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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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, 6, 9, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akerele-Ale et al (WO 2019222713, provided by applicant).
Regarding claim 1, Akerele-Ale discloses:
A tubing component (589; Fig. 18) for a particulate material delivery assembly (Fig. 18) including a particulate delivery device (584) to deliver a mixed particulate solution to a patient (Abstract; ¶0004 – the invention is a delivery assembly for delivering radioactive materials, such as radioembolizing microspheres, which requires materials that inhibit radioactive emissions from within the different elements), the tubing component (589) comprising: a material (material of component 589) including a material density (inherent to a material); a determined thickness sufficient to shield a delivery line connector (588) of the particulate delivery device (584) from at least 90% of a radiation dose (¶00203 – thickness of 9mm is chosen because the “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588,” where inhibiting gamma radiation is interpreted as protecting from at least 90% of a radiation dose), the delivery line connector configured to receive the mixed particulate solution from the particulate delivery device (584) of the particulate material delivery assembly (Fig. 18; ¶00191); wherein the determined thickness of the tubing component is calculated based on the material density to achieve shielding of the delivery line connector by the material of at least 90% of the radiation dose (¶00203); and wherein the tubing component (589) comprises an integral wall of the delivery line connector (588) (¶00190 – the tubular component 289 forms the wall of the connector 588), an outer sleeve configured to be removably disposed about the delivery line connector, or combinations thereof.
Regarding claim 2, Akerele-Ale discloses:
The tubing component of claim 1, wherein the material comprises one of polyvinyl chloride (PVC), silicone, polyurethane, thermoplastic elastomer (TPE) (¶00202 – “thermoplastic polymer”), polypropolene (PP), polyethylene (PE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), EVA, polyether block amide, polyether ether ketone (PEEK), nylon, tungsten loaded polybutylene succinate (PBS), or combinations thereof.
Regarding claim 3, Akerele-Ale discloses:
The tubing component of claim 1, wherein the tubing component (589) comprises an inner tubing wall and an outer tubing wall, and the determined thickness comprises a thickness between the outer tubing wall and the inner tubing wall (¶00203).
Regarding claim 6, Akerele-Ale discloses:
The tubing component of claim 1, further comprising another material including another material density (¶00202 – component 589 can be formed of multiple materials, each with their own inherent density).
Regarding claim 9, Akerele-Ale discloses:
The tubing component of claim 1, comprising an inner plastic tubing component (589) and a flexible metal shield tubing (557; Fig. 15; ¶00178 – “protective shield 557 is formed of a material configured to inhibit radioactive emissions from extending outwardly from the vial chamber 558, such as, for example, a metal”), the flexible metal shield tubing (557) configured to be disposed on top of the inner plastic tubing component (589).
Regarding claim 16, Akerele-Ale discloses:
The tubing component of claim 1, wherein the tubing component (589) comprises at least two layers (589, 558; Fig. 26A), the at least two layers (589, 558) formed from a same material or a different material (¶00178, 00202).
Claim Rejections - 35 USC § 102 / 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.
Claims 7-8 and 13-15 are rejected under 35 U.S.C. 102(a)(1) / 103 as being anticipated or obvious by Akerele-Ale.
Regarding claim 7, Akerele-Ale discloses the tubing component of claim 6. The limitation “the another material is configured to be extruded and bonded to the material in a co-extrusion process” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 8, Akerele-Ale discloses the tubing component of claim 7. The limitation “the co-extrusion process comprises a nesting extrusion, an overmolding direct deposit extrusion, or combinations thereof” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 13, Akerele-Ale discloses the tubing component of claim 1. The limitation “the tubing component is formed from a single layer extrusion or a multiple layer extrusion” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 14, Akerele-Ale discloses the tubing component of claim 13. The limitation “wherein when the tubing component is formed from the multiple layer extrusion, each layer of the multiple layer extrusion is made of a same material to form the material of the tubing component” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 15, Akerele-Ale discloses the tubing component of claim 13. The limitation “wherein when the tubing component is formed from the multiple layer extrusion, at least two layers of the multiple layer extrusion include different materials to form the material of the tubing component” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Akerele-Ale.
Regarding claim 4, Akerele-Ale discloses the tubing component of claim 3, wherein the inner tubing wall comprises an interior diameter (diameter of connector 588), but is silent regarding “the thickness is at least 8 times greater than the interior diameter.” However, Akerele-Ale discloses that the thickness of the tubular component (589) is 9 mm thick in order to provide “a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580” (¶00203). Akerele-Ale further discloses that a “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588” in order to allow “an operator to handle the radioactive material stored within” (¶00203), meaning the thickness is a result effective variable that is determined by the amount of radiation the wall is intended to inhibit. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Akerele-Ale to have a thickness “at least 8 times greater than the interior diameter” 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 Akerele-Ale by making the thickness at least 8 times greater than the interior diameter of the tubular component 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 5, Akerele-Ale discloses the tubing component of claim 4 but is silent regarding “the interior diameter comprises 1 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Akerele-Ale to have an interior diameter of 1 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Akerele-Ale would not operate differently with the claimed diameter because the interior diameter is meant to accommodate a desired amount of the therapeutic and the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter “may” be 1 mm (instant ¶0083).
