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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“contact member” in claims 21, 33, 36, 39. Where the “contact member” is interpreted as “a plurality of arms or struts 116” according to the specification paragraph [0273] and equivalents thereof.
“securing element” in claims 21, 33, 36, 39. Where the “securing element” is interpreted as “a single arm or multiple arms” according to the specification paragraph [0267] and equivalents thereof.
“tissue engagement features” in claim 25, 39. Where the “tissue engagement features” are “teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue engaging features” according to the specification paragraph [0274] and equivalents thereof.
“locking feature” in claim 31. There is no corresponding structure in the specification associated with the structural limitation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 31 is 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 limitation “locking feature” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no description of the “locking feature” in the disclosure only that the implant is locked as in paragraph [0389]; however, there is no structure recited for performing the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Double Patenting
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.
Claims 21, 23-25, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12303116. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of ‘116 anticipates the limitations of claims 21, 23-25, 36, and 38 of the instant application.
18748524 claims
12303116 claims
21. An apparatus, comprising: (a) a contact member, the contact member being configured to transition between a collapsed state and an expanded state, the contact member being configured to fit within a cavity or vessel in a patient in the expanded state, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state; and (b) a securing element, the securing element being movable relative to the contact member (see claim 12), the securing element being configured to engage tissue outside the cavity or vessel, the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state).
1. A device for reshaping, closing, or occluding a cavity, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state, the contact member including one or more anchor features, the contact member being positioned along a longitudinal axis;
a retaining member; and
a securing element coupled with the contact member via the retaining member;
wherein:
the contact member is configured to engage a wall portion of the cavity after the contact member has been advanced into the cavity;
the contact member is configured to rotate at least in a first angular direction from a first position to a second position;
the contact member is configured to twist at least a portion of the wall portion of the cavity in the first angular direction when the contact member is engaged with the wall portion of the cavity and is rotated from the first position to the second position to twist tissue of the wall portion of the cavity through engagement between the one or more anchor features and the tissue and thereby draw at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; and
the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state, wherein the second angular direction is opposite to the first angular direction about the longitudinal axis.
11. The device of claim 1, the retaining member being configured to bias the securing element toward the contact member.
12. The device of claim 1, wherein the retaining member comprises a threaded shaft.
23. The apparatus of claim 21, the contact member being configured to fit within a left atrial appendage in the expanded state, the contact member being further configured to deform the left atrial appendage in the expanded state upon movement of the contact member within the left atrial appendage while the contact member is in the expanded state, the securing element being configured to engage tissue outside the left atrial appendage, the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the left atrial appendage, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the left atrial appendage imparted by the contact member.
See claim 12.
24. The apparatus of claim 21, the contact member being further configured to deform the cavity or vessel in the expanded state by twisting the cavity or vessel upon rotational movement of the contact member within the cavity or vessel while the contact member is in the expanded state.
See claim 1.
25. The apparatus of claim 21, the contact member comprising a plurality of tissue engagement features (anchor features) configured to engage tissue within the cavity or vessel in the expanded state.
See claim 1.
36. An apparatus, comprising: (a) a contact member, the contact member being configured to transition between a collapsed state and an expanded state, the contact member being configured to fit within a cavity or vessel in a patient in the expanded state, the contact member being further configured to engage tissue within the cavity or vessel in the expanded state; and (b) a securing element, the securing element being movable relative to the contact member along a longitudinal axis (see claim 12), the securing element being configured to engage tissue outside the cavity or vessel, the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state).
1. A device for reshaping, closing, or occluding a cavity, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state, the contact member including one or more anchor features, the contact member being positioned along a longitudinal axis;
a retaining member; and
a securing element coupled with the contact member via the retaining member;
wherein:
the contact member is configured to engage a wall portion of the cavity after the contact member has been advanced into the cavity;
the contact member is configured to rotate at least in a first angular direction from a first position to a second position;
the contact member is configured to twist at least a portion of the wall portion of the cavity in the first angular direction when the contact member is engaged with the wall portion of the cavity and is rotated from the first position to the second position to twist tissue of the wall portion of the cavity through engagement between the one or more anchor features and the tissue and thereby draw at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; and
the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state, wherein the second angular direction is opposite to the first angular direction about the longitudinal axis.
