DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 4 December 2025. Claims 1-20 are now pending. The Examiner acknowledges the amendments to claims 1-3, 5-17 and newly added claims 18-20.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 2, 3, 6, 8, 9, 10, 12, 16, 17, 18, 19, 20 are objected to because of the following informalities:
-Claims 2, 6, 8, 9, 10, 12, 18, 19, 20 recite “the biocompatible NPR material”. Examiner recommends amending to –the biocompatible NPR foam material—
-Claim 2 recites “the organ” in lines 2-3. Examiner recommends amending to –the internal organ—
-Claim 3 recites “wherein the protrusion” in lines 2-3. Examiner recommends amending to –and wherein the protrusion—
-Claim 16 recites “wherein the application” in line 11. Examiner recommends amending to –and wherein the application—
-Claim 16 recites “the organ” in lines 3 and 13. Examiner recommends amending to –the internal organ—
Appropriate correction is required.
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 16, 17 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.
-Claim 16 recites “a patient” in line 7. It is unclear whether this is the same or different from a patient originally referenced in lines 1-2.
-Claim 16 recites “application of the magnetic field” in line 11. It is unclear whether this is the same or different from applying a magnetic field to the belt in line 11.
-Claim 17 recites “an internal organ” in lines 6-7. It is unclear whether this should refer to an organ or a tumor as originally introduced in lines 1 and 3. Further clarification should be provided.
-Claim 17 recites “the implantable belt” in line 12. There is insufficient antecedent basis for this limitation in the claim.
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(s) 1-4, 8, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011.
Regarding Claim 1, Sabatino teaches an implantable medical device comprising: a belt comprising an annular base extending around a circumference of the belt [Fig. 2, elements 200 (two-piece intervertebral implant device), 210 (first disc portion)] wherein the annular base comprises a biocompatible negative Poisson's ratio (NPR) foam material having a Poisson's ratio of between 0 and -1 [0037; “The endplate 240 could allow for increased viability at the level of the spongiosum layer of the vertebral endplate, leading to decreased bone re-sorption and less chance for osteonecrosis.”] and [0026; “Negative Poisson ratios in the -0.3 range can maximize the beneficial effects of this auxetic substances.”]
Sabatino is silent on wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle an internal organ of a patient. Murtaza teaches wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle an internal organ of a patient [Abstract; “This research discusses a novel way of fabricating an Auxetic structure (rotating-squares connected together through hinges) on Polypropylene films, by estimating the Poisson’s ratio and evaluating the plastic deformation relevant to the expansion behaviour of an Auxetic stent within the oesophageal lumen.”] and [Conclusion; “Hence, Auxetic stent will itself behave like a balloon and will dilate the oesophagus by its novel expansion behaviour in both ways, i.e. transversely and longitudinally. The large lumen diameter of the Auxetic stent is useful in solving problems like food impaction, and obstruction (stenosis). Secondly, because of the good mesh on the outer surface of the Auxetic stent.”]—where the mesh on the outer surface of the cylindrical structure shown in Fig. 11 is interpreted to be the annular base and reference to “covered Auxetic stent” [Pg 2576, “Fabrication of Auxetic oesophageal stent”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the base of the structure to encircle an organ as taught by Murtaza to provide palliative care as suggested by Sabatino as Sabatino discusses the need for the implant to be able to remain stable and mitigate needs for subsequent surgeries [0006] with Murtaza because Murtaza teaches the advantages of the stent struct reducing the chance of complications by its improved properties and unique deformation mechanisms [Conclusion].
Regarding Claim 2, Sabatino further teaches wherein the annular base is configured to be inductively heated to thereby deliver thermal therapy to the organ [0025; “Auxetic material can provide fracture resistance with high energy absorption to maintain the integrity of the device.”] In this interpretation the implantable device is considered to have the ability to absorb thermal heat for therapeutic purposes due to the material properties high energy absorption characteristics.
Regarding Claim 3, Sabatino further teaches wherein the belt comprises a protrusion attached to or integral with the annular base, wherein the protrusion extends outwardly from the circumference of the belt. See annotated Fig. 2 below.
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Regarding Claim 4, Sabatino further teaches comprising multiple protrusions arranged at regular intervals around the circumference of the belt. See annotated Fig. 2 above where the labeled protrusions are arranged symmetrically around the annular base of the implant.
