DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on February 23, 2021. Claims 1-20 are currently pending, wherein of the pending claims, claims 16-20 are withdrawn from further consideration.
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.
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 1-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, respectively, of U.S. Patent No. 11,369,355. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims 1-15 recite all the limitations of the application claims 1-15, identically, but also include additional limitations in claims 1 and 11. Therefore the patent claims 1-15 are in essence a “species” of the generic invention of the application claims 1-15. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1-15 are anticipated by the patent claims 1-15, they are not patentably distinct from the patent claims 1-15.
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, 2, 4-9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ren (US 2012/0323267) in view of Meyer et al. (US 2015/0196305, hereinafter Meyer).
Regarding claim 1, the Ren prior art reference teaches a medical device for occluding a left atrial appendage of a heart (Figure 3A; 100), comprising: a cover portion having a hub and a cover (Figure 3A; 325), the cover extending radially from the hub (Figure 3A; hub is the distal end of 350 connected to cover), the cover portion sized and configured to be positioned along a proximal side of an ostium of the left atrial appendage (Figure 3A; 250); and a mesh anchor portion (Figure 3A; 300) coupled to the cover portion with a flexible member (Figure 3A; 350), the mesh anchor portion extending between a proximal end and a distal end to define a length (300A to 300B) and an axis defined along the length of the mesh anchor portion (Figure 1; 300C), the mesh anchor portion defining a curved external surface radially extending relative to the axis such that the curved external surface extends between the proximal and distal ends of the mesh anchor portion (Figure 1; 300, cylindrical outer surface of the anchor portion defines the curved external surface), the mesh anchor portion configured to self-expand to provide an outward biasing force from the curved external surface such that a circumferential surface area of the curved external surface biases against tissue of the left atrial appendage ([¶ 0030]), but it does not specifically teach the anchor portion being foam.
However, the Meyer reference teaches a medical device for occluding a left atrial appendage of a heart comprising a cover portion (Figure 9; 20) having a hub (Figure 9; 22) and an anchor portion comprising a foam (Figure 9; 2) surrounded by a mesh (Figure 9; 24 | [¶ 0050]), therein allowing the anchor portion to be defined as a foam anchor portion.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the anchor portion of the Ren reference include both the foam and the mesh as in the Meyer reference, therein defining the anchor portion as a foam anchor portion, to provide the anchor portion with an occlusive benefit (Meyer; [¶ 0052]) that is further highly compliant and compressible, which aides in the ability to be acutely recaptured (Meyer; [¶ 0055]).
Regarding claim 2, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the Ren reference further teaches the curved external surface defining a total surface area, and wherein at least half of the total surface area of the curved external surface is sized and configured to grab and contact tissue within the left atrial appendage depending on the size of the specific left atrial appendage (Figure 3A; 225).
Regarding claim 4, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the curved external surface of the foam anchor portion of the Ren and Meyer combination comprises a raised grid pattern sized and configured to grab tissue with the outward biasing force as defined by the external mesh structure (Meyer; 8; 24).
Regarding claim 5, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the Ren reference further teaches the curved external surface of the foam anchor portion defining multiple protrusions sized and configured to grab and anchor to tissue with the outward biasing force (Figure 1; 700).
Regarding claim 6, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the curved external surface of the foam anchor portion of the Ren and Meyer combination defines multiple recesses therein, defined by the perforations of the mesh, the multiple recesses defined by raised portions of the curved external surface of the foam anchor portion as defined by the wire of the mesh.
Regarding claim 7, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the Ren reference further teaches the curved external surface of the foam anchor portion defining multiple ring shaped structures (the lateral wires of the mesh that surround the anchor portion may be defined as ring shaped structures).
Regarding claim 8, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the Ren reference further teaches the anchor portion (contains a section) expanding to a shape resembling a truncated cone (the unlabeled angled corners of the embodiment of Figure 5 provide each end of the anchor with a shape as claimed)
Regarding claim 9, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein the Meyer reference teaches that the foam anchor portion includes a variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, given it molds to the anatomy of the left atrial appendage, thus expanding to different extends along the length of the anchor ([¶ 0027]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the foam anchor portion of the Ren and Meyer combination include a variable expandability between a proximal end portion and a distal end portion of the foam anchor portion, wherein the distal end portion would be capable of having a greater foam expandability than the proximal end portion depending on the specific shape and contour of the left atrial appendage, to allow the foam anchor portion to mold to the specific anatomy of a patient’s left atrial appendage to provide for additional occlusive benefit (Meyer; [¶ 0027]).
Regarding claim 11, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, wherein, upon the cover portion and the foam anchor portion being deployed, the flexible member is capable of extending at an angle relative to the axis of the foam anchor member given it is flexible.
