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 .
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 05/11/2026 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 1-7 is contained herein.
Group II, claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application claims foreign priority to REPUBLIC OF KOREA 10-2022-0180733 filed 12/21/2022, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Specification
The disclosure is objected to because of the following informalities: In the specification, chemical formulae 1-3 at pages 4-5, 7-8, 19, 21 and 22 are fuzzy. Applicant is requested to provide formulas which are clear. Appropriate correction is required.
Claim Objections
Claims1, 3-4, and 6-8 (claim 8 not elected) are objected to because of the following informalities: In claims 1, 3, 4, 7 and 8 the name of the plant species should be italicized. The period before the term Yamaz should be deleted in claims 3, and 7. The period before and after the term Yamaz should be deleted in claims 1, 4 and 8. Claims 1 and 8 should also recite ‘to a subject in need thereof”. The chemical formulas in claims 4, 6 and 8 are fuzzy. Clear structural formulas are needed. Also, claims 4 and 6 should recite ‘a compound of formula 1, 2 or 3’ instead of reciting ‘a compound 1 represented by Chemical formula 1 below, a compound represented by Chemical formula 2 below, and a compound 3 represented by Chemical Formula 3 below’. The brackets enclosing Chemical Formula 1, Chemical formula 2 and Chemical Formula 3 should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-4, and 6-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of promoting a differentiation of CD4+ T cells into Th17 cells and suppression of a differentiation into regulatory T cells as in claim 5, wherein the extract comprises at least one compound of chemical formula 1-3, does not reasonably provide enablement for a method of enhancing immunity or anti-cancer activity via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject as in claims 1-4 and 6-7. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention
(2) The state of the prior art
(3) The relative skill of those in the art
(4) The predictability or unpredictability of the art
(5) The breadth of the claims
(6) The amount of direction or guidance presented
(7) The presence or absence of working examples; and
(8) The quantity of experimentation necessary.
The most relevant factors are discussed below.
The nature of the invention
The instant invention pertains to a method for enhancing immunity or anticancer activity comprising administering an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject.
The breadth of the claims
The instant claims recite enhancing immunity or anticancer activity. The said terms are broad and include immunity to any disease/condition and anticancer activity against all cancers.
The amount of direction provided or guidance presented by the inventor
The specification (pages 1-2) teaches the role of Th17 and Treg. It is stated that inhibition and inactivation of the Treg cells may cause tumor-specific T cell activation and improve the effectiveness of cancer immune therapy. Reports on compounds that simultaneously control the balance of the two sub-group of cells are extremely rare.
The level of Predictability or Unpredictability in the Art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed. Togashi et al (Nature Reviews: Clinical Oncology, 2010, 16, 356-371) teaches that one of the key points is that T reg cells can suppress antitumor immunity, thereby hindering immunosurveillance against cancer development in individuals without existing cancer and hampering effective antitumor immune response in tumor bearing hosts. Treg cells with an activated phenotype can be enriched in tumor compared to peripheral blood, which is associated with a poor prognosis in patients with various types of cancer (page 357-Key points; page 360, right col., first full para). No T reg cell targeted therapy has been proven to be effective in the clinic, owing predominantly to the difficulties associated with selectively targeting T reg cells. In particular, whether such drugs selectively deplete T reg cells in the tumor microenvironment of patients with cancer remains unclear (Conclusions). This means that just suppressing a differentiation into regulatory T cells is not sufficient for enhancing immunity or anticancer activity via administration of an active agent like the ones administered in the instant method.
Zou (Nature Reviews: Immunology, 2006, 6, 295-307) teaches that Treg cells can dampen adaptive immunity as well as innate immunity (page 300, left col., last para through right col., first two paragraphs). Tumors develop different mechanisms to escape tumor immunity and defeat conventional tumor immunotherapy. T reg cells might not be the only or important suppressive mechanism for certain tumor stages and/or certain tumors (page 304, right col. first para; page 305-Concluding Remarks). Therefore, differentiation of CD4+ cells into Th17 cells and suppressing a differentiation and function of regulatory T cells alone does not enable the method of enhancing immunity or anti-cancer activity via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject. The instantly claimed invention is therefore highly unpredictable.
The presence or absence of working examples
The working examples set forth in the instant specification are drawn to confirmation of differentiation and functional enhancement activity of TH17 cells and functional enhancement activity of Treg cells in a mouse model using compounds of formula 1-3. Example 3-2 at page 23 refers to Fig. 3 which is incorrect. The examples provided show enablement for a method for promoting a differentiation of CD4+ T cells into Th17 cells and suppression of a differentiation into regulatory T cells as in claim 5 via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject wherein the extract comprises at least one compound of chemical formula 1-3, but does not reasonably provide enablement for a method of enhancing immunity or anti-cancer activity via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject as in claims 1-4 and 6-7. One of ordinary skill in the art will not extrapolate the results from these examples to the method of enhancing immunity or anti-cancer activity via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject as claimed. As a result, it necessitates one of ordinary skill in the art to perform undue experimentation in search for the embodiments of using the active agents in the method as recited in the instant claims.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
In view of the information set forth, the instant disclosure is not seen to be sufficient to provide enablement for a method of enhancing immunity or anti-cancer activity via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T. Yamaz to a subject as in the instant claims. One of ordinary skill in the art would have to carry out undue experimentation to practice the instant invention.
Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Conclusion
1. Claims 1-4, and 6-7 are rejected.
2. Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form as a method of promoting a differentiation of CD4+ T cells into Th17 cells and suppress a differentiation into regulatory T cells via administration of an extract of Pseudoysimachion nakaianum (Ohwi) T Yamaz to a subject in need thereof, wherein the extract comprises at least one compound selected from the group consisting of compounds of formula 1-3.
3. Group II, claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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