DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12/29/2025. As directed by the amendment: claims 1, 3-5, 8-10, 12, 23, 25-27, 30-32, and 46 have been amended, claims 2, 13-15, 24, 35-37, 42, and 45 have been cancelled and claims 16-22, 38-41, and 43-44 remain withdrawn. Thus, claims 1, 3-12, 16-23, 25-34, 38-41, 43-44, and 46 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 9, filed 12/29/2025, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see pages 9-11, filed 12/29/2025, with respect to the rejection(s) of claim(s) 1 and 23 under 35 U.S.C. 103 as being unpatentable over Inouye et al (US 20200008812 A1), herein referenced to as “Inouye 812” in view of Inouye et al (US 20180310925 A1), herein referenced to as “Inouye 925” and Jayaraman (US 20190110796 A1), herein referenced to as “Jayaraman” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “and a lobe formed from the shape memory material… one or more eyelets coupled to the backing portion, each of the one or more eyelets being integral with the backing portion… the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe”.
The examiner agrees that this overcomes the rejection of Inouye 812 in view of Inouye 925 and Jayaraman.
The applicant further argues that Morgan which was relied to teach an eyelet previously fails to teach an eyelet that forms a closed boundary and that the “knot” of Morgan wraps around the framework of the device of Morgan and cannot be positioned entirely radially inwardly of the device body/lobe.
The examiner agrees that the eyelet is not entirely radially inwardly of the device lobe, as shown in Fig. 1A, the eyelets formed by 14A + 14b extend radially outwardly from 200.
The examiner however respectfully disagrees that a first loop 14a and a second loop 14b cannot be considered under the broadest reasonable interpretation of the term eyelet. The applicant does not clarify what the interpretation of eyelet is in their arguments.
The definition of eyelet according to the online Merriam-Webster Dictionary is “a small hole designed to receive a cord or used for decoration (as in embroidery)”, hence elements 14A + 14b meet the definition, as they are small holes that can receive a cord (see the wires 2 entering through 14A + 14B in Fig. 1d).
The applicant further asserts that Morgan fails to disclose that an eyelet forms a closed boundary, but fails to specifically assert why that is the case.
The applicant’s specification does not have a special definition of the limitation “closed boundary”. Hence, the broadest reasonable interpretation of the claim limitation “closed boundary” will be as follows:
The definition of boundary according to the online Merriam-Webster Dictionary is “something that indicates or fixes a limit or extent”.
The definition of closed according to the online Merriam-Webster Dictionary is “not open”.
Take together then, “closed boundary” is interpreted as “a not open something that indicates or fixes a limit”, and when taken in context of “eyelet”, is further interpreted “a not open indicator of a small hole designed to receive a cord”. As such, the loops 14a + 14b of Morgan meet this definition, as they have holes that are defined by the path of their loop, crossing and becoming closed (see annotated Fig. 1D below) while receiving the wires of 2.
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However, as noted above, Morgan does not teach that the eyelet is not entirely radially inwardly of the device lobe.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Inouye 812 in view of Jayaraman and Clark (US 20140188157 A1).
Claim Objections
Claim 46 is objected to because of the following informalities:
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Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: at least one engagement portion in claims 1, 4-5, 12, 23, 26-27, and 34, one or more features configured to control at least one of tissue penetration depth of the at least one engagement portion, extension of the stabilizing member from the device body, and tissue engagement of the least one engagement portion in claims 1, 14, 23, and 36, and attachable feature in claims 14 and 36.
The claim limitation “at least one engagement portion” invokes 112f because “portion” is a generic placeholder with no structural meaning modified by the functional language “engagement” and is not further modified by sufficient structure. This limitation will be interpreted as a hook or a barb (see [0048] of applicant’s specification).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-10, 12, 23, 25-32, 34, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye et al (US 20200008812 A1), herein referenced to as “Inouye 812” in view of Jayaraman (US 20190110796 A1), herein referenced to as “Jayaraman” and Clark (US 20140188157 A1), herein referenced to as “Clark”.
