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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated June 25, 2026, has been received. By way of this reply, Applicant has amended claims 1-7, 9-18, and 20-24, cancelled claims 8 and 19, and elected without traverse, the species of cancer cells in blood and with an additional treatment.
Claims 1-7, 9-18, and 20-24 are pending in the application and under examination before the Office.
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 1-7, 9-18, and 20-24 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 factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Breadth of claims and nature of invention
The claimed subject matter pertains to a method of treating cancer. As Applicant's specification does not contain a specific definition of cancer, this term is constructed to mean any disease characterized by the uncontrolled growth of aberrant cells, and not just Applicant's elected species of cancer cells in the blood.
The claims are directed to a method of treating a patient with cancer cells, comprising the steps of administering an mRNA vaccine directed to cancer cell specific neoantigens, and directing sound energy from one or more acoustic shock wave or pressure pulse treatments into the patient, and that the sound energy causes the patient's immune system to identify the cancer cells as foreign objects and trigger the patient's immune system to destroy the cancer cells, as well as unmasking a cloaking capability of the cancer cells by enhancing the ability of the patient's immune system to identify neoantigens corresponding to the administered mRNA vaccine. However, the specification does not describe the process as to how the sound energy is meant to accomplish these results.
State of the art and the level of ordinary skill
At the time of the effective filing date, the level of ordinary skill to treat cancer was high, requiring advanced knowledge of medicine and cell biology, typically requiring a doctoral degree and several years’ experience. One of skill in the art is well-aware that cancer is difficult to prevent and treat. According to The Merck Manual of Diagnosis and Therapy, there are numerous molecular mechanisms which may drive cells to become cancerous, from genetic abnormalities to environmental factors. (The Merck Manuals Online Medical Library, [online]. Whitehouse Station, NJ: Merck Research Laboratories, 2006-2007. [retrieved on 10/19/2020]. Retrieved from the Internet: < URL: https://www.merckmanuals.com/professional/hematology- and- oncology/overview-of-cancer/cellular-and-molecular-basis-of-cancer >. Cellular and Molecular Basis of Cancer). The variety of molecular mechanisms for cancer require a highly personalized treatment for each type of cancer, depending on the patient. However, the instant disclosure does not provide sufficient in vitro or in vivo evidence showing that the instantly claimed method can counter-act the cause or the manifestation of any cancer as defined above in order to ameliorate the disease.
Existing ultrasound treatments for cancer rely upon excitation of a precisely targeted sonosensitizer or nanoparticle in order to destroy cancer cells (see, for example, Li (Small. 2022 Jun;18(25):e2201342) and Wang (Mater. Horiz., 2020, 7, 2028)). There does not appear to be prior practice that acoustic shock wave or pressure pulse treatments are able to stimulate the immune system to recognize and destroy cancer cells, without the sound energy killing the cancer cells directly (claims 3 and 14). Nor is there evidence that such a treatment results in up-regulation of anti-microbial peptides, disruption of biofilms surrounding the cancer cells, an increase in short- and long-term blood supply to the cancer cells, an increase in cellular membrane permeability, or an enhancement of cellular communication causing the patient's immune system to identify and attack the cancer cells (claims 5 and 16).
The most relevant prior art is Schultheiss (US20060100550A1, cited in IDS), which teaches the use of shockwaves to target cancer cells an initiate an immune response such that healthy cells are stimulating to attack cancerous cells. However, Schultheiss is silent regarding the use of the cloaking capabilities of cancer cells. Given the complexity of treatment of cancerous cells, the condition of the prior art does not establish targeting cancerous cells with sound waves resulting in an unmasking of all cancer cells in the patient's body by destroying a cloaking capability of the cancer cells which made the cancer cells indistinguishable from normal cells allowing the cancer cells to hide from the immune system prior to the one or more acoustic shock wave or pressure pulse treatments.
The level of predictability of the art
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the compound may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the compound; (2) the compound may not reach the target area because, i.e. the compound may not be able to cross the mucosa or the compound may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the compound unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992).
The amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure
The specification offers no guidance as to how to operate the sound wave emitter such that it results in destroying a cloaking capability of cancer cells. Different kinds of acoustic shock waves and generators are recited, which are all very well known in the art, but no specifics are mentioned that cause the effects that are recited in the claims.
The specification does not adequately teach how to effectively treat the breadth of diseases or reach an appropriate beneficial therapeutic endpoint by administering a neoantigen vaccine and acoustic shock wave or pressure pulse treatments to a patient. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the claimed method to the development of effective methods of treating the plethora of the diseases broadly encompassed by the claimed invention. Applicant's specification offers no data to indicate that the claimed method would be successful in treating every conceivable cancer.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (e.g., treating cancer) to which the invention pertains, undue experimentation would be required to practice the claimed method of treatment of any cancer with a reasonable expectation of success, absent a specific and detailed description in Applicant's specification of how to effectively use the claimed method and absent working examples providing evidence which is reasonably predictive that the claimed method is effective for treating any cancer commensurate in scope with the claimed invention.
In view on the quantity of experimentation necessary, the lack of working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trial and error to practice the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1642
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