DETAILED ACTION
Claims 15-26, 28-31 and 33-42 were/stand cancelled. Claims 1-14, 27 and 32 are pending.
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 .
Priority
This application is a DIV of 16/966,683 (07/31/2020; PAT 11,911,504) which is a 371 of PCT/US2019/016494 (02/04/2019) which claims benefit of 62/625,535 (02/02/2018) and claims benefit of 62/667,834 (05/07/2018) and claims benefit of 62/717,303 (08/10/2018) as reflected in the filing receipt issued on February 28 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 13 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Specifically, page 1 (line 25); page 11 (brief description of 4A-4C); and page 14 (line 8).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, 10-13 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malfroy-Camine et al. (US Patent No. 7122537).
The instant application claims a device for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery, the device comprising: a substrate having a top surface and a bottom surface, the substrate capable of being absorbed when inserted into a site of disease within a subject where it is in contact with the subject's tissue; and a first layer of an oxidation inhibitor located on the top surface or the bottom surface of the substrate, wherein the layer is configured to trigger the subject's natural anti-oxidant defenses.
The instant application claims a device for reducing inflammation and scarring comprising, a vehicle having at least one substrate, the substrate capable of being absorbed when in contact with the subject's tissue; and a first layer of an oxidation inhibitor located on the at least one substrate of the vehicle, the first layer being configured to trigger the subject's anti-oxidant defenses, thereby reducing inflammation and scarring.
Malfroy-Camine et al. is directed to cyclic salen-metal compounds as scavengers for oxygen radicals and useful as antioxidants in the treatment and prevention of diseases. Claimed is a salen-metal compound specifically C107:
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(claim 1; 20), which is EUK-207 (see page 13 of the instant specification which states the structure of EUK-207). Claimed is a composition comprising a topical carrier and the salen-metal compound (claim 14). Exemplified are lotions which include carbomer viscosity control agents (aka polymers) (example 3).
Therefore, Malfroy-Camine et al. anticipates the claims as the claims have no limiting definition of substrate except that it has a top surface and bottom surface (which would occur with any 3-dimensional object and specific substrates claimed include gels and foams and thus substrate is not limited to a solid object) and is capable of being absorbed. Here the composition is a lotion (reading on substrate) which is capable of being absorbed. Since the lotion itself includes the salen-metal compound it meets the limitation of a first layer of an oxidation inhibitor. Furthermore, Malfroy-Camine et al. teaches the same ingredients used to make the lotion can be used to make a gel which is a specific substrate claimed.
Regarding the claimed “for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery” and “for reducing inflammation and scarring”, these limitations are directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
Regarding claim 5, the specification provides no limiting definition of customizable. Clearly a lotion can be customized as the amount applied can be controlled.
Regarding claim 6-7, the lotion intended to be applied such that it is configured contact the subject’s tissue. Furthermore, these limitations are directed to the device in use but the rejected claims are directed to the device itself. "the patentability of apparatus or composition claims depends on the claimed structure, not on the use orpurpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). Note: MPEP 2111.02
Regarding claim 8, since the salen-metal compound is found throughout the lotion it reads on a first and second layer of EUK-207.
Regarding claims 10-13, again, many of the limitations are directed to the device in use but do not modify the structural limitations of the device itself. Clearly the lotion is capable of being inserted and enclosed within a disease site. Clearly the lotion can form a film and as exemplified contains a polymer. Furthermore, Malfroy-Camine et al. states that the same ingredients can be formulated into a cream rather than a lotion, or into gels (column 22, lines 41-47).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 5-8, 10-14, 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Attawia et al. (WO2005000283A2, cited on PTO Form 1449) in view of Malfroy-Camine et al. (US Patent No. 7122537).
