DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Claims 1, 12, and 17 are currently amended. Claims 1-20 remain pending in the present application.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that claim 17 has been amended to more particularly point out the facilitation of tissue ingrowth, and that Gupta does not address tissue ingrowth in this manner, a recitation of the intended function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Gupta discloses all of the structure of claim 17 (including an inherent rigidity), and even recites a specific affinity to tissue ingrowth (¶s 7 and 42), and thus would appear to read on the function as claimed. Applicant has not demonstrated what differing structure would enable a growth response of the instant invention, while the device of Gupta would not, or how the elements of Gupta would necessarily conform/not confirm in the manner as claimed. Thus, even though Gupta does not explicitly teach such functions, Applicant must set forth how the prior art would not be capable of performing said functions to establish non-obviousness, or recite explicit structure not taught by the prior art.
Regarding claim 1, Applicant argues claim 1 has been amended to reflect the particular rigidity of the saddle region, which may contribute to greater tissue interaction, and in combination with the recited relative lengths of the device elements, contribute to the unique ability of encouraging tissue growth and resisting migration.
However, the cited paragraphs of 60 and 61 of Applicant’s specification does not provide direction as to what would be considered “more rigidity” or “sufficient rigidity”. Thus, absent other teachings, the claimed rigidity is not patentably distinct from the inherent rigidity of Gupta.
Applicant also argues Gupta does not explicitly describe the length of the retention members and/or the rigidity of the saddle region to encourage tissue growth as claimed.
However, a recitation of the intended function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the relative lengths and the rigidity of the saddle regions appear obvious in view of Gupta and Applicant has not set forth how Gupta would not be capable of performing these functions, only that Gupta is silent.
In addition, Applicant has only described a wide range of relative lengths (i.e. 20-200%) may contribute to the claimed increased tissue ingrowth. Thus, the range of “at least 75% greater” does not appear critical. Additionally, Applicant has only indicated rigidities in relative terms. Thus, Applicant has demonstrated a general association between lengths/rigidity and tissue ingrowth. Applicant may establish more specific structural features and parameters of the claimed invention in order to better overcome the prior art.
Applicants arguments with respect to claim 12 are similarly not persuasive for at least the same reasons as set forth with respect to claim 1, above.
Applicant’s arguments regarding the dependent claims on the same grounds as independent claims 1, 12, and 17 are moot as claims 1, 12, and 17 remain rejected as set forth below.
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.
Claims 1-16 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.
The term “sufficiently rigid” in claims 1 and 12 is a relative term which renders the claim indefinite. The term “sufficiently rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant’s specification describes the saddle region “may have less flexibility, or greater rigidity”, but does not indicate reference point to which the greater rigidity is considered relative to.
In an effort to promote compact prosecution, the limitation is interpreted as functional
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. (US 2019/0298559 A1).
Regarding claim 17, Gupta discloses a pyloric occlusion device (Figs. 7 and 7A; Abstract and ¶ 2 indicate pyloric occlusion), the device comprising:
an elongate body (the entire device comprises an elongate body; e.g. device 700 in Fig. 7) having a constrained configuration and an unconstrained configuration (Figs. 3-5 best illustrate a compressed, delivery configuration and an expanded, delivered configuration),
wherein, in the unconstrained configuration, the elongate body comprises a first retention member, a second retention member (rounded portions 740a/b), and a saddle region extending therebetween (saddle 715 and closure element 730);
wherein the saddle region is configured to span a pyloric sphincter (¶ 37);
wherein the first retention member and the second retention member each include an inner wall, an outwardly circumferential wall forming a cylindrical portion, and an outer wall, an interface between the inner wall and the outwardly circumferential wall, and a third interface connecting the outwardly circumferential wall and the outer wall (see annotated Figs. 7A and 9A below with Fig. 9A showing more clearly defined features; note that ¶ 43 indicates the flanges of the various embodiments may be shaped as shown in Fig. 9A), the outwardly circumferential wall including a first portion and a second portion (any section of the outer circumferential wall may be interpreted as a “portion”).
Limitations of the first portion “does not conform to a shape of a first portion of tissue wall to cause a growth response in contacted tissue”, a second portion “conforms to a shape of a second portion of the tissue wall; and for the growth response caused by the first portion of the outwardly circumferential wall reaches and interacts with the second portion of the outwardly circumferential wall to cause tissue ingrowth with respect to at least the second portion of the outwardly circumferential wall based on a rigidity of the saddle region”, are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gupta is also intended as a pyloric occlusion device and would appear to be used such that the structures are arranged against the particular anatomical structures as claimed (for example, see Fig. 2F and ¶ 37; ¶s 7 and 41 also describes how the device would encourage tissue growth in uncoated embodiments; further the device of Gupta would inherently have some degree of rigidity).
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Regarding claim 18, Gupta further discloses interface comprising a corner (i.e. where the rounded portions transition to the lip portion as shown in a Fig. 7A, thus forming a rounded corner or crease; Fig. 9A also shows clear, right angle corners at the interfaces).
Regarding claim 19, Gupta further discloses an outer wall and a second interface between the outer wall and the outwardly circumferential wall (see annotated Figs. 7A and 9A below).
