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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/28/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 02/28/2026. As directed by the amendment: claims 1 and 10 have been amended, claims 16-18 have been cancelled, claims 19-20 have been added, and claims 4, 9, and 13 remain withdrawn. Thus, claims 1-14 and 19-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 02/28/2026, with respect to the rejections of claims 1 and 10 under 35 U.S.C. 103 as being unpatentable over Edmiston et al (US 20140364941 A1), herein referenced to as “Edmiston” in view of Johnson et al (US 20130204288 A1), herein referenced to as “Johnson” and Ahonen et al (US 20130041390 A1), herein referenced to as “Ahonen” have been fully considered and are persuasive.
The applicant amended claims 1 and 10 to further recite “and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre-formed solid structure”. The examiner agrees that the combination of references do not teach the amended claim limitations. The examiner specifically agrees that the filler material relied upon of Ahonen is not a pre-formed solid structure.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Edmiston in view of Johnson and Martinez (US 20040098028 A1).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the tissue growth member with the filler material and the oxidation formed thereto is a pre-formed solid structure” must be shown or the feature(s) canceled from the claim(s). 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 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.
Claim(s) 1-3, 5-8, 10-12, 14, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edmiston et al (US 20140364941 A1), herein referenced to as “Edmiston” in view of Johnson et al (US 20130204288 A1), herein referenced to as “Johnson” and Martinez (US 20040098028 A1), herein referenced to as “Martinez”.
Claim 1
Edmiston discloses: A medical device system (see Figs. 1-12, [0091]) configured to occlude an opening 5 (see Figs. 8-11, [0096]) in a heart the LAA is within the heart, the medical device system (see Figs. 1-12) comprising: a delivery system 100 (see Fig. 4, [0091]) including a handle 106 (see Fig. 4, [0091]) and a catheter 102 (see Fig. 4, [0091]); and an implant 20 (see Figs. 4 and 8-11, [0091]) removably coupled (see Fig. 11, 20 is removably coupled from 102, [0103]) to the catheter 102, the implant 20 including: a framework 24 + 26 (see Figs. 1-12, especially Fig. 2, [0079]) including a hub 54 (see Figs. 1-12, [0083]) with frame segments 24 + 26 extending radially (see Fig. 2, 24 and 26 extend radially from 54, [0083]) from the hub 54; and a tissue growth member 28 (see Figs. 1-12, [0079]) attached (see [0079], 24 has 28 attached to it) to the framework 24 + 26, the tissue growth member 28 extending radially (see Fig. 1A, 28 extends radially along 24) along the framework 24 + 26 such that the tissue growth member 28 extends to define an outer layer portion 32 (see Figs. 1A-1B, [0081]) and an inner layer portion 30 (see Figs. 1A-1B, [0081]), the framework 24 + 26 coupled (see Figs. 1A-1B, 30 is attached to the struts of 24) to the inner layer portion 30, the tissue growth member 28 extending with multiple voids porous characteristics of 30 and pores of 32a-c (see [0081] and [0082]) defined therein.
Edmiston does not explicitly disclose: the tissue growth member including a filler material configured to temporarily fill the multiple voids of the tissue growth member; wherein the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure.
However, Johnson in a similar field of invention teaches an intravascular occlusion device (see Figs. 3-4B) with a tissue growth member 60 (see Figs. 4A-4B) extending with multiple voids 62 (see Figs. 4A-4B). Johnson further teaches: the tissue growth member 60 including a filler material 64 (see Figs. 4A-4B, [0048]) configured to temporarily fill (see [0048], 64 is erodible, hence it temporarily fills pores 62) the multiple voids 62 of the tissue growth member 60.
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 Edmiston to incorporate the teachings of Johnson and have a medical device system with the tissue growth member including a filler material configured to temporarily fill the multiple voids of the tissue growth member. Motivation for such can be found in Johnson as this allows for some nourishment to surrounding tissues, while initially providing a substantial barrier to flow and then allowing preferential eroding over time while keeping an upper limit to an increase in porosity (see [0048]).
The combination of Edmiston and Johnson does not explicitly teach: wherein the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure.