Applicant Claims
The instant application claims a device for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery, the device comprising: a substrate having a top surface and a bottom surface, the substrate capable of being absorbed when inserted into a site of disease within a subject where it is in contact with the subject's tissue; and a first layer of an oxidation inhibitor located on the top surface or the bottom surface of the substrate, wherein the layer is configured to trigger the subject's natural anti-oxidant defenses.
The instant application claims a device for reducing inflammation and scarring comprising, a vehicle having at least one substrate, the substrate capable of being absorbed when in contact with the subject's tissue; and a first layer of an oxidation inhibitor located on the at least one substrate of the vehicle, the first layer being configured to trigger the subject's anti-oxidant defenses, thereby reducing inflammation and scarring.
The instant application claims a method for protecting neurons and reducing inflammation and scarring in a subject, the method comprising providing a device of claim 1; inserting the device into a site of disease such that the substrate covers at least a portion of the tissue at the site of disease; and closing an incision site at the site of the disease if the substrate is applied as part of a surgery, thereby securing the device within the site of disease; wherein the substrate is capable of being absorbed when inserted into the site of disease within the subject where it is in contact with the subject's tissue, and the layer of oxidation inhibitor is configured to trigger the subject's anti-oxidant defenses, thereby protecting neurons and reducing inflammation and scarring.
The instant application claims a method for treating pain associated with a disease of the spine in a subject in need thereof, the method comprising, injecting a pharmaceutical composition into a spinal space of the subject, the pharmaceutical composition comprising a bioabsorbable substrate and an oxidation inhibitor, wherein the substrate is capable of being absorbed when injected into the spinal space and the oxidation inhibitor is capable of triggering the subject's anti-oxidant defenses, whereby the pain is reduced or eliminated.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Attawia et al. is directed to a method of treating degenerative disc disease. Claimed is a method of treating degenerative disc disease in an intervertebral disc having a nucleus pulposus, comprising transdiscally administering an effective amount of a formulation into an intervertebral disc (claim 1). The formulation is predominantly released form a sustained delivery device (claim 11). The formulation is administered in an amount effective to reduce pain (claim 13). The sustained release device comprises a hydrogel (claim 47). The sustained release device provides controlled and continuous release (claims 48-49). The formulation comprises a high specificity antioxidant (claim 38, page 27, lines 6-15). Antioxidants claimed include superoxide dismutase (claim 132). Degenerative disc disease (DDD) involves the progressive degeneration of a disc. In many instances, simply providing a single dose or even a regimen over the space of a few days may not be sufficient to resolve the DDD. Therefore, there is a need to provide a long-term drug therapy treatment of DDD that does not require multiple injections (page 29, lines 15-22). A sustained release device is adapted to remain within the disc for a prolonged period and slowly release the drug contained therein to the surrounding environment (page 31, lines 16-21). The bioresorbable polymer has a half-life of at least one month, more preferably at least two months, and more preferably at least 6 months (page 31, lines 27-32). It is taught in how to administer transdiscally a formulation. Specifically, the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition (example 3).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Attawia et al. teaches the inclusion of antioxidants, Attawia et al. does not expressly teach an antioxidant such as EUK-207.
Malfroy-Camine et al. is directed to cyclic salen-metal compounds as scavengers for oxygen radicals and useful as antioxidants in the treatment and prevention of diseases. Biological antioxidants include enzymes such as superoxide dismutase (column 1, lines 59-60). Claimed is a salen-metal compound specifically C107:
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(claim 1; 20), which is EUK-207 (see page 13 of the instant specification which states the structure of EUK-207). Claimed is a composition comprising a topical carrier and the salen-metal compound (claim 14). Exemplified are lotions which include carbomer viscosity control agents (aka polymers) (example 3). During inflammation, ROS are generated (column 3, line 4). Use of the cyclic salen-metal compound in anti-inflammatory compositions (column 29). It is taught that the cyclic salen-metal compounds can be used either alone or in combination with other known antioxidants and therapeutic agents (column 25, lines 33-36). As claimed the compound is present in an amount such that the composition has superoxide dismutase activity and/or catalase activity (claim 4).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al. and Malfroy-Camine et al. and utilize the cyclic salen-metal compound, specifically C107, as the antioxidant in Attawia et al. One skilled in the art would have been motivated to utilize this antioxidant with a reasonable expectation of success as Attawia et al. expressly teaches the inclusion of an antioxidant such as superoxide dismutase and Malfroy-Camine et al. teaches that the salen-metal compounds have superoxide dismutase activity.
