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.
Claims 1-15 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.
Regarding claims 1 and 10, the phrase “such as” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4, 10, 12, 14 and 15 recited the phrase “selected from the group including…or…”. If Markush language is intended, the proper Markush language should read: selected from the Group consisting of…and…”.
Claim 13 recited the phrase “Use of the granule of claim 1” in line 1. It is not quite clear whether the claim is directed a method of use or a composition for use.
Claim Rejections - 35 USC § 102
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 1, 4-9, 11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Penhasi et al. WO 2019/202604 A1.
Penhasi teaches a probiotic microcapsule comprising: a core comprising probiotic microorganisms; and a coating layer comprising a hybrid solid dispersion comprising an edible fatty molecule evenly dispersed within a water-soluble film forming polymer and an edible mediator, wherein said edible mediator is starch octenyl succinate. See Abstract, pages 7-9 and Claims. The microcapsule may be incorporated into food stuff, mainly liquid foods including for example, water based foods, liquid infant formulas, yogurt, dairy products, nectars, fruit juices and the like. See page 5, lines 20-30. At least one coating may include a specific sealing film coating comprising a hybrid solid dispersion in which an edible fatty molecule is evenly dispersed within a water-soluble film forming polymer using, for example, an edible mediator. Fatty molecule is preferably cocoa butter and/or stearic acid. See page 6. Water soluble film forming polymer includes amylose starch is found in page 6, lines 14-23. Penhasi further teaches the use of the edible mediator such as starch octenyl succinate (SOS) to reduce the interfacial tension between the water-soluble film forming polymer and the edible fatty molecule. According to some embodiments, reducing the surface tension may create a tight integration between the water-soluble film forming polymer and the edible fatty molecule, for example, assuring the formation of a uniform, firm and integer film coat surrounding the core of the microcapsules. See page 7. Method for preparing the microcapsule can be found in page 10 and Examples.
Claims 1 and 6-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Penhasi et al. US 20150265662 A1.
Penhasi teahes a process for the preparation of high temperature resisting probiotic bacteria for providing high stability and prolonged shelf life at ambient temperature for a healthy food product or for a nutritionally or nutraceutically or pharmaceutically acceptable product comprising a process, according to a preferred embodiment, for preparing microencapsules, granular or particular probiotic having i) a core with probiotic bacteria and which may contain at least one stabilizing agent, antioxidant, substrate, filler, binder, and other excipients and further having ii) a first coating layer which is the innermost coating layer comprising at least one first phase change material (PCM) having a melting point lower than 60°C and higher than 20°C, preferably lower than 55°C and higher than 20°C and most preferably lower than 50°C and higher than 20°C forming a stable film around the probiotics core particles and further having iii) a second coating layer comprising at least one second phase change material (PCM) having a melting point lower than 60°C and higher than 20°C, preferably lower than 55°C and higher than 20°C and most preferably lower than 50°C and higher than 20°C forming a stable film around the probiotics core particles coated with the first coating layer, the second PCM has a melting point which is higher than the first PCM and further optionally having iv) a third coating layer comprising at least one third phase change material (PCM) having a melting point lower than 60°C and higher than 20°C, preferably lower than 55°C and higher than 20°C and most preferably lower than 50°C and higher than 20°C forming a stable film around the probiotics core particles coated with the second coating layer, the third PCM has a melting point which is higher than the second PCM and further optionally subsequently having v) more coating layers, where each layer comprises at least one phase change material (PCM) having a melting point lower than 60°C and higher than 20°C, preferably lower than 55°C and higher than 20°C and most preferably lower than 50°C and higher than 20 °C forming a stable film around the probiotics core particles coated with the former coating layer, where each PCM has a melting point which is higher than the PCM composing the former layer (beneath layer)), wherein the first, second, third or any other PCMs, being used in the layering process, are chemically same but are different from each other by their molecular weights so that the first PCM has the lowest molecular weight and the outermost PCM has the higher molecular weight, and further optionally and preferably having vi) an outermost layer (exterior layer) comprising a polymer which is soluble in GI tract, thereby obtaining a layered structure providing stabilized probiotic granules or microsphere for forming a dosage form for oral administration. Both PCM layers as well as outermost layer may optionally further comprise at least one excipient, such as, for example, a plasticizer, a glidant including but not limited to silicon dioxide, lubricant and anti-adherents, including but not limited to microcrystalline cellulose, talc or titanium dioxide. The stabilized bacteria are capable to resist during manufacturing or preparation process or further handling process such as coating process where there is an exposure to high temperature. The stabilized bacteria are further capable to resist during storage conditions at ambient temperature. See paragraphs 0043 and 0096 and Examples. Stearic acid is found in paragraph 0096. Enteric coating layer is found in paragraphs 0099-0103 and 0110-0111. Core includes probiotic bacteria and sugar substrate is found in paragraph 0105. According to preferred embodiments of the present invention PCM layers as well as outermost layer may optionally further comprise at least one excipient, such as, for example, a plasticizer, a glidant including but not limited to silicon dioxide, lubricant and anti-adherents, including but not limited to microcrystalline cellulose, talc or titanium dioxide or combinations thereof. See paragraph 0109.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Penhasi et al. WO 2019/202604 A1, in view Miloud et al. CA 2737247 C.
Penhasi is relied upon for the reason stated above. Penhasi does not expressly teach the present of amylose starch in the microcapsule shell.
Miloud teaches a microcapsule having particle size between about 1 µm to about 200 µm having shell composed of amylose starch. See Abstract and pages 7-8. The microcapsule comprises encapsulating core including probiotic agent is found in paragraph 0033.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the microcapsule shell of Penhasi to include amylose starch as an excipient to improve the properties of the microcapsule in view of the teaching in Miloud. This is because Miloud teaches using amylose starch to obtain a microcapsule useful for the encapsulation of a probiotic agent is known in the art, and this is because Penhasi teaches the desirability to include any useful excipients in pharmaceutical art with the expectation to prepare a microcapsule to provide a stable composition for a probiotic agent.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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