DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been previously filed in the parent application number 13/260,038, filed on 09/23/2011.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/17/2025 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 74-77 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yu et. al. (From IDS, Inhibitory effects of astragaloside IV on diabetic peripheral neuropathy in rats, Canadian Journal of Physiology and Pharmacology, Vol 84, No 6, June 2006), Lee et. al. (From IDS, Polygalae Radix Extract Protects Cultured Rat Granule Cells Against Damage Induced by NMDA, The American Journal of Chinese Medicine, Vol. 32, No. 4, 99 599-610, 2004), Li et. al. (From IDS, Analysis of volatile oil in Rhizoma Ligustici Chuanxiong-Radix Paeoniae Rubra by gas chromatography-mass spectrometry and chemometric resolution, Acta Pharmacologica Sinica, 2006 Apr; 237 (4): 491-498), Hsieh et. al. (From IDS, Radix Angelica Sinensis Extracts Ameliorate Scopolamine- and Cycloheximide-Induced Amnesia, but not p-Chloroamphetamine-Induced Amnesia in Rats, The American Journal of Chinese Medicine, Vol. 28, No. 02, Sept. 1999), Qui Deyou et. al. (CN1324562A), Cha jae Yeong et. al. (KR20020072841A), Chai Kyu Yun et. al. (KR20050080881A), Zhang Suzhen Li et. al. (CN1274343C) and Qi Jixing (CN1225276C).
Yu teaches “Astragaloside IV (AGS-IV), a new glycoside of cycloartane-type triterpene isolated from the root of Astragalus membranaceus (Fisch.) Bunge, has been used experimentally for its potent immune-stimulating, anti-inflammatory, and antioxidative actions”. Yu also teaches “these results indicate that AGS-IV exerts protective effects against the progression of peripheral neuropathy in STZ-induced diabetes in rats through several interrelated mechanisms” (see abstract).
Yu does not teach the other ingredients.
Lee teaches “Polygalae Radix (PR) from Polygala tenuifolia (Polygalaceae) is traditionally used in China and Korea, as this herb has a sedative, anti-inflammatory and antibacterial agent. To extend our understanding of the pharmacological actions of PR in the CNS on the basis of its CNS inhibitory effect, the present study examined whether PR has the neuroprotective action against N-methyl-D-aspartate (NMDA)-induced cell death in primarily cultured rat cerebellar granule neurons. PR, over a concentration range of 0.05 to 5 μg/ml, inhibited NMDA (1 mM)-induced neuronal cell death, which was measured by a trypan blue exclusion test and a 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide (MTT) assay. PR (0.5 μg/ml) inhibited glutamate release into medium induced by NMDA (1 mM), which was measured by HPLC. Pre-treatment of PR (0.5 μg/ml) inhibited NMDA (1 mM)-induced elevation of intracellular Ca2+ concentration ([Ca2+]i), which was measured by a fluorescent dye, Fura 2-AM, and generation of reactive oxygen species (ROS). These results suggest that PR prevents NMDA-induced neuronal cell damage in vitro.” (see abstract).
Li teaches “the Rhizoma Ligustici Chuanxiong (RLC)-Radix Paeoniae Rubra (RPR) HP[1–4] is commonly used in TCM for promoting blood circulation to remove stasis. These 2 herbs are used together to mutually strengthen their effects for the treatment of numb extremities or traumatic injuries and headache due to blood stasis” (see bottom of 491 and top of 492).
Li also teaches “most of the volatile chemical components of RLC-RPR are derived from the constituent herbs, RLC and RPR, but the relative amounts of them are altered. The main volatile chemical components of RLC-RPR are very similar to those of RLC. Thus, the pharmacological activities of RLC-RPR almost totally depend on the volatile chemical components of RLC.”
Hsieh teaches “the effects if the methanolic extract of Radix Angelica Sinensis (Umbellifera) (abbreviated as RAS extract) and n-hexane fraction of RAS extract (RASH fraction) on the various drugs-induced amnesia in rats were studied by using passive avoidance task. RAS extract (1 g/kg) significantly prolonged the shortened step-through latency induced by SCOP and CXM, but not PCA. Furthermore, RASH fraction (1 g/kg) also significantly prolonged the shortened step-through latency induced by SCOP and CXM but not PCA. RAS extract at any dose alone did not influence the step-through latency in the training trial produced by non-shocked rats, but it plus PCA prolonged the latency compared with PCA alone. However, RASH fraction (1 g/kg) prolonged the latency in the training trial produced by non-shocked rats, but it plus any induced drugs did not differ from any induced drugs alone. These results suggest that the attenuating effects of RAS extract on the various drugs-induced amnesia were related to the memory processes, n-Hexane fraction of RAS extract might be one of the active fractions of RAS extract in the treatment of amnesia” (see abstract).