Regarding the claimed substrate, the instant application indicates the substrate can be a gel (claim 13) and Attawia et al. teaches a hydrogel.
Regarding the claimed method steps and capabilities of the substrate claimed, Attawia et al. teaches inserting the composition/hydrogel at the site of disease. The “closing” an incision site is conditional on the application being done as part of a surgery. Attawia et al. expressly teaches the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition. One skilled in the art would recognize that if necessary where the skin is punctured can be closed (to prevent bleeding). Attawia et al. teaches a bioresorbable polymer suggest the substrate is capable of being absorbed.
Regarding the claimed “for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery” and “for reducing inflammation and scarring”, these limitations are directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
Regarding claim 8, since the antioxidant is found throughout the hydrogel, thus it reads on a first and second layer of EUK-207.
Claims 1, 4-7, 9-14, 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Attawia et al. (WO2005000283A2, cited on PTO Form 1449) in view of Reddy et al. (Neurochem Int., 2014, cited on PTO Form 1449).
Applicant Claims
The instant application claims wherein the oxidation inhibitor is monosodium luminol or phenyl N-t-butylnitrone. The instant application claims further comprising a second layer of monosodium luminol or phenyl N-t-butylnitrone, the first layer being located on the top surface of the substrate, and the second layer being located on the bottom surface of the substrate and configured to contact the subject's tissue upon insertion of the device into the site of disease.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Attawia et al. is directed to a method of treating degenerative disc disease. Claimed is a method of treating degenerative disc disease in an intervertebral disc having a nucleus pulposus, comprising transdiscally administering an effective amount of a formulation into an intervertebral disc (claim 1). The formulation is predominantly released form a sustained delivery device (claim 11). The formulation is administered in an amount effective to reduce pain (claim 13). The sustained release device comprises a hydrogel (claim 47). The sustained release device provides controlled and continuous release (claims 48-49). The formulation comprises a high specificity antioxidant (claim 38, page 27, lines 6-15). Antioxidants claimed include superoxide dismutase (claim 132). Degenerative disc disease (DDD) involves the progressive degeneration of a disc. In many instances, simply providing a single dose or even a regimen over the space of a few days may not be sufficient to resolve the DDD. Therefore, there is a need to provide a long-term drug therapy treatment of DDD that does not require multiple injections (page 29, lines 15-22). A sustained release device is adapted to remain within the disc for a prolonged period and slowly release the drug contained therein to the surrounding environment (page 31, lines 16-21). The bioresorbable polymer has a half-life of at least one month, more preferably at least two months, and more preferably at least 6 months (page 31, lines 27-32). It is taught in how to administer transdiscally a formulation. Specifically, the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition (example 3).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Attawia et al. suggests antioxidants, Attawia et al. does not expressly teach monosodium luminol. However, this deficiency is cured by Reddy et al.
Reddy et al. is directed to neuroprotective effects of the drug GVT (monosodium luminol) is mediated by the stabilization of Nrf2 in astrocytes. GVT is a novel antioxidant and anti-inflammatory drug. GVT has been shown to reduce ROS levels and tissue damage (page 3).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al. and Reddy et al. and utilize GVT (monosodium luminol) as the antioxidant in Attawia et al. One skilled in the art would have been motivated to utilize this antioxidant with a reasonable expectation of success as Attawia et al. expressly teaches the inclusion of an antioxidant and Reddy et al. teaches that GVT is an antioxidant with anti-inflammatory properties and can reduce ROS levels and tissue damage.
