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 .
Information Disclosure Statement
The information disclosure statement filed 06/15/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 2-11, 13-18, and 20 are objected to because of the following informalities:
Regarding claims 2-11, 13-18, and 20, “Claim” in line 1 of each claim, should read, “claim”.
Regarding claim 4, “where the...” in line 1 of claim 4, should read, “wherein the…”.
Regarding claim 6, “comprising…” in line 1 of claim 6, should read, “further comprising…”.
Regarding claim 16, “comprising…” in line 1 of claim 16, should read, “further comprising…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christensen (US 20090177184 A1).
Regarding claim 1, Christensen discloses a system (As set forth in the abstract, [0003], and [0070]-[0075], including FIG. 1A device 100 as set forth in [0062]) for applying a lifting force to a tissue site of a patient (FIG. 1A The sealing element 140 is formed on a portion of the opening 112 and adapted to seal the portion of the extremity 130 when placed inside the internal region 113 of the body element 110 to allow a pressure to be applied to the extremity 130 and the device allows a vacuum to supply force on the extremity 130 as set forth in [0071]), the system comprising: an occlusive layer (FIG.1A Body element 110 as set forth in [0070]-[0071]) configured to define a substantially air-tight chamber around a tissue site when sealed to a patient (FIG. 1A The sealing element 140 is formed on a portion of the opening 112 and adapted to seal the portion of the extremity 130 when placed inside the internal region 113 of the body element 110 to allow a pressure to be applied to the extremity 130 as set forth in [0071]); an air displacement device (FIG. 1A Pump 163 as set forth in [0072]) fluidly coupled the chamber and operable to remove air from the chamber (FIG. 1A The pressurized volume defined by the body element 110 and sealing element 140 is formed by applying a negative pressure to the pressure port 116, which can be connected to a pump 163, for reducing the pressure of the internal region 113 inside the device 100 as set forth in [0072]); a sealing strip configured to seal the occlusive layer to the patient (FIG. 1A The pressurized volume defined by the body element 110 and sealing element 140 is formed by applying a negative pressure to the pressure port 116, which can be connected to a pump 163, for reducing the pressure of the internal region 113 inside the device 100 as set forth in [0071]), the sealing strip comprising a thermoplastic elastomer (FIG. 1A The sealing element 140 can be made of thermoplastic polyurethane as set forth in [0071]), wherein the thermoplastic elastomer is configured to provide a non-adhesive tack and a seal between the sealing strip and the patient (As set forth in [0075]; The sealing element 140 may comprise a releasable adhesive material with high initial adhesion and a low adhesive removal force so that the sealing element 140 does not pull off hair or skin and create pain when it is removed; the ability of the sealing element to be removed without pulling hair or causing pain indicating a non-adhesive tack. Examiners Note: A “non-adhesive tack” is being interpreted to mean a connection that doesn’t result in difficult removal or residue, wherein an “adhesive tack” would be one where removal is difficult and a residue is left).
Regarding claim 2, Christensen discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Christensen further discloses, wherein the thermoplastic elastomer is further configured to be hypoallergenic (The sealing materials may be manufactured and packaged such that they are sterile before use and/or hypoallergenic to meet health and safety requirements as set forth in [0071]).
Regarding claim 3, Christensen discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Christensen further discloses, wherein the thermoplastic elastomer is self-adhesive (FIG. 1 The releasable adhesive material may be any of a wide variety of commercially available materials with high initial adhesion and a low adhesive removal force so that the sealing element 140 does not pull off hair or skin and create pain when it is removed as set forth in [0075]; the adhesive nature of the sealing element would mean it can adhere to itself in a “self-adhesive” manner).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen (US 20090177184 A1) as applied to claim 1, in view of St. Anne (US 20160022399 A1).
Regarding claim 4, Christensen discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Christensen fails to explicitly disclose, wherein the thermoplastic elastomer comprises a blend of styrene block copolymer and mineral oil.