Regarding Claim 8, Sabatino further teaches wherein the biocompatible NPR material is composed of a cellular structure having a characteristic dimension of between 0.01 µm and 3 mm [0040; “This embodiment could preserve the nutrient transfer associated with non-desiccated discs at the endplate. Stem cells in the range of 10-20 microns could be capable of traversing the implant from one endplate through the extensions to the other endplate, thereby delivering nutrients across the disc space, actually improving the blood supply normally deficient in the human intervertebral disc.”] From this discussion, it is interpreted that the pore size or cellular structure of the material is assumed to be able to accommodate the stem cells discussed at a size of 10-20 µm which would fall within the range of 0.01 µm-3 mm as required by the claim.
Regarding Claim 12, Sabatino further teaches wherein the annular base comprises an inner layer and an outer layer covering the inner layer, and wherein the outer layer comprises the biocompatible NPR material [0023; “FIG. 3 shows one form of lattice structure 300 of the first disc portion 210 and the second disc portion 220. The lattice structure 300 provides auxetic behavior when subject to compression perpendicular to a surface plane parallel to at least one of the surface 216 of the first disc portion 210 and the mating surface 226 of the second disc portion 220.”] also [0034; “In a further embodiment, an internal cushion design for the male and female disc portions 210, 220 can include a smart material for shock absorption in the outer covering at the male/female interface.”] From this second reference, it is concluded that the smart material does not include that of auxetic nature.
Regarding Claim 14, Sabatino further teaches wherein the inner layer comprises a metal [0040; “One embodiment of the present application can include a micro-porous/metallic interface coated with either type 1 collagen, fibronectin, or the RGD peptide and positioned between a memory-shape alloy with a lattice structure exhibiting auxetic properties and the vertebral endplate to maintain the biological interface.”]
Claim(s) 5-7, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of Nappi (U.S. 20170326274).
Regarding Claim 5, Sabatino and Murtaza are silent on wherein the protrusion comprises a biocompatible NPR metal foam material. Nappi teaches wherein the protrusion comprises a biocompatible NPR metal foam material [Fig. 12, elements 33 (protrusions-longitudinal strips) and elements 331/332 (protrusion ends)] and [Claim 12, “wherein preferably said reinforcing layer is made of metal, such as platinum, gold, titanium or nickel.”] and further supported by [0104].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible NPR metal foam material as taught by Nappi to withstand certain stress, strain and tensile loads as suggested by Sabatino and Murtaza as Sabatino discusses reactions of the implant to different strain stress and universal loading [0021] and Murtaza which discusses testing the material by applying different tensile and strain loads [Pg. 2580, paragraph 1] with Nappi because Nappi teaches the use of these materials to enhance structural integrity of the device [0105].
Regarding Claim 6, Sabatino and Murtaza are silent on wherein the biocompatible NPR material comprises an NPR metal foam material. Nappi teaches wherein the biocompatible NPR material comprises an NPR metal foam material [Claim 12], and [0104].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible NPR metal foam material as taught by Nappi to withstand certain stress, strain and tensile loads as suggested by Sabatino and Murtaza as Sabatino discusses reactions of the implant to different strain stress and universal loading [0021] and Murtaza which discusses testing the material by applying different tensile and strain loads [Pg. 2580, paragraph 1] with Nappi because Nappi teaches the use of these materials to enhance structural integrity of the device [0105].
Regarding Claim 7, Sabatino further teaches wherein the NPR metal foam material comprises one or more of nickel, copper, palladium, or cobalt [0029; “Composite alloys of Nickel-Titanium, CuZnAI and CuAlNi in the austenite phase could be considered.”]
Regarding Claim 18, Sabatino teaches wherein the biocompatible NPR material is composed of a cellular structure having a characteristic dimension of between 0.01 µm and 3 mm [0040]. From this discussion, it is interpreted that the pore size or cellular structure of the material is assumed to be able to accommodate the stem cells discussed at a size of 10-20 µm which would fall within the range of 0.01 µm-3 mm as required by the claim, and wherein the annular base comprises an inner layer and an outer layer covering the inner layer, and wherein the outer layer comprises the biocompatible NPR material [0023] also [0034]. From this second reference, it is concluded that the smart material does not include that of auxetic nature.