Regarding the claimed substrate, the instant application indicates the substrate can be a gel (claim 13) and Attawia et al. teaches a hydrogel.
Regarding the claimed method steps and capabilities of the substrate claimed, Attawia et al. teaches inserting the composition/hydrogel at the site of disease. The “closing” an incision site is conditional on the application being done as part of a surgery. Attawia et al. expressly teaches the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition. One skilled in the art would recognize that if necessary where the skin is punctured can be closed (to prevent bleeding). Attawia et al. teaches a bioresorbable polymer suggest the substrate is capable of being absorbed.
Regarding the claimed “for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery” and “for reducing inflammation and scarring”, these limitations are directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
Regarding claim 9, since the antioxidant is found throughout the hydrogel it reads on a first and second layer of GVT.
While the instant claims indicate the substrate can be a hydrogel and thus would have a top and bottom surface as required in the claims, the following rejections are based on a narrower interpretation of substrate.
Claims 1-3, 5-8, 10-14, 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Attawia et al. (WO2005000283A2) in view of Malfroy-Camine et al. (US Patent No. 7122537) and Hodgkinson et al. (USPGPUB No. 20140155916, cited on PTO Form 1449).
Applicant Claims
The instant claims are set forth above.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Attawia et al. and Malfroy-Camine et al. are set forth above. Attawia et al. teaches a hydrogel.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Attawia et al. suggests a hydrogel, Attawia does not expressly teach a multilayered top and bottom surface. However, this deficiency is cured by Hodgkinson et al.
Hodgkinson et al. teaches a multi-layer porous film material. The material is a surgical implant (claim 1). Taught is a multi-layered implant including at least two porous film layers joined at attachment points for use in a variety of surgical applications (paragraph 0024). Taught is loading the openings with filler material such as hydrogels (paragraph 0036-0037). Other filler material include anti-inflammatory agents (paragraph 0038). The surgical implant can be used in a variety of surgical applications, wherein the properties of each layer of the implant can be controlled by material selection, pore size, and pore distribution, and the layered construction of the implant can be tailored to produce an implant having the desired mechanical strength and tissue compatibility necessary for favorable host interaction (paragraph 0005; 0011).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al., Malfroy-Camine et al. and Hodgkinson et al. and utilize the cyclic salen-metal compound, specifically C107, as the antioxidant in Attawia et al. One skilled in the art would have been motivated to utilize this antioxidant with a reasonable expectation of success as Attawia et al. expressly teaches the inclusion of an antioxidant such as superoxide dismutase and Malfroy-Camine et al. teaches that the salen-metal compounds have superoxide dismutase activity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al., Malfroy-Camine et al. and Hodgkinson et al. and utilize the hydrogel with the antioxidant in the surgical film of Hodgkinson et al. One skilled in the art would have been motivated with a reasonable expectation of success to utilize the surgical implant as it is taught for delivering compositions such as hydrogels.
Regarding the claimed method steps and capabilities of the substrate claimed, Attawia et al. teaches inserting the composition/hydrogel at the site of disease. The “closing” an incision site is conditional on the application being done as part of a surgery. Attawia et al. expressly teaches the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition. One skilled in the art would recognize that if necessary where the skin is punctured can be closed (to prevent bleeding). Attawia et al. teaches a bioresorbable polymer suggest the substrate is capable of being absorbed.
Regarding the claimed “for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery” and “for reducing inflammation and scarring”, these limitations are directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
Regarding claim 8, Hodgkinson et al. teaches a first and second porous film layer with pores. The pores are filled with filler which can be the hydrogel composition of Attawia et al. This results in the EUK-207 in both the first and second layer and on the top and bottom surface.
Claims 1, 4-7, 9-14, 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Attawia et al. (WO2005000283A2) in view of Reddy et al. (Neurochem Int., 2014) and Hodgkinson et al.