However, St. Anne teaches, wherein the material being adhered to a patient comprises a blend of styrene block copolymer (St. Anne: The adhesive layer can also include a styrene block copolymer as set forth in [0068]) and mineral oil (St. Anne: As set forth in [0076]).
Christensen and St. Anne are both considered to be analogous to the claimed invention because they are in the same field of medical applications involving an adhesive for use on patient skin. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealing strip of Christensen, specifically the adhesive portion of the thermoplastic elastomer, to incorporate the teaching of St. Anne and include, wherein the material being adhered to the patient comprises a blend of styrene block copolymer (St. Anne: The adhesive layer can also include a styrene block copolymer as set forth in [0068]) and mineral oil (St. Anne: As set forth in [0076]). Dong so would ensure the adhesive can easily be removed when stretched due to the high shear strength that provides a low debonding force in reference to the use of a styrene block copolymer (St. Anne: As set forth in [0068]), and the adhesive inactivation caused by the presence of mineral oil (St. Anne: As set forth in [0076]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Christensen (US 20090177184 A1) as applied to claim 1.
Regarding claim 5, Christensen discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Christensen fails to explicitly disclose, wherein the thermoplastic elastomer comprises: a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the thermoplastic elastomer have a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2 in the device of Christensen because Applicant has not disclosed that the specific hardness or tensile strength provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [0004] that the sealing strip is configured to seal the occlusive layer to the patient in a substantially airtight fashion, which would be true for any hardness or tensile strength that allows for the sealing strip to create an air-tight chamber in combination with the occlusive layer. One of ordinary skill in the art, furthermore, would have expected the hardness and tensile strength of Christensen, and Applicant' s hardness and tensile strength, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Christensen to obtain the invention as specified in claim 5, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Christensen.
Claims 1, 6, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph (US 20140276288 A1) in view of Elderstiern (US 20190099321 A1).
Regarding claim 1, Randolph discloses a system (As set forth in abstract and [0002]; FIG. 1 Therapy system 100 as set forth in [0027]) for applying a lifting force to a tissue site of a patient (FIG. 1-2 the sleeve 112 initially collapses against the intact skin surrounding the tissue site 104 and provides a certain amount of stiffening that functions like a splint to stabilize the tissue site 104 as set forth in [0057]), the system comprising: an occlusive layer (FIG. 1 Sleeve 112 as set forth in [0035]) configured to define a substantially air-tight chamber around a tissue site when sealed to a patient (FIG. 1-2 Sleeve 112 enclosing the manifold 110 within the chamber 101 proximate the intact skin to provide an airtight sea as set forth in [0035]); an air displacement device (FIG. 1-2 Vacuum source 106 as set forth in [0027) fluidly coupled the chamber and operable to remove air from the chamber (FIG. 1-2 Vacuum source 106 controls the airflow being delivered to the dressing 102 to achieve the desired vacuum therapy as set forth in [0027]); a sealing strip configured to seal the occlusive layer to the patient (FIG. 1-2 Attachment devices 113 may be used at each end of the sleeve 112 to enhance the sealing capability of the sleeve 112 to provide an airtight seal within the chamber 101 as set forth in [0042]), the sealing strip comprising an elastomer (The sleeve may be an elastomeric material as set forth in [0008]), wherein the elastomer is configured to provide a non-adhesive tack and a seal between the sealing strip and the patient (FIG. 1 The attachment devices 113 may be a gasket, or another sealing member as set forth in [0046], which would not require adhesive).
Randolph fails to explicitly disclose wherein the elastomer is a thermoplastic elastomer.
However, Elderstiern teaches wherein the elastomer is a thermoplastic elastomer (Elderstiern: As set forth in [0139]).
Randolph and Elderstiern are both considered to be analogous to the claimed invention because they are in the same field of medical pressure therapy devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Randolph to incorporate the teaching of Elderstiern and include wherein the elastomer is a thermoplastic elastomer (Elderstiern: As set forth in [0139]). Doing so would ensure the material affixes firmly about the limb of a user without leaving indentations or marks (Elderstiern: As set forth in [0139]).
