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 .
Formal Matters
Claims 1-15 and 17-20 are pending and under examination. Claim 16 is not present in the claim listing.
Benefit
Benefit of the application is acknowledged as a Continuation of US 18/490360 (19 October 2023), issued as 12,336,715 (24 June 2025), which claims benefit as a Continuation of US 17/846523 (22 June 2022), issued as 12,308,092 (20 May 2025) and US Provisional 63/213696, filed 22 June 2021, with the following exceptions.
The recitation of “distal shoulder region” in claims 1, 2, and 20 is not found in the instant specification or the following applications to which this application claims benefit as a Continuation: US 17/846523 filed 22 June 2022 and US Provisional 63/213696, filed 22 June 2021. The first mention of a “distal shoulder region” is in the originally filed claims of parent application 18/490360 (filed 19 October 2023). Accordingly, benefit for the limitation of a “distal shoulder region” is afforded to 19 October 2023.
Similarly, claims 1 and 20 recite the limitation “medial region framework” in the originally filed claims of parent application 18/490360 (filed 19 October 2023), but there is no support for the recitation in the specification or drawings. The instant specification discloses “medial portions” 148 and 154 in FIG 7 on page 16, but does not expressly disclose a “medial region” as claimed. Similarly, the drawings are silent as to the depiction of a medial region. There is also no recitation of “medial region framework” in the grandparent 17/846523 application to which the current and parent application claims benefit. Accordingly, benefit for the limitation of a “medial region framework” is afforded to 19 October 2023.
Claims 1-5, 7, 8, and 10-13 are granted benefit to the filing date of the instant application of 19 October 2023. Claims 14, 15, and 17-19 are granted benefit as a Continuation of US 17/846523 filed 22 June 2022 and US Provisional 63/213696, filed 22 June 2021. Details were previously discussed of record in the Office Action mailed 31 July 2024. See MPEP 2163.06 and MPEP 2163.07.
Applicant is advised that claims, as filed, in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Applicant is also advised that amendment to the instant specification (and drawings, see above) adding recitations related to the “distal shoulder region” will remove the instant rejection, but will also negate benefit to the prior filed applications. See MPEP 2163.06 and MPEP 2163.07.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 May 2026 have been considered by the examiner. Signed copies are attached.
Drawings - Objection
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. MPEP 608.02(d). The “distal shoulder region” recited in claims 1, 2, and 20 is not expressly shown in the drawings and there is no mention of it in the specification as originally filed. Similarly, the “medial region” in claims 1 and 20 is not expressly shown in the drawings and there is no mention of it in the specification as originally filed. Therefore, the “distal shoulder region” and “medial region” must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: the word “should” in line 6 appears to be a typographical error: “proximal should region”. For purposes of compact prosecution, the examiner will read the phrase as “proximal shoulder region”. Appropriate correction is required.
Advisory Notice
Claim 16 is missing. It is recommended that Applicant indicate claim 16 as cancelled in response to this Office Action in order to prevent future confusion. Applicant should also consider amending the dependencies of claims 17-19.
Claims 17-19 are provisionally rejected as set forth below in order to promote compact prosecution. The claims cannot be fully examined in view of the prior art as they are currently presented because they are directly or indirectly dependent on claim 16, which is missing in the instant application. However, the examiner is presumptively interpreting claim 17 as being dependent on independent claim 14 so that a provisional rejection can be provided to Applicant.
Non-Statutory Obviousness-Type Double Patenting Rejections
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 and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,336,715.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims and species recited within the claims of the ‘715 patent anticipate the claims and genera recited within the claims of the ‘511 application. A claim-by-claim comparison chart is provided below for ease of reference. The applicable claim language in the ‘715 patent are distinguished by italics with the respective claim number indicated.
US Patent 12,336,715
US Application 19/201,511
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the plurality of struts form a proximal shoulder region of the expandable framework proximate the proximal hub, a distal shoulder region of the expandable framework proximate the distal hub, and a medial region extending between the proximal shoulder region and the distal shoulder region; a first radiopaque marker positioned along the proximal shoulder region of the expandable framework; a second radiopaque marker positioned along the proximal shoulder region of the expandable framework; and a third radiopaque marker positioned along the proximal shoulder region of the expandable framework; wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are disposed within a plane configured to be aligned with an ostium of the left atrial appendage.
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the plurality of struts form a proximal shoulder region of the expandable framework, a distal shoulder region of the expandable framework, and a medial region extending between the proximal should region and the distal shoulder region; and a first radiopaque marker positioned along the proximal shoulder region of the expandable framework.
2. The medical implant of claim 1, wherein the proximal shoulder region includes a first row of cells, and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node, and wherein the first radiopaque marker is positioned along the first distal node.