Applicant Claims
The instant claims are set forth above.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Attawia et al. and Reddy et al. are set forth above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Attawia et al. suggests a hydrogel, Attawia does not expressly teach a multilayered top and bottom surface. However, this deficiency is cured by Hodgkinson et al.
Hodgkinson et al. teaches a multi-layer porous film material. The material is a surgical implant (claim 1). Taught is a multi-layered implant including at least two porous film layers joined at attachment points for use in a variety of surgical applications (paragraph 0024). Taught is loading the openings with filler material such as hydrogels (paragraph 0036-0037). Other filler material include anti-inflammatory agents (paragraph 0038). The surgical implant can be used in a variety of surgical applications, wherein the properties of each layer of the implant can be controlled by material selection, pore size, and pore distribution, and the layered construction of the implant can be tailored to produce an implant having the desired mechanical strength and tissue compatibility necessary for favorable host interaction (paragraph 0005; 0011).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al., Reddy et al. and Hodgkinson et al. and utilize GVT (monosodium luminol) as the antioxidant in Attawia et al. One skilled in the art would have been motivated to utilize this antioxidant with a reasonable expectation of success as Attawia et al. expressly teaches the inclusion of an antioxidant and Reddy et al. teaches that GVT is an antioxidant with anti-inflammatory properties and can reduce ROS levels and tissue damage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Attawia et al., Reddy et al. and Hodgkinson et al. and utilize the hydrogel with the antioxidant in the surgical film of Hodgkinson et al. One skilled in the art would have been motivated with a reasonable expectation of success to utilize the surgical implant as it is taught for delivering compositions such as hydrogels.
Regarding the claimed method steps and capabilities of the substrate claimed, Attawia et al. teaches inserting the composition/hydrogel at the site of disease. The “closing” an incision site is conditional on the application being done as part of a surgery. Attawia et al. expressly teaches the clinician punctures the skin of the patient dorsal the disc of concern and advances a needle to inject the composition. One skilled in the art would recognize that if necessary where the skin is punctured can be closed (to prevent bleeding). Attawia et al. teaches a bioresorbable polymer suggest the substrate is capable of being absorbed.
Regarding the claimed “for protecting neurons, reducing inflammation and scarring, and accelerating tissue recovery” and “for reducing inflammation and scarring”, these limitations are directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 and MPEP 2145.
Regarding claim 9, since the antioxidant is found throughout the hydrogel and Hodgkinson et al. teaches a first and second porous film layer with pores wherein the pores are filled with filler which can be the hydrogel composition of Attawia et al. This results in the GVT in both the first and second layer and on the top and bottom surface.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11911504. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a method for treating pain associated with a disease of the spine in a subject in need thereof, the method comprising, injecting a pharmaceutical composition into a spinal space of the subject, the pharmaceutical composition comprising a bioabsorbable substrate and an oxidation inhibitor, wherein the substrate is capable of being absorbed when injected into the spinal space and the oxidation inhibitor is capable of triggering the subject's anti-oxidant defenses, whereby the pain is reduced or eliminated.
Patent ‘504 claims a method for treating pain associated with a disease of the spine in a subject in need thereof, the method comprising: injecting a pharmaceutical composition into a spinal space of the subject, the pharmaceutical composition comprising a bioabsorbable substrate and an oxidation inhibitor; wherein the substrate is capable of being absorbed when injected into the spinal space and is a prolonged release delivery vehicle, wherein the oxidation inhibitor is capable of triggering the subject's anti-oxidant defenses, whereby the pain is reduced or eliminated, and wherein the only oxidation inhibitor administered in said method is a small molecule mimetic of superoxide dismutase and catalase, and wherein the oxidation inhibitor is EUK-8, EUK-189 or EUK-207.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another.
The examiner notes that while the instant application is a DIV, claim 32 is not consonant with the restriction as this claim is directed to the same invention. Thus the 121 shield does not apply.
Conclusion
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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