20130005830

Ref: Examiner(s) Comments in the Examination Report Dated: 18.10.2013 in the context of Patent Publication No. 20130005830 at USPTO


1. Relevant Extract of USPTO Examination Report

USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:

“Claims 1-4 and 6-8 are rejected under pre-AIA 35 U.S.C.102 (b) as being anticipated by ikseer Azam, Vol. IV 19th century, Matba Nizami, Kanpur, 1872 AD, p. 309, TKDL identifier BA4/1854C (“Azam”).

       Azam discloses a therapeutic compound formulation comprising inter alia sandalwood from S. album (which encompasses sandalwood oil) together with other pharmaceutically acceptable excipents, which is formulated as oil and is useful in the treatment of cancer. A person of skill in the art would understand this to disclose an effective amount. Administration is local as liniment, Azam discloses treatment of cancer broadly. A person of skill in the art would understand this to encompass the particular cancers of Applicant’s claims 6-8.

       Claims 1-4 and 6-8 are rejected under pre-AIA 35 U.S.C.102 (b) as being anticipated by Va gasens, 12th Century- commentator Shaligram Vaisya, Edited Shankar lalji Jain; Khemraj Shrikrishana Das Prakashan, Bombay, Edn. 1996, page 811, TKDL identifier AK/3505 (“Va gasena”).
       Va gasena discloses a therapeutic compound formulation comprising inter alia sandalwood heartwood from S. album (which encompasses sandalwood oil) together with other pharamaceutically acceptable excipients, which is formulated as medicated oil and is useful in tumor treatment. A person of skill I the art would understand this to disclose an effective amount. Administration is via the nasal route, in a dose as directed by a physician. Va gasena discloses treatment of cancer broadly. A person of skill in the art would understand this to encompass the particular cancers of applicant’s claims 6-8.
       Claims 1-4 and 6-8 are rejected under pre-AIA 35 U.S.C.102 (b) as being anticipated anticipated by Thiruvalluvar gnana vettian, 10-15th Century A.D., Ed: Mangadu Vadivel Mudalia, Pub: Parthina Nayakar & sons, thirumagal Vilakku press, Chennai, Page 272-278, TKDL identifier GP11/20 ( “Thiruvalluvar gnana vettian”).
       Thiruvalluvar gnana vettian discloses a therapeutic compound formulation comprising inter alia sandalwood seed from S. album (which encompasses sandalwood oil) together with other pharmaceutically acceptable excipients, which is formulated as medicated oil and is useful in tumor treatment. A person of skill in the art would understand this to disclose an effective amount. The administration is local, as directed by a physician. Thiruvalluvar gnana vettian discloses treatment of cancer broadly. A person of skill in the art would understand this to encompass the particular cancers of Applicant’s claims 6-8.

Claims 6-8 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over US 6,406,706 to Haque et al. ("Haque"), as applied to claims 1-4 above, further in view of Ikseer Azam, Vol. IV 19th century, Matba Nizami, Kanpur, 1872 AD, p. 309, TKDL identifier BA4/1854C ("Azam"), Va gasena, 12th Century commentator Shaligram Vaisya, Edited Shankar lalji Jain; Khemraj Shrikrishna Das Prakashan, Bombay, Edn. 1996, page 811, TKDL identifier AK11/3505 ("Va gasena") and Thiruvalluvar gnana vettian, 10-15th Century A.D., Ed: Mangadu Vadivel Mudalia, Pub: Parthina Nayakar & sons, Thirumagal vilakku press, Chennai, Page 272-278, TKDL identifier GP11/20 ("Thiruvalluvar gnana vettian").

Haque, Azam, Va gasena and Thiruvalluvar gnana vettian are discussed in the 35 USC 102 (b) rejections above.

Accordingly, it would have been obvious to a person of skill in the art, based on the combination of Haque, Azam, Va gasena and Thiruvalluvar gnana vettian to treat different types of cancer with sandalwood oil with a reasonable chance of success. A person of skill in the art would have been motivated to do so as Haque shows sandalwood oil to treat different types of cancer- e.g. of the skin and of the cervix on topical application. A person of skill in the art would have been further motivated to do so as traditional medicine sources from India point to the use of sandalwood for treating cancer broadly, and not just a particular type of cancer. Based on this disclosure, a person of skill in the art would have been motivated to use sandalwood oil for treating a variety of cancers, to include non-skin cancers.”

Full examination report can be referred at 20130005830-I.pdf

2. Outcomes of Examination Report.

As the outcome of TKDL references and other documents cited in examination report, the Examiner decided to reject the claims 1-4 and 6-8 on 18-Oct-13. Applicant amended the claims on 21-Jan-2014.