Claim 1
Inouye 812 discloses: A medical device 10 (see Figs. 1-2) for treating a target site (see Fig. 1), the medical device 10 (see Figs. 1-2, [0064]) comprising: a device body the body of 10 including a lobe 12 (see Figs. 1-2, [0067], 12 forms a lobe shape) formed from a shape memory material (see [0113], nitinol); and a plurality of stabilizing members 16 (see Fig. 2, [0071]) coupled to the lobe 12, each stabilizing member 16 respectively comprising: a backing portion 35 + 37 + 39 (see Fig. 3, [0076]) coupled to the lobe 12; at least one engagement portion 41 + 43 (see Fig. 3, [0080], This limitation will be interpreted as a hook or a barb, see [0048] of applicant’s specification) integral with the backing portion 35 + 37 + 39 (see Fig. 3, 41 + 43 are integral with the backing portion) radially outwardly relative (the engagement portions 41 + 43 extend radially outward compared to the backing portion, see Fig. 3) to the backing portion 35 + 37 + 39, wherein the engagement portion 41 + 43 extends radially outward from the lobe 12 (see Figs. 2-3).
Inouye 812 does not explicitly disclose: the device body including at least one disc formed from the shape memory material; and one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe.
However, Jayaraman in a similar field of invention teaches a medical device for implantation in the body (see Figs. 13-15) with a device body 120 + 160 (see Figs. 13-15) with a lobe 120 (see Figs. 13-15) formed from a shape memory material nitinol (see [0113]) and stabilizing members 140 (see Figs. 13-15 and 23-24, [0066]). Jayaraman further teaches: the device body 120 including at least one disc 160 + 166 + 162 (see Figs. 13-15, [0059]) formed from the shape memory material nitinol (see [0113], both the lobe 120 and the disc 160 are made from the same shape memory material, nitinol).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical device of Inouye 812 to incorporate the teachings of Jayaraman and teach a medical device with the device body including at least one disc formed from the shape memory material. Motivation for such can be found in Jayaraman as the cover can overlie an opening into an anatomical structure such as a left atrial appendage (see [0051]) to assist in occluding the structure.
The combination of Inouye 812 and Jayaraman does not explicitly teach: and one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe.
However, Clark in a similar field of invention teaches a medical device 100 (see Figs. 2-3F) with a lobe 206 (see Figs. 2-3F, 206 is a lobe) with a stabilizing member 302 + 212 (see Figs. 2-3F) with an engagement portion 302 (see Figs. 2-3F) and a backing portion 212 (see Figs. 2-3F). Clark further teaches: and one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c (see annotated Figs. 3C-3D below, forms an eyelet with 212, meets the definition of an eyelet as a small hole that is designed to receive a cord), each of the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c being integral (see [0048], 302 which forms the eyelet via 314/316 is welded to 212, the backing portion, hence being integral with the backing portion which unites the two parts by heating and allowing the metals to flow together into one piece) with the backing portion 212 and extending radially inwardly from an inward face the inward face of 212 (see Fig. 3C, where 316 is indicated to define the eyelet is all on the inner side of 212) of the backing portion 212 and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c each forming a closed boundary (see annotated Fig. 3E-3F below), the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c being positioned entirely radially inward of the lobe 206 (see Fig. 3C, where 316 is indicated to define the eyelet is all on the inner side of 212, hence on the inner side of the lobe 206)
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Clark and teach a medical device with one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe. Motivation for such can be found in Clark as this creates an undulating pattern to the fixation anchor which creates the eyelet facilitates a reduction of unintentional fixation anchor migration by a distally applied force (see [0041]-[0042]). Furthermore, the penetration depth of 318 and its radius can be altered by increasing the distance that 302 extends out from the inner side of 212 (see [0040]) which would decrease fixation strength and stiffness of the fixation anchor 302 as need be.
Claim 3
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is formed of a laser cut nitinol form (see [0073] and [0079], laser-cut is disclosed as a manufacturing technique for the device).
Claim 4
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is coupled to the lobe 12 such that an entirety of the at least one engagement portion 41 + 43 (see Figs. 2-3, the entirety of 41 + 43 are external to that of 10) and at least a portion 37 + 39 (see Fig. 3, 37 and 39 are portions of the backing portion that are external to that of 10) of the backing portion 35 + 37 + 39 is located external to the lobe 12.
