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
The instant claims are the national stage entry of PCT/CN2023/109519 filed 27 July 2023. Acknowledgement is made of the Applicant’s claim of foreign priority to CN202210930967.4 filed 4 August 2022.
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 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 19-20 are “use” claims. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
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 19-20 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. While being enabling for treating conditions known to have an effect by the claimed compounds, the specification does not reasonably provide enablement for preventing any and all conditions listed in claims 19-20. The claim 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 does not reasonably provide enablement for prevention of any and all conditions listed in claims 19-20 such as, for example, Zollinger-Ellison syndrome, gastric cancer, and functional dyspepsia. Prevention involves “attacking” the underlying cause of the recited conditions; i.e., disrupting the mechanisms which give rise to it. The skilled artisan is aware that the causes of said conditions were not fully known at the time of the invention herein. For purposes of enablement, the specification must provide reasonable detail in order for those skilled in the art to carry out the invention. In this case, the specification must disclose a means of preventing inflammation regardless of the underlying causes of the inflammation. The teachings of the specification do not enable a person of ordinary kill in the art to make and use the claimed method of prevention. Moreover, “[p]atent protection is granted only in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Genentech Inc. v. Novo Nordisk A/S, 108 F.3d at 1366, 42 USPQ2d at 1005 (Fed. Cir.), cert. denied, 118 S. Ct. 397 (1997), (“Tossing out the mere germ of an idea does not constitute an enabling disclosure”).
Reasonable guidance with respect to preventing gastric cancer, as one example, relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to particular types of cancer. This type of data might be derived from widespread genetic analysis, clusters, or family histories. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical disease and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. The instant application does not provide any data suggesting or proving that the claimed composition can prevent gastric cancer in patients. In the absence of data suggesting that the claimed method could be used to prevent every form and type of gastric cancer, claims 19-20 are not enabled.
The test of enablement is whether one skilled in the art could make and use the
claimed invention from the disclosures in the application coupled with information known
in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d
1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a
single factor, but rather a conclusion reached by weighing many factors (See Ex parte
Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d
1400 (Fed. Cir. 1988). These factors include the following:
Scope or breadth of the claims
The claims are broader in scope than the enabling disclosure. The specification does not provide evidence or data that the instant composition can reasonably prevent any and all conditions listed in claims 19-20. As no data is provided, the specification cannot be relied upon to show enablement of the claimed method for preventing anything.
Nature of the invention
The nature of the invention is directed to a method of a variety of conditions listed in claims 19-20 including, but not limited to, Zollinger-Ellison syndrome, gastric cancer, and functional dyspepsia.
Relative level of skill possessed by one of ordinary skill in the art
The relative level of skill possessed by one of ordinary skill in the art of medical research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess an Ph.D. in a scientific discipline such as organic synthetic chemistry, polymer chemistry, medicinal chemistry, biochemistry, pharmacology, biology or the like.
State of, or the amount of knowledge in, the prior art
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity relating to the treatment or prevention of Zollinger-Ellison syndrome, gastric cancer, and functional dyspepsia is generally considered to be an unpredictable factor. Unpredictability in treating these conditions generally is established by the following references:
LLUH (https://lluh.org/conditions/zollinger-ellison-syndrome-zes; available 20 July 2019) teaches that Zollinger-Ellison Syndrome is associated with cancerous tumors in the stomach (pg 1). The causes of said disease are unknown and often the patients who are affected also have a genetic disorder known as MEN-1 (pg 2).
Rangan (https://www.health.harvard.edu/blog/functional-dyspepsia-causes-treatments-and-new-directions-2020070620505) teaches that functional dyspepsia is a common condition causing stomach discomfort but yet has no clear cause (pg 2).
Cancer Research UK (https://web.archive.org/web/20220518062627/https://www.cancerresearchuk.org/about-cancer/stomach-cancer/causes-risks; available 18 May 2022) teaches that one’s risk for stomach cancer (gastric cancer) depends on many things including age and lifestyle (pg 1). While infection with H. pylori is a common cause of stomach cancer, other things such as smoking tobacco, drinking alcohol, and being overweight as also causes (pgs 1-2). As such, there is unpredictability in the cause of gastric cancer and not one specific pathway causing the condition.
Level or degree of predictability, or a lack thereof, in the art
The art teaches that many different pathways and molecular targets contribute to the mechanism of gastric cancer and that the causes of both Zollinger-Ellison syndrome and functional dyspepsia are unknown. As such, the art teaches that many unrelated pathways contribute to stomach cancer rendering preventing thereof as a whole as nearly impossible. In addition, without knowing the causes of both Zollinger-Ellison syndrome and functional dyspepsia, a prevention thereof would also be nearly impossible.
Amount of guidance or direction provided by the inventor
The Applicant was required to provide in the specification additional guidance and direction with respect to the use of the claimed subject matter in order for the application to be enabled with respect to the full scope of the claimed invention. However, the Applicant has not provided guidance on how to use their claimed invention to prevent any of the claimed conditions.
Presence or absence of working examples
The specification fails to provide scientific data and working embodiments with respect to all conditions in instant claims 19-20 that will work in this invention.
Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure
One of ordinary skill in the art would have to conduct a myriad number of experiments comprising picking and choosing patients or subjects with the claimed conditions, administering the claimed invention, and testing for efficacy. The art teaches that the causes for both Zollinger-Ellison syndrome and functional dyspepsia are unknown and that gastric cancer has many known causes and mechanisms. Therefore, in view of the Wands factors discussed above, to prevent the conditions in claims 19-20, a person of skill in the art would have to engage in undue experimentation, with no assurance of success.
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 19-20 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.
Claims 19-20 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 claims imply a method of using however do not include any active method steps for using the injectable composition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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