2 The medical implant of claim 1, wherein the proximal shoulder region includes a first row of cells, and wherein a first cell in the row of cells includes a first strut segment and a second strut segment joined at a first distal node, and wherein the first radiopaque marker is positioned along the first distal node.
3. The medical implant of claim 2, wherein the first row of cells extends circumferentially around the central longitudinal axis of the expandable framework.
3. The medical implant of claim 2, wherein the row of cells extends circumferentially around the longitudinal axis of the expandable framework.
4. The medical implant of claim 3, wherein the first row of cells further includes in a second cell including a third strut segment and a fourth strut segment joined at a second distal node, and wherein the second radiopaque marker is positioned along the second distal node.
4. The medical implant of claim 3, wherein the first row of cells further includes in a second cell including a third strut segment and a fourth strut segment joined at a second distal node, and wherein a second radiopaque marker is positioned along the second distal node.
5. The medical implant of claim 4, wherein the first row of cells further includes in a third cell including a fifth strut segment and a sixth strut segment joined at a third distal node, and wherein the third radiopaque marker is positioned along the third distal node.
5. The medical implant of claim 4, wherein the first row of cells further includes in a third cell including a fifth strut segment and a sixth strut segment joined at a third distal node, and wherein a third radiopaque marker is positioned along the third distal node.
6. The medical implant of claim 5, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are spaced equidistant from one another around the central longitudinal axis.
6. The medical implant of claim 5, wherein the first radiopaque marker and the second radiopaque marker are spaced equidistant from one another around the longitudinal axis.
8. The medical implant of claim 1, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are oriented longitudinally relative to the central longitudinal axis of the expandable framework.
7. The medical implant of claim 5, wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are spaced equidistant from one another around the longitudinal axis.
8. The medical implant of claim 1, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are oriented longitudinally relative to the central longitudinal axis of the expandable framework.
7. The medical implant of claim 5, wherein the plane is oriented perpendicular to the central longitudinal axis.
8. The medical implant of claim 5, wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane oriented substantially perpendicular to the longitudinal axis.
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the plurality of struts form a proximal shoulder region of the expandable framework proximate the proximal hub, a distal shoulder region of the expandable framework proximate the distal hub, and a medial region extending between the proximal shoulder region and the distal shoulder region; a first radiopaque marker positioned along the proximal shoulder region of the expandable framework; a second radiopaque marker positioned along the proximal shoulder region of the expandable framework; and a third radiopaque marker positioned along the proximal shoulder region of the expandable framework; wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are disposed within a plane configured to be aligned with an ostium of the left atrial appendage.
7. The medical implant of claim 5, wherein the plane is oriented perpendicular to the central longitudinal axis.
9. The medical implant of claim 5, wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane substantially perpendicular to an ostium of the left atrial appendage.
8. The medical implant of claim 1, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are oriented longitudinally relative to the central longitudinal axis of the expandable framework.
10. The medical implant of claim 1, wherein the radiopaque marker is oriented longitudinally relative to the longitudinal axis of the expandable framework.
9. The implant of claim 1, further comprising an occlusive element disposed over at least a portion of the expandable framework.
11. The implant of claim 1, further comprising an occlusive element disposed over at least a portion of the expandable framework.
10. The implant of claim 1, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are formed from a different material than the expandable framework.
12. The implant of claim 1, wherein the radiopaque marker is formed from a different material than the expandable framework.
11. The implant of claim 1, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker have a different density than the expandable framework.
13. The implant of claim 1, wherein the radiopaque marker has a different density than the expandable framework.
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub;
wherein the plurality of struts form a proximal shoulder region of the expandable framework proximate the proximal hub,
a distal shoulder region of the expandable framework proximate the distal hub, and a medial region extending between the proximal shoulder region and the distal shoulder region; a first radiopaque marker positioned along the proximal shoulder region of the expandable framework; a second radiopaque marker positioned along the proximal shoulder region of the expandable framework; and a third radiopaque marker positioned along the proximal shoulder region of the expandable framework; wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are disposed within a plane configured to be aligned with an ostium of the left atrial appendage.
2. The medical implant of claim 1, wherein the proximal shoulder region includes a first row of cells, and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node, and wherein the first radiopaque marker is positioned along the first distal node.
14. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the expandable framework includes a plurality of cells defining a proximal- most row of cells, and wherein each cell in the proximal row of cells includes a first strut segment and a second strut segment joined at a distal node, and wherein a radiopaque marker is positioned along at least one of the distal nodes.
2. The medical implant of claim 1, wherein the proximal shoulder region includes a first row of cells, and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node, and wherein the first radiopaque marker is positioned along the first distal node.
3. The medical implant of claim 2, wherein the first row of cells extends circumferentially around the central longitudinal axis of the expandable framework.
15. The medical implant of claim 14, wherein the proximal-most row of cells extends circumferentially around the longitudinal axis of the expandable framework.