Regarding claim 6, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Randolph as modified further discloses the system, further comprising a decompression layer (FIG. 1-2 Manifold 110 as set forth in [0035]) coupled to the occlusive layer such that the decompression layer is disposed within the chamber when the occlusive layer is sealed to the patient (FIG. 1-2 Dressing 102 comprises a manifold 110 adapted to contact the intact skin surrounding the tissue site 104, a sleeve 112 enclosing the manifold 110 within the chamber 101 proximate the intact skin to provide an airtight seal as set forth in [0035]), wherein the decompression layer is configured to compress in a direction away from the tissue site and toward the occlusive layer when the air displacement device operates to remove air from the chamber (FIG. 1-2 When the vacuum evacuates most of the air from the chamber 101 so that the sleeve 112 is fully collapsed and the manifold 110 is compressed, the vacuum then begins to pull the intact skin radially outwardly as described above and shown in FIG. 2 as set forth in [0058]).
Regarding claim 8, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Randolph as modified further discloses, wherein the occlusive layer forms an annular structure (FIG. 1-2 Sleeve 112 surrounds the limb/tissue sight in an annular fashion as most readily seen in FIG. 2) having a first open end (FIG. 1 The end of the sleeve 112, located on the calf portion of the patient as shown in FIG. 1, with attachment device 113) and the sealing strip is formed as a ring positioned at the first open end (As shown in FIG. 1-2, and as set forth in [0046], attachment device 113 surrounds sleeve 112, which is substantially formed as a ring around the patient’s calf).
Regarding claim 9, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Randolph as modified fails to explicitly disclose, wherein the sealing strip is configured to exert a pressure on a limb of the patient extending through the ring, wherein the pressure is in a range between 20 mmHg and 32 mmHg.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the thermoplastic elastomer have a pressure is in a range between 20 mmHg and 32 mmHg in the device of Randolph as modified because Applicant has not disclosed that the specific pressure, is used for a particular purpose, or solves a stated problem apart from ensuring the patient’s blood circulation is not closed off, and that a proper seal is formed. Specifically, the specification states in [0095] that providing pressure above approximately 20 mm Hg may ensure a sufficient seal between the sealing ring and the tissue, while keeping the pressure below approximately 32 mmHg may prevent or reduce ligation. However, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art. In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the pressure applied by the sealing strip of Randolph, and Applicant' s pressure, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Randolph to obtain the invention as specified in claim 9, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Randolph.
Regarding claim 10, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Randolph as modified further discloses, the annular structure defining a sleeve-like structure that further comprises a second open end, further comprising an additional sealing strip positioned at the second open end (FIG. 1 The end of the sleeve 112 located near the foot/toe portion of the patient as shown in FIG. 1, with attachment second attachment device 113).
Regarding claim 11, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Randolph as modified further discloses, wherein the annular structure has a boot-like configuration (FIG. 1 Shows the dressing 102 of therapy system 100 surrounding the ankle portion of a foot 103 as set forth in [0025], in a boot-like configuration defined by the way the dressing extends from the calf/ankle portion to the foot portion of the patient).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Randolph (US 20140276288 A1) in view of Elderstiern (US 20190099321 A1) as applied to claim 6, in further view of Brown (US 20140257154 A1).
Regarding claim 7, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Randolph as modified fails to explicitly disclose, wherein the decompression layer comprises a macro-mesh material.
However, Brown teaches wherein a layer contacting the patient’s skin comprises a macro-mesh material (Brown: Referring to FIGS. 1, 2, 4, and 5, The inner layers 13 can be made of a polyester mesh fabric as set forth in [0076]).
Randolph and Brown are both considered to be analogous to the claimed invention because they are in the same field of medical applications involving a garment in contact with patient skin. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the decompression layer of Randolph to incorporate the teaching of Brown and include wherein the layer contacting the patient’s skin comprises a macro-mesh material (Brown: Referring to FIGS. 1, 2, 4, and 5, The inner layers 13 can be made of a polyester mesh fabric as set forth in [0074]). Doing so would ensure the material is capable of wicking moisture away from a wearer's skin (Brown: As set forth in [0074]).
