DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 27-28, 34, 36, 63-64, 72-73, 75-82 are pending and are under examination.
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 28, 34, and 36 contains the trademark/trade name SPYTAGTM OR SPYCATCHERTM Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a immunogenic carrier product and, accordingly, the identification/description is indefinite.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 63-64, 80-82 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 alleviating or treating a condition selected from atherosclerosis, coronary artery disease, cardiovascular disease, acute coronary syndrome, a dyslipidemia, and cancer in and individual comprising administering a composition comprising a sequence of amino acids consisting essentially of SEQ ID NO: 145 or SEQ ID NO: 146 to the individual;
does not reasonably provide enablement for:
a method of preventing a condition selected from atherosclerosis, coronary artery disease, cardiovascular disease, acute coronary syndrome, a dyslipidemia, and cancer in an individual, or a method of alleviating, preventing, or treating Alzheimer’s’ disease in an individual, comprising administering a composition comprising a sequence of amino acids consisting essentially of SEQ ID NO: 145 or SEQ ID NO: 146 to the individual;
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, 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, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
The instant claims encompass “preventing” diseases ranging from atherosclerosis, cardiovascular disease, Alzheimer’s disease, or cancer. This would encompass a complete prevention such that no signs or symptoms of the disease ever develop, which would be highly unpredictable. For example, the claims would encompass preventing any arterial plaque buildup or preventing any signs or symptoms of any cardiovascular disease, which would be highly unpredictable. Furthermore, preventing or curing cancer is extremely unpredictable due the heterogeneous nature of the disease, the difficulty in identifying at risk individuals, and the numerous challenges in effective treatment (see for example, Carey, 2010). The claims also encompass treating or preventing Alzheimer’s disease. However, the state of the art is such that while PCSK9 can be a biomarker of Alzheimer’s disease, it is not a causative one, and there is a lack of causal evidence for PCSK9 in Alzheimer’s (See Suswidiantoro, 2025). Thus, using the claimed polypeptide which induce inhibitory PCSK9 antibodies, to treat or prevent Alzheimer’s disease, would also be highly unpredictable.
Thus, based on the unpredictability of the art and the breadth of the claims, the instant specification must provide a sufficient and enabling disclosure commensurate in scope with the instant claims. The specification discloses that the polypeptides of SEQ ID NO: 145 and 146 can be used to induce anti-PCSK9 antibodies that will bind to PSK9 and reduce LCL-C, HDL-C and cholesterol. However, no guidance regarding “prevention” of disease or treatment of Alzheimer’s disease is provided by the instant specification. Thus, based on the unpredictability of the art, the breadth of the claims, and the lack of guidance provided by the instant specification, it would require undue experimentation to practice the full scope of the claimed method.
Claims 1, 27, 72-73, 75-79 are allowable. The prior art does not teach or suggest SEQ ID NO: 145 or SEQ ID NO: 146, and therefore the claimed composition comprising a polypeptide comprising a sequence of amino acids consisting essentially of SEQ ID NO: 145 or SEQ ID NO: 146, or nucleic acids encoding said polypeptide, are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644