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub;
wherein the plurality of struts form a proximal shoulder region of the expandable framework
proximate the proximal hub, a distal shoulder region of the expandable framework proximate the distal hub, and a medial region extending between the proximal shoulder region and the distal shoulder region;
a first radiopaque marker positioned along the proximal shoulder region of the expandable framework;
a second radiopaque marker positioned along the proximal shoulder region of the expandable framework;
and a third radiopaque marker positioned along the proximal shoulder region of the expandable framework;
wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are disposed within a plane configured to be aligned with an ostium of the left atrial appendage.2. The medical implant of claim 1, wherein the proximal shoulder region includes a first row of cells, and wherein a first cell in the first row of cells includes a first strut segment and a second strut segment joined at a first distal node, and
wherein the first radiopaque marker is positioned along the first distal node.
4. The medical implant of claim 3, wherein the first row of cells further includes in a second cell including a third strut segment and a fourth strut segment joined at a second distal node, and
wherein the second radiopaque marker is positioned along the second distal node.
5. The medical implant of claim 4, wherein the first row of cells further includes in a third cell including a fifth strut segment and a sixth strut segment joined at a third distal node, and wherein
the third radiopaque marker is positioned along the third distal node.
17. The medical implant of claim 16, wherein the expandable framework includes a first radiopaque marker positioned along a first distal node, a second radiopaque marker positioned along a second distal node and a third radiopaque marker positioned along a third distal node.
6. The medical implant of claim 5, wherein the first radiopaque marker, the second radiopaque marker, and the third radiopaque marker are spaced equidistant from one another around the central longitudinal axis.
18. The medical implant of claim 17, wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are spaced equidistant from one another around the longitudinal axis.
1. A medical implant, comprising: an expandable framework having a plurality of struts disposed about a central longitudinal axis, the plurality of struts being joined at a proximal hub and a distal hub; wherein the plurality of struts form a proximal shoulder region of the expandable framework proximate the proximal hub, a distal shoulder region of the expandable framework proximate the distal hub, and a medial region extending between the proximal shoulder region and the distal shoulder region; a first radiopaque marker positioned along the proximal shoulder region of the expandable framework; a second radiopaque marker positioned along the proximal shoulder region of the expandable framework; and a third radiopaque marker positioned along the proximal shoulder region of the expandable framework; wherein when the implant is positioned within a left atrial appendage,
the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are disposed within a plane configured to be aligned with an ostium of the left atrial appendage.
7. The medical implant of claim 5, wherein the plane is oriented perpendicular to the central longitudinal axis.
19. The medical implant of claim 18, wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane oriented substantially perpendicular to the longitudinal axis.
Claim Rejections - 35 USC § 112(b)
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 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is dependent on claim 16, which is not present in the instant claim set. Claim 18 is dependent on claim 17 and claim 19 is dependent on claim 18. Accordingly, there is insufficient antecedent basis in claims 17-19 due to the direct and indirect dependency on claim 16, which is not among the claims presented in this application.
Claims 8, 9, and 19 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 “a plane substantially perpendicular” in claims 8, 9, and 19 is a relative term which renders the claim indefinite. The term “substantially” 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-9, 11-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al., US 20200060849 (27 February 2020) in view of Onushko et al., US 20190083075 (21 March 2019).
Regarding independent claim 1, Inouye teaches a medical implant (100) , comprising an expandable framework (FIGs 1, 2; expandable framework 110) having a plurality of struts (FIG 3, interconnected struts 112, ¶55) disposed about a central longitudinal axis (¶62), the plurality of struts being joined at a proximal hub (¶¶52, 54) the plurality of struts (112) form a proximal shoulder region (FIG 3) of the expandable framework (110), a distal shoulder region of the expandable framework (FIGs 2, 3), and a medial region extending between the proximal should[er] region and the distal shoulder region (FIG 2; ¶55); and a first radiopaque marker positioned along the proximal shoulder region of the expandable framework (¶131).
Inouye does not expressly teach where the plurality of struts are joined at a proximal hub and a distal hub.
However, Inouye teaches the plurality of struts being joined at a proximal hub (¶54). Additionally, an embodiment of Inouye, FIG 9, appears to show both a proximal and distal strut-joining hub as two boxes.
Onushko teaches medical implant 10 (FIG 3) comprising an expandable framework (FIG 3, 12; ¶71) disposed about a central longitudinal axis (FIG 3), the expandable framework (12) being joined at a proximal hub and a distal hub (FIG 3).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye and Onushko, given that the prior art provided a teaching, suggestion, or motivation, for each element claimed, although not necessarily in a single reference. Inouye and Onushko teach in the same field of endeavor, of occlusive medical implants comprising expandable frameworks.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising struts and a proximal hub connecting the struts, Inouye does not expressly teach that a distal hub connects the struts, although one appears to be shown in an embodiment in FIG 9.
Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Because Inouye includes a proximal hub in the occlusive device comprising an expandable framework, a person of ordinary skill in the art, seeking to control device orientation during implantation would reasonably consult Onushko’s dual (proximal and distal) hub solution. Onushko’s distal hub can be incorporated alongside Inouye’s proximal hub for connecting core wire 30 of Inouye (core wire 18 of Onushko, ¶69). Inouye’s occlusive device provides the same general structure, same intended delivery location and the same interaction with the core wire and delivery catheter as that of Onushko such that one of ordinary skill in the art, using known assembly methods could readily incorporate Onushko’s distal hub without redesigning Inouye’s core device or delivery path. Because the references address the same engineering problem (deployment of an occlusive medical device with an expandable framework into a left atrial appendage) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a distal hub on the expandable framework), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Inouye modified by Onushko teaches the medical implant of claim 1, as set forth above, for the reasons above.
Inouye teaches wherein the proximal shoulder region (FIG 3, part of expandable framework 110) includes a first row of cells (FIG 3, ¶53), wherein a first cell in the row of cells (FIG 3, ¶53), includes a first strut segment and a second strut segment (FIG 5, interconnected struts 112, ¶53) joined at a first distal node (FIGs 3, 5; ¶55), and wherein the first radiopaque marker is positioned along the first distal node (¶131).
Regarding claim 3, Inouye modified by Onushko teaches the medical implant of claim 2, as set forth above, for the reasons above.
Inouye teaches wherein the row of cells (FIG 3, ¶53), extends circumferentially around the longitudinal axis (FIGs 2, 3; ¶55) of the expandable framework (110).
Regarding claim 4, Inouye modified by Onushko teaches the medical implant of claim 3, as set forth above, for the reasons above.
Inouye teaches wherein the first row of cells (FIG 3, ¶53), further includes in a second cell including a third strut segment and a fourth strut segment joined at a second distal node, (FIG 5, interconnected struts 112; ¶55).
Inouye does not expressly teach wherein a second radiopaque marker is positioned along the second distal node.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning of a second radiopaque marker positioned along the second distal node as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 5, Inouye as modified by Onushko teaches the medical implant of claim 4, as set forth above, for the reasons above.
Inouye teaches wherein the first row of cells (FIG 3, ¶53) further includes in a third cell including a fifth strut segment and a sixth strut segment joined at a third distal node (FIG 5, interconnected struts 112; ¶55).
Inouye does not expressly teach wherein a third radiopaque marker is positioned along the third distal node.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning of a second radiopaque marker positioned along the second distal node as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 7, Inouye modified by Onushko teaches the medical implant of claim 5, as set forth above, for the reasons above.
Inouye modified by Onushko does not expressly teach wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are spaced equidistant from one another around the longitudinal axis.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning and spacing of a first, second, and third radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or spacing of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 8, Inouye modified by Onushko teaches the medical implant of claim 5, as set forth above, for the reasons above.
Inouye modified by Onushko does not expressly teach wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane oriented substantially perpendicular to the longitudinal axis.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning and spacing of a first, second, and third radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or spacing of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 9, Inouye modified by Onushko teaches the medical implant of claim 5, as set forth above, for the reasons above.
Inouye modified by Onushko does not expressly teach wherein when the implant is positioned within a left atrial appendage, the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane substantially perpendicular to an ostium of the left atrial appendage.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning and alignment of a first, second, and third radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or alignment of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 11, Inouye modified by Onushko teaches the implant of claim 1, as set forth above, for the reasons above.
Inouye teaches the implant further comprising an occlusive element disposed over at least a portion of the expandable framework (FIG 3, occlusive element 120, ¶56).
Regarding claim 12, Inouye modified by Onushko teaches the implant of claim 1, as set forth above, for the reasons above.
Inouye teaches wherein the radiopaque marker is formed from a different material (¶¶131, 133) than the expandable framework (¶126).
Regarding claim 13, Inouye modified by Onushko teaches implant of claim 1, as set forth above, for the reasons above.
Inouye teaches the implant wherein the radiopaque marker has a different density (¶¶131, 133) than the expandable framework (¶126).
Density is a physical property of a composition. Inouye teaches that the radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy (¶131). Inouye teaches that the expandable framework or portions thereof my be made from polymeric compositions including polyesters, polyurethanes, and polyamides (¶133). These materials have very specific innate physical densities which are innate to the compositional chemical structure.