11. The device of claim 1, the retaining member being configured to bias the securing element toward the contact member.
12. The device of claim 1, wherein the retaining member comprises a threaded shaft.
38. The apparatus of claim 36, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the securing element is configured to prevent a rotation of the wall portion of the cavity in a second angular direction when the securing element is implanted in an operable state, to thereby maintain the tissue in a twisted state).
See claim 1.
Claims 21, 23, 24, 30, 32, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11219462. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 13 of ‘462 anticipates the limitations of claims 21, 23, 24, 30, 32, 36, 38 of the instant application.
18748524 claims
11219462 claims
21. An apparatus, comprising: (a) a contact member, the contact member being configured to transition between a collapsed state and an expanded state, the contact member being configured to fit within a cavity or vessel in a patient in the expanded state, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state (twist at least a portion of a left atrial appendage); and (b) a securing element, the securing element being movable relative to the contact member (see claim 13), the securing element being configured to engage tissue outside the cavity or vessel, the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (see claim 13), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (prevent the left atrial appendage that has been twisted from untwisting).
1. A device for treating a left atrial appendage, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state; and
a securing element;
wherein:
at least a portion of the contact member is larger in a radial direction when the implant is in the second state as compared to the first state;
the contact member is configured to be rotatable at least in a first direction from a first position to a second position that is at least 45 degrees from the first position to twist at least a portion of a left atrial appendage in the first direction from a first position to a second position that is at least 45 degrees from the first position of the left atrial appendage when the contact member is engaged with an inner wall of the left atrial appendage; and
the securing element is configured to engage a tissue of the left atrium and/or the left atrial appendage to prevent the left atrial appendage that has been twisted from untwisting back to the first position of the left atrial appendage.
11. The device of claim 1, comprising a retention member configured to couple the securing element with the contact member.
13. The device of claim 11, wherein the device is configured such that a rotation of the retention member in a first direction causes the securing element to move toward the contact member.
23. The apparatus of claim 21, the contact member being configured to fit within a left atrial appendage in the expanded state, the contact member being further configured to deform the left atrial appendage in the expanded state upon movement of the contact member within the left atrial appendage while the contact member is in the expanded state, the securing element being configured to engage tissue outside the left atrial appendage, the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the left atrial appendage, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the left atrial appendage imparted by the contact member.
See claims 13.
24. The apparatus of claim 21, the contact member being further configured to deform the cavity or vessel in the expanded state by twisting the cavity or vessel upon rotational movement of the contact member within the cavity or vessel while the contact member is in the expanded state.
See claim 1.
30. The apparatus of claim 21, the securing element being movable relative to the contact member along a longitudinal axis, the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel.
See claim 13.
32. The apparatus of claim 30, the contact member being further configured to rotate about the longitudinal axis to thereby deform the cavity or vessel while the contact member is within the cavity or vessel while the contact member is in the expanded state.
See claim 1.
36. An apparatus, comprising: (a) a contact member, the contact member being configured to transition between a collapsed state and an expanded state, the contact member being configured to fit within a cavity or vessel in a patient in the expanded state, the contact member being further configured to engage tissue within the cavity or vessel in the expanded state; and (b) a securing element, the securing element being movable relative to the contact member along a longitudinal axis (see claim 13), the securing element being configured to engage tissue outside the cavity or vessel, the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (prevent the left atrial appendage that has been twisted from untwisting).
1. A device for treating a left atrial appendage, comprising:
an implant comprising:
a contact member configured to move between a first state and a second state; and
a securing element;
wherein:
at least a portion of the contact member is larger in a radial direction when the implant is in the second state as compared to the first state;
the contact member is configured to be rotatable at least in a first direction from a first position to a second position that is at least 45 degrees from the first position to twist at least a portion of a left atrial appendage in the first direction from a first position to a second position that is at least 45 degrees from the first position of the left atrial appendage when the contact member is engaged with an inner wall of the left atrial appendage; and
the securing element is configured to engage a tissue of the left atrium and/or the left atrial appendage to prevent the left atrial appendage that has been twisted from untwisting back to the first position of the left atrial appendage.
