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 .
Election/Restrictions
Applicant’s election of claims 1-9 in the reply filed on 5/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/2026.
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 5, 8,9 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 that Eurotium cristatum with an accession number of CICC No.2099 and/or Bacillus coagulans with an accession number of CGMCC No.21801 is to be present in the fermentation step. Note that the bacteria strains are recited in the alternative and both strains are not required to meet the claim. However, claims 5 and 8 assume that both strains are present. Therefore, it is unclear if bother bacteria strains are presumed to be required for claims 5 and 8. For the purposes of this action, only one bacteria strain is required for claims 5 and 8.
Regarding claim 9, it is unclear that temperature range is acceptable to be considered a “low temperature” as claimed.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wei(CN115192614) in view of Wen(CN1475159).
Regarding claims 1,7, 9,Wei teaches a preparation method of a probiotic-containing sea cucumber peptide composition for improving an immunity, comprising the following steps(abstract, embodiment 1):
(1)to a homogenate of a body wall of a sea cucumber(sea cucumber with organs removed and then further crushed with water), adding a neutral protease and a papain to allow enzymatic hydrolysis to obtain an enzymatic hydrolysate; and
(2) adding a probiotic to the enzymatic hydrolysate to allow fermentation, and collecting a supernatant produced after the fermentation
Wei teaches adding the papain and the protease together and does not teach adding it in separate steps as claimed. However, where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”
Wei does not specifically teach that the probiotic is Eurotium cristatum with an accession number of CICC No.2099 and/or Bacillus coagulans with an accession number of CGMCC No.21801. Wei does not specifically teach that the composition is dried into a powder.
However, Wen teaches a fermented sea cucumber product in which a sea cucumber homogenate is formed and said homogenate is fermented with a probiotic bacteria comprising Bacillus coagulans. The supernatant is further spray dried into a powder in order to form a nutritional composition with a large amount of beneficial bacteria that can be formed into tablets and capsules(embodiment 2, example 2, abstract).
It would have been obvious to ferment the enzymatic hydrolysate of Wei with Bacillus coagulans and further spray dry the supernatant of the fermentation product into a powder as taught in Wen in order to form a versatile product with a large amount of beneficial bacteria. It would have been obvious to adjust the temperature of the spray drying, including using a “low temperature” as claimed in order to not destroy the beneficial bacteria(probiotics) present.
It would have been obvious to adjust the amount of Bacillus coagulans in order to maximize the amount of beneficial bacteria present. It would have been obvious to choose a Bacillus coagulans strain that is effective at producing a large amount of beneficial bacteria, including the claimed strain. As such, the applicant has not shown that the claimed strain produces unexpected results.
Regarding claim 2, Wei is silent on the enzymatic ratio of the neutral protease to the papain. However, since Wei teaches extracting of sea cucumber peptides and fermenting of said peptides to improve immunity as claimed, it would have been obvious to adjust the ratio of enzymes in order to efficiently extract the said peptides.
Regarding claim 3, Wei is silent on the amount of neutral protease and papin and does not disclose wherein a first and second enzymatic hydrolysis are conducted for 3 h to 5 h in total at 50°C to 55°C and a pH of 6.5 to 7.5. However, since Wei teaches extracting of sea cucumber peptides and fermenting of said peptides to improve immunity as claimed, it would have been obvious to adjust the amount of enzymes and the time, temperature and pH of the enzymatic hydrolysis process in order to efficiently extract the said peptides.
Regarding claim 4, Wei does not disclose wherein in the step (2), the fermentation is conducted at 36°C to 38°C for 40 min to 60 min. However, since Wei teaches extracting of sea cucumber peptides and fermenting of said peptides to improve immunity as claimed, it would have been obvious to adjust the fermentation time and temperature in order to provide fermented sea cucumber peptides that improve immunity as claimed.
Regarding claims 5, 6, and 8, as stated in the 112(b) rejection, only one bacteria strain is required to be present in order to meet claim 1. Therefore, further limiting of both bacteria strains does not limit the claim when both bacteria strains are not explicitly required. As noted above, Wen teaches the presence of Bacillus coagulans as required in claim 1.
Conclusion
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