Regarding independent claim 14, Inouye teaches a medical implant (100) , comprising an expandable framework (FIGs 1, 2; expandable framework 110) having a plurality of struts (FIG 3, interconnected struts 112, ¶55) disposed about a central longitudinal axis (¶62), the plurality of struts (FIGs 2, 3; 112) being joined at a proximal hub (core wire 30, ¶¶52, 54), wherein the expandable framework (110) includes a plurality of cells (¶53) defining a proximal-most row of cells (FIG 3, ¶53), and wherein each cell in the proximal first row of cells includes a first strut segment and a second strut segment (FIG 5, interconnected struts 112, ¶53) joined at a first distal node (FIGs 3, 5; ¶55), and wherein the first radiopaque marker is positioned along the first distal node (¶131).
Inouye does not expressly teach where the plurality of struts are joined at a proximal hub and a distal hub.
However, Inouye teaches the plurality of struts being joined at a proximal hub (¶54). Additionally, an embodiment of Inouye, FIG 9, appears to show both a proximal and distal strut-joining hub as two boxes.
Onushko teaches medical implant 10 (FIG 3) comprising an expandable framework (FIG 3, 12; ¶71) disposed about a central longitudinal axis (FIG 3), the expandable framework (12) being joined at a proximal hub and a distal hub (FIG 3).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye and Onushko, given that the prior art provided a teaching, suggestion, or motivation for each element claimed, although not necessarily in a single reference. Inouye and Onushko teach in the same field of endeavor, of occlusive medical implants comprising expandable frameworks.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising struts and a proximal hub connecting the struts, Inouye does not expressly teach that a distal hub connects the struts, although one appears to be shown in an embodiment in FIG 9.
Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Because Inouye includes a proximal hub in the occlusive device comprising an expandable framework, a person of ordinary skill in the art, seeking to control device orientation during implantation would reasonably consult Onushko’s dual (proximal and distal) hub solution. Onushko’s distal hub can be incorporated alongside Inouye’s proximal hub for connecting core wire 30 of Inouye (core wire 18 of Onushko, ¶69). Inouye’s occlusive device provides the same general structure, same intended delivery location and the same interaction with the core wire and delivery catheter as that of Onushko such that one of ordinary skill in the art, using known assembly methods could readily incorporate Onushko’s distal hub without redesigning Inouye’s core device or delivery path. Because the references address the same engineering problem (deployment of an occlusive medical device with an expandable framework into a left atrial appendage) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a distal hub on the expandable framework), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 15, Inouye modified by Onushko teaches the medical implant of claim 14, as set forth above, for the reasons above.
Inouye teaches wherein the proximal-most row of cells (FIGs 2, 3) extends circumferentially (¶55) around the longitudinal axis (¶62) of the expandable framework (110, ¶55).
Regarding independent claim 20, Inouye teaches a system (FIGs 1, 2, system 10; ¶51) for occluding a left atrial appendage (¶2), comprising: a delivery sheath (catheter 40, ¶52) and core wire (core wire 30, ¶52) slidably disposed within a lumen of the delivery sheath (¶52) and an implant (100) for occluding a left atrial appendage releasably securable to a distal end of the core wire (¶52), the implant (100) comprising: an expandable framework (expandable framework 110) having a plurality of struts (FIG 3, interconnected struts 112; ¶53) disposed about a central longitudinal axis (¶62), the plurality of struts (112) being joined at a proximal hub (¶¶52, 54) wherein the plurality of struts (112) form a proximal shoulder region (FIGs 2, 3) of the expandable framework (110), a distal shoulder region of the expandable framework (FIGs 2,3, 110; ¶55); and a medial region extending between the proximal should region and the distal shoulder region (FIG 2; ¶55); and a first radiopaque marker positioned along the proximal shoulder region of the expandable framework (¶131).
Inouye does not expressly teach where the plurality of struts are joined at a proximal hub and a distal hub.
However, Inouye teaches the plurality of struts being joined at a proximal hub (¶54). Additionally, an embodiment of Inouye, FIG 9, appears to show both a proximal and distal strut-joining hub as two boxes.
Onushko teaches medical implant 10 (FIG 3) comprising an expandable framework (FIG 3, 12; ¶71) disposed about a central longitudinal axis (FIG 3), the expandable framework (12) being joined at a proximal hub and a distal hub (FIG 3).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye and Onushko, given that the prior art provided a teaching, suggestion, or motivation each element claimed, although not necessarily in a single reference. Inouye and Onushko teach in the same field of endeavor, of occlusive medical implants comprising expandable frameworks.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising struts and a proximal hub connecting the struts, Inouye does not expressly teach that a distal hub connects the struts, although one appears to be shown in an embodiment in FIG 9.
Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Because Inouye includes a proximal hub in the occlusive device comprising an expandable framework, a person of ordinary skill in the art, seeking to control device orientation during implantation would reasonably consult Onushko’s dual (proximal and distal) hub solution. Onushko’s distal hub can be incorporated alongside Inouye’s proximal hub for connecting core wire 30 of Inouye (core wire 18 of Onushko, ¶69). Inouye’s occlusive device provides the same general structure, same intended delivery location and the same interaction with the core wire and delivery catheter as that of Onushko such that one of ordinary skill in the art, using known assembly methods could readily incorporate Onushko’s distal hub without redesigning Inouye’s core device or delivery path. Because the references address the same engineering problem (deployment of an occlusive medical device with an expandable framework into a left atrial appendage) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a distal hub on the expandable framework), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al., US 20200060849 (27 February 2020) in view of Onushko et al., US 20190083075 (21 March 2019) and further in view of Sheps, US 20150272734 (1 October 2015).
Regarding claim 6, Inouye modified by Onushko teaches the medical implant of claim 5, as set forth above, for the reasons set forth above.
Inouye modified by Onushko does not expressly teach wherein the first radiopaque marker and the second radiopaque marker are spaced equidistant from one another around the longitudinal axis.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches radiopaque markers being longitudinally spaced at a constant interval (¶479). Sheps also teaches equidistant spacing (¶479).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye, Onushko, and Sheps given that the prior art included each element claimed, although not necessarily in a single reference. Inouye, Onushko, and Sheps teach in the same field of endeavor, cardiac medical implants.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising radiopaque markers, Inouye does not expressly teach wherein the first radiopaque marker and the second radiopaque marker are spaced equidistant from one another around the longitudinal axis. However, Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches cardiac medical implant systems comprising radiopaque components for fluoroscopic visualization. Sheps expressly teaches at least three radiopaque markers being longitudinally spaced at a constant interval (¶479). Sheps also teaches equidistant spacing (¶479).
Because Inouye and Onushko expressly provide radiopaque markers that can be positioned, spaced, and aligned in any manner necessary according to the desire of the particular device, use-case anatomy, or anatomical positioning needs and both references expressly teach that radiopaque markers can positioned anywhere in the design of the medical occlusion device system including the expandable framework and the plurality of securement members, a person of ordinary skill in the art, seeking to determine the best fit and alignment of the implanted device using visualization methods to see the radiopaque markers of the implanted device would seek to place markers on or within the device in locations and with spacing and alignment variations to best control the position, orientation, and placement of the device in vivo, would reasonably consult Sheps’ teachings of spacing and equidistant placement solution. Sheps’ radiopaque spacing preferences can be incorporated alongside Inouye and Onushko’s variable placement teachings, suggestions, and motivation to provide the ability to visualize the implanted device in vivo and to optimize placement of the device in vivo. One of ordinary skill in the art, using known assembly methods could readily incorporate Sheps’ radiopaque marker equidistant placement into Inouye’s base device modified by Onushko’s distal hub without redesigning Inouye’s core device. Because the references address the same engineering problem (incorporation of radiopaque markers into implantable cardiac devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding radiopaque markers at defined intervals throughout the structure of an implantable medical device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Further, the examiner interprets the positioning, spacing, and alignment of a first and second radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or alignment of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding claim 10, Inouye modified by Onushko teaches the medical implant of claim 5, as set forth above, for the reasons set forth above.
Inouye modified by Onushko does not expressly teach wherein the radiopaque marker is oriented longitudinally relative to the longitudinal axis of the expandable framework. Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110), the and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches radiopaque markers being longitudinally spaced relative to longitudinal sites (¶479).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye, Onushko, and Sheps given that the prior art included each element claimed, although not necessarily in a single reference. Inouye, Onushko, and Sheps teach in the same field of endeavor, cardiac medical implants.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising radiopaque markers, Inouye does not expressly teach wherein the radiopaque marker is oriented longitudinally relative to the longitudinal axis of the expandable framework. However, Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches cardiac medical implant systems comprising radiopaque components for fluoroscopic visualization. Sheps expressly teaches at least three radiopaque markers being longitudinally spaced relative to longitudinal sites (¶479).
Because Inouye and Onushko expressly provide radiopaque markers that can be positioned, spaced, and aligned in any manner necessary according to the desire of the particular device, use-case anatomy, or anatomical positioning needs and both references expressly teach that radiopaque markers can positioned anywhere in the design of the medical occlusion device system including the expandable framework and the plurality of securement members, a person of ordinary skill in the art, seeking to determine the best fit and alignment of the implanted device using visualization methods to see the radiopaque markers of the implanted device would seek to place markers on or within the device in locations and with spacing and alignment variations to best control the position, orientation, and placement of the device in vivo, would reasonably consult Sheps’ solutions of radiopaque markers being longitudinally spaced relative to longitudinal sites. Sheps’ radiopaque spacing preferences can be incorporated alongside Inouye and Onushko’s variable placement teachings, suggestions, and motivation to provide the ability to visualize the implanted device in vivo and to optimize placement of the device in vivo. One of ordinary skill in the art, using known assembly methods could readily incorporate Sheps’ radiopaque marker solutions into Inouye’s base device modified by Onushko’s distal hub, without redesigning Inouye’s core device. Because the references address the same engineering problem (incorporation of radiopaque markers into implantable cardiac devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding radiopaque markers at variable defined intervals throughout the structure of an implantable medical device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Further, the examiner interprets the positioning, spacing, and alignment of a first and second radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or alignment of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Provisional Claim Rejections
In order to promote compact prosecution, a provisional claim rejection over claims 17-19 is set forth below, based on a presumptive/contemplated amendment of the dependency of claim 17 on independent claim 14.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 17 is provisionally rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al., US 20200060849 (27 February 2020) in view of Onushko et al., US 20190083075 (21 March 2019).