11. The device of claim 1, comprising a retention member configured to couple the securing element with the contact member.
13. The device of claim 11, wherein the device is configured such that a rotation of the retention member in a first direction causes the securing element to move toward the contact member.
38. The apparatus of claim 36, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (prevent the left atrial appendage that has been twisted from untwisting).
See claim 1.
Claim Rejections - 35 USC § 102
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 21-25, 27-30, 32-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Subramaniam (US2019/0183512).
Regarding claim 21, Subramaniam discloses an apparatus, comprising:
a contact member (anchor portion 2206, see Fig. 22; where the anchor portion 2206 is an equivalent structure to the “contact member” interpreted under 112(f) by being an expandable member with arms 2210, [0087], see Fig. 22), the contact member being configured to transition between a collapsed state and an expanded state (where the arms of the anchor 2206 expand outwardly in the same manner as the embodiment of Figs. 18A-18B, [0087], [0084]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state ([0087]), the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state (the device is capable of deforming the cavity by rotating or expansion within the cavity, the claims do not require the tissue to be deformed, but is instead interpreted as part of the intended use of the device); and
a securing element (sealing portion 2202, see Fig. 22; where the sealing poriton 2202 is an equivalent structure to the “securing element” interpreted under 112(f) by being an expandable member with arms as described in [0082] where the sealing portion of the embodiment of Fig. 18 is substantially the same as the embodiment of Fig. 22, [0087]), the securing element being movable relative to the contact member (coupling element 2204 allows sealing portion 2202 to flex relative to anchor portion 2206, [0087]), the securing element being configured to engage tissue outside the cavity or vessel (see Fig. 22), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the securing element/sealing portion 2202 is securable to the contact member/anchoring member 2206 by the coupling member 2204 to maintain engagement between the components), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the implant 2206 and sealing portion 2202 cooperate by the spring-like spiral feature connecting them, where the deformation of the cavity imparted by the contact member would be maintained by this cooperation since the structures are coupled by the spring-like spiral feature is stretched and then released to be at rest it would hold a deformation).
Regarding claim 22, Subramaniam discloses the apparatus of claim 21, the contact member and the securing element being configured to cooperate to prevent fluid flow into the cavity or vessel through the maintained deformation of the cavity or vessel imparted by the contact member (the sealing portion 2202 is intended to seal the left atrial appendage, [0087] and further described in [0081]; where the seal formed at the ostium would prevent fluid flow from the maintained deformation of the cavity imparted by the contact member).
Regarding claim 23, Subramaniam discloses the apparatus of claim 21, the contact member being configured to fit within a left atrial appendage in the expanded state (see Fig. 22), the contact member being further configured to deform the left atrial appendage in the expanded state upon movement of the contact member within the left atrial appendage while the contact member is in the expanded state (anchor portion is described in paragraph [0082] which is substantially the same as the embodiment of Fig. 22; the anchor portion 2202 is expanded and engages with tissue of the left atrial appendage, and is capable of deforming this tissue by rotation or other movement), the securing element being configured to engage tissue outside the left atrial appendage (see Fig. 22), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the left atrial appendage (the implant 2206 and sealing portion 2202 are securable by spring-like spiral feature connecting them, see Fig. 22; and is capable of maintaining engagement between the contact member/implant 2206 and the tissue within the left atrial appendage), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the left atrial appendage imparted by the contact member (the implant 2206 and sealing portion 2202 cooperate by the spring-like spiral feature connecting them, where the deformation of the cavity imparted by the contact member would be maintained by this cooperation since the structures are coupled by the spring-like spiral feature is stretched and then released to be at rest it would hold a deformation).
Regarding claim 24, Subramaniam discloses the apparatus of claim 21, the contact member being further configured to deform the cavity or vessel in the expanded state by twisting the cavity or vessel upon rotational movement of the contact member within the cavity or vessel while the contact member is in the expanded state (the device is capable of being rotated to twist the cavity when the contact member is in the expanded state, since the prior art is not required to disclose the implant twisting the tissue but merely have the capability of being manipulated in the recited manner, the claims do not actually require the tissue to be twisted but is instead interpreted as part of the intended use of the device).
