DETAILED ACTION
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 .
Priority
2. The instant application claims is a national stage entry of PCT/CN2022/102041, filed June 28, 2022.
3. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) by application no. CN202110744200.8 filed in the Chinese Patent Office July 1, 2021, which papers have been placed of record in the file. The application names an inventor or inventors named in the prior application.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on October 14, 2024 is in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS document was considered. A signed copy of form 1449 is enclosed herewith.
Election/Restrictions
5. Applicant’s election with traverse of Group I in the reply filed on March 27, 2026 is acknowledged. Upon further consideration, the restriction requirement mailed February 11, 2026 is withdrawn. All claims are rejoined.
Status of Claims
6. Claims 1-20 are pending and under consideration herein.
Claim Objections
7. Claim 12 is objected to for being written in improper Markush format. As written, the word "or" should be added between the second to last and last species of the Markush series. See MPEP 2173.05(h). “When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.”
8. Claim 12 is missing a period at the end of the claim.
9. Claim 19 is missing a period at the end of the claim.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 17-18 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 treating TXA2-related disease or thrombotic disease selected from myocardial infarction, pulmonary embolism, or cerebral thrombosis, does not reasonably provide enablement for preventing the aforementioned conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claims is drawn to methods for the treatment and prevention of myocardial infarction, pulmonary embolism, or cerebral thrombosis.
(b) Nature of the invention - The nature of the invention is therefore drawn to the pharmaceutical art. These claims cover diseases that are known to exist and those that may be discovered in the future, for which there is no enablement provided.
(c,e) State of the prior art and predictability 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 or preventative regimen on its face.
The term treatment is defined in the specification as follows:
The prophylaxis or “prevention” means to anticipate or counter in advanced, to keep from happening, etc. and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compounds and compositions can be administered in order to have the "preventive" effect, and if the instantly claimed compounds are administered to the subject, how can one of skill in the art reasonably prove that the administration caused the subject not to contract the disorder, or if they would not have contracted it without administration? How the initial onset of claimed conditions prevented?
While a full discussion of each disease which is encompasses by Applicant’s claim language will not be given, the following examples teach that the state of the prior art with respect to the claimed diseases has not advanced to the point of being predictive of the treatment of the breadth of diseases instantly claimed.
A heart attack, or myocardial infarction, occurs when blood flow to a part of the heart is blocked, often due to fatty deposits that form plaques in the arteries. This blockage can lead to damage or death of heart muscle tissue if not treated promptly. Common symptoms include chest pain, shortness of breath, and discomfort in other areas of the upper body. Risk factors include high cholesterol, high blood pressure, smoking, and diabetes. Treatment options may involve medications, lifestyle changes, or surgical procedures to restore blood flow. Healthy habits are the best defense against heart disease. You can reduce some risk factors for heart disease by not smoking, exercising, eating healthy, getting enough sleep and being at a healthy weight. There is no current known preventative medication for myocardial infarction in the current state of 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.
(d) Level of one of ordinary skill in the art - The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
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.
(f-g) Amount of direction provided by the inventor and existence of working examples - The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable and preventable by the claimed.
There are absolutely no working examples present for the prevention of any disease encompassed by the claims.
Test assays and procedures are not provided in the specification and the disclosure does not provide how the in vitro data correlates to the treatment and prevention of the assorted disorders of the instant claims. The assay data of the specification does not provide adequate correlation for the treatment and prevention of the broad scope of disorders claimed. See pages 91-96 of the specification.
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).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases/disorders or conditions claimed herein. That a single compound can be used to treat/prevent all diseases/disorders and conditions embraced by the claim is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all of the diseases/disorders or conditions by administering the instant claimed compound.
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases, disorders, or conditions out of all diseases, disorders, or conditions would be benefited by the compounds of formula I and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment and prevention of the diseases.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the pharmaceutical compositions for the full scope of the claimed intended uses.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, 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. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
While being enabling for compositions and methods for the treatment of anemia, chronic kidney disease, renal insufficiency, coronary heart disease, angina pectoris, myocardial infarction, arteriosclerosis, pulmonary and malignant hypertension, and peripheral arterial occlusive disease, does not reasonably provide enablement for compositions and methods for the prophylaxis of anemia, chronic kidney disease, renal insufficiency, coronary heart disease, angina pectoris, myocardial infarction, arteriosclerosis, pulmonary and malignant hypertension, and peripheral arterial occlusive disease or compositions and methods for the treatment and prophylaxis of the full scope of claimed diseases.
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 compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 14, 16, 17, 18, and 20 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.
Regarding claims 14, 17, and 20 the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 16 recites the broad recitation “a method for inhibiting TXA2 synthase,” and the claim also recites “preferably the method is used in mammalian organisms in vivo or used in vitro” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 recites the broad recitation “a method for treating or preventing a TXA2- related disease,” and the claim also recites “preferably the TXA-2related disease is a thrombotic disease” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18 recites the broad recitation “a method for treating or preventing a thrombotic disease,” and the claim also recites “preferably the thrombotic disease is myocardial infarction, pulmonary…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 recites “the leaving group is Cl or Br” and “the hydroxyl protecting group is TBS.” There is insufficient antecedent basis for these limitations in the claim.
Conclusion
14. Claims 1-11, 13, and 15 are allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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