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 .
DETAILED ACTION
Claims 1 and 2 are pending.
For clarity of record, a declaration fulfilling the requirement for biological material for strain Lactiplantibacillus plantarum denoted as probiotic PTA22 and with deposit number BP-03477 has been received in Application No. 17895071 on 08/25/2022.
Claim Objections
Claim 2 is objected to because of the following informalities: “selected from” should be replaced with “selected from the group consisting of” since the claim recites a Markush group. Appropriate correction is required.
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 and 2 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.
In claim 1, the set of parentheses around the phrase "denoted as probiotic PTA22 below" renders the claim indefinite because it is unclear whether the limitations inside the set of parentheses are part of the claimed invention.
Claim 1 recites the limitation "the 16S" in line 8. There is insufficient antecedent basis for this limitation in the claim. Applicant may consider amending the claim to deleted “the”.
Claim 2 which depends from claim 1 does not cure the indefiniteness and is also rejected.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Iino (US 9,788,557 B2, published 10/172017) in view Mahidsanan (Lwt-Food Science and Technology 77 (2017): 152-159), Amer (World Journal of Dairy & Food Sciences 9 (2): 86-94, 2014), Cui (CN 111019857A, published 04/17/2020), and as evidenced by Appendix A (Sequence alignment of instant SEQ ID NO: 3 and Iino SEQ ID NO: 1, 2026).
Regarding claim 1, Iino teaches Lactobacillus plantarum comprising a sequence 100% identical to instant SEQ ID NO: 3 (See Appendix A for alignment). Iino teaches the bacterium is used in lyophilized preparations (column 6 line 17).
Iino does not teach mixing a lyoprotectant solution with a pellet of the bacterium and does not teach the lyoprotectant solution comprises 5-10 wt/vol% soybean protein.
However, Mahidsanan teaches mixing bacterial cell pellet with 10% w/v soy protein or 10% w/v soybean flour to protect the cells during freeze-drying process, and teaches soybean flour comprises protein (Title, Abstract, page 153 left colum para. 4, para. “Freeze drying method”).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Iino by pelleting the cells and mixing the pellet with 10% soy protein or soybean flour prior to freeze-drying, as suggested by Mahidsanan. One of ordinary skill in the art would be motivated to do so in order to protect the cells during the freeze-drying process. Since Iino teaches a desire to lyophilize Lactobacillus plantarum and since Mahidsanan teaches mixing bacterial cell pellet with 10% w/v soy protein or 10% w/v soybean flour to protect the cells during freeze-drying process, there is a reasonable expectation of success.
Iino and Mahidsanan do not teach the lyoprotectant solution comprises 5-10 wt/vol % Moringa oleifera.
However, Amer teaches mixing probiotic bacteria with 8% (v/v) Moringa oleifera leaves extract and teaches the Moringa oleifera leaves extract protected the bacteria from acid bile and gastrointestinal conditions (Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Iino by adding 8% v/v Moringa oleifera leaves extract, as suggested by Amer. One of ordinary skill in the art would be motivated to do so in order to protect the cells from acid bile and gastrointestinal conditions.
Iino, Mahidsanan, and Amer do not teach the lyoprotectant solution comprises 10-20 wt/vol% fructo-oligosaccharides.
However, Cui teaches adding a lyoprotectant solution to Lactobacillus plantarum pellet and teaches the solution comprises 10.6% wt/v fructooligosaccharide (80 g of fructooligosaccharides in 750 ml) (page 1 para. 10-11).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method taught by Iino by adding 10.6% wt/v of fructooligosaccharide, as suggested by Cui.
MPEP §2144.06(I) states that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Regarding claim 2, Iino teaches the composition can be prepared with a carrier such as starch (column 6 lines 20-23) and forming the composition in form of cakes and tablets (column 6 lines 38-43).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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