Regarding claim 25, Subramaniam discloses the apparatus of claim 21, the contact member comprising a plurality of tissue engagement features (barbs 2208, where the barbs are an equivalent structure to the “tissue engagement features” interpreted under 112(f) by being barbs, [0082], [0087]) configured to engage tissue within the cavity or vessel in the expanded state ([0082], [0087]).
Regarding claim 27, Subramaniam discloses the apparatus of claim 25, the tissue engagement features protruding in one or more directions other than radially outwardly from the contact member such that the tissue engagement features do not protrude radially outwardly from the contact member (the barbs face upward toward the ostium, [0082]; where the protruding is interpreted as the protrusion at the distal end of the barbs which face upward and not radially outward).
Regarding claim 28, Subramaniam discloses the apparatus of claim 25, the plurality of tissue engagement features including features selected from the group consisting of teeth, cleats, barbs, nubs, texture, studs, and anchors (barbs 2208).
Regarding claim 29, Subramaniam discloses the apparatus of claim 25, the plurality of tissue engagement features being configured to engage tissue in response to rotation of the contact member within the cavity or vessel in the expanded state in a first rotational direction (the device is capable of performing the claimed function where the tissue can be engaged by the upward barbs 2208 when rotated in one direction, since the prior art is not required to disclose the implant rotating and engaging the tissue but merely have the capability of being manipulated in the recited manner), the plurality of tissue engagement features being configured to disengage tissue in response to rotation of the contact member within the cavity or vessel in the expanded state in a second rotational direction (the device is capable of performing the claimed function when the device is rotated in a second direction and moved to disengage the barbs 2208, since the prior art is not required to disclose the implant rotating to disengage tissue but merely have the capability of being manipulated in the recited manner).
Regarding claim 30, Subramaniam discloses the apparatus of claim 21, the securing element being movable relative to the contact member along a longitudinal axis (the securing element/sealing portion 2202 is movable relative to the contact member/anchor portion 2206 by the coupling element 2204 which is a spiral or helical coil that would allow the structures to be movable relative to each other along a longitudinal axis by stretching along the longitudinal axis, see Fig. 23, [0087]), the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the implant 2206 and sealing portion 2202 are securable by spring-like spiral feature connecting them along the longitudinal axis, see Fig. 23; and is capable of maintaining engagement between the contact member/implant 2206 and the tissue within the left atrial appendage).
Regarding claim 32, Subramaniam discloses the apparatus of claim 30, the contact member being further configured to rotate about the longitudinal axis to thereby deform the cavity or vessel while the contact member is within the cavity or vessel while the contact member is in the expanded state (the contact member/anchor portion 2206 in the expanded state is capable of rotating about the longitudinal axis to deform the cavity by the operator rotating the device, where the rotation would occur along the longitudinal axis by rotating around the axis coupling member 2204 as shown in Fig. 23, since the prior art is not required to disclose the implant deforming the tissue by rotation but merely have the capability of being manipulated in the recited manner, the claims do not actually require the tissue to be deformed by rotation but is instead interpreted as part of the intended use of the device).
Regarding claim 33, Subramaniam discloses an apparatus, comprising:
a contact member (anchor portion 2206, see Fig. 22; where the anchor portion 2206 is an equivalent structure to the “contact member” interpreted under 112(f) by being an expandable member with arms 2210, [0087], see Fig. 22), the contact member being configured to transition between a collapsed state and an expanded state (where the arms of the anchor 2206 expand outwardly in the same manner as the embodiment of Figs. 18A-18B, [0087], [0084]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state ([087]), the contact member being further configured to engage tissue within the cavity or vessel in the expanded state (barbs 2208 of anchor portion 2206 engage tissue within the cavity, [0087], [0082]); and
a securing element (sealing portion 2202, see Fig. 22; where the sealing portion 2202 is an equivalent structure to the “securing element” interpreted under 112(f) by being an expandable member with arms as described in [0082] where the sealing portion of the embodiment of Fig. 18 is substantially the same as the embodiment of Fig. 22, [0087]), the securing element being movable relative to the contact member (coupling element 2204 allows sealing portion 2202 to flex relative to anchor portion 2206, [0087]), the securing element being configured to engage tissue outside the cavity or vessel (see Fig. 22), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the securing element/sealing portion 2202 is securable to the contact member/anchoring member 2206 by the coupling member 2204 to maintain engagement between the components), the contact member being further configured to prevent fluid flow into the cavity or vessel while the securing element maintains engagement between the contact member and the tissue within the cavity or vessel (the sealing portion 2202 is intended to seal the left atrial appendage, [0087] and further described in [0081]; where the seal formed at the ostium would prevent fluid flow from the maintained deformation of the cavity imparted by the contact member).