Sabatino and Murtaza are silent on wherein the biocompatible NPR material comprises an NPR metal foam material. Nappi teaches wherein the biocompatible NPR material comprises an NPR metal foam material [Claim 12] and [0104].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible NPR metal foam material as taught by Nappi to withstand certain stress, strain and tensile loads as suggested by Sabatino and Murtaza as Sabatino discusses reactions of the implant to different strain stress and universal loading [0021] and Murtaza which discusses testing the material by applying different tensile and strain loads [Pg. 2580, paragraph 1] with Nappi because Nappi teaches the use of these materials to enhance structural integrity of the device [0105].
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of Soman (U.S. 9631171).
Regarding Claim 9, Sabatino and Murtaza are silent on wherein the annular base comprises a composite material comprising the biocompatible NPR material and a positive Poisson's ratio (PPR) material. Soman teaches wherein the annular base comprises a composite material comprising the biocompatible NPR material and a positive Poisson's ratio (PPR) material [Fig. 10D, elements “NPR” and “PPR”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a both NPR and PPR materials as taught by Soman to cause combinations of material properties to the structures as suggested by Sabatino and Murtaza as Sabatino discusses the implant being able to withstand compression, maintain shape, shock absorption and flexibility [0025] and Murtaza which discusses lateral expansion of the flexible stent with shape tunability [Pg. 2574, “Auxetic Structure”] with Soman because Soman teaches NPR and PPR materials to impart combinations of character to the scaffold with rib flexure, stretching and angular deformation [Col 6, lines 26-29].
Regarding Claim 10, Sabatino and Murtaza are silent on wherein the composite material comprises alternating layers of the biocompatible NPR material and the PPR material. Soman teaches wherein the composite material comprises alternating layers of the biocompatible NPR material and the PPR material [Col 3, lines 34-44; “stacking the single layer…does not affect Poisson’s ratio.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alternate layers of NPR and PPR materials as taught by Soman to use covering, layering and manufacturing features to assemble as suggested by Sabatino and Murtaza as Sabatino discusses the use of additive layer manufacturing to assemble the layers of the implant [0025] and Murtaza which discusses using metals and aluminum and metal piping to secure the covered Auxetic stent [Pg. 2576, “Fabrication…stent”] with Soman because Soman teaches the use of hybrid-NPR-PPR scaffolds to mimic tissue behavior and withstand compressive and stretching forces imparted on the implant [Col 14, lines 12-18].
Regarding Claim 11, Sabatino and Murtaza are silent on wherein the alternating layers are oriented parallel to the circumference of the belt. Soman teaches wherein the alternating layers are oriented parallel to the circumference of the belt [Fig. 11f]. However, Soman does not disclose a parallel orientation of these layers around a circumference on the belt.
Regarding the shape of the belt in regards to these alternating layers, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. “In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), [t]he court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” MPEP § 2144.04-IV-B.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient the alternate PPR and NPR materials as taught by Soman to exhibit auxetic behavior when compressed suggested by Sabatino and Murtaza as Sabatino discusses the first and second surfaces being parallel to one another [0047] and Murtaza which discusses showing elastic deformation under tensile load [Pg. 2576, “Examination of deformation behaviour”] with Soman because Soman teaches hybrid NPR/PPR behavior under conditions of axial loading [Col 6, lines 66-67].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of Passman (U.S. 11007061).
Regarding Claim 13, Sabatino and Murtaza are silent on wherein the inner layer comprises a PPR material. Passman teaches wherein the inner layer comprises a PPR material [Col 11, lines 54-56; “The stent 146 consists of a positive Poisson's ratio stent which undergoes a proportional shortening in length when radially expanded.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a PPR material as the inner layer of the implant as taught by Passman to allow for expansion of the material as suggested by Sabatino and Murtaza as Sabatino discusses considerations for transverse expansion in the spine to prevent impingement and maintain range of motion [0026] and Murtaza which discusses expansion of the stent within the esophagus [Pg. 2580, “Discussion”] with Passman because Passman teaches self-expanding stents that expand outward in absence of radial constraints [Col 2, lines 41-43].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of White (U.S. 7497820).