Claims 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Randolph (US 20140276288 A1) in view of Christensen (US 20090177184 A1).
Regarding claim 12, Randolph discloses a method for providing decompression therapy (As set forth in abstract and [0002]; FIG. 1 Therapy system 100 as set forth in [0027]), comprising: positioning an occlusive layer of a dressing over a tissue site of a patient (FIG. 1-2 Sleeve 112 enclosing the manifold 110 within the chamber 101 proximate the intact skin to provide an airtight sea as set forth in [0035]) by stretching a sealing strip coupled to the occlusive layer; sealing an edge of the occlusive layer to the patient (FIG. 1-2 The attachment devices 113 may be an elastic tape wrapped around each end of the sleeve 112 against the epidermis 103 (not shown) to provide an airtight seal within the chamber 101 as set forth in [0046]), the sealing strip providing a seal, thereby defining a chamber between the occlusive layer and the tissue site (FIG. 1 Chamber 101 as set forth in [0027]); operating an air displacement device fluidly coupled to the chamber to evacuate air from the chamber (FIG. 1-2 Vacuum source 106 controls the airflow being delivered to the dressing 102 to achieve the desired vacuum therapy as set forth in [0027]); wherein the evacuation of air from the chamber pulls intact skin in a direction outward relative to the tissue site (FIG. 1-2 When the vacuum evacuates most of the air from the chamber 101 so that the sleeve 112 is fully collapsed and the manifold 110 is compressed, the vacuum then begins to pull the intact skin radially outwardly as described above and shown in FIG. 2 as set forth in [0058]).
Fails to explicitly disclose the sealing strip will accommodate movement of the tissue site relative to the sealing strip and the occlusive layer, wherein the sealing strip will rebound into contact with the tissue site at the edge of the occlusive layer.
However, given the elastic nature of the sealing strip (FIG. 1-2 The attachment devices 113 may be an elastic tape wrapped around each end of the sleeve 112 against the epidermis 103 (not shown) to provide a better airtight seal within the chamber 101), it would be obvious to one of ordinary skill in the art that the elasticity of the strip would accommodate movement of the tissue site relative to the sealing strip and the occlusive layer, wherein the sealing strip will rebound into contact with the tissue site at the edge of the occlusive layer, in other words, the elastic tape would maintain contact with the tissue. The elastic behavior present in elastic tape is well-known to one of ordinary skill in the art.
Randolph as modified fails to explicitly wherein the sealing strip providing a non-adhesive tack.
However, Christensen teaches, wherein the sealing strip provides a non-adhesive tack (Christensen: As set forth in [0075]; The sealing element 140 may comprise a releasable adhesive material with high initial adhesion and a low adhesive removal force so that the sealing element 140 does not pull off hair or skin and create pain when it is removed; the ability of the sealing element to be removed without pulling hair or causing pain indicating a non-adhesive tack. Examiners Note: A “non-adhesive tack” is being interpreted to mean a connection that doesn’t result in difficult removal or residue, wherein an “adhesive tack” would be one where removal is difficult and a residue is left).
Randolph and Christensen are both considered to be analogous to the claimed invention because they are in the same field of medical pressure therapy devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Randolph to incorporate the teaching of Christensen and include wherein the sealing strip provides a non-adhesive tack (Christensen: As set forth in [0075]; The sealing element 140 may comprise a releasable adhesive material with high initial adhesion and a low adhesive removal force so that the sealing element 140 does not pull off hair or skin and create pain when it is removed; the ability of the sealing element to be removed without pulling hair or causing pain indicating a non-adhesive tack. Examiners Note: A “non-adhesive tack” is being interpreted to mean a connection that doesn’t result in difficult removal or residue, wherein an “adhesive tack” would be one where removal is difficult and a residue is left). Doing so would ensure the ability of the sealing strip to be removed without pulling hair or causing pain (Christensen: As set forth in [0075]).