Claim 5
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is coupled to the lobe 12 such that an entirety of the at least one engagement portion 41 + 43 (see Figs. 2-3, the entirety of 41 + 43 are external to that of 10 is located external to the device body 10 and at least a portion 35 (see Fig. 3, 35 is located internal of 10) of the backing portion 35 + 37 + 39 is located internal to the lobe 12.
Claim 6
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 respectively further comprises at least one penetration stop angle formed by x and 47 (see Fig. 5, [0083]) defining a tissue penetration depth limit at a location 47 is meets 35 (see Fig. 5) where the at least one penetration stop angle formed by x and 47 adjoins the backing portion 35 (see Fig. 5).
Claim 7
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein each engagement portion 41 + 43 is selected from at least one hook (see Figs. 2-5, 41 and 43 are hooked barbs) and at least one barb (see Figs. 2-5, 41 and 43 are hooked barbs).
Claim 8
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein the shape memory material nitinol comprises a braided mesh fabric (see [0073], braided structure), and wherein each stabilizing member 16 is coupled to an interior surface (see Fig. 3, where 35 is coupled to interior at 45) of the lobe 12.
Claim 9
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 further discloses: wherein the shape memory material nitinol comprises a braided mesh fabric (see [0073], braided structure), and wherein each stabilizing member 16 is coupled to an exterior surface (see Fig. 3, where 37 + 39 coupled to exterior at 25 and 27) of the lobe 12.
Claim 10
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 does not explicitly disclose: wherein each stabilizing member is coupled to the lobe by being sewn directly onto the lobe through the one or more eyelets.
However, Jayaraman in a similar field of invention teaches a medical device for implantation in the body (see Figs. 13-15) with a disc 166, a lobe 120, and stabilizing members 140 (see Figs. 13-15 and 23-24, [0066]) with one or more eyelets the eyelets formed by 144 (see Figs. 13-15 and 23). Jayaraman further teaches: wherein each stabilizing member 140 is coupled to the device body body of 120 by being sewn directly 176 (see Figs. 13-15, [0066]) onto the lobe 120 through the one or more eyelets the eyelets formed by 144 (see Figs. 13-15, [0066], the suture extends through 144 to tie onto 120, as can be seen Fig. 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Jayaraman and have a medical device with each stabilizing member is coupled to the lobe by being sewn directly onto the lobe through the one or more eyelets. Motivation for such can be found in Jayaraman as this allows the anchors/stabilizing members maintain a particular angular disposition with respect to the surface of the device after deployment (see [0066]).
Claim 12
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Inouye 812 and Jayaram does not explicitly teach: wherein the at least one engagement portion curves radially inwardly relative to the backing portion to form a recess angle between the engagement portion and the backing portion adjacent to an end of the engagement portion at which the engagement portion adjoins the backing portion, such that the at least one engagement portion does not extend linearly straight from the backing portion.
However, Clark in a similar field of invention teaches a medical device 100 (see Figs. 2-3F) with a stabilizing member 302 + 212 (see Figs. 2-3F) with an engagement portion 302 (see Figs. 2-3F) and a backing portion 212 (see Figs. 2-3F). Clark further teaches: wherein the at least one engagement portion 302 curves radially inwardly (see Fig. 3F, the portion of 302 that enters into 308b, and moves radially inwardly in relation to 212) relative to the backing portion 212 to form a recess angle the angle of 302 that is formed when it enters 308b and exits 308c in relation to 212 (see Fig. 3F) between the engagement portion 302 and the backing portion 212 adjacent to an end 318 (see Fig. 3F, [0035], this end is adjacent by being next to 212) of the engagement portion 302 at which the engagement portion 302 adjoins (see Fig. 3F, 302 adjoins 212, according to the online Oxford languages dictionary as being “next to and joined with”, in this case this section of 302 is next to and joins with 212 by extending through it) the backing portion 212, such that the at least one engagement portion 302 does not extend linearly straight (see Figs. 3A-3F, 302 is curved, not linearly straight) from the backing portion 212.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812, Inouye 925, and Jayaraman to incorporate the teachings of Clark and teach a medical device with the at least one engagement portion curves radially inwardly relative to the backing portion to form a recess angle between the engagement portion and the backing portion adjacent to an end of the engagement portion at which the engagement portion adjoins the backing portion, such that the at least one engagement portion does not extend linearly straight from the backing portion. Motivation for such can be found in Clark as this creates an undulating pattern to the engagement portion/fixation anchor that facilitates a reduction of unintentional fixation anchor migration by a distally applied force (see [0041]-[0042]).