However, Martinez in a similar field of invention teaches a vasoocclusive device 10 (see Figs. 1-4) with a framework 13 (see Figs. 1-4) with a tissue growth material 12 (see Figs. 1-4, see [0023]-[0024], hydrogel with sufficient porosity to permit cellular ingrowth) and a filler material (see [0023], 12 impregnated, grafted, bound to deliver therapeutic compounds, proteins, etc.). Martinez further teaches: wherein the tissue growth member 12 and the filler material (see [0023], 12 impregnated, grafted, bound to deliver therapeutic compounds, proteins, etc.) comprise oxidation (see [0029], crosslinking of the monomer via reduction-oxidation, hence oxidation forms, and uses UV radiation as well) formed thereto; and wherein, upon attachment of the tissue growth member 12 to the framework 13 (see Figs. 1-2, 12 attached to 13), the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure (see [0029]-[0032], 12, the hydrogel with filler material which is oxidizes is a pre-formed solid structure that is dried and attached to 13, as seen in Figs. 1-2, this then allows the hydrogel to expand in-vivo later).
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 combination of Edmiston and Johnson to incorporate the teachings of Martinez and teach a medical device system with the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure. Motivation for such can be found in Martinez as this allows the tissue growth member to dry down to a smaller dimension than it is untreated, allowing it to fit more easily in a catheter (see [0032]) and additionally this can control the rate of expansion in vivo (see [0031]).
Claim 2
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. The combination of Edmiston and Johnson further teaches: wherein the filler material 62 (Johnson) is configured to fill the multiple voids (as combined the multiple voids of Edmiston is filled within the filler material 64 of Johnson as shown in Fig. 4B of Johnson resulting in the entire extent of the multiple voids of Edmiston, which includes the pores in outer layers 32 to be filled through completely, which includes the outer surface of the outer layer portions) defined along an outer surface outer surface of 32 (Edmiston, see Fig. 1B) of the outer layer portion 32 (Edmiston, see Fig. 1B).
Claim 3
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 2, see 103 rejection above. The combination of Edmiston and Johnson further teaches: wherein the filler material 62 (Johnson) is configured to fill the multiple voids (as combined the multiple voids of Edmiston is filled within the filler material 64 of Johnson as shown in Fig. 4B of Johnson resulting in the entire extent of the multiple voids of Edmiston, which includes the pores in outer layers 32 to be filled through completely, which includes the portions below the outer surface of the outer layer portion) defined in portions below the outer surface outer surface of 32 (Edmiston, see Fig. 1B) of the outer layer portion 32 (Edmiston, see Fig. 1B).
Claim 5
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. Johnson further teaches: wherein the filler material 64 comprises a bio- dissolvable material (see [0048], biodegrading).
Claim 6
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. Johnson further teaches: wherein the bio-dissolvable material 64 comprises a bio-absorbable material (see [0051], bio-absorbable).
Claim 7
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. Edmiston further discloses: wherein the outer layer portion 32 comprises multiple ePTFE layers 32a-c (see Fig. 1B, [0081], one or more layers of ePTFE material).
Claim 8
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. Edmiston further discloses: wherein the tissue growth member 28 comprises a polyurethane material (see Fig. 1B, 30 comprises polyurethane foam, 30 is a part of 28).
Claim 10
Edmiston discloses: A medical device 20 (see Figs. 4 and 8-11, [0091]) configured to be percutaneously delivered to a heart with a catheter 102 (see Fig. 4, [0091]) of a medical device delivery system 100 (see Fig. 4, [0091]), the medical device 20 comprising: a framework 24 + 26 (see Figs. 1-12, especially Fig. 2, [0079]) including a hub 54 (see Figs. 1-12, [0083]) with frame segments 24 + 26 extending radially (see Fig. 2, 24 and 26 extend radially from 54, [0083]) from the hub 54; and a tissue growth member 28 (see Figs. 1-12, [0079]) attached (see [0079], 24 has 28 attached to it) to the framework 24 + 26, the tissue growth member 28 extending radially (see Fig. 1A, 28 extends radially along 24) along the framework 24 + 26 such that the tissue growth member 28 extends to define an outer surface outer surface of 28 adjacent to 32a (see Figs. 1A-1B, [0081]) and an inner surface inner surface of 28 adjacent to 30 (see Figs. 1A-1B, [0081]), the framework 24 + 26 coupled (see Figs. 1A-1B, 30 is attached to the struts of 24) to the inner surface inner surface of 28 adjacent to 30 of the tissue growth member 28, the tissue growth member 28 extending with multiple voids porous characteristics of 30 and pores of 32a-c (see [0081] and [0082]) defined therein.
Edmiston does not explicitly disclose: the tissue growth member including a filler material configured to temporarily fill the multiple voids of the tissue growth member; wherein the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure.
