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 .
Claims 11-21 are pending in this application.
Specification
The disclosure is objected to because of the following informalities: page 23 contains a table that includes shading.
Appropriate correction is required.
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 11 and 13-21 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 bone fracture, does not reasonably provide enablement for bone-related disease or a disorder associated therewith. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (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. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(A) Breadth of claims.
(a) Scope of the compounds. The instant claims encompass pharmaceutical composition comprising β-caryophyllene and a statin.
(b) Scope of the diseases covered. Instant claim 1 and claims dependent thereon are drawn to a method of treating a subject afflicted with a bone-related disease or a disorder associated therewith, including bone fractures, which comprises administering to a human in need thereof, a therapeutically effective amount of a pharmaceutical composition comprising β-caryophyllene and a statin. Bone-related diseases embrace a vast array of problems, some of which are contradictory to others. This covers various forms of osteoporosis, osteopenia, rickets and osteomalacia, Paget’s Disease, osteogenesis imperfecta, fibrous dysplasia, osteomyelitis, primary bone cancers like osteosarcoma or Ewing sarcoma, joint and cartilage diseases like osteoarthritis or rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, scoliosis, osteonecrosis, etc.
(B) The nature of the invention and predictability in the art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(C) Direction or Guidance:
That provided is very limited. The lack of dosage range information in the Specification is not enabling for the treatment of bone-related disease or a disorder associated therewith. Moreover, this is generic, the same for the many disorders covered by the specification. Thus, there is no specific direction or guidance regarding a regimen or dosage effective specifically for any and all bone-related diseases or disorders.
(D) State of the Prior Art:
The pharmaceutical composition comprising a β-caryophyllene and a statin of any kind have been used for inhibiting or treating any and all bone-related diseases.
(E) Working Examples:
The invention is drawn to a method of treating bone-related diseases or disorders. There are no working examples or even animal models, in the Specification drawn to this utility to support the use of a pharmaceutical composition comprising a β-caryophyllene and a statin to treat any and all bone-related diseases or disorders.
(F) Skill of those in the art:
These diseases and disorders disclosed in the Specification on page 13 cannot be treated generally by any one drug. These are all different diseases and disorders, which occur at different locations and by different modes of action in the body.
(G) The quantity of experimentation needed:
Owing especially to factors A, C, E and F, the amount of experimentation is expected to be high.
MPEP 2164.01(a) states, “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).” That conclusion is clearly justified here.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, "The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)" (emphasis added). The "make and use the full scope of the invention without undue experimentation" language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: "A lack of enablement for the full scope of a claim, however, is a legitimate rejection." The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. lnt'I, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Claims 11-19 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 lovastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin and/or pitavastatin, does not reasonably provide enablement for statin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The nature of the instant invention has claims which embrace a pharmaceutical composition comprising β-caryophyllene and a statin.
The method of the instant invention where the pharmaceutical composition comprising β-caryophyllene and a statin. The specification does not define that which is intended in the use of a “statin”. The following is a list of statins, i.e. atorvastatin, bemfivastatin, cerivastatin, crilvastatin, dalvastatin, glenvastatin, mevastatin, tenivastatin, etc., which includes statins which are neither supported nor contemplated. This is just a few statins embraced by “statin”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Prosecution Insights