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 use of the term "GE Healthcare" (page 18), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because the metes and bounds of what are considered to be “complex” extracts are unclear. Claim 2 and the specification gives an example of a “complex” extract; however, the specification specifically states that this is only considered to be a non-limiting example of a “complex” extract (see paragraph 17). Thus, it is unclear what other types of extracts would be considered “complex”. Claims 3 and 4 are also considered indefinite because they do not clarify the definition of “complex.” Clarification of the claimed scope is needed.
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, 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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (WO 2006099783 A1 – English translation provided) in view of Yang (KR 100881368 B1 – English translation provided), Wang (CN 1105748666 A – English translation provided), Meyer (U.S. Pub. No. US 2021/0052684 A1), Gao (CN 109550035 A – English translation provided), Abubakar et al (Journal of Pharmacy & BioAllied Sciences (Year: 2020), vol. 12, issue. 1, pp 1-10), and Payne et al (Journal of the Academy of Nutrition and Dietetics (Year: 2012), vol. 112, issue. 12, pp 2022-2027).
Regarding claim 1, Zhang teaches a pharmaceutical composition for treating depression (abstract). Zhang also teaches the [pharmaceutical] composition comprises [including but not limited to] Radix Glycyrrhizae, or their aqueous or alcoholic extract [and] Fructus Jujubae or its aqueous or alcoholic extract can also be included in the composition (abstract). Zhang does not teach a composition comprising six extracts: Zizyphi spinosi semen, Jujubae fructus, Hordei fructus germinatus, Glycyrrhizae radix et rhizoma, Angelicae gigantis radix, and Beta vulgaris. Yang teaches a pharmaceutical composition of preventing and treating depression comprises extract from [including but not limited to]: Zizyphi spinosi semen (abstract). Wang teaches a medicine composition containing folium artemisiae argyi [for] preventing and treating depression…the medicine is prepared from the following raw materials in part by weight [including but not limited to]: Chinese angelica 8-12 parts by weight (abstract). Meyer teaches a method of treating or preventing postpartum blues or depression (abstract), comprising administering to a subject in need thereof [including but not limited to]: an antioxidant source (abstract), the antioxidant source may comprise a food or an extract derived from such a food as [including but not limited to]: beets (abstract). Gao teaches a traditional Chinese medicine composition in preparing antidepressant medicine, said traditional Chinese medicine composition is composed of the following raw materials in terms of parts by weight [including but not limited to]: 4~12 parts of malt (abstract). Abubakar et al teaches the preparation of medicinal plants for experimental purposes is an initial step and key in achieving quality research outcome (abstract). It involves extraction and determination of quality and quantity of bioactive constituents before proceeding with the intended biological testing (abstract). Payne et al teaches that higher consumption of fruits and vegetables has been found to lead to better cognitive test scores, fewer depressive symptoms, and lower risk of depression (page 2).
The pharmaceutical composition as taught by Zhang can be modified to include the extracts of Glycyrrhizae radix et rhizome (e.g. liquorice or licorice) and Jujubae fructus (e.g. Fructus Jujubae) as taught by Zhang, Zizyphi spinosi semen as taught by Yang, Angelicae gigantis radix (e.g. Chinese angelica) as taught by Wang, Beta vulgaris (e.g. beets) as taught by Meyer, and Hordei fructus germinates (e.g. malt) as taught by Gao. In addition, beets as taught by Meyer, are considered as an antioxidant source combined with the teachings of Payne et al, that demonstrates that fruits and vegetables (e.g. beets) have the ability to contribute to a reduction in depressive symptoms and risk of depression thus making the Meyer reference sufficient to include within the modification of Zhang. The Abubakar et al reference teaches the importance of extraction from medicinal plants in order to achieve bioactive constituents which can also be used in the modification of Zhang, thus contributing to a production of the pharmaceutical composition composed of the six ingredients as stated within the claimed invention. The method used for obtaining the extracts, as taught by Zhang, licorice is extracted with water (page 3); the water extraction method taught by Zhang can be applied to the six ingredients, as claimed within the present invention, to achieve a product: a pharmaceutical composition for treating depression in a subject. In addition, it is intrinsic that an extraction from a mixture of different ingredients will yield a complex mixture of isolated bioactive compound(s) necessary for the presently claimed invention composition of interest. These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients further extracted complex extracts in a composition that would treat depression. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a composition which is useful for the same purpose. The idea for combining them flows logically from them having been used individually in the prior art.
Based on the disclosure by these references that these ingredients are used in compositions to treat depression, an artisan of ordinary skill would have a reasonable expectation that a combination of the ingredients would also be useful in creating compositions to treat depression. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
Regarding claim 2, the Yang reference teaches lower alcohol of C1 to C4 or Hot water extraction, cold extraction, reflux cooling with a mixed solvent thereof, preferably water, for about 1 hour to 1 day, preferably 2 hours to 8 hours at a temperature of 0 to 120 ° C., preferably 20 to 100 ° C (page 5). The person of ordinary skill in the art would have found it obvious to use Yang’s method of extraction in order to obtain complex extracts of the six ingredients, as claimed within the present invention, in order to create a pharmaceutical composition, as taught by Zhang, to administer to a subject in need thereof.
Regarding claim 3, Zhang teaches a group selected from the group consisting of [including but not limited to]: 3 to 14 parts by weight of licorice (page 2), Further, in the above pharmaceutical composition (1), the group (A) or (B) may further include: 3 to 14 parts by weight of jujube water extract or ethanol extract (page 2). However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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)” Varying the concentration or amount within or between ingredients is not considered to be inventive unless the concentration or amount are deemed as critical. In this particular case, there is no evidence that the claimed amounts of ingredients within a mixture that is used to produce an extract would yield an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious before the effective filing date of the applicant’s claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (WO 2006099783 A1 – English translation provided) in view of Yang (KR 100881368 B1 – English translation provided), Wang (CN 109512972 A – English translation provided), Meyer (U.S. Pub. No. US 2021/0052684 A1), Gao (CN 109550035 A – English translation provided), Abubakar et al (Journal of Pharmacy & BioAllied Sciences (Year: 2020), vol. 12, issue. 1, pp 1-10), Payne et al (Journal of the Academy of Nutrition and Dietetics (Year: 2012), vol. 112, issue. 12, pp 2022-2027), and Wang et al (Molecular Neurobiology (Year: 2019), vol. 56, pp 6179-6205). Regarding claim 4, the teachings are described above for Zhang, Yang, Wang, Meyer, Gao, Abubakar et al and Payne et al. Wang et al teaches brain-derived neurotrophic factor (BDNF), an immediate upstream regulator of ERK, and cAMP response element-binding protein (CREB), a transcription factor downstream to ERK, were downregulated in parallel and play a similar role as ERK in depression (page 2). A person of ordinary skill in the art would modify Zhang’s pharmaceutical composition to include the teachings of Wang et al to further emphasize the gene(s), kinase(s), and protein(s) that are impacted on a cellular and molecular scale in order to treat a subject. It would have been intrinsic to combine all references, Zhang, Yang, Wang, Meyer, Gao, Abubakar et al, Payne et al, and Wang et al to create a pharmaceutical composition to administer to a subject in need thereof using Zhang’s method that would intrinsically increase the protein expression of Brain-Derived Neurotrophic Factor (e.g. BDNF), Extracellular Signal-Regulated Kinase (e.g. ERK), and cAMP Response Element-Binding Protein (CREB) as claimed within the present invention.
Conclusion
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/NASHARA L MOREAU/Examiner, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655