstream surface of the mesh element such that material flows from the upstream surface of the mesh element to the downstream surface of the mesh element and directly therefrom to the body passage, whereby the mesh element regulates flow of materials through the body passage without another flow-regulating device such that the mesh openings are determinative of the flow of material through the body passage . 2 . The device of claim 1, wherein: said support structure comprises a proximal retention member at said proximal end thereof sized to inhibit migration of said flow-regulating device through the body passage; and said mesh element is coupled to said proximal retention member. 2. The device of claim 1, wherein: said support structure comprises a proximal retention member at said proximal end thereof sized to inhibit migration of said flow-regulating device through the body passage; and said mesh element is coupled to said proximal retention member. 4 . The device of claim 2, wherein said proximal retention member is formed of a first proximal wall adjacent said proximal end of said support structure and a second proximal wall distally spaced from said first proximal wall in a direction towards said distal end of said support structure. 3. The device of claim 2, wherein said proximal retention member is formed of a first proximal wall adjacent said proximal end of said support structure and a second proximal wall distally spaced from said first proximal wall in a direction towards said distal end of said support structure. 5 . The device of claim 4, wherein said mesh element is positioned and held between said first proximal wall and said second proximal wall of said proximal retention member of said support structure. 4. The device of claim 3, wherein said mesh element is positioned and held between said first proximal wall and said second proximal wall of said proximal retention member of said support structure. 6 . The device of claim 1, wherein said mesh element has an upstream end and a downstream end, and is sheet-like to define an upstream surface on the upstream end and a downstream surface on the downstream end with the openings defined through the mesh element to allow fluid to flow from the upstream surface, through the mesh element, and to the downstream surface. 5. The device of claim 1, wherein said mesh element is sheet-like to define an upstream surface and a downstream surface with the openings defined through the mesh element to allow fluid to flow from the upstream surface, through the mesh element, and to the downstream surface. 8 . The device of claim 1, further comprising at least one fastener coupling a periphery of said mesh element to said proximal end of said support structure to mount said mesh element with respect to said support structure. 1 . and a plurality of fasteners coupling a periphery of said mesh element to the open proximal end of said support structure. 9 . The device of claim 1, wherein said at least one fastener is selected from the group consisting of loops, clips, barbs, and hooks. 6. The device of claim 1, wherein said plurality of fasteners is selected from the group consisting of loops, clips, barbs, and hooks. 10. The device of claim 1, wherein said plurality of fasteners are configured to allow removal of said mesh element from said support structure. 11. The device of claim 1, wherein said plurality of fasteners are flexible to facilitate removal from said mesh element and said support structure to remove said mesh element from said support structure. 11 . The device of claim 1, wherein a plurality of fasteners are provided on a base separately formed from said mesh element and said support structure and selectively positionable over a periphery of said mesh element and said support structure to couple together said mesh element and said support structure, and removable to permit removal of said mesh element from said support structure. 12 . The device of claim 1, wherein said plurality of fasteners are provided on a base separately formed from said mesh element and said support structure and selectively positionable over a periphery of said mesh element and said support structure to couple said mesh element and said support structure and removable to permit removal of said mesh element from said support structure. 12 . The device of claim 1, wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage. 13. The device of claim 1, wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage. 14 . A system for controlling flow of materials through a body passage, said system comprising: a support structure having an open proximal end and an open distal end, wherein a lumen is defined through said support structure extending between said open proximal end and said open distal end; and two or more mesh elements each having a different mesh gauge and formed separately from said support structure and configured for extending across the open proximal end of said support structure; wherein each mesh element is selectively operably couplable to said support structure to regulate flow of materials through the lumen of said support structure based on the mesh gauge of the selected mesh element. 1. A device for regulating flow of materials through a body passage, said device comprising: a support structure having an open proximal end and an open distal end, wherein a lumen is defined through said support structure extending between said open proximal end and said open distal end ; a mesh element extending across the open proximal end of said support structure and having openings therethrough selected to control flow of materials through said lumen; and a plurality of fasteners coupling a periphery of said mesh element to the open proximal end of said support structure. 