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 .
Claim Rejections - 35 USC § 112
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.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 is indefinite because it is unclear what diseases are considered to “attributable” to Porphyromonoas gingivalis. Page 9 of the specification lists examples of “attributable” disease; however, states that these are not limiting examples. Thus, the metes and bounds of the claim are unclear.
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.
Claim(s) 7, 10, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kawada (JP 2003171292 A– English translation provided) in view of Kim (KR 20190041864 A – English translation provided), and Chen et al (Mucosal Immunology, (Year: 2017), vol. 10, pp. 215-227).
Kawada teaches periodontal disease-causing bacteria to be exterminated [to] include, for example, Porphyromonas gingivalis (PG bacterium) (page 4), Kawada also teaches the preventive or therapeutic agent for periodontal disease of the present invention is characterized by containing bacteria belonging to Bifidobacteria, lactic acid bacteria or butyric acid bacteria, and the bacteria can be Streptococcus (Enterococcus) faecalis (pages 3-4), Kawada also teaches periodontal disease-causing bacteria, [such as gingipains] (page 3).
Kawada does not teach the methods for the prevention and/or treatment of Porphyromonas gingivalis infection, disease attributable to Porphyromonas gingivalis, for inhibition of the growth of Porphyromonas gingivalis, and for inhibition of gingipain activity, all using a heat-killed E. faecalis.
Kim teaches a composition for preventing or treating periodontitis ([a disease that is mentioned in page 9 in the specification of the claimed invention]) using heat-treated Enterococcus faecalis (page 4).
Chen et al teaches that heat-killed E. faecalis is a widely used probiotic (abstract), Chen et al also teaches that heat-killed probiotics are safer than live probiotics for purposes such as eliminating antibiotic-resistant genes, preventing production of recombinant strains, controlling the microbial load during probiotic supplementation, and application in children and immunosuppressed patients (page 215).
The method as taught by Kawada can be modified to include the knowledge that P. gingivalis secretes gingipains ([that can cause an infection]), that the bacterium is involved in the pathogenicity of [a disease, like periodontitis], and that a preventative or therapeutic agent for periodontal disease can be E. faecalis, all taught by Kawada. In addition, Kawada’s method can be modified to include information that heat-treated E. faecalis is used in preventing or treating periodontitis as taught by Kim along with more knowledge that heat-treated E. faecalis has antibiotic elimination capabilities and the ability to help immunosuppressed individuals.
The references combined do explicitly teach that heat-treated and non heat-treated E. faecalis treats an infection, inhibition of gingipain activity, or the growth of bacteria all attributed to P. gingivalis with an explanation of the advantageous effects of using the heat-treated bacterium. One of ordinary skill in the art would reasonably expect that the combination of references would effectively accomplish the overall goal of the claimed invention: to treat P. gingivalis using a pharmaceutically effective amount of a killed strain of E. faecalis to treat or reduce the presence of P. gingivalis activity, which may lead to a reduction or occurrence of infections ([which may prevent the progression to a disease]), growth and virulence growth factors attributed the P. gingivalis bacterium. In addition, one of ordinary skill in the art would expect to administer an effective amount of heat-killed E. faecalis necessary to achieve the reduction and/or amelioration of P. gingivalis activity.
Conclusion
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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