DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenberg (PG PUB 2007/0233013) in view of Kreidemacher et al. (WO 2020/127135)1.
Re claim 1, Schoenberg discloses a septal closure membrane 115 (Fig 1B-1D) for a medical device (it is noted that the italicized text constitutes functional language and, therefore, a “medical device” is not a part of the claimed invention; this limitation is met in view of Para 39 that discloses that the device which the membrane 115 is a part of is a “tissue engaging device”) comprising: a first portion comprising a first material and a second portion comprising a second material (since the claims do not define the shape of the “portions” or the arrangement of the “portions” relative to each other or to the membrane as a whole, the “first portion” is interpreted as the part of the membrane that comprises the “first material” and the “second portion” is interpreted as the part of the membrane that comprises the “second material”; Para 18 discloses that the soft polymer body 115 can be formed by “one or more of” a variety of materials; the “more” comprises at least two materials), wherein the first material comprises an ionomer (Para 18, “ionomer), and wherein the second material comprises at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin (Para 18, “a styrene oligoblock copolymer (so-called TPE-S), a thermoplastic polyolefin (TPE-O), a thermoplastic polyurethane (TPE-U)”), wherein the first portion and the second portion are each solid portions (as seen in Fig 1B; Para 31), and wherein the septal closure membrane is a self-healing septal closure membrane (as seen in comparison of Fig 1C-1D; Para 31). Schoenberg does not explicitly disclose that the first portion covers at least a portion of the second portion.
Kreidemacher, however, teaches a septal closure membrane 1 (Fig 1) comprising a first portion 10 (Fig 1) comprising a first material (“surrounding material” – Page 4, Line 22 – Page 5, Line 1) covering a second portion 11 (Fig 1) (as seen in Fig 1; Page 9, Lines 6-8) comprising a second material (“core material” – Page 4, Line 22 – Page 5, Line 1) different from the first material (“the surrounding material is more rigid than the core material” – Page 5, Lines 1-3); Kreidemacher teaches that covering the second portion with the first portion provides the advantage of limiting the expansion of the septal closure membrane, thus ensuring a tight seal between the septal closure membrane and any element inserted therethrough (Page 5, Lines 4-12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Schoenberg to include the first and second portions such that the first portion covers the second portion, as taught by Kreidemacher, for the purpose of limiting the expansion of the septal closure membrane, thus ensuring a tight seal between the septal closure membrane and any element inserted therethrough (Page 5, Lines 4-12).
Re claim 2, Schoenberg disclose that at least one of the first material and the second material comprise a lubricating additive (Para 18, “PTFE” which is a known lubricating additive (see claim 3 below).
Re claim 3, Schoenberg discloses that the lubricating additive comprises at least one of boron nitride, polytetrafluoroethylene, wax, and mineral oil (Para 18, “PTFE”).
Re claim 4, Schoenberg as modified by Kreidemacher in the rejection of claim 1 discloses all the claimed features but both references are silent as to the wt% of the lubricating addition in the portion which comprises it; therefore, neither Schoenberg nor Kreidemacher disclose that the lubricating additive is 10 wt% of less of the portion which comprises it. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the lubricating addition in an amount that is 10 wt% or less of the portion which comprises it since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the lubricating additive in an amount that is 10 wt% or less of the portion which comprises it since Applicant has not disclosed that having such a wt% solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this wt%, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 5, Schoenberg as modified by Kreidemacher in the rejection of claim 1 disclose all the claimed features except that the first material has a Shore D hardness of 39-68. Kreidemacher, does teach that the first material is intended to be a harder material than the second material (Page 7, Lines 12-16), but does not teach that the hardness of the first material is a Shore D of 39-68. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the first material with a Shore D hardness of 39-68 since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the first material with a Shore D hardness of 39-68 since Applicant has not disclosed that having such a hardness solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this hardness, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 6, Schoenberg as modified by Kreidemacher in the rejection of claim 1 above discloses all the claimed features but both references are silent as to the tensile strength of the first material; therefore, Schoenberg as modified by Kreidemacher does not disclose that the first material has a tensile strength of 2.1 – 5.4 kpsi. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the first material with a tensile strength of 2.1 – 5.4 kpsi since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the first material with a tensile strength of 2.1 – 5.4 kpsi since Applicant has not disclosed that having such a tensile strength solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this tensile strength, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 7, Schoenberg as modified by Kreidemacher discloses all the claimed features except that the ionomer of the first material comprises an ethylene acrylic acid copolymer. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the ionomer of the first material such that it comprises an ethylene acrylic acid copolymer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the ionomer of the first material such that it comprises ethylene acrylic acid copolymer since Applicant has not disclosed that having this specific material solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this material, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. It is noted that this claim has also been rejected with art, as set forth below.
