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 Objections
Claim 11 is objected to because of the following informalities: please provide a space between the numerical value for temperature and the unit; e.g. 37 °C. 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.
Claim 4 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 4 is considered indefinite because it is unclear how to interpret the metes and bounds of the claimed “drug.” The term drug is not defined in the specification, and possesses many overlapping definitions. Since a drug can range from plant extract to synthetic molecule, it is unclear what the Applicant intended when providing this limitation. For all intents and purposes, any compound that affects a subject’s physiology can be considered a “drug,” and as such, this is how the term will be interpreted.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a deposited strain of Lactobacillus acidophilus, designated as JYLA-126. This judicial exception is not integrated into a practical application because the claims provide for only the product of nature. The analysis of the claims under 35 USC 101 can be found in MPEP 2106, and especially the flow chart found in section III.
The first question of the flow chart asks if the claim is drawn to a statutory category. Since the claims are drawn to a specifically claimed microbial strain, the claims provide for a composition, and as such, do provide for one of the statutory categories. The next question asks if the composition is drawn to a product of nature. Since the claimed L. acidophilus appears as it does when it was plucked from nature, and has not been demonstrably changed from that form (i.e. by recombinant technologies), the claimed L. acidophilus is considered a product of nature. That is to say, the claimed strain appears identical to the naturally occurring strain, and as there have been no demonstrable changes to the microbe’s physiology, it must be considered a product of nature. The final question asks if there is significantly more than the judicial exception. Since the cited claims provide for the microbe, per se, and nothing else, these claims provide for a product of nature, as defined by the MPEP. As such, these claims are not eligible under 35 USC 101.
Claim Rejections - 35 USC § 102
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.
Claims 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han, et al (CN112961895 [Machine translation attached to the provided document]). Han explicitly teaches L. acidophilus JYLA-126. See page 4, paragraph beginning “In the present invention…”. While the preamble of the claims is considered, it must be noted that the preamble of the claims does not further limit the structure or compositional elements of the claimed composition and merely provides for an intended use; based upon the fact that the preamble provides for an intended use, this does not affect the structure of the claimed strain. See MPEP 2111.02.
Claim Rejections - 35 USC § 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 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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Park, et al (Journal of Endocrinology, 237, 87-100, 2018) and Han, et al (CN112961895 [Machine translation attached to the provided document]). Park teaches methods of preventing and treating obesity by providing a strain of L. acidophilus to subjects. See page 87, “Abstract” section. Park teaches the NS1 strain of L. acidophilus, and is silent with respect to the claimed JYLA-126 strain.
As discussed above, Han teaches the claimed L. acidophilus JYLA-126 strain. Although Han does not teach obesity, Han does discuss methods of regulating and improving the digestive and endocrine systems. See page 1, “Abstract” section.
Based upon Park, it would be reasonable for the ordinary artisan to assume that all strains of L. acidophilus would provide some degree of obesity treatment/prevention, or would at least provide the ordinary artisan with a basis to try other strains. However, when viewing Park along with Han, who describes an L. acidophilus strain that can improve digestive and endocrine systems, there would be a reasonable expectation of success when using the JYLA-126 strain.
With respect to claim 1, Park teaches L. acidophilus can be used to treat/prevent obesity through improvements in lipid metabolism and endocrinological improvements, while Han teaches that the claimed strain of L. acidophilus and suggests digestive and endocrinological improvements. As such, it would be obvious to use Han’s strain for Parks method, to predictable results.
With respect to claim 3, Han teaches that the microbe is provided with a fermented composition. This fulfills the claimed “drug” limitation.
Claim(s) 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Park, et al (Journal of Endocrinology, 237, 87-100, 2018) Han, et al (CN112961895 [Machine translation attached to the provided document]) and Silva, et al (LWT – Food Science Technology, 89, 503-509, 2018). See the discussion of Park and Han above. Neither reference teaches providing a coating solution to the L. acidophilus.
Silva teaches providing a gelatin-based solution to L. acidophilus as a means of microencapsulating the cells. Silva notes that using this coating solution to coat the cells with gelatin, provides for a significant improving of microbial survival. See page 503, “Abstract” section. It would be clear to the ordinary artisan that improved survival is a clear an obvious improving to the uncoated L. acidophilus. It would be obvious to the ordinary artisan to apply Silva’s coating solution, since the claimed probiotic bacteria would survive longer in storage than without the coating solution.
With respect to claims 4 and 7, Han teaches the claimed microbe, and Silva indicates that the species L. acidophilus, the species taught by Han, has improved survival when a coating solution is applied to it. Since Silva teaches the same species, there would be a reasonable expectation of success.
With respect to claims 9-11, Silva teaches the claimed steps, using the same medium and temperature. See page 504, “Activation of culture of L. acidophilus” section.
With respect to claim 12, Silva teaches dissolving gelatin in water. See page 504, “Biopolymer-based solutions” section.
With respect to claim 13, Silva teaches a 0.15 g: 1000 mL ratio (1.5 g:100 mL). See page 504, “Biopolymer-based solutions” section. Although the value is not exactly the claimed value, the claimed value would not be outside of the range for what an ordinary artisan would find obvious. See MPEP 2144.05.
With respect to claim 14, Silva teaches the dissolution of gelatin at 45 °C. See page 504, “Biopolymer-based solutions” section. While 45 °C is certainly different than the claimed 60 °C, as long as the gelatin is fully dissolved in the water, the temperature is immaterial. There does not appear to be any functional or structural difference between the gelatin solutions, regardless of dissolution temperature. As such, although the temperatures are different, they provide for functionally the same result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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