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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/15/2025 has been entered.
Status of Claims
Claims 1-3, 5, 12-14, 16, 22-23, 25, 27, 31, 37-38, 42-43, 45, 54-55 and 61-64 are pending and currently under consideration for patentability.
Claims 10 and 13 are currently canceled.
Claims 1, 5, 14, 37-38, 43, 54, and 61-62 are currently amended.
Claims 63-64 are currently added.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5, 14, 37-38, 43, 54, and 61-62 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.
In response to the applicant’s argument that the Office fails to clearly communicate the findings, conclusions, and reasons for the claim rejections over at least Paulos. The examiner has taken these notes elaborated on the rejection to clarify details.
In response to the applicant that Paulos is not related to wounds. Paulos reaches a medical insert used for repair which would be considered a wound insert.
The applicant also argues the Office fails to clearly communicate the findings, conclusions, and reasons for the claim rejections over at least Kladakis. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claims 1, 2, 13, 14, 16, 22, 23, 27, 31, 37, 63, and 64 are patentable over Kladakis, Haaga, and Petrosenko. This rejection is amended to further clarify the rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 43, 45, 54, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Paulos (US 9179976 B2) in view of Petrosenko (US 7896856 B2).
Regarding Claim 43, Paulos teaches a method of manufacturing a medical insert(column 2, lines 8-20) comprising:
fabricating an inner core (11) of the wound insert from a slurry comprising one or more biopolymers, wherein the inner core is the slurry having a pH from about 3 to about 7 (column 11, lines 4-11), and the inner core being in the form of a rope or rod (figure 1B) (column 2, lines 8-20);
drying the inner core by heating or freeze drying the inner core (column 11, lines 21-25);
fabricating the outer layer (11 and 15) comprising a bioabsorbable polymer wherein the outer layer is shaped around the inner core (column 14, lines 18-29); and
has a wound-facing side and an opposite inner core-facing side (figure 1a and 1b); and
wherein: the wound insert is [[an]] in a shape comprising a cylinder, a sphere, a cube, a cuboid, a hexagonal prism, a cone, a square-based pyramid, triangular- based pyramid, or a triangular prism (column 15, lines 63-67);
the outer layer has a modulus of elasticity from about 0.5 MPa to about 5.0 MPa (column 11, lines 60-65); and
the inner core exhibits a lower modulus of elasticity than the outer layer (column 16, lines 64-column 17, line 3: elasticity may be reduced on inner core, 13)).
Paulos fails to teach forming through-holes through an entire width, height, and/or length of the wound insert, the through-holes being interconnected and configured to provide fluid pathways through the wound insert for the distribution of negative pressure to a wound In the same field of endeavor, namely wound inserts, Petrosenko teaches forming through-holes through an entire width, height, and/or length of the wound insert, the through-holes (138) being interconnected and configured to provide fluid pathways (claim 1 and 11) through the wound insert for the distribution of negative pressure to a wound (claim 1 and 11). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Paulos to add the through holes of Petrosenko in order to allow communication from intersecting conduits, (claim 1 and 11).
Regarding Claim 45, Paulos teaches the method of claim 43. Paulos further teaches wherein the slurry comprises one or more biopolymers comprising collagen (column 2, lines 8-20), oxidized cellulose, oxidized regenerated cellulose (ORC), polysaccharide, chitosan, hyaluronic acid, or a combination of any two or more thereof, and wherein the one or more biopolymers comprise about 10 wt. % to about 50 wt. % of the slurry based on the dry weight of the slurry (column 12, lines 21-30).
Regarding Claim 54, Paulos teaches the method of claim 43. Paulos further teaches wherein fabricating the outer layer comprises laminating a solid or mesh sheet of the bioabsorbable polymer around the inner core by forming a weld or joint including excess bioabsorbable polymer along the length of the wound insert. (column 14, lines 57-62)
Regarding Claim 55, Paulos teaches the method of claim 43. Paulos further teaches wherein fabricating the outer layer comprises forming a sheath comprising the bioabsorbable polymer (column 15, lines 44-54)and having a hollow center (figure 1B), wherein the inner core is inserted into the hollow center of the sheath column 2, lines 8-20).
