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 .
Claim Status
Claims 1-20 are pending and being examined on the merits.
Information Disclosure Statement
The information disclosure statements do not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Specification
The disclosure is objected to because all scientific names throughout the specification should be italicized with the genus name capitalized and the species name in lowercase. For example, in [0007], “Carthamus Tinctorius” should instead read “Carthamus tinctorius” and “Prunus Persica” should instead read “Prunus persica.” Similar corrections should be made throughout the specification.
Appropriate correction is required.
Claim Objections
Claims 2 and 4 are objected to because all scientific names should be italicized with the genus name capitalized and the species name in lowercase. For example, “Prunus Persica” should instead read “Prunus persica.”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10-13, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moha Ou Maati et al. (AU 2014253521 A1).
The instant claims are as of record, drawn to a method for inducing or accelerating recovery from a spinal cord injury comprising administering to a patient in need thereof a composition comprising at least the four herbal components Radix Polygalae, Radix Astragali, Rhizome Ligusticum chuanxiong, and Radix Angelica sinensis.
Moha Ou Maati et al., however, anticipate the claims by teaching the herbal composition MLC901, which comprises Radix astragali, Radix salvia miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Semen persica, Radix polygala, and Rhizoma acori tatarinowii (Moha Ou Maati et al., Table, pg. 18; as required for instant Claims 1-4, 7, and 8). The composition can also be provided as a pharmaceutical composition (Moha Ou Maati et al., pg. 30, ln. 6; as required for instant Claim 5) and include dextrin or maltodextrin as an excipient (Moha Ou Maati et al., pg. 18, ln. 10-11; as required for instant Claim 6). The composition is administered to a subject orally three times per day in the form of 0.4 g (400 mg) capsules (effective amount), which for an 80 kg subject is a dose of 5 mg/kg (e.g., subjects could weigh between 4 kg and 400 kg and still receive the effective dose; Moha Ou Maati et al., pg. 33, ln. 14-23; as required for instant Claims 1 and 18).
The composition can be used for treating neurological disorders such as traumatic injuries to the spinal cord (induce or accelerate recovery; Moha Ou Maati et al., pg. 21, ln. 15-19; as required for instant Claim 1) and promotes survival of nervous system cells which are at risk of dying due to traumatic nerve damage resulting from a spinal cord injury (Moha Ou Maati et al., pg. 24, ln. 8-16). Additionally, the composition increased the mean number of neurites in cultured cortical neurons (regeneration of damaged neuronal tissue or cells; derived from cortical neuronal cells; promotes growth of neuronal cells; human neuronal cells (e.g., subject is a human, see pg. 9, ln. 5-13); Moha Ou Maati et al., pg. 42-45; as required for instant Claims 10-13).
Claim 1-5, 7, 8, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. (JMIR Res Protoc, 2016, 9 pages).
The instant claims are as of record, drawn to a method for inducing or accelerating recovery from a spinal cord injury comprising administering to a patient in need thereof a composition comprising at least the four herbal components Radix Polygalae, Radix Astragali, Rhizome Ligusticum chuanxiong, and Radix Angelica sinensis.
Kumar et al., however, anticipate the claims by teaching a method for treating (accelerate or induce recovery) patients with moderately severe to severe spinal cord injury with MLC901, an herbal composition comprising Radix astragali, Radix salviae miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Prunus persica, Radix polygalae, and Rhizoma acori tatarinowii which is provided in the form of 400 mg capsules (pharmaceutical composition; effective amount; Kumar et al., Abstract, pg. 1; Treatment, pg. 4; as required for instant Claims 1-5, 7, and 8). The dosage is two capsules, three times daily, and the capsules are 400 mg, which for an 80 kg subject is a dose of 5 mg/kg (e.g., subjects could weigh between 4 kg and 400 kg and still receive the effective dose) per capsule, or 2400 mg daily, which for an 80 kg subject is a dose of 30 mg/kg (e.g., subjects could weigh between 24 kg and 2400 kg and still receive the effective dose; Kumar et al., Treatment, pg. 4; as required for instant Claims 1 and 18). The subjects may receive concomitant medications and treatments (administering a second agent used for treating a subject with spinal cord injury; Kumar et al., Variables Collected, pg. 5; as required for instant Claim 19), including standard care deemed appropriate by the prescribing physician (Kumar et al., Treatment, pg. 4), and a common treatment for spinal cord injury is methylprednisolone, a corticosteroid which reduces inflammation (control pain; Kumar et al., Background, pg. 2; as required for instant Claim 20).
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.
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.
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 1-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Moha Ou Maati et al. (AU 2014253521 A1).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to a method for inducing or accelerating recovery from a spinal cord injury comprising administering to a patient in need thereof a composition comprising at least the four herbal components Radix Polygalae, Radix Astragali, Rhizome Ligusticum chuanxiong, and Radix Angelica sinensis.