8. The device of claim 1, wherein said mesh element is formed separately from said support structure. 13. The device of claim 1, wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage. 15. The system of claim 14, wherein each of said two or more mesh elements is removably couplable with said proximal end of said support structure to allow exchange and replacement with another of said two or more mesh elements. 13. The device of claim 1, wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage. 12. The device of claim 1, wherein said plurality of fasteners are provided on a base separately formed from said mesh element and said support structure and selectively positionable over a periphery of said mesh element and said support structure to couple said mesh element and said support structure and removable to permit removal of said mesh element from said support structure . 16 . The system of claim 14, wherein each of said two or more mesh elements is formed separately from said support structure. 8. The device of claim 1, wherein said mesh element is formed separately from said support structure. 13. The device of claim 1, wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage. 18 . A method of controlling flow of material through a pylorus, said method comprising: deploying a support structure across the pylorus; and coupling a mesh element across an opening of said support structure after the support structure has been deployed, said mesh element having a mesh gauge dimensioned to control flow of materials through said support structure. 18. A method of controlling flow of material through a pylorus, said method comprising: inserting a support structure through the pylorus; and coupling a mesh element across an opening of said support structure, said mesh element having a mesh gauge dimensioned to control flow of materials through said support structure; wherein material flow through the pylorus is regulated by only the mesh gauge of the mesh element without being further regulated by another flow-regulating device. 19 . The method of claim 18, further comprising exchanging the mesh element with a different mesh element having a different mesh gauge. 19. The method of claim 18, further comprising exchanging the mesh element with a different mesh element having a different mesh gauge. 20 . The method of claim 18, further comprising selecting said mesh element based on the mesh gauge thereof to regulate flow of materials through a lumen defined through the support structure lumen and thereby to control flow of materials through the pylorus. 18. A method of controlling flow of material through a pylorus, said method comprising: inserting a support structure through the pylorus; and coupling a mesh element across an opening of said support structure, said mesh element having a mesh gauge dimensioned to control flow of materials through said support structure; wherein material flow through the pylorus is regulated by only the mesh gauge of the mesh element without being further regulated by another flow-regulating device. 1. A device for regulating flow of materials through a body passage, said device comprising: a support structure having an open proximal end and an open distal end, wherein a lumen is defined through said support structure extending between said open proximal end and said open distal end; a mesh element extending across the open proximal end of said support structure and having openings therethrough selected to control flow of materials through said lumen ; and a plurality of fasteners coupling a periphery of said mesh element to the open proximal end of said support structure. 20. The method of claim 18, further comprising: inserting the support structure through said pylorus before coupling the mesh element to the support structure; allowing the support structure to anchor within the pylorus; allowing material to flow through a lumen defined through the support structure; and coupling the mesh element to the support structure after the support structure has been anchored within the pylorus to control flow of materials through the support structure lumen and thereby to control flow of materials through the pylorus . Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 1, 6, 8, and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bar et al., US 11,051,959 (6 July 2021, benefit to 21 November 2007) . Regarding independent claim 1 , Bar teaches a device ( FIGs 1, 2, stent apparatus 100 , col 12, lines 48-49 ) for regulating flow of materials through a body passage ( Abstract ), said device comprising: a support structure ( FIGs 1, 2, support element 102; col 12, lines 50-55) structure, claim 1 ) having an open proximal end ( FIGs 1, 6a; “tubular in shape”, col 12, line 53 ) and an open distal end ( FIGs 1, 6a; “tubular in shape”, col 12, line 53 ), wherein a lumen is defined through said support structure extending between said proximal end and said distal end ( FIGs 1, 6a ; central axis 106, col 3, lines 3-17; “ central fluid passage”, claim 1 ); and a mesh element ( FIGs 1, 2, porous structure 104; col 16, lines 49-67 ; “ knitted mesh cover”, claim 1 ) formed separately from said support structure ( col 22, lines 61-34 ) and configured for extending across the open proximal end of said support structure ( col 4, lines 44, 45; claim 1 ) and having a plurality of openings ( FIG 1, apertures 110 in porous structure 104; col 15, lines 17-18; claim 1 ) therethrough selected to control flow of materials through the lumen ( col 12, lines 32-34 ; “ minimize or prevent an aneurism-filling material from exiting the aneurysm ” , claim 1 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (“ apertures through the cover which apertures are at least 20 microns