Claims 1-2,13-14 16, 22, 23, 27, 31 and 37, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070031470 A1) in view of Haaga (US 5254105 A) in view of Petrosenko (US 7896856 B2).
Regarding Claim 1, Kladakis teaches a wound insert (scaffold) comprising: an outer layer comprising one or more bioabsorbable polymers (paragraph [0052]), wherein the outer layer has a modulus of elasticity of about 0.5 MPa to about 5.0 MPa (paragraph [0064]); and an inner core comprising a biopolymer, wherein the inner core has a lower modulus of elasticity than the outer layer (paragraphs [0052], [0065], [0069]) (claims 1-37).
Kladakis fails to explicitly teach the inner core having an elongated shape with a length greater than a width and/or height thereof and wherein the outer layer envelops the inner core and extends around the entire width and/or height of the inner core. Haaga teaches a wound insert having an elongated shape with a length greater than a width and/or height thereof (figure 1) and wherein the outer layer (83) envelops the inner core (84) and extends around the entire width and/or height of the inner core (column 8, lines 1-17) and having a wound- facing side and an opposite inner core-facing side (figure 1). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shape of Kladakis so the inner core having an elongated shape with a length greater than a width and/or height thereof and wherein the outer layer envelops the inner core and extends around the entire width and/or height of the inner core similar to Haaga so the wound insert may conform to the shape of the vessel (column 3, line 60- column 4, line 3)
Kladakis fails to teach forming through-holes through an entire width, height, and/or length of the wound insert, the through-holes being interconnected and configured to provide fluid pathways through the wound insert for the distribution of negative pressure to a wound In the same field of endeavor, namely wound inserts, Petrosenko teaches forming through-holes through an entire width, height, and/or length of the wound insert, the through-holes (138) being interconnected and configured to provide fluid pathways (claim 1 and 11) through the wound insert for the distribution of negative pressure to a wound (claim 1 and 11). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Kladakis to add the through holes of Petrosenko i in order to allow communication from intersecting conduits, (claim 1 and 11).
Regarding Claim 2, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. Kladakis further teaches wherein the outer layer has a modulus of elasticity of about 1.0 MPa to about 2.5 MPa (paragraph [0064]).
Regarding Claim 14, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. Kladakis fails to explicitly teach wherein the through-holes have a width and/or height of about 2 mm to about 8 mm. Kladakis teaches wherein the pore size can vary, but preferably, the pores are sized to allow tissue ingrowth. More preferably, the pore size is in the range of about 25 to 1000 microns, and even more preferably, in the range of about 50 to 500 microns (paragraph [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the through-holes have a width and/or height of about 2 mm to about 8 mm in order to fit the particular procedure being done since this claimed dimension of the pore size is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraph 0059 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 16, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. Kladakis further teaches wherein the one or more bioabsorbable polymers of the outer layer comprise polylactic acid (PLA), gelatin, polyglycolide, polycaprolactone, or a combination of any two or more thereof (paragraph [0065]), and wherein the one or more bioabsorbable polymers comprise about 0.01 wt.% to about 100 wt. % of the outer layer by weight of the outer layer (entire outer layer, claim 8).
Regarding Claim 22, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 16. Kladakis further teaches wherein the outer layer further comprises collagen (paragraph [0024]) however fails to explicitly teach wherein the collagen comprises about 0.001 wt. % to about 10 wt. % of the outer layer based on the weight of the outer layer. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kladakis in view of Haaga device to have a collagen weight within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kladakis in view of Haaga by making the collagen comprises about 0.001 wt. % to about 10 wt. % of the outer layer based on the weight of the outer layer as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 23, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 16. Kladakis further teaches wherein the outer layer further comprises one or more functional agents, wherein the one or more functional agents comprises antimicrobial agents (paragraph [0027]), growth factors, peptides, antioxidants , or combinations of any two or more thereof. Kladakis however fails to explicitly teach wherein the one or more functional agents comprise about 0.001 wt. % to about 5 wt. % of the outer layer based on the weight of the outer layer Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kladakis in view of Haaga device to have a collagen weight within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kladakis in view of Haaga by making the collagen comprises about 0.001 wt. % to about 5 wt. % of the outer layer based on the weight of the outer layer as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 27, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. Kladakis further teaches wherein the biopolymer of the inner core comprises collagen (paragraph [0024]), an oxidized cellulose (paragraph [0010]), an oxidized regenerated cellulose (ORC), a polysaccharide (paragraph [0022]), a chitosan, hyaluronic acid, or a combination of any two or more thereof (paragraph [0022]), however fails to explicitly teach wherein the biopolymer comprises about 10 wt. % to about 50 wt. % of the inner core based on the weight of the inner core. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Kladakis in view of Haaga device to have a collagen weight within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Kladakis in view of Haaga by making the biopolymer comprises about 10 wt. % to about 50 wt. % of the inner core based on the weight of the inner core as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 37, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1.