Regarding Claim 15, Sabatino and Murtaza are silent on wherein the belt is configured for brachytherapy, and wherein the inner layer comprises a radioactive material. White teaches wherein the belt is configured for brachytherapy, and wherein the inner layer comprises a radioactive material [Fig. 10B, element 40 (expandable device)] and [Col 9, lines 8-12; “A syringe may be employed to fill balloon 14 with saline solution via inflation lumen 25, as shown in FIG. 5, and/or may be employed to after load one or more radioactive sources into source lumens 7 and/or internal lumen 18, as shown in FIG. 5.”] and [Abstract; “The brachytherapy device is inserted into a body cavity. After insertion, the movable surface is moved to position the at least one source lumen closer to the tissue boundary of the cavity.”] In this interpretation, the expandable device is interpreted to be the belt for brachytherapy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material for brachytherapy as taught by White to understand energy applications for materials design as suggested by Sabatino and Murtaza as Sabatino discusses auxetic materials being able to provide high energy absorption to maintain device integrity [0026] and Murtaza which discusses application of heat to ease internal stresses of the structure[Pg. 2576, “Fabrication…”] with White because White teaches the use of the device and method for treatment of interstitial breast cancer [Col 17, lines 39-41].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diederich (U.S. 7819826) in view of Sabatino (U.S. 20140058517) and in further view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011.
Regarding Claim 16, Diederich teaches a method of providing a thermal treatment to an internal organ of a patient [Col 16, lines 20-26”], the method comprising: positioning a belt to surround the organ [Col 36, lines 48-57], and applying a magnetic field to the belt [Col 59, lines 38-44] and [Col 62, lines 20-23], wherein application of the magnetic field induces an electrical current in the belt [Col 60, lines 1-4], the electrical current generating heat for the thermal treatment of the organ [Col 35, lines 51-52] and [Col 50, lines 24-25].
Diedrich is silent on the belt comprising: an annular base extending around a circumference of the belt, and wherein the annular base comprises a biocompatible negative Poisson's ratio (NPR) foam material having a Poisson's ratio of between 0 and -1. Sabatino teaches he belt comprising: an annular base extending around a circumference of the belt [Fig. 2, elements 200 (two-piece intervertebral implant device), 210 (first disc portion)], and wherein the annular base comprises a biocompatible negative Poisson's ratio (NPR) foam material having a Poisson's ratio of between 0 and -1 [0026 and 0037].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the described method for providing thermal treatment as taught by Diedrich incorporating a belt with an annular base and NPR materials as suggested by Sabatino as Sabatino discusses the disclosed device to deliver secondary materials and therapies to the area of interest [0009] with Diederich because Diederich teaches the use of the disclosed technologies for delivering energy to cancerous tumors [Col 2, lines 15-18].
Diederich and Sabatino are silent on wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle the internal organ of a patient. Murtaza teaches wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle the internal organ of a patient [Abstract; “This research discusses a novel way of fabricating an Auxetic structure (rotating-squares connected together through hinges) on Polypropylene films, by estimating the Poisson’s ratio and evaluating the plastic deformation relevant to the expansion behaviour of an Auxetic stent within the oesophageal lumen.”] and [Conclusion; “Hence, Auxetic stent will itself behave like a balloon and will dilate the oesophagus by its novel expansion behaviour in both ways, i.e. transversely and longitudinally. The large lumen diameter of the Auxetic stent is useful in solving problems like food impaction, and obstruction (stenosis). Secondly, because of the good mesh on the outer surface of the Auxetic stent.”]—where the mesh on the outer surface of the cylindrical structure shown in Fig. 11 is interpreted to be the annular base and reference to “covered Auxetic stent” [Pg 2576, “Fabrication of Auxetic oesophageal stent”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the implant in relation to the organ of the patient as taught by Murtaza to provide palliative care as suggested by Sabatino and Diederich, as Sabatino discusses the need for the implant to be able to remain stable and mitigate needs for subsequent surgeries [0006] and Diederich which discloses controlling long-term thermal therapy of tissues [Col 14, lines 26-31] with Murtaza because Murtaza teaches the advantages of the stent struct reducing the chance of complications by its improved properties and unique deformation mechanisms [Conclusion].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diederich (U.S. 7819826) in view of Sabatino (U.S. 20140058517) and in further view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in even further view of White (U.S. 7497820).