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Regarding claim 20, Gupta further teaches wherein at least apportion of the outer wall is covered and the interface is uncovered (see annotated Fig. 7A above; a second interface is partially uncovered while the outer wall is covered by coating 765; ¶s 41-42).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, and 10-11, are rejected under 35 U.S.C. 103 as being unpatentable over Gupta.
Regarding claim 1, Gupta teaches a pyloric occlusion device (Figs. 7 and 7A; Abstract and ¶ 2 indicate pyloric occlusion) comprising:
an elongate body (the entire device comprises an elongate body; e.g. device 700 in Fig. 7) having a first configuration and second configuration (Figs. 3-5 best illustrate a compressed, delivery configuration and an expanded, delivered configuration),
wherein the elongate body comprises a first retention member, a second retention member (rounded portions 740a/b), and a cylindrical saddle region extending therebetween (saddle 715 and closure element 730);
wherein the first retention member and the second retention member each include an inner wall, an outwardly circumferential wall forming a cylindrical portion, and an outer wall, a first interface connecting the cylindrical saddle region and the inner wall, a second interface connecting the inner wall and the outwardly circumferential wall, and a third interface connecting the outwardly circumferential wall and the outer wall (see annotated Figs. 7A and 9A below with Fig. 9A showing more clearly defined features; note that ¶ 43 indicates the flanges of the various embodiments may be shaped as shown in Fig. 9A);
wherein, in the second configuration:
the first and the second retention members are expanded to have greater diameters than in the first configuration (Figs. 3-5 best illustrate a compressed, delivery configuration and an expanded, delivered configuration).
Limitations of the device “configured to encourage tissue growth”, at least one of the outwardly circumferential wall, the second interface, or the third interface of either the first retention member of the second retention member is configured “to oppose a pyloric antrum wall”, the cylindrical saddle region is configured “to span a pyloric sphincter”, and the saddle region “is sufficiently rigid to encourage a growth response of tissue along the length of the first and second retention members” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gupta is also intended as a pyloric occlusion device and would appear to be used such that the structures are arranged against the particular anatomical structures as claimed (for example, see Fig. 2F and ¶ 37; ¶s 7 and 41 also describes how the device would encourage tissue growth in uncoated embodiments; the device also must inherently have some amount of rigidity).
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Gupta does not explicitly disclose each of the first and second retention members extend along a length at least 75% greater than a length of the cylindrical saddle region.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Gupta to have the length of the first and second members be such that retention members extends along a length at least 75% greater than a length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Gupta would not operate differently with the claimed length ratio (¶s 50 and 53 of Gupta further indicate these lengths are adjustable). Further, applicant places no criticality on the range claimed, indicating that the length of the retention members may be anywhere between 20 and 200% a magnitude of the length of the saddle (middle of page 15 of Applicant’s specification) and further does not describe unexpected results regarding said range.
Regarding claim 2, Gupta further teaches wherein at least apportion of the outer wall is covered and one of the first and second interfaces is uncovered (see annotated Fig. 7A above; a second interface is partially uncovered while the outer wall is covered by coating 765; ¶s 41-42).
Regarding claim 3, Gupta further teaches wherein the first and second retention members comprise a lip (edges 706 and 707 form a lip).
Regarding claim 4, Gupta further teaches the first and second retention members having a surface (inherent to the shape of the device).
Limitations of the surfaces “do not conform to a shape of a tissue wall with respect to which said pyloric occlusion devices deployed, and thereby causes a growth response of the tissue wall with respect to said pyloric occlusion device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gupta is also intended as a pyloric occlusion device and would appear to be capable of not conforming to certain tissue shapes, and encouraging tissue ingrowth (also see ¶ 41 which indicates uncoated portions promote tissue ingrowth)
Regarding claim 5, Gupta further teaches the first and second retention members comprising a crease (i.e. where the rounded portions transition to the lip portion as shown in Fig. 7A, thus forming a rounded corner or crease; Fig. 9A also shows clear, right angle corners at the interfaces).
Regarding claim 6, Gupta further teaches the inner wall and the outer wall of at least one of the first or second retention members are substantially parallel (the inner and outer walls as indicated in annotated Fig. 7A above are interpreted as being substantially parallel; Fig. 9A above shows more explicitly parallel inner and outer walls).
Regarding claim 7, Gupta further teaches the retention members as being semi-spherical, and thus would have non-parallel inner and outer walls (i.e. Fig. 9B; note that ¶ 35 indicates the different shapes are applicable to the various disclosed embodiments).
Regarding claim 10, Gupta does not explicitly disclose the diameter of the first retention member, the diameter of the second retention member, or both is 300-600% a diameter of the cylindrical saddle region.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Gupta to have the diameter of the first retention member, the diameter of the second retention member, or both is 300-600% a diameter of the cylindrical saddle region since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Gupta would not operate differently with the claimed diameter ratio. Further, applicant places no criticality on the range claimed, indicating that the length of the retention members may be anywhere between 100 and 700% a magnitude of the length of the saddle (top of page 15 of Applicant’s specification) and further does not describe unexpected results regarding said range.