to 300 microns ”, claim 1 ). Regarding claim 6 , Bar teaches the device of claim 1, as set forth above, wherein said mesh element ( 104 ) has an upstream end and a downstream end ( FIGs 1, 20c ), and is sheet-like ( FIGs 1, 6a, 16; col 23, line 50-51, 53-56) to define an upstream surface on the upstream end and a downstream surface on the downstream end ( FIG 20c ) with the openings ( apertures 110 in porous structure 104; col 15, lines 17-18 ) defined through the mesh element ( 104 ) to allow fluid to flow from the upstream surface, through the mesh element, and to the downstream surface ( col 3, lines 55-66 ). The phases “upstream” and “downstream” are disclosed in the Specification at ¶29 to confer directionality based on the “the environment in which the device is disclosed” . Accordingly, the phrases are interpreted in their broadest reasonable interpretation in light of the directionality recited int Regarding claim 8 , Bar teaches the device of claim 1, as set forth above, further comprising at least one fastener ( FIG 16 , at least one loop 1604, col 29, lines 13-21 ), coupling ( “slidably attached”, col 29, lines 13-21; claim 1 ) a periphery of said mesh element to said proximal end of said support structure to mount said mesh element with respect to said support structure ( col 29, lines 13-21 ). Regarding claim 9 , Bar teaches the device of claim 1, as set forth above, wherein said at least one fastener is selected from the group consisting of loops, clips, barbs, and hooks ( FIG 16 , at least one loop 1604, col 29, lines 13-21 ) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1 and 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma, US 20140276336 (18 September 2014) . Regarding independent claim 1 , Sharma teaches a device ( FIG 29, intragastric device 2905, ¶550 ) for regulating flow of materials through a body passage ( gastrointestinal tract, Abstract ), said device comprising: a support structure ( FIG 3A, spherical wire mesh structure 2907, ¶550 ) having an open proximal end ( ¶550 )and an open distal end ( ¶550 ), wherein a lumen is defined through said support structure extending between said proximal end and said distal end ( FIG 29, ¶550 ). In embodiment 2905, Sharma does not teach that sleeve 2910 (FIG 29, ¶550) is a sleeve that controls flow of materials through said lumen. In embodiment 2905, Sharma does not expressly teach that the mesh structure (sleeve 2910) is formed separately from said support structure. In embodiment 2905 Sharma does not expressly teach that the mesh structure and configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶ 402 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶ 402 ). However, Sharma expressly teaches that “ it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device ” (¶ 432 ). In embodiment 300a ( FIG 3A, ¶¶461-462 ) Sharma expressly teaches device 300a , comprising wire mesh structure 301 coupled with sleeve 360 ( FIG 3A , ¶ 461 ) where sleeve 360 includes a sleeve body 361 having a proximal end, a distal end, and a lumen within, where sleeve body 361 is comprised of a flexible and compressible mesh material (¶ 462 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. In the general teachings about the wire mesh structure, Sharma expressly teaches a mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶ 402 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶ 402 ). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the embodiments of Sharma, given that Sharma teaches included each element claimed, although not necessarily in a single embodiment. Sharma teaches multiple embodiments of intragastric devices and expressly teaches that “it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device” (¶ 432 ). Although, Sharma’s embodiment 2905 discloses the claimed base device ( FIG 29, device 2905, ¶550) comprising: a support structure having an open proximal end and an open distal end wherein a lumen is defined through said support structure extending between said proximal end and said distal end and a sleeve ( 2910 ) ( FIG 3A, spherical wire mesh structure 2907, ¶550 ), Sharma does not provide a teaching in embodiment 2905 that sleeve 2910 is a mesh sleeve that controls flow of materials through said lumen. Similarly, in embodiment 2905 , Sharma does not expressly teach that the mesh structure ( sleeve 2910 ) is formed separately from said support structure. Further, in embodiment 2905 Sharma does not expressly teach that the mesh structure and configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen wherein flow of materials through said device is controlled by the size of the openings through said mesh element. However, Sharma specifically addresses the structures and functions missing in embodiment 2905 in other embodiments. In embodiment 300a ( FIG 3A, ¶¶461-462 ) Sharma expressly teaches device 300a , comprising wire mesh structure 301 coupled with sleeve 360 ( FIG 3A , ¶ 461 ) where sleeve 360 includes a sleeve body 361 having a proximal end, a distal end, and a lumen within, where sleeve body 361 is comprised of a flexible and compressible mesh material (¶ 462 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. In the general teachings about the wire mesh structure, Sharma expressly teaches a mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶ 402 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶ 402 ). Additionally, Sharma expressly teaches that he size of the openings through the mesh element will impact the flow of material through the device by varying the size of the opening, shape, and position can be optimized depending on the end effect desired for the use case (¶ 374 ). Because Sharma teaches the base device in one embodiment and related devices with similar and