Regarding Claim 17, Diederich teaches a method of treating a tumor with a brachytherapy treatment, and allowing the implantable belt to remain in position surrounding the tumor for a predefined amount of time to deliver radiation to the tumor [Col 62, lines 9-11], [Col 34, lines 55-60], and [Col 59, lines 38-44], the method comprising: positioning a belt to surround a tumor [Col 62, lines 9-11].
Diedrich is silent on the belt comprising an annular base extending around a circumference of the belt, wherein the belt comprises: an outer layer covering the inner layer, the outer layer comprising biocompatible negative Poisson's ratio (NPR) foam material having a Poisson's ratio of between 0 and -1. Sabatino teaches the belt comprising an annular base extending around a circumference of the belt [Fig. 2, elements 200 (two-piece intervertebral implant device), 210 (first disc portion)], wherein the belt comprises: an outer layer covering the inner layer [0023 and 0034], the outer layer comprising biocompatible negative Poisson's ratio (NPR) foam material having a Poisson's ratio of between 0 and -1 [0026 and 0037].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the described method for providing thermal treatment as taught by Diedrich incorporating a belt with an annular base and NPR materials as suggested by Sabatino as Sabatino discusses the disclosed device to deliver secondary materials and therapies to the area of interest [0009] with Diederich because Diederich teaches the use of the disclosed technologies for delivering energy to cancerous tumors [Col 2, lines 15-18].
Diedrich and Sabatino are silent on wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle an internal organ of a patient. Murtaza teaches wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle an internal organ of a patient, [Abstract; “This research discusses a novel way of fabricating an Auxetic structure (rotating-squares connected together through hinges) on Polypropylene films, by estimating the Poisson’s ratio and evaluating the plastic deformation relevant to the expansion behaviour of an Auxetic stent within the oesophageal lumen.”] and [Conclusion; “Hence, Auxetic stent will itself behave like a balloon and will dilate the oesophagus by its novel expansion behaviour in both ways, i.e. transversely and longitudinally. The large lumen diameter of the Auxetic stent is useful in solving problems like food impaction, and obstruction (stenosis). Secondly, because of the good mesh on the outer surface of the Auxetic stent.”]—where the mesh on the outer surface of the cylindrical structure shown in Fig. 11 is interpreted to be the annular base and reference to “covered Auxetic stent” [Pg 2576, “Fabrication of Auxetic oesophageal stent”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the implant in relation to the organ of the patient as taught by Murtaza to provide palliative care as suggested by Sabatino and Diederich, as Sabatino discusses the need for the implant to be able to remain stable and mitigate needs for subsequent surgeries [0006] and Diederich which discloses controlling long-term thermal therapy of tissues [Col 14, lines 26-31] with Murtaza because Murtaza teaches the advantages of the stent struct reducing the chance of complications by its improved properties and unique deformation mechanisms [Conclusion].
Diederich, Sabatino and Murtaza are silent on an inner layer comprising a radioactive material. White teaches an inner layer comprising a radioactive material [Fig. 10B, element 40 (expandable device)] and [Col 9, lines 8-12] and [Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material for brachytherapy as taught by White to understand energy applications for materials design as suggested by Diederich, Sabatino, and Murtaza, as Diederich discloses the use of energy delivery elements to deliver controlled, directed or focused highly localized thermal treatment [Col 14, lines 18-25] and Sabatino which discusses auxetic materials being able to provide high energy absorption to maintain device integrity [0026] and Murtaza which discusses application of heat to ease internal stresses of the structure[Pg. 2576, “Fabrication…”] with White because White teaches the use of the device and method for treatment of interstitial breast cancer [Col 17, lines 39-41].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of Nappi (U.S. 20170326274) and in even further view of White (U.S. 7497820).
Regarding Claim 19, Sabatino teaches wherein the annular base comprises an inner layer and an outer layer covering the inner layer, and in which wherein the outer layer comprises the biocompatible NPR material [0023] also [0034]. From this second reference, it is concluded that the smart material does not include that of auxetic nature, wherein the biocompatible NPR material is composed of a cellular structure having a characteristic dimension of between 0.01 µm and 3 mm [0040]. From this discussion, it is interpreted that the pore size or cellular structure of the material is assumed to be able to accommodate the stem cells discussed at a size of 10-20 µm which would fall within the range of 0.01 µm-3 mm as required by the claim.