The provisional rejection is made in order to promote compact prosecution in light of the claims’ direct or indirect dependency on a claim that does not exist.
Regarding amended claim 17, Inouye modified by Onushko teaches the medical implant of claim 14, as set forth above, for the reasons set forth above.
Inouye teaches wherein the first row of cells (FIG 3, ¶53) further includes in a third cell including a fifth strut segment and a sixth strut segment joined at a third distal node (FIG 5, interconnected struts 112; ¶55).
Inouye modified by Onushko does not expressly teach wherein a third radiopaque marker is positioned along the third distal node.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
The examiner interprets the positioning of a second radiopaque marker positioned along the second distal node as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers positioned along the second distal or any other node as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Claims 18 and 19 are provisionally rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al., US 20200060849 (27 February 2020) view of Onushko et al., US 20190083075 (21 March 2019) and further in view of Sheps, US 20150272734 (1 October 2015).
The provisional rejection is made in order to promote compact prosecution in light of the claims’ direct or indirect dependency on a claim that does not exist.
Regarding amended claim 18, Inouye modified by Onushko teaches the medical implant of claim 17, as set forth above, for the reasons set forth above.
Inouye modified by Onushko does not expressly teach wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are spaced circumferentially equidistant from one another around the central longitudinal axis.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches radiopaque markers being longitudinally spaced at a constant interval, equidistant spacing, and longitudinal spacing relative to longitudinal sites (¶479).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye, Onushko, and Sheps given that the prior art provided a teaching, suggestion, or motivation for each element claimed, although not necessarily in a single reference. Inouye, Onushko, and Sheps teach in the same field of endeavor, cardiac medical implants.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising radiopaque markers, Inouye does not expressly teach wherein the first radiopaque marker and the second radiopaque marker are spaced equidistant from one another around the longitudinal axis. However, Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches cardiac medical implant systems comprising radiopaque components for fluoroscopic visualization. Sheps expressly teaches radiopaque markers being longitudinally spaced at a constant interval, equidistant spacing, and longitudinal spacing relative to longitudinal sites (¶479).
Because Inouye and Onushko expressly provide radiopaque markers that can be positioned, spaced, and aligned in any manner necessary according to the desire of the particular device, use-case anatomy, or anatomical positioning needs and both references expressly teach that radiopaque markers can positioned anywhere in the design of the medical occlusion device system including the expandable framework and the plurality of securement members, a person of ordinary skill in the art, seeking to determine the best fit and alignment of the implanted device using visualization methods to see the radiopaque markers of the implanted device would seek to place markers on or within the device in locations and with spacing and alignment variations to best control the position, orientation, and placement of the device in vivo, would reasonably consult Sheps’ teachings of longitudinal spacing and equidistant spacing solutions. Sheps’ radiopaque spacing solutions can be incorporated alongside Inouye and Onushko’s variable placement teachings, suggestions, and motivation to provide the ability to visualize the implanted device in vivo and to optimize placement of the device in vivo. One of ordinary skill in the art, using known assembly methods could readily incorporate Sheps’ radiopaque marker equidistant placement into Inouye’s base device modified by Onushko’s distal hub without redesigning Inouye’s core device. Because the references address the same engineering problem (incorporation of radiopaque markers into implantable cardiac devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding radiopaque markers at defined intervals throughout the structure of an implantable medical device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Further, the examiner interprets the positioning, spacing, and alignment of a first and second radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or alignment of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers spaced circumferentially equidistant from one another around the central longitudinal axis as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding amended claim 19, Inouye modified by Onushko and Sheps teaches the medical implant of claim 18, as set forth above, for the reasons set forth above.
Inouye modified by Onushko and Sheps does not expressly teach wherein the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane oriented perpendicular to the central longitudinal axis.
Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches radiopaque markers being longitudinally spaced at a constant interval, equidistant spacing, and longitudinal spacing relative to longitudinal sites (¶479).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Inouye, Onushko, and Sheps given that the prior art provided a teaching, suggestion, or motivation for each element claimed, although not necessarily in a single reference. Inouye, Onushko, and Sheps teach in the same field of endeavor, cardiac medical implants.
