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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/19/2025 has been entered.
Claim Rejections - 35 USC § 112
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 7, 8, 17 and 18 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.
Claims 7 and 17 each recite “wherein the first material [of the septal closure membrane] comprises an ethylene acrylic acid copolymer”. This language renders it unclear whether (a) the claims are requiring the “ionomer” of claims 1 and 13 to be “ethylene acrylic acid copolymer” or (b) the “first material” to include both an “ionomer” and an “ethylene acrylic acid copolymer”. It is unclear from the Specification which is the intended interpretation. Therefore, for the sake of examination, claims 7 and 17 are interpreted as requiring either interpretation. If Applicant intends for (a) to be the interpretation applied to the claims, then it is suggested to amend this phrase to recite “wherein the ionomer of the first material [of the septal closure membrane] comprises an ethylene acrylic acid copolymer”; If Applicant intends for (b) to be the interpretation applied to the claims, then it is suggested to amend this phrase to recite “wherein the first material [of the septal closure membrane] additionally comprises an ethylene acrylic acid copolymer”.
Claims 8 and 18 each recite “wherein the second material [of the septal closure membrane] comprises at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer”. This language renders it unclear whether (a) the claims are requiring the “at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin” of claims 1 and 13 to be “at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer” or (b) the “second material” to include both “at least one of a thermoplastic elastomer, a thermoplastic polyurethane, and a thermoplastic olefin” and “at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer”. It is unclear from the Specification which is the intended interpretation. Therefore, for the sake of examination, claims 8 and 18 are interpreted as requiring either interpretation. If Applicant intends for (a) to be the interpretation applied to the claims, then it is suggested to amend this phrase to recite “wherein 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”; If Applicant intends for (b) to be the interpretation applied to the claims, then it is suggested to amend this phrase to recite “wherein the second material [of the septal closure membrane] additionally comprises at least one of a styrene-based thermoplastic elastomer and an olefin-based thermoplastic elastomer”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 8, 13-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schoenberg (PG PUB 2007/0233013).
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).
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 8, Schoenberg discloses that 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 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).
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 18, Schoenberg discloses that 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)”).
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 4-7, 9, 11, 12, 16, 17 and 19 are rejected under 35 U.S.C. 103 as being obvious over Schoenberg (PG PUB 2007/0233013).
Re claim 4, Schoenberg discloses all the claimed features but is silent as to the wt% of the lubricating addition in the portion which comprises it; therefore, Schoenberg does not 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 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 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 discloses all the claimed features but is silent as to the hardness of the first material; therefore, Schoenberg does not disclose that the first material has a Shore D hardness 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 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 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 discloses all the claimed features but is silent as to the tensile strength of the first material; therefore, Schoenberg 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 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 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 discloses all the claimed features except that 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 to include 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 to include 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 9, Schoenberg discloses all the claimed features but is silent as to the volume percentage of the first portion in the septal closure membrane; therefore, Schoenberg 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 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 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 11, the claimed phase “formed separately” is being treated as a product-by-process limitation and since 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, therefore, even though Schoenberg is silent as to the process used to make form the septal closure membrane, it appears that Schoenberg’s product would be the same or similar as that claimed, especially since both applicant’s product and the prior art product is 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.
Re claim 12, the claimed phase “formed integrally” is being treated as a product-by-process limitation and since 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, therefore, even though Schoenberg is silent as to the process used to make form the septal closure membrane, it appears that Schoenberg’s product would be the same or similar as that claimed, especially since both applicant’s product and the prior art product is 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.
Re claim 16, Schoenberg discloses all the claimed features but is silent as to the hardness of the first material of the septal closure membrane; therefore, Schoenberg does not disclose that the first material has a Shore D hardness 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 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 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 discloses all the claimed features except that 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 to include 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 to include 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 19, Schoenberg discloses all the claimed features but is silent as to the volume percentage of the first portion in the septal closure membrane; therefore, Schoenberg 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 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 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.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenberg (PG PUB 2007/0233013) in view of Webler et al. (PG PUB 2007/0167822).
Re claims 7 and 17, Schoenberg discloses all the claimed features except that 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
Claims 10 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Dependent claims 10 and 20 each require the septal closure membranes of claims 1 and 13, respectively, to include the first portion as an outer layer enclosing the second portion. As set forth above, Schoenberg discloses that the part of the membrane that comprises the first material is the “first portion” and the part of the membrane that comprises the second material is the “second portion”. However, Schoenberg does not disclose how these two materials are arranged relative to each other (that is, Schoenberg does not disclose if the two materials are mixed together throughout the membrane, alternate across or along the membrane, arranged laterally to each other, are arranged longitudinally to each other, if one surrounds the other, etc.). Because Schoenberg only discloses that the membrane can have both of these materials, but does not disclose how they would be arranged relative to each other, Schoenberg does not disclose or teach that the first portion is an outer layer enclosing the second portion. Additionally, a self-healing septal membrane having a first portion comprising an ionomer forming an outer layer that encloses a second portion comprising at least one of a thermoplastic elastomer, a thermoplastic polyurethane, or a thermoplastic olefin could not be found nor was suggested elsewhere in the prior art of record; absent a teaching to modify Schoenberg’s membrane to include the first portion as an outer layer enclosing the second portion, it would not have been obvious to one of ordinary skill in the art to make such a modification.
Response to Arguments
Applicant’s arguments filed 11/19/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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