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 .
Election/Restrictions
Applicant's election with traverse of Claims 1-13 and 16-21 in the reply filed on May 27, 2026 is acknowledged. The traversal is on the grounds that the method recited in claims 14 and 15 can only be used to produce the invention recited in claim 1. This is not found persuasive because the common technical feature of the invention recited in the instant claims exist in the prior art, and is therefore not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities: “A composition comprising first solid…” should read “A composition comprising a first solid…”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “for use in activating an ileal brake ain a subject” should read “for use in activating an ileal brake in a subject”. Appropriate correction is required.
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.
Claim 17 is rejected under 35 U.S.C. 101. Step 1: Is the claim directed to a statutory category of invention? The statutory categories are as follows: a process, machine, manufacture, and composition of matter. The claimed invention is directed to nonstatutory subject matter because the recitation in claim 17 of, “Use of the composition according to claim 1 for controlling or reducing a body weight of a subject” does not fall within any of the categories. Therefore, Claim 17 is rejected under 35 U.S.C. 101.
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 1-13 and 16-21 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.
With respect to Claims 1 and 19, The recitation of “first solid or semi-solid fat or liquid or viscous oil” is indefinite due to a lack of clarity as to the properties of the components, as well as there being no definition provided for the term “viscous”. Additionally, in claim 1, the recitation of “an at least partially digestible or slowly digestible material” is indefinite due to a lack of definition provided for the terms “partially digestible” and “slowly digestible”.
Firstly, for the purposes of examination, “viscous” will be understood as having a viscosity between 100-20000 mPa-s, the term “partially digestible” will be understood to mean comprising indigestible material, and the term “slowly digestible” will be understood to mean comprising material that inhibits digestion.
Considering the limitation of “first solid or semi-solid fat or liquid or viscous oil”, the list will be interpreted as a list of four separate components, that is to say “a first solid, semi-solid fat, liquid, or viscous oil”. Additionally, this interpretation will be applied to each instance of the limitation, specifically in claims 2-5, 7-11, 18, and 21.
Due to their dependency on Claim 1, claims 2-11, and 16-18 are also rejected, and due to their dependency on claim 19, claims 20 and 21 are also rejected.
With respect to Claim 10, The recitation of “The composition according to claim 1, wherein the composition is a powder” is indefinite due to a lack of clarity as to the subject of “the composition”. Claim 1 recites both a composition that is the invention claimed, and a composition in which the droplets recited in claim 1 are dispersed. For the purposes of examination, the limitation will be interpreted as reciting the invention of claim 1.
With respect to Claim 13, The recitation of “chocolate-type” is indefinite due to a lack of clarity as to the definition of the term. The term “chocolate-type” is not defined in the claim or the specification, and there is no universally understood definition within the field of endeavor. For the purposes of examination, the term will be interpreted to mean tasting like chocolate.
With respect to Claim 17, The recitation of “Use of the composition” without reciting a method step is considered incomplete for lacking essential method steps, resulting in a gap in the method, see MPEP 2172.01. Therefore Claim 17 is rejected.
With respect to Claim 20, The recitation of “such as soluble corn fiber and/or soluble wheat fiber” in line 2 and “such as resistant starch” in line 3 renders claim 20 indefinite because it is unclear whether or not the recitation is further limiting the claim or providing an example of the invention. See MPEP § 2173.05(d). Additionally, the terms “low methoxyl pectin”, “high methoxyl pectin”, and “rapid-set pectin”, render the claim indefinite due to a lack of definition provided within the instant disclosure as well as there being no understood meaning within the field of endeavor.
For the purposes of examination, the recitation after “such as” in both instances will be understood to be not further limiting the claim, and the terms “low methoxyl pectin”, “high methoxyl pectin”, and “rapid-set pectin”, will be understood to mean “pectin having a methylation level of 40”, “pectin having a methylation level of 58-65”, and “pectin having a methylation level of 71-74” respectively.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 recites the composition according to claim 1, but the recitation “for use in a subject” does not provide an additional limitation to the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 5-9, 11-13, and 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McClements et al. (US 2005/0202149 A1).
With respect to Claim 1, McClements et al. teaches an emulsion comprising an oil droplet, wherein the membrane is substantially indigestible, which is then incorporated into a second, liquid composition. [0038] Therefore, McClements et al. anticipates the invention recited in claim 1.
With respect to Claim 2, McClements et al. teaches that the invention can be multilayered and encased in an indigestible material. [0038]
With respect to Claims 5, 11, and 18, McClements et al. teaches that the lipid component of the invention can be indigestible. [0017] Additionally, McClements et al. teaches the that the first emulsion, comprising the lipid and the indigestible encapsulation, is 95% indigestible material. [0053] Therefore, the embodiment of McClements et al. reads on the droplet comprising at least 10% indigestible material.
