1. Relevant Extract of USPTO Examination Report

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

“Claim 1-4 and 6-8 are rejected under pre-AIA 35 U.S.C 103(a) as being unpatentable over US 6,406,706 to Haque et al. (“Haque”, of record).. or in combination with either or all of – Ikseer Azam, Vol. IV 19th century, Matab Nizami, Kanpur, 1872 AD, p. 309, TKDL identifier BA4/1854C(“Azam”, of record), 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”, of record) and Thiruvalluvar gnana vettian, 10-15th Century A.D.,ED: Mangadu Vadivel Mudalia, Pub: Parthina Nayakar & Sons, Thiruvalluvar vilakku press, Chennai, Page 275-278, TKDL identifier GP11/20 (“Thiruvalluvar gnana vettian”, or record).

Azam discloses a therapeutic compound formulation comprising, inter alia, sandalwood form S. album ( which encompasses sandalwood oil) together with other pharmaceutically acceptable excipients, which is formulated as oil and is useful in the treatment of cancer. 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 Appellant’s claims 6-8.

Va gasena discloses a therapeutic compound formulation comprising inter alia sandalwood heartwood 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. Administration is via the nasal route, in a dose as directed by physician. Va gasena discloses treatment of cancer broadly. A person of skill in the art would understand this to encompass the particular cancers of Appellant’s claim 6-8.

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. 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 Appellant’s claims 6-8.

Accordingly, it would have been obvious to a person of skill in the art, based on the combination of Haque, pigott and Banerjee- alone, or in comnbination with and either or all of Azam, Va gasena and Thiruvalluvar gnana vettian, to treat different types of cancer with sandalwood oil with a reasonable expectation of success.

A person of skill in the art would have been further motivated to do so as traditional medicine sources from India (Azam, Va gasena and Thiruvalluvar gnana vettian) point to the use of sandalwood for treating cancer broadly, and not just a particular type of cancer.

Applicant’s arguments against Azam, Va gasena and Thiruvalluvar gnana vettian are further not found to be persuasive. First, against Appellant’s arguments that these references disclose ‘complex mixtures of a wide variety of components”, it is noted that Appellant’s transitional phrase “comprising” is open –ended, and as such does not preclude the presence of other ingredients. Second, the references explicitly disclose treatment of cancer. Third, statements by Appellant that one of skill in the art “might view” these compositions as “sacred unguents”, or “may expect” that sandalwood oil was used as a perfume or flavorant, are arguments by counsel that are speculative at best, and do not find support in the explicit language of the references.”

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

2. Outcomes of Examination Report.

As the outcome of TKDL references and other documents cited in examination report, the Examiner again rejected the claims 1-4 and 6-8 on 29.05.2015.