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 .
DETAILED ACTION
Claims 1-6 are currently pending in the instant application. Applicants have amended claims 1-6 in an amendment filed on October 18, 2024. Claims 1-6 are rejected in this Office Action.
I. Priority
The instant application claims benefit of Foreign Application CHINA 202311377639.7, filed on October 23, 2023.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 18, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 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. Specifically, claim 1 is drawn to “The method of dimyricetin-yl-diselenide” but there is no mention of “A method” and it is unclear what method Applicants are referring to in claims 1-3. The claims are considered indefinite because the limitation lacks antecedent basis. Applicants are suggested to amend claim 1 so that it reads “A method” and not “The method” to overcome the rejection.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps required in preparing the pharmaceutical composition. Applicants have provided no steps in the method for preparing the composition. Therefore, the claims are considered indefinite because it is unclear what method Applicants are claiming as the claimed invention. Applicants are suggested to include at least one step in the preparation method to overcome the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 1-6 are rejected under 35 U.S.C. 112(a) or 112, first paragraph, while being enabling for a pharmaceutical composition for alleviating and/or treating cardiovascular diseases does not reasonably provide enablement for a pharmaceutical composition for preventing cardiovascular diseases. 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.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
Applicants are claiming a pharmaceutical composition for alleviating and/or treating cardiovascular diseases. Support for the intended use is found in in vivo data for the effect on average body weight in mice; effect on SOD and MDA in plasma of mice; effect of the drug tested on aortic plaques in mice, etc. on pages 6-12 of the specification.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regard to therapeutic or prophylactic effects of any condition mediated by mimicking the activity of glutathione peroxidase, whether or not the condition is affected by the instant compounds' activity would make a difference.
For example, Applicants' claim is drawn to a method of preventing congenital heart disease. It is the state of the art that congenital heart disease is a problem with how the heart forms before birth. This disease prevents normal blood flow through the heart and beyond. More specifically, congenital heart disease is an issue with the heart’s structure that’s present at birth. The issues could be a hole in the heart wall, issues with the blood vessels or problems with the heart valves. Some cases are simple and does not cause any symptoms whereas other cases can be life-threatening. It is still unclear why the fetal heart doesn’t develop correctly in the uterus. There are no proven strategies for preventing congenital heart disease because people are born with it, usually from unknown causes (see URL https://my.clevelandclinic.org/health/diseases/21674-congenital-heart-disease)
There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is minimal for preventing cardiovascular diseases. There are no working examples present for prevention.
Test assays and procedures are provided in the specification such as in vivo data for the effect on average body weight in mice; effect on SOD and MDA in plasma of mice; effect of the drug tested on aortic plaques in mice, etc. on pages 6-12.
Receptor activity is generally unpredictable and the data provided is insufficient for one of ordinary skill in the art in order to extrapolate to the other compounds of the claims. It is inconceivable as to how the claimed compounds can treat the extremely difficult diseases embraced by the instant claims.
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The breadth of the claims
The breadth of the claims is a pharmaceutical composition for preventing, alleviating and/or treating cardiovascular diseases.
The quantity of experimentation needed and the level of the skill in the art
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases would be benefited by the effects of administering the claimed compound and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment or prevention of the diseases.
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
This rejection can be overcome, for example, by deleting “preventing” from the rejected claims.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song, et al. (US 2022/0071947 A1). The instant invention claims
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The Song, et al. reference teaches the pharmaceutical application of the compound
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(See page 2, paragraph 0025) for treating tumors and resistance of new coronavirus. The prior art also teaches preparing a composition comprising the claimed compound (see paragraph 0034, page 3). This species of compound anticipates the species compound of the instant invention.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626
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