Regarding claim 34, Subramaniam discloses the apparatus of claim 33, the contact member being configured to prevent fluid flow into the cavity or vessel by deforming the cavity or vessel (the sealing portion 2202 is intended to seal the left atrial appendage, [0087] and further described in [0081]; where the seal formed at the ostium would prevent fluid flow from the maintained deformation of the cavity imparted by the contact member), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the implant 2206 and sealing portion 2202 cooperate by the spring-like spiral feature connecting them, where the deformation of the cavity imparted by the contact member would be maintained by this cooperation since the structures are coupled by the spring-like spiral feature is stretched and then released to be at rest it would hold a deformation).
Regarding claim 35, Subramaniam discloses the apparatus of claim 33, the contact member being further configured to provide overlaps of tissue within the cavity or vessel to thereby prevent fluid flow into the cavity or vessel (the contact member/anchor portion 2206 is capable of providing overlaps of tissue is interpreted as folds of tissue as the cavity of the left atrial appendage when it is manipulated; where fluid flow is further prevented by the cavity being shrunken with the overlaps of tissue), the contact member and the securing element being configured to maintain the overlaps of tissue while the securing element maintains engagement between the contact member and the tissue within the cavity or vessel (device is capable of performing the claimed function where the tissue would remain in the same state when the device is held steady and have the same overlaps tissue when the anchoring portion 2206 and sealing portion 2202 are held stationary, [0087]).
Regarding claim 36, Subramaniam discloses an apparatus, comprising:
a contact member (anchor portion 2206, see Fig. 22; where the anchor portion 2206 is an equivalent structure to the “contact member” interpreted under 112(f) by being an expandable member with arms 2210, [0087], see Fig. 22), the contact member being configured to transition between a collapsed state and an expanded state (where the arms of the anchor 2206 expand outwardly in the same manner as the embodiment of Figs. 18A-18B, [0087], [0084]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state ([0087]), the contact member being further configured to engage tissue within the cavity or vessel in the expanded state (barbs 2208 of anchor portion 2206 engage tissue within the cavity, [0087], [0082]); and
a securing element (sealing portion 2202, see Fig. 22; where the sealing portion 2202 is an equivalent structure to the “securing element” interpreted under 112(f) by being an expandable member with arms as described in [0082] where the sealing portion of the embodiment of Fig. 18 is substantially the same as the embodiment of Fig. 22, [0087]), the securing element being movable relative to the contact member along a longitudinal axis (the securing element/sealing portion 2202 is movable relative to the contact member/anchor portion 2206 by the coupling element 2204 which is a spiral or helical coil that would allow the structures to be movable relative to each other along a longitudinal axis by stretching along the longitudinal axis, see Fig. 23, [0087]), the securing element being configured to engage tissue outside the cavity or vessel (see Fig. 22), the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the implant 2206 and sealing portion 2202 are securable by spring-like spiral feature connecting them along the longitudinal axis, see Fig. 23; and is capable of maintaining engagement between the contact member/implant 2206 and the tissue within the left atrial appendage).
Regarding claim 37, Subramaniam discloses the apparatus of claim 36, the contact member and the securing element being configured to cooperate to prevent fluid flow into the cavity or vessel through the maintained engagement between the contact member and the tissue within the cavity or vessel (the sealing portion 2202 is intended to seal the left atrial appendage, [0087] and further described in [0081]; where the seal formed at the ostium would prevent fluid flow from the maintained engagement between the cavity and the contact member).