However, Johnson in a similar field of invention teaches an intravascular occlusion device (see Figs. 3-4B) with a tissue growth member 60 (see Figs. 4A-4B) extending with multiple voids 62 (see Figs. 4A-4B). Johnson further teaches: the tissue growth member 60 including a filler material 64 (see Figs. 4A-4B, [0048]) configured to temporarily fill (see [0048], 64 is erodible, hence it temporarily fills pores 62) the multiple voids 62 of the tissue growth member 60.
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 Edmiston to incorporate the teachings of Johnson and have a medical device with the tissue growth member including a filler material configured to temporarily fill the multiple voids of the tissue growth member. Motivation for such can be found in Johnson as this allows for some nourishment to surrounding tissues, while initially providing a substantial barrier to flow and then allowing preferential eroding over time while keeping an upper limit to an increase in porosity (see [0048]).
The combination of Edmiston and Johnson does not explicitly teach: wherein the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure.
However, Martinez in a similar field of invention teaches a vasoocclusive device 10 (see Figs. 1-4) with a framework 13 (see Figs. 1-4) with a tissue growth material 12 (see Figs. 1-4, see [0023]-[0024], hydrogel with sufficient porosity to permit cellular ingrowth) and a filler material (see [0023], 12 impregnated, grafted, bound to deliver therapeutic compounds, proteins, etc.). Martinez further teaches: wherein the tissue growth member 12 and the filler material (see [0023], 12 impregnated, grafted, bound to deliver therapeutic compounds, proteins, etc.) comprise oxidation (see [0029], crosslinking of the monomer via reduction-oxidation, hence oxidation forms, and uses UV radiation as well) formed thereto; and wherein, upon attachment of the tissue growth member 12 to the framework 13 (see Figs. 1-2, 12 attached to 13), the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure (see [0029]-[0032], 12, the hydrogel with filler material which is oxidizes is a pre-formed solid structure that is dried and attached to 13, as seen in Figs. 1-2, this then allows the hydrogel to expand in-vivo later).
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 combination of Edmiston and Johnson to incorporate the teachings of Martinez and teach a medical device with the tissue growth member and the filler material comprise oxidation formed thereto; and wherein, upon attachment of the tissue growth member to the framework, the tissue growth member with the filler material and the oxidation formed thereto is a pre- formed solid structure. Motivation for such can be found in Martinez as this allows the tissue growth member to dry down to a smaller dimension than it is untreated, allowing it to fit more easily in a catheter (see [0032]) and additionally this can control the rate of expansion in vivo (see [0031]).
Claim 11
The combination of Edmiston, Johnson, and Martinez teaches: The medical device of claim 10, see 103 rejection above. The combination of Edmiston and Johnson further teaches: wherein the filler material 62 (Johnson) is configured to fill the multiple voids (as combined the multiple voids of Edmiston is filled within the filler material 64 of Johnson as shown in Fig. 4B of Johnson resulting in the entire extent of the multiple voids of Edmiston, which includes the pores in outer layers 32 to be filled through completely, which includes the outer surface of the outer layer portions) defined along the outer surface outer surface of 28 adjacent to 32a (Edmiston, see Fig. 1B) of the tissue growth member 28 (Edmiston, see Fig. 1B).
Claim 12
The combination of Edmiston, Johnson, and Martinez teaches: The medical device of claim 11, see 103 rejection above. The combination of Edmiston and Johnson further teaches: wherein the filler material 62 (Johnson) is configured to fill the multiple voids (as combined the multiple voids of Edmiston is filled within the filler material 64 of Johnson as shown in Fig. 4B of Johnson resulting in the entire extent of the multiple voids of Edmiston, which includes the pores in outer layers 32 to be filled through completely, which includes the portions below the outer surface of the outer layer portion) defined in portions below the outer surface outer surface of 28 adjacent to 32a (Edmiston, see Fig. 1B) of the tissue growth member 28 (Edmiston, see Fig. 1B).
Claim 14
The combination of Edmiston, Johnson, and Martinez teaches: The medical device of claim 10, see 103 rejection above. Johnson further teaches: wherein the filler material 64 comprises a bio- dissolvable material (see [0048], biodegrading).
Claim 19
The combination of Edmiston, Johnson, and Martinez teaches: The medical device system of claim 1, see 103 rejection above. Martinez further teaches: wherein the pre-formed solid structure 12 (see Figs. 1-4) comprises a hydrophilic structure (see [0036], hydrophilic hydrogel).
Claim 20
The combination of Edmiston, Johnson, and Martinez teaches: The medical device of claim 10, see 103 rejection above. Martinez further teaches: wherein the pre-formed solid structure 12 (see Figs. 1-4) comprises a hydrophilic structure (see [0036], hydrophilic hydrogel).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771