Sabatino and Murtaza are silent on wherein the biocompatible NPR material comprises an NPR metal foam material. Nappi teaches wherein the biocompatible NPR material comprises an NPR metal foam material [Claim 12] and [0104].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a biocompatible NPR metal foam material as taught by Nappi to withstand certain stress, strain and tensile loads as suggested by Sabatino and Murtaza, as Sabatino discusses reactions of the implant to different strain stress and universal loading [0021] and Murtaza which discusses testing the material by applying different tensile and strain loads [Pg. 2580, paragraph 1] with Nappi because Nappi teaches the use of these materials to enhance structural integrity of the device [0105].
Sabatino, Murtaza and Nappi are silent on and wherein the inner layer comprises a radioactive material. White teaches and wherein the inner layer comprises a radioactive material [Fig. 10B, element 40 (expandable device)] and [Col 9, lines 8-12] and [Abstract]. In this interpretation, the expandable device is interpreted to be the belt for brachytherapy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the material for brachytherapy as taught by White to understand energy applications for materials design as suggested by Sabatino, Murtaza, and Nappi, as Sabatino which discusses auxetic materials being able to provide high energy absorption to maintain device integrity [0026] and Murtaza which discusses application of heat to ease internal stresses of the structure[Pg. 2576, “Fabrication…”] and Nappi which discloses an implant with high-energy absorption and high fracture resistance [0104] with White because White teaches the use of the device and method for treatment of interstitial breast cancer [Col 17, lines 39-41].
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sabatino (U.S. 20140058517) in view of Murtaza et al. An Auxetic structure configured as oesophageal stent with potential to be used for palliative treatment of oesophageal cancer; development and in vitro mechanical analysis, J Mater Sci: Mater Med, 22: 2573-2581, 2011 and in further view of Soman (U.S. 9631171).
Regarding Claim 20, Sabatino teaches wherein the biocompatible NPR material is composed of a cellular structure having a characteristic dimension of between 0.01 µm and 3 mm [0040]. From this discussion, it is interpreted that the pore size or cellular structure of the material is assumed to be able to accommodate the stem cells discussed at a size of 10-20 µm which would fall within the range of 0.01 µm-3 mm as required by the claim, and wherein the biocompatible NPR material comprises an NPR metal foam material comprising one or more of nickel, copper, palladium, or cobalt [Fig. 10B, element 40 (expandable device)] and [Col 9, lines 8-12] and [Abstract]. In this interpretation, the expandable device is interpreted to be the belt for brachytherapy [0029].
Sabatino and Murtaza are silent on wherein the annular base comprises a composite material comprising alternating layers of the biocompatible NPR material and a positive Poisson's ratio (PPR) material. Soman teaches wherein the annular base comprises a composite material comprising alternating layers of the biocompatible NPR material and a positive Poisson's ratio (PPR) material [Col 3, lines 34-44; “stacking the single layer…does not affect Poisson’s ratio.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient the alternate PPR and NPR materials as taught by Soman to exhibit auxetic behavior when compressed suggested by Sabatino and Murtaza as Sabatino discusses the first and second surfaces being parallel to one another [0047] and Murtaza which discusses showing elastic deformation under tensile load [Pg. 2576, “Examination of deformation behaviour”] with Soman because Soman teaches hybrid NPR/PPR behavior under conditions of axial loading [Col 6, lines 66-67].
Response to Arguments
Applicant's arguments filed 4 December 2025 with respect to the drawing and specification objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 4 December 2025 with respect to the claim objections have been fully considered and are however, new objections are presented in light of the amendments.
Applicant's arguments filed 4 December 2025 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 21 September 2025 with respect to the rejection of
claims 1-17 under 35 U.S.C.103 have been fully considered and are persuasive,
however, new rejections are presented above in light of the amendments for claims 1-17 and newly added claims 18-20. In regards to claim 1, applicant contends that Sabatino fails to teach “a belt comprising an annular base extending around a circumference of the belt, wherein the annular base defines a rounded opening of the belt that is configured to receive and circumferentially encircle an internal organ
of a patient.” In light of the amendment adding additional limitations pertaining to rounding openings and encircling an internal organ, additional reference has been added in view of Murtaza et al..
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791