overlapping structures in different embodiments and provides express motivation for the combining of structures taught in the reference, a person of ordinary skill in the art, seeking to optimize the structural structure of a gastrointestinal device, particularly the one using RGB (roux-en-y gastric bypass) as taught in embodiment 2905, would reasonably consult Sharma’s other embodiments to combine device components suitable for the intended use case of any given patient population of interest. The structures of Sharma’s multiple embodiments are taught as being capable of being incorporated alongside Sharma’s other embodiments (e.g. device 2905) for the same purpose, using known assembly methods without redesigning the core structure of embodiment 2905. It would be obvious, based on the teachings, suggestions, and motivations of Sharma to make sleeve body 2910 (FIG 29, ¶550) out of mesh material, as taught for sleeve body 361 (¶462). FIG 35C expressly teaches how to construct the separately formed pieces of the support structure and mesh element (¶¶413, 421). Further, Sharma teaches that the mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶402), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶402). This is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that the size of the openings through the mesh element will impact the flow of material through the device by varying the size of the opening, shape, and position can be optimized depending on the end effect desired for the use case (¶374). Based on the express teachings of Sharma, one of ordinary skill in the art would have had a reasonable expectation of success to vary the size range of the openings based on the use-case need and anatomical structures affected. The size of the mesh element openings can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the size of the openings would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie , 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch , 617 F.2d 272, 205 USPQ 215 (CCPA 1980)). Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (the structure of devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the needed use-case), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 7 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above. Sharma teaches wherein said mesh element ( sleeve 2910 ) is in the general shape of a disk with a perimeter ( BRI: tube shaped ) , the perimeter being coupled with respect to said support structure ( FIG 29 ). Regarding claim 8 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above, further comprising at least one fastener ( anchoring mechanisms 2940 ) coupling a periphery of said mesh element to said proximal end of said support structure to mount said mesh element with respect to said support structure ( FIG 29 ). Regarding claim 9 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above. Sharma teaches wherein said at least one fastener is selected from the group consisting of loops, clips, barbs, and hooks ( FIG 29 , anchoring mechanisms 2940 are barbs, ¶551; hooks as anchoring mechanisms are taught at ¶436 ). Regarding claim 10 , Sharma teaches the device of claim 1, as set forth for the reasons set forth above. Sharma does not expressly teach wherein said plurality of fasteners are configured to allow removal of said mesh element from said support in embodiment 2905. In other embodiments and general teachings, Sharma teaches wherein said plurality of fasteners ( thread ) are configured to allow removal of said mesh element from said support structure (¶ 202 ). See also embodiments 4800 and 4901 (¶¶ 593-594 ) where the silk sutures include T-tags, clips and clamps (¶ 594 ) to aid in removal. Sharma teaches general methods of delivery and removal applicable to multiple intragastric devices. Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (providing devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the needed use-case, such as removing a thread (e.g. suture) fastener from the mesh element), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 11 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above. Sharma does not teach teaches wherein a plurality of fasteners are provided on a base separately formed from said mesh element and said support structure and selectively positionable over a periphery of said mesh element and said support structure to couple together said mesh element and said support structure, and removable to permit removal of said mesh element from said support structure in the embodiment of 2905. In other embodiments, Sharma teaches embodiments 4800 and 4900 (¶¶ 593-594 ) wherein a plurality of fasteners ( T-tags, clips, clamps, ¶594 ) are provided on a base ( circumferential constraining mechanism 4871, 4981 is a silk suture ) separately formed from said mesh element (¶ 594 ) and said support structure (¶ 594 ) and selectively positionable over a periphery of said mesh element and said support structure to couple together said mesh element and said support structure, and removable to permit removal of said mesh element from said support structure (¶¶ 593-594 ). Sharma teaches general methods of delivery and removal applicable to multiple intragastric devices. Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (providing devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the needed use-case, such as removing a thread (e.g. suture) fastener from the mesh element), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 12 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above. Sharma does not teach wherein said mesh element is a first mesh element having a first mesh gauge, said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge, said first mesh element being removable from said support structure and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage in the embodiment 2905. In other embodiments, Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge ( ¶¶402, 403 ), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge ( ¶402 ), said first mesh element being removable from said support structure (¶¶ 191, 594, 597 ) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶ 403 ). In the general teachings about the wire mesh structure, Sharma expressly teaches that there can be multiple mesh elements with multiple structures, weave patterns, and segmentations (¶403), similar to the ability to adjust the size of the openings through the mesh element to affect the flow of materials through the device and through a body passage (¶403). Additionally, Sharma expressly teaches that surface area matters and this can be controlled by varying the structure of the device in order to optimized the end flow results, depending on the end effect desired for the use case (¶ 374 ). The claims are device claims. The recitation that the mesh element (structure) that is configured to be deployed with respect to said support structure after tissue ingrowth into the support structure has occurred (function, results-effective variable) is broadly interpreted as a function that the structure is “capable of” performing. The disclosure does not teach any criticality or requirement for tissue ingrowth into the support structure. Rather, the language of the specification at ¶32 is that the support structure or scaffold may be deployed or implanted during a separate procedure before the mesh element is deployed to allow time for secure implantation (e.g. as a result of tissue ingrowth therein). However, there is no requirement that this delay or ingrowth occur a priori . None of paragraphs 35, 36, 40 or 57 indicate any criticality of this limitation and all recite the optional language “may” in association with regard to a delay and ingrowth. Absent evidence to the contrary, the mesh element of Sharma has the ability to so perform (¶ 417 ). See In re Hutchison , 69 USPQ 138, 33 CCPA 879 (1946). As set forth in the rationale above, Sharma expressly teaches that “ it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device ” (¶ 432 ). Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (the structure of devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the needed use-case), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 13 , Sharma teaches the device of claim 1, as set forth above, for the reasons set forth above. Embodiment 2905 of Sharma does not expressly teach that said mesh element is configured to be deployed with respect to said support structure after tissue ingrowth into the support structure has occurred. In other embodiments, Sharma teaches wherein said support structure is configured to be deployed within a patient separately from said mesh element ( FIG 35; ¶402 ). The claims are device claims. The recitation that the mesh element (structure) that is configured to be deployed with respect to said support structure after tissue ingrowth into the support structure has occurred (function, results-effective variable) is broadly interpreted as a function that the structure is “capable of” performing. The disclosure does not teach any criticality or requirement for tissue ingrowth into the support structure. Rather, the language of the specification at ¶32 is that the support structure or scaffold may be deployed or implanted during a separate procedure before the mesh element is deployed to allow time for secure implantation (e.g. as a result of tissue ingrowth therein). However, there is no requirement that this delay or ingrowth occur a priori . None of paragraphs 35, 36, 40 or 57 indicate any criticality of this limitation and all recite the optional language “may” in association with regard to a delay and ingrowth. Absent evidence to the contrary, the mesh element of Sharma has the ability to so perform (¶ 417 ). See In re Hutchison , 69 USPQ 138, 33 CCPA 879 (1946). Regarding independent claim 14 , Sharma teaches a system ( FIG 29, intragastric device 2905, ¶550 ) for controlling flow of materials through a body passage, ( gastrointestinal tract, Abstract ), said system comprising: a support structure ( FIG 3A, spherical wire mesh structure 2907, ¶550 ) having an open proximal end ( ¶550 )and an open distal end ( ¶550 ), wherein a lumen is defined through said support structure extending between said proximal end and said distal end ( FIG 29, ¶550 ). In embodiment 2905, Sharma does not expressly teach two or more mesh elements each having a different mesh gauge and formed separately from said support structure and configured for extending across the open proximal end of said support structure. In embodiment 2905, Sharma does not expressly teach wherein each mesh element is selectively operably couplable to said support structure to regulate flow of materials through the lumen of said support structure based on the mesh gauge of the selected mesh element. However, Sharma expressly teaches that “ it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device ” (¶ 432 ). Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge ( ¶¶402, 403 ), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge (¶ 402 ), said first mesh element being removable from said support structure (¶¶ 191, 594, 597 ) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶ 403 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. In the general teachings about the wire mesh structure, Sharma expressly teaches a mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶ 402 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶ 402 ). In the general teachings about the wire mesh structure, Sharma expressly teaches that there can be multiple mesh elements with multiple structures, weave patterns, and segmentations (¶ 403 ), similar to the ability to adjust the size of the openings through the mesh element to affect the flow of materials through the device and through a body passage (¶ 403 ). Additionally, Sharma expressly teaches that surface area matters and this can be controlled by varying the structure of the device in order to optimized the end flow results, depending on the end effect desired for the use case (¶ 374 ). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the embodiments of Sharma, given that Sharma teaches included each element claimed, although not necessarily in a single embodiment. Sharma teaches multiple embodiments of intragastric devices and expressly teaches that “it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device” (¶ 432 ). Although, Sharma’s embodiment 2905 discloses the claimed base device ( FIG 29, device 2905, ¶550) comprising: a support structure having an open proximal end and an open distal end wherein a lumen is defined through said support structure extending between said proximal end and said distal end and a sleeve (2910) ( FIG 3A, spherical wire mesh structure 2907, ¶550 ), Sharma does not provide a teaching in embodiment 2905 that two or more mesh elements each having a different mesh gauge are formed separately from said support structure and configured for extending across the open proximal end of said support structure or that each mesh element is selectively operably couplable to said support structure to regulate flow of materials through the lumen of said support structure based on the mesh gauge of the selected mesh element. However, Sharma specifically addresses the structures and functions missing in embodiment 2905 in other embodiments. Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge (¶¶402, 403), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge (¶¶402), said first mesh element being removable from said support structure (¶¶191, 594, 597) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶403). In embodiment of FIG 35C, Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract” ¶¶413, 421. In the general teachings about the wire mesh structure, Sharma expressly teaches a mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶402), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶402). Additionally, Sharma expressly teaches that he size of the openings through the mesh element will impact the flow of material through the device by varying the size of the opening, shape, and position can be optimized depending on the end effect desired for the use case (¶374). Because Sharma teaches the base device in one embodiment and related devices with similar and overlapping structures in different embodiments and provides express motivation for the combining of structures taught in the reference, a person of ordinary skill in the art, seeking to optimize the structural structure of a gastrointestinal device, particularly the one using RGB (roux-en-y gastric bypass) as taught in embodiment 2905, would reasonably consult Sharma’s other embodiments to combine device components suitable for the intended use case of any given patient population of interest. The structures of Sharma’s multiple embodiments are taught as being capable of being incorporated alongside Sharma’s other embodiments (e.g. device 2905) for the same purpose, using known assembly methods without redesigning the core structure of embodiment 2905. It would be obvious, based on the teachings, suggestions, and motivations of Sharma to make sleeve body 2910 (FIG 29, ¶550) out of mesh material, as taught for sleeve body 361 (¶462). FIG 35C expressly teaches how to construct the separately formed pieces of the support structure and mesh element (¶¶413, 421). Further, Sharma teaches that the mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶402), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶402). This is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that the size of the openings through the mesh element will impact the flow of material through the device by varying the size of the opening, shape, and position can be optimized depending on the end effect desired for the use case (¶374). Based on the express teachings of Sharma, one of ordinary skill in the art would have had a reasonable expectation of success to vary the size range of the openings based on the use-case need and anatomical structures affected. The size of the mesh element openings can be optimized by a person of ordinary skill in the art without undue experimentation based on the potential needs for the intended use case and the anatomical structures for which the devices are designed to service. As such, adjusting the size of the openings would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie , 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch , 617 F.2d 272, 205 USPQ 215 (CCPA 1980)). Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (the structure of devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting one mesh component for two mesh components (first and second) as taught in a different embodiment on a use-case basis to alter the flow of materials through the system (results-effective variable)), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Further, the claims are system claims (drawn to devices/apparatus). There is no recitation or indication of criticality in the Specification that the two or more mesh element (structures) that are configured to be deployed with respect to said support structure have any particular structure or function other than the broad disclosure of being useful depending on the ability to alter the flow of materials, which is a results-effective variable. This is broadly interpreted as a function that the structure of Sharma is “capable of” performing, as expressly set forth in Sharma (¶¶374, 402). Absent evidence to the contrary, the mesh elements one and two of Sharma have the ability to so perform to regulate the flow of materials (¶ 417 ). See In re Hutchison , 69 USPQ 138, 33 CCPA 879 (1946). As set forth in the rationale above, Sharma expressly teaches that “it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device” (¶432). Regarding claim 15 , Sharma teaches the system of claim 14, as set forth above, for the reasons set forth above. Sharma does not expressly teach wherein each of said two or more mesh elements is removably couplable with said proximal end of said support structure to allow exchange and replacement with another of said two or more mesh elements in embodiment 2905. In other embodiments, Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge ( ¶¶402, 403 ), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge (¶ ¶402 ), said first mesh element being removable from said support structure (¶¶ 191, 594, 597 ) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶ 403 ). Sharma teaches embodiments 4800 and 4900 (¶¶ 593-594 ) wherein a plurality of fasteners ( T-tags, clips, clamps, ¶594 ) are provided on a base ( circumferential constraining mechanism 4871, 4981 is a silk suture ) separately formed from said mesh element (¶ 594 ) and said support structure (¶ 594 ) and selectively positionable over a periphery of said mesh element and said support structure to couple together said mesh element and said support structure, and removable to permit removal of said mesh element from said support structure (¶¶ 593-594 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. In the general teachings about the wire mesh structure, Sharma expressly teaches a mesh element configured for extending across the open proximal end of said support structure and having a plurality of openings therethrough selected to control flow of materials through the lumen (¶ 402 ), wherein flow of materials through said device is controlled by the size of the openings through said mesh element (¶ 402 ). In the general teachings about the wire mesh structure, Sharma expressly teaches that there can be multiple mesh elements with multiple structures, weave patterns, and segmentations (¶ 403 ), similar to the ability to adjust the size of the openings through the mesh element to affect the flow of materials through the device and through a body passage (¶ 403 ). Additionally, Sharma expressly teaches that surface area matters and this can be controlled by varying the structure of the device in order to optimized the end flow results, depending on the end effect desired for the use case (¶ 374 ). It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the embodiments of Sharma, given that Sharma teaches included each element claimed, although not necessarily in a single embodiment. Sharma teaches multiple embodiments of intragastric devices and expressly teaches that “it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device” (¶ 432 ). Although, Sharma’s embodiment 2905 discloses the claimed base device ( FIG 29, device 2905, ¶550) comprising: a support structure having an open proximal end and an open distal end wherein a lumen is defined through said support structure extending between said proximal end and said distal end and a sleeve (2910) ( FIG 3A, spherical wire mesh structure 2907, ¶550 ), Sharma does not provide a teaching in embodiment 2905 that two or more mesh elements each having a different mesh gauge are formed separately from said support structure and configured for extending across the open proximal end of said support structure or that each mesh element is selectively operably couplable to said support structure to regulate flow of materials through the lumen of said support structure based on the mesh gauge of the selected mesh element. As set forth above, Sharma teaches general methods of delivery and removal applicable to multiple intragastric devices. Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (providing devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the based on the desired use-case), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 16 , Sharma teaches the system of claim 14, as set forth above, for the reasons set forth above. Sharma does not expressly teach wherein each of said two or more mesh elements is formed separately from said support structure in embodiment 2905. In embodiment 2905, Sharma does not expressly teach two or more mesh elements is formed separately from said support structure. However, Sharma expressly teaches that “ it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device ” (¶ 432 ). Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge ( ¶¶402, 403 ), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge (¶ ¶402 ), said first mesh element being removable from said support structure (¶¶ 191, 594, 597 ) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶ 403 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. As set forth above, Sharma teaches general methods of delivery and removal applicable to multiple intragastric devices. Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (providing devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the desired use-case), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings. Regarding claim 17 , Sharma teaches the system of claim 16, as set forth above, for the reasons set forth above. In the embodiment of 2905, Sharma does not expressly teach wherein said support structure is configured to be deployed within a patient separately from said two or more mesh elements, and each of said two or more mesh element is configured to deployed with respect to said support structure after tissue ingrowth into the support structure has occurred. However, Sharma expressly teaches that “ it should be appreciated that any combination of one or more of any the embodiments of the wire mesh structure, sleeve, retrieval mechanism, and anti-migration component disclosed in the present specification can be used to create an intragastric device ” (¶ 432 ). Sharma teaches multiple embodiments and general teachings, suggestions, and motivations wherein said mesh element is a first mesh element having a first mesh gauge ( ¶¶402, 403 ), said device further comprising a second mesh element having a second mesh gauge different from said first mesh gauge (¶ 402 ), said first mesh element being removable from said support structure (¶¶ 191, 594, 597 ) and replaceable with said second mesh element to alter the flow of materials through said device and through the body passage (¶ 403 ). In embodiment of FIG 35C , Sharma expressly provides a flow chart that shows that the structural support and mesh element are formed separately and how to attach them surgically inside of a patient. Additionally, Sharma expressly teaches that “ wire mesh structure and sleeve are delivered separately and assembled within a patient’s gastrointestinal tract ” ¶¶413, 421. The claims are system claims. The recitation that the two or more (first and second) mesh elements (structure) are configured to be deployed with respect to said support structure after tissue ingrowth into the support structure has occurred (function, results-effective variable) is broadly interpreted as a function that the structure is “capable of” performing. The disclosure does not teach any criticality or requirement for tissue ingrowth into the support structure. Rather, the language of the specification at ¶32 is that the support structure or scaffold may be deployed or implanted during a separate procedure before the mesh element is deployed to allow time for secure implantation (e.g. as a result of tissue ingrowth therein). However, there is no requirement that this delay or ingrowth occur a priori . None of paragraphs 35, 36, 40 or 57 indicate any criticality of this limitation and all recite the optional language “may” in association with regard to a delay and ingrowth. Absent evidence to the contrary, the mesh element of Sharma has the ability to so perform (¶417). See In re Hutchison , 69 USPQ 138, 33 CCPA 879 (1946). As set forth above, Sharma teaches general methods of delivery and removal applicable to multiple intragastric devices. Because the multiple embodiments, teachings, suggestions, and motivations of Sharma are drawn to the same engineering problem (providing devices for regulating flow of materials through the body) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the component of one embodiment for another based on the desired use-case), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Conclusion Claims 1, 2, and 4-20 are rejected. Claim 3 is objected to. 07-96 The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure: Bar et al., US 20160058589 (3 March 2016) (issued as US 11,051,959 (6 July 2021) cited above) teaches intravascular aneurysm treatment device and methods. Anderson et al., US 20030171771 (11 September 2003) teaches vascular protection devices and methods of use. Behan, US 20140350694 (27 November 2014) teaches luminal prosthesis and a gastrointestinal implant device (see Figures and Claims). Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000 /CHERIE M POLAND/Examiner, Art Unit 3771 Application/Control Number: 19/171,918 Page 2 Art Unit: 3771 Application/Control Number: 19/171,918 Page 3 Art Unit: 3771 Application/Control Number: 19/171,918 Page 4 Art Unit: 3771 Application/Control Number: 19/171,918 Page 5 Art Unit: 3771 Application/Control Number: 19/171,918 Page 6 Art Unit: 3771 Application/Control Number: 19/171,918 Page 7 Art Unit: 3771 Application/Control Number: 19/171,918 Page 8 Art Unit: 3771 Application/Control Number: 19/171,918 Page 9 Art Unit: 3771 Application/Control Number: 19/171,918 Page 10 Art Unit: 3771 Application/Control Number: 19/171,918 Page 11 Art Unit: 3771 Application/Control Number: 19/171,918 Page 12 Art Unit: 3771 Application/Control Number: 19/171,918 Page 13 Art Unit: 3771 Application/Control Number: 19/171,918 Page 14 Art Unit: 3771 Application/Control Number: 19/171,918 Page 15 Art Unit: 3771 Application/Control Number: 19/171,918 Page 16 Art Unit: 3771 Application/Control Number: 19/171,918 Page 17 Art Unit: 3771 Application/Control Number: 19/171,918 Page 18 Art Unit: 3771 Application/Control Number: 19/171,918 Page 20 Art Unit: 3771 Application/Control Number: 19/171,918 Page 21 Art Unit: 3771 Application/Control Number: 19/171,918 Page 22 Art Unit: 3771 Application/Control Number: 19/171,918 Page 23 Art Unit: 3771 Application/Control Number: 19/171,918 Page 24 Art Unit: 3771 Application/Control Number: 19/171,918 Page 25 Art Unit: 3771 Application/Control Number: 19/171,918 Page 26 Art Unit: 3771 Application/Control Number: 19/171,918 Page 27 Art Unit: 3771 Application/Control Number: 19/171,918 Page 28 Art Unit: 3771 Application/Control Number: 19/171,918 Page 29 Art Unit: 3771 Application/Control Number: 19/171,918 Page 30 Art Unit: 3771 Application/Control Number: 19/171,918 Page 31 Art Unit: 3771 Application/Control Number: 19/171,918 Page 32 Art Unit: 3771 Application/Control Number: 19/171,918 Page 33 Art Unit: 3771 Application/Control Number: 19/171,918 Page 34 Art Unit: 3771 Application/Control Number: 19/171,918 Page 35 Art Unit: 3771 Application/Control Number: 19/171,918 Page 36 Art Unit: 3771
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