Regarding claim 18, Akerele-Ale discloses:
A tubing component (589; Fig. 18) for a particulate material delivery assembly (Fig. 18) including a particulate delivery device (584) to deliver a mixed particulate solution to a patient (Abstract; ¶0004 – the invention is a delivery assembly for delivering radioactive materials, such as radioembolizing microspheres, which requires materials that inhibit radioactive emissions from within the different elements), the tubing component (589) comprising: a material (material of component 589) including a material density (inherent to a material); a determined thickness sufficient to shield a delivery line connector (588) of the particulate delivery device (584) from at least 90% of a radiation dose (¶00203 – thickness of 9mm is chosen because the “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588,” where inhibiting gamma radiation is interpreted as protecting from at least 90% of a radiation dose), the delivery line connector configured to receive the mixed particulate solution from the particulate delivery device (584) of the particulate material delivery assembly (Fig. 18; ¶00191); wherein the determined thickness of the tubing component is calculated based on the material density to achieve shielding of the delivery line connector by the material of at least 90% of the radiation dose (¶00203); and wherein the tubing component (589) comprises an integral wall of the delivery line connector (588) (¶00190 – the tubular component 289 forms the wall of the connector 588), an outer sleeve configured to be removably disposed about the delivery line connector, or combinations thereof.
Akerele-Ale is silent regarding “a determined thickness between an interior diameter and an outer diameter such that the outer diameter is at least 8 times great than the interior diameter” and “wherein the tubing component is formed from a single layer extrusion or a multiple layer extrusion.”
Regarding “a determined thickness between an interior diameter and an outer diameter such that the outer diameter is at least 8 times great than the interior diameter,” Akerele-Ale discloses that the thickness of the tubular component (589) is 9 mm thick in order to provide “a plurality of atoms disposed within the vial body 589 that are capable of encountering the electron particles generating beta radiation and reducing an emission of said radiation from the vial assembly 580” (¶00203). Akerele-Ale further discloses that a “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588” in order to allow “an operator to handle the radioactive material stored within” (¶00203), meaning the thickness is a result effective variable that is determined by the amount of radiation the wall is intended to inhibit. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Akerele-Ale to have a thickness “at least 8 times greater than the interior diameter” 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 Akerele-Ale by making the thickness at least 8 times greater than the interior diameter of the tubular component 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).
The limitation “the tubing component is formed from a single layer extrusion or a multiple layer extrusion” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 19, Akerele-Ale discloses the tubing component of claim 18. The limitation “wherein the multiple layer extrusion comprises a nesting extrusion, an overmolding direct deposit extrusion, or combinations thereof” is a product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a catheter with properties to shield at least 90% radiation. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Akerele-Ale in view of Bruce et al (US 2009/0292157).
Regarding claim 20, Akerele-Ale discloses:
A method to form a tubing component (589; Fig. 18) for a particulate material delivery assembly (Fig. 18) including a particulate delivery device (584) to deliver a mixed particulate solution to a patient (Abstract; ¶0004 – the invention is a delivery assembly for delivering radioactive materials, such as radioembolizing microspheres, which requires materials that inhibit radioactive emissions from within the different elements), the method comprising: determining a determined thickness between an interior diameter and an outer diameter sufficient to shield a delivery line connector (588) of the particulate delivery device (584) from at least 90% of a radiation dose (¶00203 – thickness of 9mm is chosen because the “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588,” where inhibiting gamma radiation is interpreted as protecting from at least 90% of a radiation dose), the determined thickness of the tubing component (589) calculated based on a material density to achieve shielding of the delivery line connector (588) by the material of at least 90% of the radiation dose (¶00203 – “density and material composition of the vial body 589 may collectively inhibit gamma radiation emission from electron particles stored within the internal chamber 588,” where inhibiting gamma radiation is interpreted as protecting from at least 90% of a radiation dose), wherein the delivery line connector (588) is configured to receive the mixed particulate solution (¶0004) from the particulate delivery device (584) of the particulate material delivery assembly (Fig. 18); forming the tubing component (589) based on the determined thickness, wherein the tubing component (589) comprises an integral wall of the delivery line connector (588; ¶00190 – the tubular component 289 forms the wall of the connector 588), an outer sleeve configured to be removably disposed about the delivery line connector, or combinations thereof.
Akerele-Ale is silent regarding “forming the tubing component from a single layer extrusion or a multiple layer extrusion.” However, Bruce teaches a radiation shielded device (Abstract), thus being in the same field of endeavor, that forms the components using extruding (¶0032). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have made the device of Akerele-Ale using extrusion as taught by Bruce in order to provide a sufficient step of forming the device.
Allowable Subject Matter
Claims 10-12 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783