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 .
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 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-6 require the presence of WIKIM0109. Since the microorganism(s) is/are essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism(s) is/are not so obtainable or available, the requirements of 35 USC 112 may be satisfied by deposit(s) of the microorganism(s). The specification does not disclose a repeatable process to obtain the microorganism(s) and it is not clear from the specification or record that the microorganism(s) is/are readily available to the public.
This rejection may be overcome by establishing that each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth herein.
If the depository is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney over his/her registration number, showing that,
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon the granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and,
(d) the deposit will be replaced if it should ever become inviable.
The specification must also state the date of deposit(s), the number(s) granted the deposit(s) by the depository and the name and address of the depository.
As noted above, this rejection may be overcome by providing as statement that establishes that each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth herein.
Claims 1-6 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 ameliorating or treating arthritis, does not reasonably provide enablement for preventing arthritis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(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.
At the outset, it is acknowledged that the level of skill (D) is high as the claims are directed to a method of treating arthritis. Researchers in these fields often have PhDs. A PhD is the highest degree level a student can achieve and basically it acts as your initiation into the world of research and academia.
However, as to the breadth of the claims (A) in the present invention, the claims are directed to preventing, treating or ameliorating arthritis. Thus, the claims are very broad.
As to the nature of the invention (B), state of the prior art (C) and level of predictability (E), people have been working for years to prevent arthritis. However, researchers have yet to prevent or cure arthritis. Arthritis cannot be completely prevented, but one can reduce the risk and delay its onset.
As to the amount of direction provided by the inventor (F) and quantity of experimentation (H), the specification discusses on pg. 14 that administering Lactobacillus sakei to animals. The result is an inhibition or amelioration of cytokines such as IgG, IgG2a, etc… after administration (see Table 1). However, there is no indication arthritis would be entirely prevented.
In view of the above, it is most respectfully submitted that although the level of skill in the art is high, the evidence available to date indicates that the level of experimentation needed to make or use the claimed invention in its current breadth is undue.
Claims 2-6 are rejected as they depend on or rely on claim 1 as an independent claim and include all the limitations of claim 1.
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.
Claims 1-6 are 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 1 recites “Lactobacillus sakei WIKIM0109 (accession number: KCTC13818BP), a culture thereof, a lysate thereof or an extract thereof”. It is unclear what components from the culture, lysates and extracts are required to satisfy the claim.
Claims 2-6 are rejected as they depend on or rely on claim 1 as an independent claim and include all the limitations of claim 1.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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 1-6 are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over United States Patent Application No. 2009/0274672 (YU).
YU teaches Lactobacillus sakei GMNL-76 can be orally administered as a pharmaceutical to treat rheumatoid arthritis [0003], [0044]. In [0012], it is indicated that the compositions possess anti-inflammatory activities that can stimulate generation of large amounts of IL-10 and inhibits IFN-γ and/or TNF-α. Therefore, these Lactobacillus isolates are useful in treating diseases associated with inflammation, including, but not limited to, rheumatoid arthritis. Lactobacillus sakei GMNL-76 is the same genus and species of the microorganism, as claimed. Additionally, Lactobacillus sakei GMNL-76 also exhibits the same properties and administered to treat arthritis. Given YU teaches a bacterium with the same genus and species that exhibits the same properties, the bacterium of YU inherently inhibits IgG and IgG2a in blood to reduce inflammation. There is no evidence to suggest that the claimed deposited strain is different from that claimed. Given the same composition is administered, the composition inherently inhibits IgG and IgG2a in blood to reduce inflammation.
In the alternative, it would have been obvious to one skilled in the art to administer other strains of Lactobacillus sakei, as it is known that Lactobacillus sakei strains exhibit anti-inflammatory activities and can be used to treat arthritis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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, Nikki Dees can be reached on 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP A DUBOIS/Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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