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 6,8-10,and 12-13 are under examination.
Response to Applicants Arguments/Amendments
The former rejections have been amended to address the new claim limitations. Applicants arguments for each rejection are addressed directly below the rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6,8-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Versalovic (US 20130022586) in view of Graff (US 20050020515)
Versalovic teaches using histamine producing lactic acid bacteria strains in the treatment or prophylaxis of inflammatory conditions (Abstract) and/or cancers (Paragraph 31). A preferred strain is Lactobacillus reuteri 6475 (ATCC PTA 6475) (Paragraph 56); this strain is a lactic acid bacteria strain that has an active histidine operon and produces and extracellularly releases a diacylglycerol kinase (DagK). Such a strain can be orally administered to a mammal in order to cause a significant reduction in inflammation in areas such as the colon (Paragraph 57-58). Versalovic discusses that strains such as L. reuteri 6475 are useful in protecting against cancer by suppressing inflammation, cell proliferation, and apoptosis via inhibition of ERK activation (Paragraph 98 of Versalovic). Versalovic teaches that the Lactobacillus reuteri strain can be used to treat/reduce cancers (Paragraphs 31,51,65 of Versalovic) as in instant Claims 6,8-10,12-13.
Versalovic expressly teaches that L reuteri lactic acid bacteria strains that have an active histidine operon and produce and extracellularly release a diacylglycerol kinase (DagK) can be used to treat inflammation in the colon and can be used to also treat cancer in general. However, Versalovic does not specifically state that its composition can be used to treat colon cancer. Graff teaches that a L. reuteri containing composition can treat colon cancer (Paragraph 19 of Graff). Graff’s composition is administered orally (Paragraph 19 of Graff).
It would have been obvious to an artisan of ordinary skill to have used Versalovic’s L reuteri composition to treat colon cancer because Graff teaches that probiotics such as L. reuteri paired with an aminoglycoside antibiotic can be used in a colorectal cancer treatment regime (Abstract and Paragraph 19 of Graff). Graff teaches that its method can treat cancer neoplasia/cancer tumor growth (thus having an anti-tumorigenic effect--Abstract of Graff). The instant claims are so broad that they encompass any orally administered treatment for colon cancer and can include other agents. An artisan would have been motivated to use the L reuteri strains taught in Versalovic because Graff teaches that probiotic compositions with L. reuteri can be used successfully in cancer treatment regimens to counteract negative side effects of antibiotic agents that are administered in colon cancer treatments (Paragraph 18 of Graff). Because L. reuteri can help ameliorate the negative effects of other anti-cancer agents in colon cancer treatments, there would have been a high expectation for success (Paragraphs 18-19 of Graff) as in instant Claims 6,8,10,12.
Versalovic teaches that its L. reuteri strains can be used to treat cancers and to prevent inflammation in the colon (Abstract and Paragraph 31). This provides a strong motivation to use the L. reuteri strain to treat colon cancer since Versalovic teaches that L. reuteri can treat cancer and also treat the colon. Versalovic fails to state expressly that colon cancer is treated. However, Graff teaches that L. reuteri can be used successfully in colon cancer treatment regimes. Therefore, an artisan would have been motivated to have used the L. reuteri compositions of Versalovic to treat colon cancer because Graff teaches that L. reuteri compositions can be used successfully in the treatment of colon cancers (Paragraphs 18-19 of Graff). Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.’s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, probiotic manufacture, cell culture. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments
Applicants argue the following:
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The Versalovic reference still teaches that the Lactobacillus reuteri ATCC PTA 6475 strain can be used to treat multiple cancer types. Paragraph 31 of Versalovic states that, “certain strains of Lactobacillus reuteri (including ATCC PTA 6475) produces histamine under specific growth conditions, and that such produced histamine will benefit the host by for example reducing inflammation, reducing certain cancers etc.” Versalovic is stating very broadly that Lactobacillus reuteri ATCC PTA 6475 can be used to treat multiple cancer types. Paragraph 77 of Versalovic further states, “another object of the invention is to reduce proliferation of certain cancers including leukemia (for example AML) or malignant melanoma. Thus, such cancers are preferred diseases which could be treated using the strains, products, and compositions of the present invention.” In this paragraph, Versalovic is broadly stating that its Lactobacillus reuteri ATCC PTA 6475 strain can be used to successfully treat a wide range of cancers.
Versalovic fails to mention using the L. reuteri ATCC PTA 6475 strain to treat colon cancer. However, Graff teaches that Lactobacillus reuteri (Paragraph 18) in general can be used in colorectal cancer treatment (Paragraph 9). The term “treatment” recited in the claims is so broad that it can include prophylactic treatment or a treatment with an active cancer. Garff teaches that development of colorectal neoplasia can be reduced thru the administration of both an aminoglycoside antibiotic and L. reuteri
Applicants argue that L. reuteri is used to avoid development of undesirable effects of antibiotics usage in the Graff reference. Graff still uses L. reuteri in a colorectal cancer treatment. The claim has the transition term “comprising” which allows for other agents besides L. reuteri to be present in a therapeutic composition used to treat cancer. Applicants can further amend the claims to state that the active cancer treating agent is only L. reuteri and/or restrict the claims to exclude other agents including antibiotics.