Claim 23
Inouye 812 discloses: A delivery system (see Figs. 1-5) comprising: a medical device 10 (see Figs. 1-2, [0064]) comprising: a device body the body of 10 including a lobe 12 (see Figs. 1-2, [0067], 12 forms a lobe shape) formed from a shape memory material (see [0113], nitinol); and a plurality of stabilizing members 16 (see Fig. 2, [0071]) coupled to the lobe 12, each stabilizing member 16 comprising: a backing portion 35 + 37 + 39 (see Fig. 3, [0076]) coupled to the lobe 12; at least one engagement portion 41 + 43 (see Fig. 3, [0080], This limitation will be interpreted as a hook or a barb, see [0048] of applicant’s specification) extending radially outwardly relative (the engagement portions 41 + 43 extend radially outward compared to the backing portion, see Fig. 3) to the backing portion 35 + 37 + 39 of the backing portion 35 + 37 + 39, wherein the at least one engagement portion 41 + 43 integral with the backing portion 35 + 37 + 39 (see Fig. 3, 41 + 43 are integral with the backing portion) and extends radially outward from the device body 10 (see Figs. 2-3); and a delivery sheath 24 (see Fig. 1, [0065]) configured to retain and recapture the medical device 10 during deployment of the medical device 10 to a target site (see Fig. 1, [0064]-[0065]).
Inouye 812 does not explicitly disclose: the device body including at least one disc formed from the shape memory material; and one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe.
However, Jayaraman in a similar field of invention teaches a medical device for implantation in the body (see Figs. 13-15) with a device body 120 + 160 (see Figs. 13-15) with a lobe 120 (see Figs. 13-15) formed from a shape memory material nitinol (see [0113]) and stabilizing members 140 (see Figs. 13-15 and 23-24, [0066]). Jayaraman further teaches: the device body 120 including at least one disc 160 + 166 + 162 (see Figs. 13-15, [0059]) formed from the shape memory material nitinol (see [0113], both the lobe 120 and the disc 160 are made from the same shape memory material, nitinol).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical device of Inouye 812 to incorporate the teachings of Jayaraman and teach a medical device with the device body including at least one disc formed from the shape memory material. Motivation for such can be found in Jayaraman as the cover can overlie an opening into an anatomical structure such as a left atrial appendage (see [0051]) to assist in occluding the structure.
The combination of Inouye 812 and Jayaraman does not explicitly teach: and one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe.
However, Clark in a similar field of invention teaches a medical device 100 (see Figs. 2-3F) with a lobe 206 (see Figs. 2-3F, 206 is a lobe) with a stabilizing member 302 + 212 (see Figs. 2-3F) with an engagement portion 302 (see Figs. 2-3F) and a backing portion 212 (see Figs. 2-3F). Clark further teaches: and one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c (see annotated Figs. 3C-3D below, forms an eyelet with 212, meets the definition of an eyelet as a small hole that is designed to receive a cord), each of the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c being integral (see [0048], 302 which forms the eyelet via 314/316 is welded to 212, the backing portion, hence being integral with the backing portion which unites the two parts by heating and allowing the metals to flow together into one piece) with the backing portion 212 and extending radially inwardly from an inward face the inward face of 212 (see Fig. 3C, where 316 is indicated to define the eyelet is all on the inner side of 212) of the backing portion 212 and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c each forming a closed boundary (see annotated Fig. 3E-3F below), the one or more eyelets the portion of 314 where 316 is in Fig. 3C extending between 308b and 308c being positioned entirely radially inward of the lobe 206 (see Fig. 3C, where 316 is indicated to define the eyelet is all on the inner side of 212, hence on the inner side of the lobe 206)
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Clark and teach a medical device with one or more eyelets, each of the one or more eyelets being integral with the backing portion and extending radially inwardly from an inward face of the backing portion and being configured to control extension of the stabilizing member from the lobe, the one or more eyelets each forming a closed boundary, the one or more eyelets being positioned entirely radially inward of the lobe. Motivation for such can be found in Clark as this creates an undulating pattern to the fixation anchor which creates the eyelet facilitates a reduction of unintentional fixation anchor migration by a distally applied force (see [0041]-[0042]). Furthermore, the penetration depth of 318 and its radius can be altered by increasing the distance that 302 extends out from the inner side of 212 (see [0040]) which would decrease fixation strength and stiffness of the fixation anchor 302 as need be.
