DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 5-16 and Species D the NK 112 strain and/or the Cuscuta japonica Choisy extract and the Cuscuta australis R. Br. Extract, in the reply filed on 5/12/26 is acknowledged.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-Deposit Information
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain Lactobacillus paracasei NK112 strain (Accession Number: KCCM12566P). Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required.
Applicants have provided a copy the Deposit Certificate for the NK112 strain and the Deposit was made under the Budapest Treaty. Paragraph [0123] of the instant specification recites the date of the deposit and the complete name and full street address of the depository
However, if the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Applicants need to provide this affidavit/declaration or statement.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5, 9-13 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claims are drawn to a product which exists in nature. The instant claims currently allow for just one selected from the group consisting of a Lactobacillus paracasei NK112 stain, a Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract. The NK112 strain was isolated from human feces. Accordingly, the claimed product is not markedly different from what naturally exists in nature. Even though isolation structurally changes a bacterium from its natural state, the resultant difference is no enough to render the isolated bacterium different because the genetic structure and composition has not been altered. The term “pharmaceutical composition” is an intended use only and the composition is identical to that found in nature. Additionally, the claimed functional limitations in the dependent claims would be inherent properties since the structure is the same. With respect to the elected Species which includes all three components, e.g., a Lactobacillus paracasei NK112 stain, a Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract, while there is no indication that mixing these three components has any changes to the structure of any of the components, the mixture has a changed functional property in that the function of treating cognitive dysfunction and/or intestinal dysfunction is higher than the sum of its individual components. This is a changed functional property that constitutes a markedly different characteristic. Therefore, the claimed mixture is not a “product of nature” exception and thus, is eligible. See Myriad, 133 S.Ct. at 2166-18.
Claim Rejections - 35 USC § 112-2nd paragraph
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 5-16 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 5 recites the Lactobacillus paracasei NK112 strain, but fails to recite the “deposited under the accession number: KCCM12566P,” e.g., as recited in withdrawn claim 1. The name NK112 alone does not adequately define the composition without the identifying deposit number. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. The deposit number is a critical limitation which should be recited in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5, 9-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moon et al (Behavioural Brain Research, 9/15/2016, Vol. 311, pp. 173-182).
The instant claims 5, 9-13 and 15 currently allow for just one selected from the group consisting of a Lactobacillus paracasei NK112 stain, a Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract.
Moon et al teaches the memory-enhancing effects of Cuscuta japonica Choisy via enhancement of adult hippocampal neurogenesis in mice. hippocampus are involved in learning and memory and that adult neurogenesis in this region may modulate cognition. The extract of Cuscuta japonica Choisy (CJ) is a well-known traditional Chinese herbal medicine that has been used since ancient times as a rejuvenation remedy. The systemic effects of this herb are widely known and can be applied for the treatment of a number of physiological diseases, but there is a lack of evidence describing its effects on brain function. Thus, the present study investigated whether CJ would enhance memory function and/or increase hippocampal neurogenesis using mice orally administered with CJ water extract or vehicle for 21days. Performance on the novel object recognition and passive avoidance tests revealed that treatment with CJ dose-dependently improved the cognitive function of mice. Additionally, CJ increased the Ki-67-positive proliferating cells and the number of doublecortin-stained neuroblasts in the dentate gyrus (DG) of the hippocampus, and double labeling with 5-bromo-2-deoxyuridine and neuronal specific nuclear protein showed that CJ increased the number of mature neurons in the DG. Finally, CJ resulted in the upregulated expression of neurogenic differentiation factor, which is essential for the maturation and differentiation of granule cells in the hippocampus. Taken together, the present findings indicate that CJ stimulated neuronal cell proliferation, differentiation, and maturation, which are all processes associated with neurogenesis. Additionally, these findings suggest that CJ may improve learning and memory via the enhancement of adult hippocampal neurogenesis. The functions recited in instant claims 9-13 and 15 would be inherent properties since the structure is the same as the composition instantly claimed.
Claim(s) 5, 9-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (KR 2014008804; 1/22/2014; provided by Applicants).
The instant claims 5, 9-13 and 15 currently allow for just one selected from the group consisting of a Lactobacillus paracasei NK112 stain, a Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract.