Regarding claim 38, Subramaniam disclose the apparatus of claim 36, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state (the contact member/anchor portion 2206 in the expanded state is capable of rotating or being manipulated to deform the cavity, since the prior art is not required to disclose the implant deforming the tissue but merely have the capability of being manipulated in the recited manner, the claims do not actually require the tissue to be deformed but is instead interpreted as part of the intended use of the device), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the implant 2206 and sealing portion 2202 cooperate by the spring-like spiral feature connecting them, where the deformation of the cavity imparted by the contact member would be maintained by this cooperation since the structures are coupled by the spring-like spiral feature is stretched and then released to be at rest it would hold a deformation).
Claims 21-24, 30-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slaughter (US2015/0250482).
Regarding claim 21, Slaughter discloses an apparatus, comprising:
a contact member (occluding member 330), the contact member being configured to transition between a collapsed state and an expanded state ([0041]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state (see Fig. 12L, 12M; [0042]), the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state (see Fig. 12L, 12M; [0042]); and
a securing element (anchoring member 340), the securing element being movable relative to the contact member ([0042]), the securing element being configured to engage tissue outside the cavity or vessel (see Fig. 12M), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the anchoring member 340 can be slid down the insertion rod 320 and locked to thereby collapse the left atrial appendage, where the anchoring member 340 is locked after movement toward the occluding member 330 and secured relative to the occluding member 330 to collapse the left atrial appendage, [0039]), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (anchoring member 340 locked relative to occluding member 330 as discussed in paragraphs [0039], [0042]).
Regarding claim 22, Slaughter discloses the apparatus of claim 21, the contact member and the securing element being configured to cooperate to prevent fluid flow into the cavity or vessel through the maintained deformation of the cavity or vessel imparted by the contact member (the occluding member 330 is intended to occlude the left atrial appendage by sealing off the left atrial appendage from the left atrium, [0041]).
Regarding claim 23, Slaughter discloses the apparatus of claim 21, the contact member being configured to fit within a left atrial appendage in the expanded state (see Fig. 12L, 12M; [0042]), the contact member being further configured to deform the left atrial appendage in the expanded state upon movement of the contact member within the left atrial appendage while the contact member is in the expanded state (see Fig. 12L, 12M; [0042]), the securing element being configured to engage tissue outside the left atrial appendage (see Fig .12M), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the left atrial appendage (the anchoring member 340 can be slid down the insertion rod 320 and locked to thereby collapse the left atrial appendage, where the anchoring member 340 is locked after movement toward the occluding member 330 and secured relative to the occluding member 330 to collapse the left atrial appendage, [0039]), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the left atrial appendage imparted by the contact member (anchoring member 340 locked relative to occluding member 330 as discussed in paragraphs [0039], [0042]).
Regarding claim 24, Slaughter discloses the apparatus of claim 21, the contact member being further configured to deform the cavity or vessel in the expanded state by twisting the cavity or vessel upon rotational movement of the contact member within the cavity or vessel while the contact member is in the expanded state (the device is capable of being rotated to twist the cavity when the contact member is in the expanded state, since the prior art is not required to disclose the implant twisting the tissue but merely have the capability of being manipulated in the recited manner, the claims do not actually require the tissue to be twisted but is instead interpreted as part of the intended use of the device).
Regarding claim 30, Slaughter discloses the apparatus of claim 21, the securing element being movable relative to the contact member along a longitudinal axis (see Fig. 12L, 12M), the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the anchoring member 340 can be slid down the insertion rod 320 and locked to thereby collapse the left atrial appendage, where the anchoring member 340 is locked after movement toward the occluding member 330 and secured relative to the occluding member 330 to collapse the left atrial appendage, [0039]; where this occurs along a longitudinal axis by occurring along the axis of the insertion rod 320 as shown in Fig. 12L-12N).
Regarding claim 31, Slaugther discloses the apparatus of claim 30, further comprising a locking feature configured to lock a position of the securing element relative to the contact member along the longitudinal axis after the securing element has been moved toward the contact member along the longitudinal axis ([0039]).
Regarding claim 32, Slaugther discloses the apparatus of claim 30, the contact member being further configured to rotate about the longitudinal axis to thereby deform the cavity or vessel while the contact member is within the cavity or vessel while the contact member is in the expanded state (the device is capable of being rotated to deform the cavity when the contact member is in the expanded state where the rotation would occur along the longitudinal axis by rotating around the axis of the insertion rod 320, see Fig. 12M, since the prior art is not required to disclose the implant deforming the tissue by rotation but merely have the capability of being manipulated in the recited manner, the claims do not actually require the tissue to be deformed by rotation but is instead interpreted as part of the intended use of the device).