Moha Ou Maati et al., however, anticipate the claims by teaching the herbal composition MLC901, which comprises Radix astragali, Radix salvia miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Semen persica, Radix polygala, and Rhizoma acori tatarinowii (Moha Ou Maati et al., Table, pg. 18; as required for instant Claims 1-4, 7, and 8). The composition can also be provided as a pharmaceutical composition (Moha Ou Maati et al., pg. 30, ln. 6; as required for instant Claim 5) and include dextrin or maltodextrin as an excipient (Moha Ou Maati et al., pg. 18, ln. 10-11; as required for instant Claim 6). The composition is administered to a subject orally three times per day in the form of 0.4 g (400 mg) capsules (effective amount), which for an 80 kg subject is a dose of 5 mg/kg (e.g., subjects could weigh between 4 kg and 400 kg and still receive the effective dose; Moha Ou Maati et al., pg. 33, ln. 14-23; as required for instant Claims 1 and 18).
The composition can be used for treating neurological disorders such as traumatic injuries to the spinal cord (induce or accelerate recovery; Moha Ou Maati et al., pg. 21, ln. 15-19; as required for instant Claim 1) and promotes survival of nervous system cells which are at risk of dying due to traumatic nerve damage resulting from a spinal cord injury (Moha Ou Maati et al., pg. 24, ln. 8-16). Additionally, the composition increased the mean number of neurites in cultured cortical neurons (regeneration of damaged neuronal tissue or cells; derived from cortical neuronal cells; promotes growth of neuronal cells; human neuronal cells (e.g., subject is a human, see pg. 9, ln. 5-13); Moha Ou Maati et al., pg. 42-45; as required for instant Claims 10-13).
Although Moha Ou Maati et al. teach each of the active steps in the claimed method, they are silent regarding the intended effects of the administration of the composition of the method as recited in instant Claims 9 (neuronal cell regeneration); 14 (spinal cord regeneration); 15 (regeneration of a connection between brain and spinal cord); and 17 (promotes limb motion recovery in paralyzed subjects). The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the composition of the prior art is the same as that of the instant invention. The single-step method of administration of a pharmaceutical composition in 400 mg capsule form comprising Radix astragali, Radix salvia miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Semen persica, Radix polygala, and Rhizoma acori tatarinowii to a subject with a spinal cord injury is the same, and thus the properties of neuronal cell regeneration, spinal cord regeneration, regeneration of a connection between brain and spinal cord, and promotion of limb motion recovery are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the method of the prior are is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses administration of a pharmaceutical composition in 400 mg capsule form comprising Radix astragali, Radix salvia miltiorrhizae, Radix paeoniae rubra, Rhizoma chuanxiong, Radix angelicae sinensis, Carthamus tinctorius, Semen persica, Radix polygala, and Rhizoma acori tatarinowii to a subject with a spinal cord injury which appears to be identical to the presently claimed method since the composition is formulated and/or obtained from the same component materials and is administered/administrable to a subject with a spinal cord injury. Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference. In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect for neuronal cell regeneration, spinal cord regeneration, regeneration of a connection between brain and spinal cord, and promotion of limb motion recovery are inherent) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 61, 62, 64, 68-70, 72-80 of copending Application No. 19/112,005 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the intended uses of instant Claim 1 (induce or accelerate recovery from a spinal cord injury) differs from those of ‘005 Claims 61 (treating neuroinflammation; caused by injury in Claim 64); 72 (preventing or limiting neuroinflammation; includes spinal cord injury in Claim 75); and 76 (at risk of developing a disease or condition as a result of neuroinflammation), the single-step method of administration is the same, as is the composition (instant Claims 1-8 overlap ‘005 Claims 61, 62, 68, 72-74, 76-80) and dose (instant Claim 18 overlaps ‘005 Claims 69) to be administered. The compositions may also be administered concomitantly with known treatments (instant Claim 19 and ‘005 Claim 70). Since the same composition is administered to the same populations (e.g., those with neuroinflammation which can be caused by spinal cord injury) at the same doses, the effects of instant Claims 9-17 are inherent to the methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and 7-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3 and 6 of U.S. Patent No. 9,289,459 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the intended uses of instant Claim 1 (induce or accelerate recovery from a spinal cord injury) differs from those of ‘459 Claims 1 (diminishing the effects of stroke or neurodegeneration) and 6 (at risk of stroke or neurodegeneration), the single-step method of administration is the same, as is the composition which is administered (instant Claims 1-4, 7, and 8 overlap ‘459 Claims 1-3 and 6). Since the same composition is administered to the same patient populations (e.g., those with neurodegeneration which can be caused by spinal cord injury; see e.g., instant specification at [00146]-[00147]), the effects of instant Claims 9-17 are therefore inherent.
Conclusion
No claims are currently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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