Kim et al teaches a composition comprising Cuscutae Semen ext. (Cuscuta australis R. Br. Extract) or a compound derived from the ext. for preventing and treating degenerative brain diseases. The extract can induce the secretion of nerve growth factor to help the growth of nerve cells. Therefore, the extract can be used in pharmaceutical compositions or health food for preventing or treating degenerative brain diseases. Cuscuta australis R. Br. extract is an extract from the seeds (or occasionally the whole plant) of a parasitic vine commonly known as Australian dodder. In traditional East Asian medicine, the dried seeds are known as Cuscutae Semen (Tu Si Zi) and have long been used as a medicinal herb. The functions recited in instant claims 9-13 and 15 would be inherent properties since the structure is the same as the composition instantly claimed.
Status of Claims:
No claims are presently allowed.
The pharmaceutical composition comprising Lactobacillus paracasei NK112 and the Cuscuta australis R. Br. Extract and/or a Cuscuta japonica Choisy extract strain is free of the prior art. Additionally, while the Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract are well-known individually and taught to be effective compositions for treatment of cognitive dysfunction, the combination of said Lactobacillus NK112 strain with a Cuscuta australis R. Br. Extract and/or a Cuscuta japonica Choisy extract is free of the prior art. Further, L. paracasei strains in general have been shown in the art to treat cognitive decline (see cited Background art below), but have not been shown to be combined with Cuscuta australis R. Br. Extract and a Cuscuta japonica Choisy extract which Applicants have shown creates an enhanced function.
Background art, not presently relied upon:
Huang et al (Nutrients (2018), 10(7), 894/1-894/13) Lactobacillus paracasei PS23 delays progression of
age-related cognitive decline in senescence
accelerated mouse prone 8 (SAMP8) mice
Probiotic supplements are potential therapeutic agents for age-related
disorders due to their antioxidant and anti-inflammatory properties.
However, the effect of probiotics on age-related brain dysfunction remains
unclear. To investigate the effects of Lactobacillus paracasei PS23
(LPPS23) on the progression of age-related cognitive decline, male and
female senescence-accelerated mouse prone 8 (SAMP8) mice were divided into
two groups (n = 6 each): the control and PS23 groups. From the age of 16
wk, these groups were given saline and LPPS23, resp., because SAMP8 mice
start aging rapidly after four months of age. After 12 wk of treatment,
we evaluated the effect of LPPS23 by analyzing their appearance,
behavior, neural monoamines, anti-oxidative enzymes, and inflammatory
cytokines. The PS23 group showed lower scores of senescence and less
serious anxiety-like behaviors and memory impairment compared to the
control group. The control mice also showed lower levels of neural
monoamines in the striatum, hippocampus, and serum. Moreover, LPPS23
induced the anti-oxidative enzymes superoxide dismutase (SOD) and
glutathione peroxidase (GPx). Higher levels of tumor necrosis factor
(TNF)-α and monocyte chemotactic protein-1 (MCP1) and lower levels
of interleukin (IL)-10 indicated that LPPS23 modulated the inflammation.
Our results suggest that LPPS23 supplements could delay age-related
cognitive decline, possibly by preventing oxidn. and inflammation and
modulating gut-brain axis communication.
Corpuz, Henry (: Nutrients, (2018 Jun 13) Vol. 10, No. 6. 6/13/18)
Long-Term Diet Supplementation with Lactobacillus
paracasei K71 Prevents Age-Related Cognitive Decline in
Senescence-Accelerated Mouse Prone 8.
This study aimed to assess the suppressive effect of long-term diet
supplementation with Lactobacillus strains on cognitive decline in the
senescence-accelerated mouse prone 8 (SAMP8) model. For 43 weeks,
fourteen-week-old female SAMP8 mice were fed a standard diet containing
0.05% (w/w) Lactobacillus casei subsp. casei 327 (L. 327) or
Lactobacillusparacasei K71 (L. K71) derived from rice grains and sake
lees, respectively. SAMP8 mice that were fed a L. K71-supplemented
diet had better cognitive performance compared with the control and L.
327 groups in the Barnes maze and passive avoidance tests.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 7/6/26
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