Regarding claim 13, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Randolph as modified further discloses, wherein the tissue site is a location corresponding to a sprained tissue and a strained tissue (As set forth in [0002]), and wherein the evacuation of air from the chamber reduces swelling at the tissue site (As set forth in [0062]) from a first degree of swelling (The amount of swelling prior to use of the therapy system 100) to a second degree of swelling (The amount of swelling after use of the therapy system 100, which has been reduced as set forth in [0062]).
Randolph does not explicitly disclose, wherein the tissue site corresponds to the location of a broken bone. However, it would be obvious to one of ordinary skill in the art that the device, capable of managing pain by reducing swelling and inflammation, and accelerating healing by increasing blood flow and lymph flow (As set forth in [0062]), could also be applied to a broken bone.
Regarding claim 14, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Randolph as modified further discloses, wherein positioning the occlusive layer over the tissue site further comprises inserting an extremity of the patient comprising the tissue site (FIG. 1 The sleeve 112 is molded as a single component in a generally tubular shape formed from the sealing material described above that is stretched over the affected limb and pulled over the manifold 110 to the tissue site 104 as set forth in [0045]) into a first open end of an annular structure formed by the occlusive layer (FIG. 1 The end of the sleeve 112, located on the calf portion of the patient as shown in FIG. 1, with attachment device 113; in order to be stretch over the affected limb as shown in FIG. 1, the extremity would have to be inserted through the open end of an annular structure formed by the occlusive layer).
Regarding claim 15, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 14 above.
Randolph as modified fails to explicitly disclose, wherein allowing the sealing strip to rebound into contact with the tissue site comprises positioning the sealing strip around the extremity such that the sealing strip exerts a pressure in a range between 20 mmHg and 32 mmHg on the extremity.
However, However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the thermoplastic elastomer have a pressure is in a range between 20 mmHg and 32 mmHg in the device of Randolph as modified because Applicant has not disclosed that the specific pressure, is used for a particular purpose, or solves a stated problem apart from ensuring the patient’s blood circulation is not closed off, and that a proper seal is formed. Specifically, the specification states in [0095] that providing pressure above approximately 20 mm Hg may ensure a sufficient seal between the sealing ring and the tissue, while keeping the pressure below approximately 32 mmHg may prevent or reduce ligation. However, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art. In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the pressure applied by the sealing strip of Randolph, and Applicant' s pressure, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Randolph to obtain the invention as specified in claim 15, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Randolph.
Regarding claim 16, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Randolph as modified is silent as to the removal of the device and fails to explicitly disclose, wherein removing the occlusive layer from the tissue site is by stretching the sealing strip coupled to the occlusive layer to accommodate movement of the tissue site relative to the sealing strip and the occlusive layer.
However, given that the occlusive layer of Randolph is a generally tubular shape (As set forth in [0045]), and that in order to be put on, the occlusive layer has to be stretched over the affected limb and the extremity would have to be inserted through the open end of an annular structure formed by the occlusive layer, including the sealing strip (As shown in FIG. 1), it would be obvious that in order to remove the device the sealing strip would have to be stretched and widened to accommodate movement of the tissue site relative to the sealing strip and the occlusive layer.
Regarding claim 17, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 16 above.
Randolph as modified fails to explicitly disclose cleaning the sealing strip; and repositioning the occlusive layer over the tissue site.
However, given that the elastic nature of the sealing strip (FIG. 1-2 The attachment devices 113 may be an elastic tape wrapped around each end of the sleeve 112 against the epidermis 103 (not shown) to provide a better airtight seal within the chamber 101), it would be obvious to one of ordinary skill in the art that you would be able to clean the sealing strip for sanitation purposes by pulling it away from the tissue, possible due to its elasticity, and repositioning the occlusive layer over the tissue site.