Re claim 8, Schoenberg discloses that the at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefine of the second material comprises at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer (Para 18, “a styrene oligoblock copolymer (so-called TPE-S), a thermoplastic polyolefin (TPE-O)”).
Re claim 9, Schoenberg as modified by Kreidemacher in the rejection of claim 1 above discloses all the claimed features but is silent as to the volume percentage of the first portion in the septal closure membrane; therefore, Schoenberg as modified by Kreidemacher does not disclose that the first portion comprises 25% or less of a volume of the septal closure membrane. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the first portion such that it comprises 25% or less of a volume of the septal closure membrane since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the first portion such that it comprises 25% or less of a volume of the septal closure membrane since Applicant has not disclosed that having such a volume percentage solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this volume percentage, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 10, Schoenberg as modified by Kreidemacher in the rejection of claim 1 discloses all the claimed features with Kreidemacher teaching the that the first portion is an outer layer enclosing the second portion (as seen in Fig 1; Page 9, Lines 6-8; Page 10, Lines 15-19). The motivation cited in the rejection of claim 1 also applies to this claim.
Re claim 11, Schoenberg as modified by Kreidemacher in the rejection of claim 1 discloses all the claimed features with Kreidemacher teaching that the first and second portions are formed separately (Page 9, Lines 6-10). Additionally, it is noted that the claimed phase “formed separately” is a product-by-process limitation and it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited; since both Applicant’s product and the prior art product are made of a first material comprising an ionomer and a second material comprising at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefine, it appears that Schoenberg/Kreidemacher’s product would be the same or similar as that claimed.
Re claim 12, Schoenberg as modified by Kreidemacher in the rejection of claim 1 disclose all the claimed features with Kreidemacher teaching that the first and second portions are formed integrally (Page 9, Lines 6-10). Additionally, it is noted that the claimed phase “formed integrally” is a product-by-process limitation and it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited; since both Applicant’s product and the prior art product are made of a first material comprising an ionomer and a second material comprising at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin, it appears that Schoenberg/Kreidemacher’s product would be the same or similar as that claimed.
Re claim 13, Schoenberg discloses a medical device 100+115 (seen in Fig 1A) comprising: a body 100 (Fig 1A) having a first end (to the right in Fig 1A) and a second end (to the left in Fig 1A), the body defining a passageway (between front side 102a and back side 102b, as seen in Fig 1A); a line connection 108 (Fig 1A; since 130 is a “tissue engaging member” for “sample collecting or delivery devices” (Para 13) and slot 108 connects the medical device 100+115 to the base 120 of the tissue engaging member 130, Para 29) positioned at the second end of the body (as seen in Fig 1A); and a septal closure membrane 115 (Fig 1A) positioned at the first end of the body (as seen in Fig 1A), the septal closure membrane comprising: a first portion comprising a first material and a second portion comprising a second material (since the claims do not define the shape of the “portions” or the arrangement of the “portions” relative to each other or to the membrane as a whole, the “first portion” is interpreted as the part of the membrane that comprises the “first material” and the “second portion” is interpreted as the part of the membrane that comprises the “second material”; Para 18 discloses that the soft polymer body 115 can be formed by “one or more of” a variety of materials; the “more” comprises at least two materials), wherein the first material comprises an ionomer (Para 18, “ionomer), and wherein the second material comprises at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin (Para 18, “a styrene oligoblock copolymer (so-called TPE-S), a thermoplastic polyolefin (TPE-O), a thermoplastic polyurethane (TPE-U)”), wherein the first portion and the second portion are each solid portions (as seen in Fig 1A; Para 31), and wherein the septal closure membrane is a self-healing septal closure membrane (as seen in comparison of Fig 1C and 1D; Para 31). Schoenberg does not explicitly disclose that the first portion covers at least a portion of the second portion.
Kreidemacher, however, teaches a septal closure membrane 1 (Fig 1) comprising a first portion 10 (Fig 1) comprising a first material (“surrounding material” – Page 4, Line 22 – Page 5, Line 1) covering a second portion 11 (Fig 1) (as seen in Fig 1; Page 9, Lines 6-8) comprising a second material (“core material” – Page 4, Line 22 – Page 5, Line 1) different from the first material (“the surrounding material is more rigid than the core material” – Page 5, Lines 1-3); Kreidemacher teaches that covering the second portion with the first portion provides the advantage of limiting the expansion of the septal closure membrane, thus ensuring a tight seal between the septal closure membrane and any element inserted therethrough (Page 5, Lines 4-12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Schoenberg to include the first and second portions such that the first portion covers the second portion, as taught by Kreidemacher, for the purpose of limiting the expansion of the septal closure membrane, thus ensuring a tight seal between the septal closure membrane and any element inserted therethrough (Page 5, Lines 4-12).