Regarding claim 12, the Ren prior art reference teaches a medical device system for occluding a left atrial appendage of a heart, comprising: a delivery device ([¶ 0033], vascular catheter) having a handle (portion of the catheter that is gripped may be interpreted as the handle) and a catheter extending between a proximal and a distal end (the rest of the catheter may be defined as the catheter), the catheter defining a lumen extending longitudinally through the catheter between the proximal and distal ends of the catheter (lumen in which occluder is inserted); and a medical device operatively coupled to the handle (Figure 3A; 100, operatively coupled to handle via the catheter), the medical device sized and configured to be moved between a constricted state and an expanded state such that, in the constricted state, the medical device is within a distal portion of the catheter and, in the expanded state, the medical device is advanced from the catheter ([¶ 0033]), the medical device comprising: a cover portion having a hub and a cover (Figure 3A; 325), the cover extending radially from the hub (Figure 3A; hub is the distal end of 350 connected to cover), the cover portion sized and configured to be positioned along a proximal side of an ostium of the left atrial appendage (Figure 3A; 250); and a mesh anchor portion coupled to the cover portion (Figure 3A; 300) with a flexible member (Figure 3A; 350), the mesh anchor portion extending between a proximal end and a distal end to define a length and an axis defined along the length of the mesh anchor portion (Figure 1; 300, 300C), the mesh anchor portion defining a curved external surface radially extending relative to the axis such that the curved external surface extends between the proximal and distal ends of the mesh anchor portion (Figure 1; 300, cylindrical outer surface of the anchor portion defines the curved external surface), the mesh anchor portion configured to self-expand to provide an outward biasing force from the curved external surface such that a circumferential surface area of the curved external surface biases against tissue of the left atrial appendage ([¶ 0030]), but it does not specifically teach the anchor portion being foam.
However, the Meyer reference teaches a medical device for occluding a left atrial appendage of a heart comprising a cover portion (Figure 9; 20) having a hub (Figure 9; 22) and an anchor portion comprising a foam (Figure 9; 2) surrounded by a mesh (Figure 9; 24 | [¶ 0050]), therein allowing the anchor portion to be defined as a foam anchor portion.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the anchor portion of the Ren reference include both the foam and the mesh as in the Meyer reference, therein defining the anchor portion as a foam anchor portion, to provide the anchor portion with an occlusive benefit (Meyer; [¶ 0052]) that is further highly compliant and compressible, which aides in the ability to be acutely recaptured (Meyer; [¶ 0055]).
Regarding claim 13, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 12, wherein the Ren reference further teaches the curved external surface defining a total surface area, and wherein at least half of the total surface area of the curved external surface is sized and configured to grab and contact tissue within the left atrial appendage depending on the size of the specific left atrial appendage (Figure 3A; 225).
Regarding claim 15, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 12, wherein, upon the cover portion and the foam anchor portion being deployed, the flexible member is capable of extending at an angle relative to the axis of the foam anchor member given it is flexible.
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ren (US 2012/0323267) in view of Meyer et al. (US 2015/0196305, hereinafter Meyer) as applied to claims 1, 2, 4-9, 11-13, and 15 above, and further in view of Sargeant et al. (US 2011/0087272, hereinafter Sargeant).
Regarding claims 3 and 14, the combination of the Ren and Meyer references as discussed above teaches the medical device of claims 1 and 12, but does not specifically teach the curved external surface of the foam anchor portion comprising microprotrusions sized and configured to grab and contact tissue within the left atrial appendage with the outward biasing force.
However, the Sargeant reference teaches a medical device for occluding an opening (Figure 5; 50) including a cover portion (Figure 5; 54) and a foam anchor portion (Figure 5; 52), wherein the foam anchor portion defines a curved external surface which may comprise microprotrusions sized and configured to grab and contact tissue within an opening with an outward biasing force ([¶ 0117]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the foam anchor portion of the Ren and Meyer combination include microprotrusions sized and configured to grab and contact tissue within the left atrial appendage with the outward biasing force as in the Sargeant reference to promote adhesion of the anchor within the hollow body opening (Sargeant; [¶ 0117]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ren (US 2012/0323267) in view of Meyer et al. (US 2015/0196305, hereinafter Meyer) as applied to claims 1, 2, 4-9, 11-13, and 15 above, and further in view of Lesh et al. (US 6152144, hereinafter Lesh).
Regarding claim 10, the combination of the Ren and Meyer references as discussed above teaches the medical device of claim 1, but does not specifically teach the cover portion extending from a proximal facing surface having a concave structure, the proximal facing surface facing away from a distal end of the medical device.
However, the Lesh reference teaches a medical device for occluding a left atrial appendage (1; 10) including a cover portion (Figure 1; 11), wherein the cover portion may have a proximal facing surface having a concave (Figure 4; 41) or a convex (Figure 5; 52) structure, the proximal facing surface facing away from a distal end of the medical device.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the cover portion of the Ren and Meyer combination include a proximal facing surface having a concave structure as in the Lesh reference given the Lesh reference teaches that concave and convex structures for the cover portion are each useful for certain morphologies of a patient’s left atrial appendage (Lesh; Column 9, Lines 1-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. 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. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS MCEVOY/Primary Examiner, Art Unit 3771