Claim 25
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is formed of a laser cut nitinol form (see [0073] and [0079], laser-cut is disclosed as a manufacturing technique for the device).
Claim 26
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is coupled to the lobe 12 such that an entirety of the at least one engagement portion 41 + 43 (see Figs. 2-3, the entirety of 41 + 43 are external to that of 10) and at least a portion 37 + 39 (see Fig. 3, 37 and 39 are portions of the backing portion that are external to that of 10) of the backing portion 35 + 37 + 39 is located external to the lobe 12.
Claim 27
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 is coupled to the lobe 12 such that an entirety of the at least one engagement portion 41 + 43 (see Figs. 2-3, the entirety of 41 + 43 are external to that of 10 is located external to the device body 10 and at least a portion 35 (see Fig. 3, 35 is located internal of 10) of the backing portion 35 + 37 + 39 is located internal to the lobe 12.
Claim 28
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein each stabilizing member 16 respectively further comprises at least one penetration stop angle formed by x and 47 (see Fig. 5, [0083]) defining a tissue penetration depth limit at a location 47 is meets 35 (see Fig. 5) where the at least one penetration stop angle formed by x and 47 adjoins the backing portion 35 (see Fig. 5).
Claim 29
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein each engagement portion 41 + 43 is selected from at least one hook (see Figs. 2-5, 41 and 43 are hooked barbs) and at least one barb (see Figs. 2-5, 41 and 43 are hooked barbs).
Claim 30
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein the shape memory material nitinol comprises a braided mesh fabric (see [0073], braided structure), and wherein each stabilizing member 16 is coupled to an interior surface (see Fig. 3, where 35 is coupled to interior at 45) of the lobe 12.
Claim 31
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 further discloses: wherein the shape memory material nitinol comprises a braided mesh fabric (see [0073], braided structure), and wherein each stabilizing member 16 is coupled to an exterior surface (see Fig. 3, where 37 + 39 coupled to exterior at 25 and 27) of the lobe 12.
Claim 32
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 does not explicitly disclose: wherein each stabilizing member is coupled to the lobe by being sewn directly onto the lobe through the one or more eyelets.
However, Jayaraman in a similar field of invention teaches a medical device for implantation in the body (see Figs. 13-15) with a disc 166, a lobe 120, and stabilizing members 140 (see Figs. 13-15 and 23-24, [0066]) with one or more eyelets the eyelets formed by 144 (see Figs. 13-15 and 23). Jayaraman further teaches: wherein each stabilizing member 140 is coupled to the device body body of 120 by being sewn directly 176 (see Figs. 13-15, [0066]) onto the lobe 120 through the one or more eyelets the eyelets formed by 144 (see Figs. 13-15, [0066], the suture extends through 144 to tie onto 120, as can be seen Fig. 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Jayaraman and have a delivery system with each stabilizing member is coupled to the lobe by being sewn directly onto the lobe through the one or more eyelets. Motivation for such can be found in Jayaraman as this allows the anchors/stabilizing members maintain a particular angular disposition with respect to the surface of the device after deployment (see [0066]).
Claim 34
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. Inouye 812 and Jayaram does not explicitly teach: wherein the at least one engagement portion curves radially inwardly relative to the backing portion to form a recess angle between the engagement portion and the backing portion adjacent to an end of the engagement portion at which the engagement portion adjoins the backing portion, such that the at least one engagement portion does not extend linearly straight from the backing portion.