Claims 6,8-10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Versalovic (US 20130022586) in view of Iyer “Probiotic Lactobacillus reuteri promotes TNF-induced apoptosis in human myeloid leukemia-derived cells by modulation of NF-kappaBeta and MPAK signaling” Cellular Microbiology (2008) 10(7), 1442-1452.
Versalovic teaches using histamine producing lactic acid bacteria strains in the treatment or prophylaxis of inflammatory conditions (Abstract) and/or cancers (Paragraph 31). A preferred strain is Lactobacillus reuteri 6475 (ATCC PTA 6475) (Paragraph 56); this strain is a lactic acid bacteria strain that has an active histidine operon and produces and extracellularly releases a diacylglycerol kinase (DagK). Such a strain can be orally administered to a mammal in order to cause a significant reduction in inflammation in areas such as the colon (Paragraph 57-58). Versalovic discusses that strains such as L. reuteri 6475 are useful in protecting against cancer by suppressing inflammation, cell proliferation, and apoptosis via inhibition of ERK activation (Paragraph 98 of Versalovic). Versalovic teaches that the Lactobacillus reuteri strain can be used to treat/reduce cancers (Paragraphs 31,51,65 of Versalovic) as in instant Claims 6,8-10,12-13.
Versalovic expressly teaches that L reuteri lactic acid bacteria strains that have an active histidine operon and produce and extracellularly release a diacylglycerol kinase (DagK) can be used to treat inflammation in the colon and can be used to also treat cancer in general. However, Versalovic does not specifically state that its composition can be used to treat colon cancer. Iyer teaches the use of probiotics such as Lactobacillus reuteri ATCC 6475 to treat colon cancer (Page 1, Summary of Iyer). It would have been obvious to an artisan of ordinary skill in the art to have used the probiotic composition of Versalovic to treat colon cancer. An artisan would have been motivated to have used Versalovic’s probiotic composition containing Lactobacillus reuteri ATCC 6475 to treat other forms of cancer such as colon cancer because Iyer teaches using such a probiotic to treat other conditions/cancer such as colorectal cancer or inflammatory bowel disease (Summary of Iyer). Furthermore, Iyer also discusses how the probiotic Lactobacillus reuteri ATCC PTA 6475 protects the gastrointestinal tract which includes the colon (Page 1, 1st Paragraph of the Introduction Section of Iyer). Iyer also teaches that treatment with Lactobacillus reuteri ATCC PTA 6475 suppresses production of Bcl-2 and BCL-xL which normally protect cancer cells by suppressing apoptosis of neoplastic cells and prolonging survival of neoplastic cells (Page 1443, Lactobacillus reuteri suppressed cell proliferation and anti-apoptotic proteins). L. reuteri 6475 secrete cancer cell proliferative proteins (Cox-2 and cyclin D1) (Discussion of Iyer). Because L. reuteri can suppress Bcl-2 and BCL-xL, administration of such an agent can help target tumor/neoplasia present. Because Iyer teaches that Lactobacillus reuteri ATCC PTA 6475 has anticancer effects and such a probiotic strain could be used in colon cancer treatments, there would have been a high expectation for success using the Lactobacillus reuteri ATCC PTA 6475 composition of Versalovic to treat colon cancer as in instant Claims 6,8-10,12-13.
Versalovic teaches that its L. reuteri strains can be used to treat cancers and to prevent inflammation in the colon (Abstract and Paragraph 31). This provides a strong motivation to use the L. reuteri strain to treat colon cancer since Versalovic teaches that L. reuteri can treat cancer and also treat the colon. Versalovic fails to state expressly that colon cancer is treated. However, Iyer teaches using probiotics such as L. reuteri ATCC PTA 6475 to target colon cancer (Summary of Iyer). Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.’s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, probiotic manufacture, cell culture. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments
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Iyler teaches that Lactobacillus reuteri ATCC PTA 6475 is able to “secrete factors that potentiates apoptosis in cancer cells.” That would be considered an active treatment because it is killing cancer tumor cells that are currently in existence. The Iyler reference further teaches the concept of further expanding such treatment from myeloid leukemia derived cells to colorectal cancer cells and inflammatory bowel disease. Therefore, the concept of treating colorectal cancer is taught. Furthermore, Iyer also discusses how the probiotic Lactobacillus reuteri ATCC PTA 6475 protects the gastrointestinal tract which includes the colon (Page 1, 1st Paragraph of the Introduction Section of Iyer). Iyer also teaches that treatment with Lactobacillus reuteri ATCC PTA 6475 suppresses production of Bcl-2 and BCL-xL which normally protect cancer cells by suppressing apoptosis of neoplastic cells and prolonging survival of neoplastic cells (Page 1443, Lactobacillus reuteri suppressed cell proliferation and anti-apoptotic proteins). Because L. reuteri administration can suppress Bcl-2 and BCL-xL, administration of L. reuteri can help target tumor/neoplasia present. This additional information provides evidence that L. reuteri can successfully treat the gastrointestinal tract where colon cancer resides and L. reuteri can promote cancer cell apoptosis in general through the suppression of Bcl-2 and BCL-xL.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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