Regarding claim 33, Slaughter discloses an apparatus, comprising:
a contact member (occluding member 330), the contact member being configured to transition between a collapsed state and an expanded state ([0041]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state (see Fig. 12L, 12M; [0042]), the contact member being further configured to engage tissue within the cavity or vessel in the expanded state (occluding member 330 is at least capable of engaging tissue within the cavity when it is pushed into the cavity, see Fig. 12L, 12M; [0042]); and
a securing element (anchoring member 340), the securing element being movable relative to the contact member ([0042]), the securing element being configured to engage tissue outside the cavity or vessel (see Fig. 12M), the securing element being securable relative to the contact member to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (anchoring member 340 can be slid down the insertion rod 320 and locked to thereby collapse the left atrial appendage, where the anchoring member 340 is locked after movement toward the occluding member 330 and secured relative to the occluding member 330 to collapse the left atrial appendage, [0039]), the contact member being further configured to prevent fluid flow into the cavity or vessel while the securing element maintains engagement between the contact member and the tissue within the cavity or vessel (the occluding member 330 is intended to occlude the left atrial appendage by sealing off the left atrial appendage from the left atrium, [0041]).
Regarding claim 34, Slaughter discloses the apparatus of claim 33, the contact member being configured to prevent fluid flow into the cavity or vessel by deforming the cavity or vessel (the occluding member 330 is intended to occlude the left atrial appendage by sealing off the left atrial appendage from the left atrium, [0041]; and the deforming further prevents fluid flow into the cavity by collapsing the left atrial appendage, [0042]), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (anchoring member 340 locked relative to occluding member 330 as discussed in paragraphs [0039], [0042]).
Regarding claim 35, Slaughter discloses the apparatus of claim 33, the contact member being further configured to provide overlaps of tissue within the cavity or vessel to thereby prevent fluid flow into the cavity or vessel (overlaps of tissue is interpreted as folds of tissue as the cavity of the left atrial appendage is collapsed as shown in Fig. 12L, 12M; where fluid flow is further prevented by the cavity being collapsed with the overlaps of tissue, [0042]), the contact member and the securing element being configured to maintain the overlaps of tissue while the securing element maintains engagement between the contact member and the tissue within the cavity or vessel (where the tissue would remain in the same collapsed state and have the same overlaps tissue when the occluding member 330 and anchoring member 340 are locked, see Fig. 12N, [0039]).
Regarding claim 36, Slaughter discloses an apparatus, comprising:
a contact member (occluding member 330), the contact member being configured to transition between a collapsed state and an expanded state ([0041]), the contact member being configured to fit within a cavity or vessel in a patient in the expanded state (see Fig. 12L, 12M; [0042]), the contact member being further configured to engage tissue within the cavity or vessel in the expanded state (occluding member 330 is at least capable of engaging tissue within the cavity when it is pushed into the cavity, see Fig. 12L, 12M; [0042]); and
a securing element (anchoring member 340), the securing element being movable relative to the contact member along a longitudinal axis, the securing element being configured to engage tissue outside the cavity or vessel, the securing element being securable relative to the contact member along the longitudinal axis to thereby maintain engagement between the contact member and the tissue within the cavity or vessel (the anchoring member 340 can be slid down the insertion rod 320 and locked to thereby collapse the left atrial appendage, where the anchoring member 340 is locked after movement toward the occluding member 330 and secured relative to the occluding member 330 to collapse the left atrial appendage, [0039]; where this occurs along a longitudinal axis by occurring along the axis of the insertion rod 320 as shown in Fig. 12L-12N).
Regarding claim 37, Slaughter disclose the apparatus of claim 36, the contact member and the securing element being configured to cooperate to prevent fluid flow into the cavity or vessel through the maintained engagement between the contact member and the tissue within the cavity or vessel (the occluding member 330 is intended to occlude the left atrial appendage by sealing off the left atrial appendage from the left atrium, [0041]; where the cooperation between occluding element 330 and anchoring element 340 work together to seal off left atrial appendage by collapsing it, [0042]).