Regarding claim 18, Randolph as modified discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Randolph as modified fails to explicitly disclose 18, wherein the sealing strip comprises a thermoplastic elastomer having properties comprising: a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the material of the sealing strip comprise a thermoplastic elastomer with have a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2 in the device of Randolph because Applicant has not disclosed that the specific material, hardness, or tensile strength provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [0004] that the sealing strip is configured to seal the occlusive layer to the patient in a substantially airtight fashion, which would be true for any hardness or tensile strength that allows for the sealing strip to create an air-tight chamber in combination with the occlusive layer. One of ordinary skill in the art, furthermore, would have expected the material, hardness, and tensile strength of Randolph, and Applicant' s material, hardness, and tensile strength, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Randolph to obtain the invention as specified in claim 18, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Randolph.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen (US 20090177184 A1).
Regarding claim 19, Christensen discloses sealing ring (FIG. 1A The sealing element 140) for use with an annular dressing (FIG.1A Body element 110 as set forth in [0070]-[0071]; annular in the way it surrounds and encloses a portion of the extremity 130 as set forth in [0069]), comprising: a thermoplastic elastomer (FIG. 1A The sealing element 140 can be made of thermoplastic polyurethane as set forth in [0071]) formed in a ring (FIG. 1A The sealing element 140 is configured to wrap around extremity 130, which means the sealing element will be shaped in a ring while sealing the body element 110 to the patient, as shown in FIG. 1A)
Christensen fails to explicitly disclose wherein the thermoplastic elastomer has a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the thermoplastic elastomer have a hardness in a range between 20 and 60 Shore 000; and a tensile strength in a range between 9 and 19 lbs/inch2 in the device of Christensen because Applicant has not disclosed that the specific hardness or tensile strength provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [0004] that the sealing strip is configured to seal the occlusive layer to the patient in a substantially airtight fashion, which would be true for any hardness or tensile strength that allows for the sealing strip to create an air-tight chamber in combination with the occlusive layer. One of ordinary skill in the art, furthermore, would have expected the hardness and tensile strength of Christensen, and Applicant' s hardness and tensile strength, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Christensen to obtain the invention as specified in claim 19, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Christensen.
Christensen fails to explicitly disclose wherein the thermoplastic elastomer has wherein the ring is configured to contract to exert a pressure greater than 20 mmHg and less than 32 mmHg on an extremity of a patient inserted through the ring.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the thermoplastic elastomer have a pressure is in a range between 20 mmHg and 32 mmHg in the device of Christensen as modified because Applicant has not disclosed that the specific pressure, is used for a particular purpose, or solves a stated problem apart from ensuring the patient’s blood circulation is not closed off, and that a proper seal is formed. Specifically, the specification states in [0095] that providing pressure above approximately 20 mm Hg may ensure a sufficient seal between the sealing ring and the tissue while keeping the pressure below approximately 32 mmHg may prevent or reduce ligation. However, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art. In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected the pressure applied by the sealing strip of Christensen, and Applicant' s pressure, to perform equally well because both mechanisms perform the same function of ensuring a seal is formed between the occlusive layer and the patient in a substantially airtight fashion.
Therefore, it would have been prima facie obvious to further modify Christensen to obtain the invention as specified in claim 9, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired seal and thus fails to patentably distinguish over the prior art of Christensen.
Regarding claim 20, Christensen as modified discloses the claimed invention substantially as claimed as set forth for claim 19 above.
Christensen as modified further discloses, wherein the thermoplastic elastomer is self-adhesive and is configured to provide a non-adhesive tack between the thermoplastic elastomer and skin of the patient (As set forth in [0075]; The sealing element 140 may comprise a releasable adhesive material with high initial adhesion and a low adhesive removal force so that the sealing element 140 does not pull off hair or skin and create pain when it is removed; the ability of the sealing element to be removed without pulling hair or causing pain indicating a non-adhesive tack. Examiners Note: A “non-adhesive tack” is being interpreted to mean a connection that doesn’t result in difficult removal or residue, wherein an “adhesive tack” would be one where removal is difficult and a residue is left).
Conclusion
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785