Although, Inouye discloses the claimed base occlusive medical implant comprising an expandable framework comprising radiopaque markers, Inouye does not expressly teach that the first radiopaque marker, the second radiopaque marker and the third radiopaque marker are aligned within a plane oriented perpendicular to the central longitudinal axis. However, Inouye teaches radiopaque markers positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131). Similarly, Onushko specifically addresses an occlusive medical implant comprising an expandable framework comprising a proximal hub and a distal hub at FIG 3. Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109).
Sheps teaches cardiac medical implant systems comprising radiopaque components for fluoroscopic visualization. Sheps expressly teaches radiopaque markers being longitudinally spaced at a constant interval, equidistant spacing, and longitudinal spacing relative to longitudinal sites (¶479).
Because Inouye and Onushko expressly provide radiopaque markers that can be positioned, spaced, and aligned in any manner necessary according to the desire of the particular device, use-case anatomy, or anatomical positioning needs and both references expressly teach that radiopaque markers can positioned anywhere in the design of the medical occlusion device system including the expandable framework and the plurality of securement members, a person of ordinary skill in the art, seeking to determine the best fit and alignment of the implanted device using visualization methods to see the radiopaque markers of the implanted device would seek to place markers on or within the device in locations and with spacing and alignment variations to best control the position, orientation, and placement of the device in vivo, would reasonably consult Sheps’ teachings of longitudinal spacing and equidistant spacing solutions. Sheps’ radiopaque spacing solutions can be incorporated alongside Inouye and Onushko’s variable placement teachings, suggestions, and motivation to provide the ability to visualize the implanted device in vivo and to optimize placement of the device in vivo. One of ordinary skill in the art, using known assembly methods could readily incorporate Sheps’ radiopaque marker longitudinal alignment and placement into Inouye’s base device modified by Onushko’s distal hub without redesigning Inouye’s core device. Because the references address the same engineering problem (incorporation of radiopaque markers into implantable cardiac devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding radiopaque markers at defined intervals throughout the structure of an implantable medical device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Further, the examiner interprets the positioning, spacing, and alignment of a first and second radiopaque marker as a design choice, there being no teaching in the specification as to the criticality of the number of radiopaque markers or the criticality as to any particular location or alignment of radiopaque markers. The specification expressly discusses the optional inclusion of radiopaque markers (p. 12) and the variability of the number of radiopaque markers to include wide variability (pp. 12-14).
Design choice applies when old elements in the prior art perform the same function as the now claimed structures. See In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (use of claimed feature solves no stated problem and presents no unexpected result and “would be an obvious matter of design choice within the skill of the art”). However, when the claimed structure performs differently from the prior art a finding of obvious design choice is precluded. In re Gal, 980 F.2d 717, 719 (Fed. Cir. 1992) (finding of obvious design choice precluded when claimed structure and the function it performs are different from the prior art). See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function).
Given that Inouye teaches that radiopaque markers can be positioned anywhere in the design of the medical occlusion device system including the expandable framework (110) and the plurality of securement members (140) (¶131) and Onushko teaches that portions or all of the inclusive implant and variations, systems, or components thereof may be doped with make of or otherwise include a radiopaque material (¶109), it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to include of a plurality of radiopaque markers spaced circumferentially equidistant from one another around the central longitudinal axis as a matter of design choice in light of the teachings, suggestions, and motivations of Inouye and Onushko.
Additionally, the claimed positioning of a plurality of radiopaque markers is a results-effective variable which can be optimized. One of skill in the art would clearly recognize that placement of radiopaque markers can be optimized depending on the end effect desired for the use case. This is shown by the teachings of Inouye at ¶131. One of ordinary skill in the art would have had a reasonable expectation of success to apply radiopaque markers to into the design of the medical devices at any of one or more of the locations taught and suggested by Inouye. The placement of the radiopaque markers can be optimized by a person of ordinary skill in the art without undue experimentation based on the teachings and suggestions of Inouye at ¶131. As such, positioning, spacing, and aligning the radiopaque markers would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
O’Brien et al., US 20170007260 (12 January 2017) teaches vascular occlusion devices.
Inouye et al., US 20200008812 (9 January 2020) teaches an occlusive medical device.
Inouye et al., US 20180310925 (1 November 2018) teaches a left atrial appendage implant with a continuous covering.
Tischler et al., US 20190125362 (2 May 2019) teaches occlusive medical device with cushioning member.
Tischler et al., US 20150196300 (16 July 2015) teaches an occlusive implant system.
Tischler et al., US 9,730,701 (15 August 2017) teaches an occlusive implant system.
Cao et al., US 20190350591 (21 November 2019) teaches an occlusive medical device with charged polymer coating.
Zaver et al., US 20070233175 (4 October 2007) teaches embolic protection devices having radiopaque markers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
Prosecution Insights