Regarding claim 38, Slaugther discloses the apparatus of claim 36, the contact member being further configured to deform the cavity or vessel in the expanded state upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state, the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (anchoring member 340 locked relative to occluding member 330 as discussed in paragraphs [0039], [0042]; when locked the cavity is deformed by being collapsed and the deformation is maintained by the locking, [0042]).
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 26, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Subramaniam.
Regarding claim 26, Subramaniam discloses the apparatus of claim 25; yet, does not explicitly disclose the tissue engagement features being configured to atraumatically engage tissue within the cavity or vessel in the expanded state. Subramaniam according to the embodiment of Fig. 14 describes filaments 1402 (arms) of the anchor element 1404 (contact member) that engage tissue atraumatically ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the barbs of the embodiment of Fig. 22 to be atrauamatic in order to engage tissue without damaging tissue to prevent thrombosis or other bodily reactions to tissue damage ([0072])
Regarding claim 39, Subramaniam discloses an apparatus, comprising:
a contact member (anchor portion 2206, see Fig. 22; where the anchor portion 2206 is an equivalent structure to the “contact member” interpreted under 112(f) by being an expandable member with arms 2210, [0087], see Fig. 22), the contact member being configured to expand outwardly from a collapsed state to an expanded state (where the arms of the anchor 2206 expand outwardly in the same manner as the embodiment of Figs. 18A-18B, [0087], [0084]), the contact member being configured to fit within a left atrial appendage in a patient in the expanded state ([0087]), the contact member having one or more tissue engagement features (barbs 2208; where the barbs are an equivalent structure to the “tissue engagement features” interpreted under 112(f) by being barbs, [0082], [0087]) configured to engage tissue within the left atrial appendage in the expanded state ([0082], [0087]), the tissue engagement features protruding in one or more directions other than radially outwardly from the contact member such that the tissue engagement features do not protrude radially outwardly from the contact member (the barbs face upward toward the ostium, [0082]; ; where the protruding is interpreted as the protrusion at the distal end of the barbs which face upward and not radially outward); and
a securing element (sealing portion 2202, see Fig. 22; where the sealing portion 2202 is an equivalent structure to the “securing element” interpreted under 112(f) by being an expandable member with arms as described in [0082] where the sealing portion of the embodiment of Fig. 18 is substantially the same as the embodiment of Fig. 22, [0087]) configured to cooperate with the contact member to maintain engagement between the one or more tissue engagement features and the left atrial appendage (the implant 2206 and sealing portion 2202 cooperate by spring-like spiral feature connecting them and is capable of maintaining engagement between the contact member/implant 2206 barbs 2208 and the tissue within the left atrial appendage).
Subramaniam does not explicitly disclose the tissue engagement features being configured to atraumatically engage tissue within the cavity or vessel in the expanded state. Subramaniam according to the embodiment of Fig. 14 describes filaments 1402 (arms) of the anchor element 1404 (contact member) that engage tissue atraumatically ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the barbs of the embodiment of Fig. 22 to be atrauamatic in order to engage tissue without damaging tissue to prevent thrombosis or other bodily reactions to tissue damage ([0072])
Regarding claim 40, Subramaniam makes obvious the apparatus of claim 39, the contact member being further configured to deform the cavity or vessel in the expanded state, through engagement between the one or more tissue engagement features and the tissue, upon movement of the contact member within the cavity or vessel while the contact member is in the expanded state (the device is capable of deforming the cavity by rotating or expansion within the cavity where the barbs 2208 engage the tissue and would assist in deformation, further the claims do not require the tissue to be deformed, but is instead interpreted as part of the intended use of the device), the contact member and the securing element being configured to cooperate to thereby maintain deformation of the cavity or vessel imparted by the contact member (the implant 2206 and sealing portion 2202 cooperate by the spring-like spiral feature connecting them, where the deformation of the cavity imparted by the contact member would be maintained by this cooperation since the structures are coupled by the spring-like spiral feature is stretched and then released to be at rest it would hold a deformation).
Conclusion
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