Deyou teaches that “red sage root is China's traditional Chinese medicine, has to activate blood circulation and disperse blood clots inducing meastruation to relieve menalgia function. Contain two active components in the red sage root: fat-soluble diterpene quinone and water-soluble phenolic acid compounds. Diterpene quinone, as salvia miltiorrhiza bge I, tanshinone IIA, Cryptotanshinones etc. have and suppress platelet aggregation, anoxia enduring, improve pharmacological action such as coronary artery blood supply, are the important drugs of treatment disease of cardiovascular system. Phenolic acid compound, as salviandic acid A, tanshin polyphenolic acid B, alkannic acid, Rosmarinic acid, protocatechualdehyde, danshensus etc. have very strong lipotropism matter oxidation, anti-hepatic fibrosis, improve uremia, improve effects such as renal function” (see 2nd para., page 2).
Yeong teaches “Carthamus tinctorius flower as an active ingredient and a process for preparation thereof. The extract inhibits the peroxidation of lipid and is excellent in hydrogen donor activity and antioxidation activity” (see abstract).
Yun teaches that peach seed is known to contain compounds useful in treating inflammation (see abstract).
Li (CN1274343C) teaches that dried root slice of grassleaf sweetflag rhizomeis can be used to treat Herpe simple virus (see abstract).
Jixing teaches that red peony root can be used to treat cerebral infarction by improving behavior disorder, reduce water content in brain tissue, relieve lipoid peroxidation damage and increase the capacity for resting acute hypozxia (see abstract). Jixing also teaches that Radix Paeoniae Rubra has many-sided pharmacological actions such as protection heart, coronary blood flow increasing, antithrombotic formation and atherosclerosis, sedation and analgesia, anti-inflammatory, antibacterial, antioxidation (see first para.).
Therefore, it would have been obvious at the effective filing date to any person having skill in the art to combine the four ingredients into a composition in use for neuroprotection. Yu teaches that Astragaloside IV, a component of radix astragali exerts protective effects against the progression of peripheral neuropathy. Lee teaches Polygalae Radix prevents NMDA-induced neuronal cell damage in vitro. Li teaches Rhizoma Ligustici Chuanxiong (RLC) is commonly used in TCM for promoting blood circulation to remove stasis and that the pharmacological activities of RLC-RPR almost totally depend on the volatile chemical components of RLC. Thus, the beneficial activities for promoting blood circulation and removing stasis would be expected in the RLC extracts. Hsieh teaches the extract of Radix Angelica Sinensis can improve neuronal functions in amnesiac patients thus showing a neuroprotective and additionally added benefit being relied to the composition. It would have been obvious to include red sage root for treatment of the cardiovascular system and for improving renal function, Carthamus tinctorius flower for its antioxidant activity, peach seed for treating inflammation, grassleaf sweetflag rhizomeis for treating herpes simplex virus and red peony root for its many properties of heart protection, increasing coronary blood flow, antithrombotic formation or analgesia, anti-inflammatory, antibacterial, antioxidation agent. Doing so would create a traditional Chinese medicine composition that could thwart of a combination of ailments.
It would have been further obvious to formulate the composition as a tablet or capsule for oral administration and wherein the composition further comprises a pharmaceutically acceptable additive, carrier or diluent because these are all conventionally done in the art and themselves are not inventive.
There would have been a reasonable expectation of success in arriving at the instant invention of a composition consisting essentially of purified extracts of each of four herbal components:i) Radix Astragali (root of Membranous Milkvetch or Huang Qi); iii) Rhizome of Ligusticum Chuanxiong (Chuan Xiong); and iv) Radix Angelicae (root of Chinese Angelica or Dang Gui) because combining each into a composition for neuroprotection would have been obvious for the reasons stated above.
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 claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 74-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of U.S. Patent No. 10,188,688. Although the claims at issue are not identical, they are not patentably distinct from each other because the composition contains the same four ingredients: i) Radix Astragali; ii) Radix Polygalae; iii) Rhizoma Chuanxiong; and iv) Radix Angelicae at the same ratios of 1:1:1:5. The claims in U.S. patent No. US 10,188,688 states “Chinese angelica” and Rhizome of Ligsticum Chuanxiong, however, these are the common names for Angelica sinensis and for rhizome Chuanxiong.
The claims as written appear to contain the exact same ingredients and in the same ratios. U.S. Patent No. UScommon names for the ingredients. For instance, Radix Angelicae is commonly known as Radix Angelica sinensis. Furthermore, the specifications describe the use of radix Angelica sinensis being utilized in the examples and the parenthesis which comes after the term directs readers to the Chinese common name for Angelica sinensis, Dang Gui. The U.S. Patent No. US
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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