With respect to Claim 6, McClements et al. teaches the use of cellulose and its derivatives, chitosan, alginates, and more. [0029]
With respect to Claim 7, McClements et al. teaches the use of alginates, [0029] and the instant claim 20 teaches the use of alginates as a reinforcing material.
With respect to Claim 8, McClements et al. teaches the use of LACTEM, [0026] which reads on one or more saturated or unsaturated monoglycerides.
With respect to Claim 9, McClements et al. teaches the primary emulsion, comprising 5% corn oil by mass, is added to a secondary emulsion, resulting in 1% corn oil by mass. [0053] This reads on an emulsion comprising 20% of the first composition into a second composition.
With respect to Claims 12 and 13, McClements et al. teaches that the composition can be used in food products, such as spreads. [0044]
With respect to Claims 16 and 17, McClements et al. teaches the use of the invention in a food composition. [0013] MPEP 2112 II states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. Therefore, the invention taught by McClements would possess the same properties of body weight control and reduction.
With respect to Claims 19 and 20, McClements et al. teaches an emulsion comprising an oil droplet, wherein the membrane is substantially indigestible, [0038] and teaches the use of alginates. [0029] The instant claim 20 teaches the use of alginates as a reinforcing material. Therefore, the composition taught by McClements et al. anticipates the inventions recited in claim 19 and 20.
With respect to Claim 21, McClements et al. teaches the first emulsion is incorporated into a second, liquid composition. [0038] Therefore, McClements et al. anticipates the invention recited in claim 21.
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.
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over McClements et al. (US 2005/0202149 A1) as applied to claim 1, in view of Singh et al. (Advances in edible oleogel technologies – A decade in review, Food Research International).
With respect to Claim 3, McClements et al. teaches the invention recited in claim 1, as described above, but is silent to the use of an oleogel in the production of the composition. The instant specification teaches that an oleogel can be formed by adding an oil to a structuring agent, such as a gelator. [0099] McClements et al. teaches the use of a number of polymeric components capable of forming gels [0029] and the use of olive oil. [0024]
Singh et al. teaches a study of oleogels, [Abstract] and provides a specific example that is well suited for incorporation into food compositions comprising beeswax and olive oil. [Pg. 315, Col. 1, Par. 2] Singh et al. teaches that the oleogel provides desirable organoleptic properties to the foods into which they are incorporated. [Pg. 315, Col. 1, Par. 2]
McClements et al. and Singh et al. exist within the same field of endeavor in that they teach food composition comprising lipid components. Where McClements et al. teaches a multilayered lipid composition, Singh et al. teaches oleogels and their properties.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of McClements et al. in view of Singh et al. in order to produce the invention recited in claim 1, wherein the first composition is an oleogel, thereby rendering claim 3 obvious.
With respect to Claim 4, McClements et al. teaches the invention recited in claim 1, as described above, but is silent to the use of an oleogel in the production of the composition. The instant specification teaches that an oleogel can be formed by adding an oil to a structuring agent, such as a gelator. [0099] McClements et al. teaches the use of a number of polymeric components capable of forming gels [0029] and the use of olive oil. [0024]
Singh et al. teaches a study of oleogels, [Abstract] and provides a specific example that is well suited for incorporation into food compositions comprising beeswax and olive oil. [Pg. 315, Col. 1, Par. 2] Singh et al. teaches that the oleogel provides desirable organoleptic properties to the foods into which they are incorporated. [Pg. 315, Col. 1, Par. 2]
McClements et al. and Singh et al. exist within the same field of endeavor in that they teach food composition comprising lipid components. Where McClements et al. teaches a multilayered lipid composition, Singh et al. teaches oleogels and their properties.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of McClements et al. in view of Singh et al. in order to develop the invention according to claim 1, wherein the droplets formed of a liquid and an indigestible material are encapsulated in a secondary composition that is an oleogel, thereby rendering claim 4 obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McClements et al. (US 2005/0202149 A1) as applied to claim 1, in view of Klinkesorn et al. (Stability of Spray-Dried Tuna Oil Emulsions Encapsulated with Two-Layered Interfacial Membranes, Journal of Agricultural and Food Chemistry).
With respect to Claim 10, McClements et al. teaches the invention recited in claim 1, but is silent to the composition being in powdered form.
Klinkesorn et al. teaches a method of spray-drying a multi-layered oil droplet composition. [Intro. Par. 3] Klinkesorn et al. teaches that the powderization of the oil composition leads to increased oxidative stability of the oil. [Pg. 8370, Col. 1, Par. 2]
McClements et al. and Klinkesorn et al. exist within the same field of endeavor, in that they both teach multi-layered, encapsulated, oil compositions. Where McClements et al. teaches a general composition, Klinkesorn et al. teaches the benefits of powderizing the composition.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of McClements et al. in view of Klinkesorn et al. in order to develop the invention recited in claim 1, wherein the composition is powdered, thereby rendering claim 10 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CULLEN MERCHLINSKY whose telephone number is (571)272-2260. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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