Haaga teaches wherein an entire exterior surface of the inner core is adjoined with the inner core-facing side of the outer layer, and wherein the inner core conforms to and fills an entire interior region of the wound insert defined by the inner core-facing side of the outer layer(column 8, lines 1-17) (figure 1). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the implant of Kladakis similar to Haaga so the wound insert may conform to the shape of the vessel (column 3, line 60- column 4, line 3).
However both Kladakis and Haaga do not teach such nonwoven materials can be formed from webs of previously prepared/formed fibers, filaments, or films processed into arranged networks of a desired structure (paragraph [0047]). Radisic teaches a tissue scaffold wherein the tissue scaffold of the invention is in the form of a sheet, a graft, a bead, a wafer, a chip, a disc, a tube, a cylinder or a cone (paragraph [0029]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Kladakis the inner core is in the form of a rope or rod, wherein the rope and/or rod conforms to the overall shape of the wound insert, similar to Radisic, so that the scaffold may fit best into the intended area.
Regarding Claim 63, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. The combination further teaches wherein the outer layer of the wound insert is configured to be applied to directly to a wound (Haaga, figure 3).
Regarding Claim 64, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 37. Kladakis further teaches wherein the outer layer has a thickness defined between the wound-facing side and the inner-core facing side thereof, wherein the outer layer of the wound insert comprises perforations extending through the entire thickness thereof (paragraph [0066]), wherein the perforations have a width and/or height of about 0.1 micrometer to about 100 micrometers (paragraph [0066]), and wherein the perforations are configured to facilitate tissue integration (paragraph [0061]).
Claims 3, 5, 10 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070031470 A1) in view of Haaga (US 5254105 A) in view of Petrosenko (US 7896856 B2) in view of Radisic (US 20190328824 A).
Regarding Claim 3, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. Kladakis fails to explicitly teach wherein the wound insert is in a shape of a cylinder, a cylinder with at least one rounded edge, a cuboid, or a cuboid with at least one rounded edge. However Kladakis does teach such nonwoven materials can be formed from webs of previously prepared/formed fibers, filaments, or films processed into arranged networks of a desired structure (paragraph [0047]).
Radisic teaches a tissue scaffold wherein the tissue scaffold of the invention is in the form of a sheet, a graft, a bead, a wafer, a chip, a disc, a tube, a cylinder or a cone (paragraph [0029]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Kladakis so the wound insert is in a shape of a cylinder, a cylinder with at least one rounded edge, a cuboid, or a cuboid with at least one rounded edge, similar to Radisic, so that the scaffold may fit best into the intended area.
Regarding Claim 5, Kladakis in view of Radisic teaches the wound insert of claim 3. Kladakis further teaches, wherein the outer layer has a thickness defined between a wound-facing side and an opposite inner-core facing side thereof of about 20 pm to about 1.5 mm (paragraph [0012]).