Regarding claim 11, Gupta further teaches the cylindrical saddle region defines an outer surface of the elongate body extending a full length between the first and second retention members (Figs. 7A and 9B show the saddle directly connected to the retention members, thus extending a full length between said retention members).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta, as applied to claim 1, and further in view of Belhe et al. (US 2019/0298560 A1).
Regarding claim 8, Gupta does not explicitly teach the outer wall, the inner wall, or both of the first retention member comprises a convex portion bending towards a vertical center plane of the first retention member.
However, Belhe teaches a gastrointestinal prosthesis (Figs. 1-3; Abstract), thus being in the same field of endeavor, comprising concaved and convexed inner walls (walls 148 and 150 in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner walls of Gupta to comprise a convex portion bending towards a vertical center plane of the first retention member, as taught by Belhe. Doing so would be advantageous in applying force to the pylorus to help keep the implant in place (¶ 71).
Regarding claim 9, Gupta does not explicitly teach the outer wall, the inner wall, or both of the first retention member comprises a concave portion bending away from a vertical center plane of the first retention member.
However, Belhe teaches a gastrointestinal prosthesis (Figs. 1-3; Abstract), thus being in the same field of endeavor, comprising concaved and convexed inner walls (walls 148 and 150 in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner walls of Gupta to comprise a concave portion bending towards a vertical center plane of the first retention member, as taught by Belhe. Doing so would be advantageous in applying force to the pylorus to help keep the implant in place (¶ 71).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta in view of Belhe.
Regarding claim 12, Gupta teaches a pyloric occlusion device (Figs. 7 and 7A; Abstract and ¶ 2 indicate pyloric occlusion) comprising:
an elongate body (the entire device comprises an elongate body; e.g. device 700 in Fig. 7) having a first configuration and second configuration (Figs. 3-5 best illustrate a compressed, delivery configuration and an expanded, delivered configuration),
wherein, in the second configuration, the elongate body comprises a saddle region (saddle 715) and a gastric extension (rounded portions 740a/b) with an inner wall , an outwardly circumferential wall, and an outer wall, a first interface connecting the inner wall and the outwardly circumferential wall, and the second interface connecting the outwardly circumferential wall and the outer wall (see annotated Figs. 7A and 9A below),
wherein the saddle region defines a lumen characterized by a sufficiently small diameter so as to limit flow therethrough (¶ 36 describes how the saddle is occluded); and
wherein the outwardly circumferential wall defines a cylindrical portion (Figs. 7-9D, as well as 10A-10B show various shapes which are all generally cylindrical at least in part).
Limitations of the length being “sufficient to encourage tissue ingrowth along the outwardly circumferential wall” and the saddle region “is sufficiently rigid to encourage a growth response of tissue along the outwardly circumferential wall” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2144. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gupta is also intended as a pyloric occlusion device and would appear to be capable of encouraging tissue ingrowth (also see ¶ 41 which indicates uncoated portions/device promote tissue ingrowth, thus indicating tissue growth would be inherently encourage in embodiments without a coating; ¶s 7 and 41 also describes how the device would encourage tissue growth in uncoated embodiments; the device also must inherently have some amount of rigidity).
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Gupta does not explicitly teach the outer wall, the inner wall, or both of the first interface and the second interface includes a concave portion and a convex portion.
However, Belhe teaches a gastrointestinal prosthesis (Figs. 1-3; Abstract), thus being in the same field of endeavor, comprising concaved and convexed inner walls (walls 148 and 150 in Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified either the first interface of Gupta to comprise a concave and convex portions, as taught by Belhe. Doing so would thus comprise interfaces including concave and convex portions. Doing so would be advantageous in applying force to the pylorus to help keep the implant in place (¶ 71).
Regarding claim 13, Gupta further teaches the second interface including a substantially straight portion (see annotated Figs. 7A and 9A above; the second interfaces interpreted as having a substantially straight portion).
Regarding claim 14, Gupta further discloses wherein at least apportion of the outer wall is covered and one of the first and second interfaces is uncovered (see annotated Fig. 7A above; a second interface is partially uncovered while the outer wall is covered by coating 765; ¶s 41-42).
Regarding claim 15, Gupta further discloses the first and second retention members comprising a crease (i.e. where the rounded portions transition to the lip portion as shown in Fig. 7A, thus forming a rounded corner or crease; Fig. 9A also shows clear, right angle corners at the interfaces).
Regarding claim 16, Gupta does not explicitly disclose each of the first and second retention members extend along a length at least 75% a length of the cylindrical saddle region, the inner wall being at least 28mm, wherein a diameter of the saddle region is less than 5mm, or any combination thereof.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Gupta to have the length of the first and second members be such that retention members extends along a length at least 75% greater than a length, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Gupta would not operate differently with the claimed length ratio (¶s 50 and 53 of Gupta further indicate these lengths are adjustable). Further, applicant places no criticality on the range claimed, indicating that the length of the retention members may be anywhere between 20 and 200% a magnitude of the length of the saddle (middle of page 15 of Applicant’s specification) and further does not describe unexpected results regarding said range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781