However, Clark in a similar field of invention teaches a medical device 100 (see Figs. 2-3F) with a stabilizing member 302 + 212 (see Figs. 2-3F) with an engagement portion 302 (see Figs. 2-3F) and a backing portion 212 (see Figs. 2-3F). Clark further teaches: wherein the at least one engagement portion 302 curves radially inwardly (see Fig. 3F, the portion of 302 that enters into 308b, and moves radially inwardly in relation to 212) relative to the backing portion 212 to form a recess angle the angle of 302 that is formed when it enters 308b and exits 308c in relation to 212 (see Fig. 3F) between the engagement portion 302 and the backing portion 212 adjacent to an end 318 (see Fig. 3F, [0035], this end is adjacent by being next to 212) of the engagement portion 302 at which the engagement portion 302 adjoins (see Fig. 3F, 302 adjoins 212, according to the online Oxford languages dictionary as being “next to and joined with”, in this case this section of 302 is next to and joins with 212 by extending through it) the backing portion 212, such that the at least one engagement portion 302 does not extend linearly straight (see Figs. 3A-3F, 302 is curved, not linearly straight) from the backing portion 212.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812, Inouye 925, and Jayaraman to incorporate the teachings of Clark and teach a medical device with the at least one engagement portion curves radially inwardly relative to the backing portion to form a recess angle between the engagement portion and the backing portion adjacent to an end of the engagement portion at which the engagement portion adjoins the backing portion, such that the at least one engagement portion does not extend linearly straight from the backing portion. Motivation for such can be found in Clark as this creates an undulating pattern to the engagement portion/fixation anchor that facilitates a reduction of unintentional fixation anchor migration by a distally applied force (see [0041]-[0042]).
Claim 46
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. Clark further teaches: wherein the at least one eyelet the portion of 314 extending between 308b and 308c adjoins the inward face the radially inward portion of 212 (see Figs. 3A-3F) of the backing portion 212 intermediate to a first end a first end of 212 adjacent to 318 (see Fig. 3C) of the backing portion 212 and an opposite second end a second end of 212 adjacent to 322 (see Fig. 3C) of the backing portion 212.
Claims 11 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Inouye 812 in view of Jayaraman and Clark as applied to claims 1 and 23 above, and further in view of Morgan et al (EP 3552556 A1), herein referenced to as “Morgan”.
Claim 11
The combination of Inouye 812, Jayaraman, and Clark teaches: the medical device of claim 1, see 103 rejection above. The combination of Inouye 812, Jayaraman, and Clark does not explicitly teach: wherein each stabilizing member further comprises a rotation restraint selected from the group consisting of a tail, a loop and a T-bar.
However, Morgan in a similar field of invention teaches a medical device to be implanted to a target location (see Figs. 1a-1d) with a disc 200, a stabilizing member 5, and at least one engagement portion 15a + 15b. Morgan further teaches: wherein each stabilizing member 5 further comprises a rotation restraint 14a + 14b (see Figs. 1a-1d, [0042]) selected from the group consisting of a tail (will not be examined due to being an optional claim limitation), a loop 14a + 14b (see Figs. 1a-1d, [0042], these are loops) and a T-bar (will not be examined due to being an optional claim limitation).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Morgan and have a medical device with the stabilizing member further comprising a rotation restraint in the form of a loop. Motivation for such can be found in Morgan, as this loop helps secure the anchor member/stabilizing member to the framework of the medical device (see [0016]).
Claim 33
The combination of Inouye 812, Jayaraman, and Clark teaches: the delivery system of claim 23, see 103 rejection above. The combination of Inouye 812, Jayaraman, and Clark does not explicitly teach: wherein each stabilizing member further comprises a rotation restraint selected from the group consisting of a tail, a loop and a T-bar.
However, Morgan in a similar field of invention teaches a medical device to be implanted to a target location (see Figs. 1a-1d) with a disc 200, a stabilizing member 5, and at least one engagement portion 15a + 15b. Morgan further teaches: wherein each stabilizing member 5 further comprises a rotation restraint 14a + 14b (see Figs. 1a-1d, [0042]) selected from the group consisting of a tail (will not be examined due to being an optional claim limitation), a loop 14a + 14b (see Figs. 1a-1d, [0042], these are loops) and a T-bar (will not be examined due to being an optional claim limitation).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inouye 812 to incorporate the teachings of Morgan and have a delivery system with the stabilizing member further comprising a rotation restraint in the form of a loop. Motivation for such can be found in Morgan, as this loop helps secure the anchor member/stabilizing member to the framework of the medical device (see [0016]).
Conclusion
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/ Examiner, Art Unit 3771
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