Kladakis fails to explicitly teach, wherein the wound insert has a width and/or height of about 0.1 cm to about 3 cm and a length of about 1 cm to about 10 cm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the wound insert has a width and/or height of about 0.1 cm to about 3 cm and a length of about 1 cm to about 10 cm in order to fit the particular procedure being done since this claimed dimension of the length and width is noncritical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0056 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 62, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 5. Kladakis fails to explicitly teach wherein the width and/or height of the wound insert is about 0.3 cm to about 1.5 cm, the thickness of the outer layer is about 50 pm to about 1 mm, and the width and/or height of the inner core is about 2.95 mm to about 1.4 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the width and/or height of the wound insert is about 0.3 cm to about 1.5 cm, the thickness of the outer layer is about 50 pm to about 1 mm, and the width and/or height of the inner core is about 2.95 mm to about 1.4 cm. since this claimed dimension of the noncritical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0026 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
For example, the ranges are discussed as “may be” or “about” in the claimed ranges in [0026])."
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070031470 A1) in view of Haaga (US 5254105 A) in view of Petrosenko (US 7896856 B2) in view of Carter (US 20150374878 A1).
Regarding Claim 25, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 16. Kladakis fails to explicitly teach wherein the outer layer further comprises one or more plasticizers, the one or more plasticizers comprise glycerin, polyethylene oxide, or a combination thereof, and wherein the one or more plasticizers comprise about 1 wt.% to about 20 wt. % of the outer layer based on the weight of the outer layer.
Carter teaches a temporary scaffold for the in-growth of cells wherein the outer layer further comprises one or more plasticizers, the one or more plasticizers comprise glycerin, polyethylene oxide, or a combination thereof, and wherein the one or more plasticizers comprise about 1 wt.% to about 20 wt. % of the outer layer based on the weight of the outer layer (paragraph [0043]).
Carter utilizes a plasticizer to increase flexibility ([0043]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer layer of Kladakis to include a plasticizer similar to Carter in order to increased flexibility.
Claims 38 and 63 re rejected under 35 U.S.C. 103 as being unpatentable over Kladakis (US 20070031470 A1) in view of Haaga (US 5254105 A) in view of Petrosenko (US 7896856 B2) in view of Lambert (US 20130017227 A1).
Regarding Claim 38, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. However fails to teach a method for treating a wound in a subject in need thereof, the method comprising administering directly to the wound the wound insert of claim 1; and then administering negative pressure to the wound, wherein the wound is a tunneling wound.
In a similar field of endeavor Lambert teaches a method for treating a wound in a subject in need thereof (paragraph [0076]), the method comprising administering directly to the wound a wound insert, wherein the wound is a tunneling wound (paragraph [0092]).
Lambert provides wound inserts that are also applicable to tunnel wound ([0092]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Kladakis so the wound is a tunneling wound similar to Lambert.
Regarding Claim 63, Kladakis in view of Haaga and Petrosenko teaches the wound insert of claim 1. However fails to teach wherein the outer layer of the wound insert is configured to be applied to directly to a wound.
In a similar field of endeavor Lambert teaches a method for treating a wound in a subject in need thereof (paragraph [0076]), the method comprising administering directly to the wound a wound insert, wherein the wound is a tunneling wound (paragraph [0092]).
Lambert provides wound inserts that are also applicable to tunnel wound ([0092]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the wound insert of Kladakis so the wound is a tunneling wound similar to Lambert.
Claims 61 is rejected under 35 U.S.C. 103 as being unpatentable over Paulos (US 9179976 B2) in view of Petrosenko (US 7896856 B2) in view of Haaga (US 5254105 A).
Regarding Claim 61, Kladakis teaches the method of claim 43. Paulos fails to explicitly teach wherein the outer layer is shaped around the inner core such an entire exterior surface of the inner core is adjoined with the inner core-facing side of the outer layer, and the inner core conforms to and fills an entire interior region of the wound insert defined by the inner core-facing side of the outer layer.
Haaga teaches wherein the outer layer is shaped around the inner core (84) such that the outer layer (83) has a wound-facing side and an opposite inner core-facing side (figure 1), an entire exterior surface of the inner core is adjoined with the inner core-facing side of the outer layer (figure 1), and the inner core conforms to and fills an entire interior region of the wound insert defined by the inner core-facing side of the outer layer core (column 8, lines 1-17) (figure 1).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the implant of Paulos similar to Haaga so the wound insert may conform to the shape of the vessel (column 3, line 60- column 4, line 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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