Re claim 14, Schoenberg discloses that the septal closure membrane is received in an opening (formed by the distal ends of front side 102a and back side 102b of cover 100, as seen in Fig 1A) defined by the body (as seen in Fig 1A).
Re claim 15, Schoenberg disclose that at least one of the first material and the second material of the septal closure membrane comprise a lubricating additive comprising at least one of boron nitride, polytetrafluoroethylene, wax, and/or mineral oil (Para 18, “PTFE”).
Re claim 16, Schoenberg as modified by Kreidemacher in the rejection of claim 13 disclose all the claimed features except that the first material has a Shore D hardness of 39-68. Kreidemacher does teach that the first material is intended to be a harder material than the second material (Page 7, Lines 12-16), but does not teach that the hardness of the first material is a Shore D of 39-68. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the first material with a Shore D hardness of 39-68 since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the first material with a Shore D hardness of 39-68 since Applicant has not disclosed that having such a hardness solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this hardness, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 17, Schoenberg as modified by Kreidemacher in the rejection of claim 13 discloses all the claimed features except that the ionomer of the first material of the septal closure membrane comprises an ethylene acrylic acid copolymer. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the ionomer of the first material such that it comprises an ethylene acrylic acid copolymer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the ionomer of the first material such that it comprises ethylene acrylic acid copolymer since Applicant has not disclosed that having this specific material solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this material, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. It is noted that this claim has also been rejected with art, as set forth below.
Re claim 18, Schoenberg discloses that the at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin of the second material of the septal closure membrane comprises at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer (Para 18, “a styrene oligoblock copolymer (so-called TPE-S), a thermoplastic polyolefin (TPE-O)”).
Re claim 19, Schoenberg as modified by Kreidemacher in the rejection of claim 13 discloses all the claimed features but is silent as to the volume percentage of the first portion in the septal closure membrane; therefore, Schoenberg as modified by Kreidemacher does not disclose that the first portion comprises 25% or less of a volume of the septal closure membrane. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Schoenberg/Kreidemacher to include the first portion such that it comprises 25% or less of a volume of the septal closure membrane since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been an obvious matter of design choice to modify Schoenberg/Kreidemacher to include the first portion such that it comprises 25% or less of a volume of the septal closure membrane since Applicant has not disclosed that having such a volume percentage solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs; Absent a teaching as to the criticality of this volume percentage, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Re claim 20, Schoenberg as modified by Kreidemacher in the rejection of claim 13 discloses all the claimed features with Kreidemacher teaching the that the first portion is an outer layer enclosing the second portion (as seen in Fig 1; Page 9, Lines 6-8; Page 10, Lines 15-19). The motivation cited in the rejection of claim 1 also applies to this claim.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenberg (PG PUB 2007/0233013)/Kreidemacher et al. (WO 2020/127135) in view of Webler et al. (PG PUB 2007/0167822).
Re claims 7 and 17, Schoenberg/Kreidemacher discloses all the claimed features except that the ionomer of the first material comprises an ethylene acrylic acid copolymer. Webler, however, teaches providing two materials, wherein one of the two materials includes an ethylene acrylic acid copolymer added thereto (Para 12) for the purpose of assuring a secure bond between the two materials (Para 12). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Schoenberg to include the first material with an ethylene acrylic acid copolymer, as taught by Webler, for the purpose of assuring the secure bonding of the two materials (Para 12).
Allowable Subject Matter
Although claims 10 and 20 were previously indicated as containing allowable subject matter, this is no longer the case in view of Applicant’s 7/21/2026 IDS that presented the newly-cited Kreidemacher et al. reference.
Response to Arguments
Applicant’s arguments filed 6/16/2026 have been considered but are moot in view of the above rejections that utilize the newly-cited Kreidemacher et al. reference (provided on the 7/21/2026 IDS) to teach a first material enclosing a second material of a septal closure membrane.
Conclusion
Applicant's amendment and submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 7/21/2026 prompted the new grounds of rejection presented in this Office Action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 A copy of which was provided by the Applicant with the 7/21/2026 IDS.
Prosecution Insights