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 .
Claims 1-12 are pending in the application. Preliminary amendment filed 07 August 2024.
Priority
This application is a 371 of PCT/IB2022/050979 filed 02/04/2022.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites suspensions or solutions. It should recite aqueous suspension or solution. 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.
Claims 1-12 are rejected under 35 U.S.C. 101 because it is not clear what statutory class the claim falls into. Specifically, by reciting a use, the claim could be drawn to a process, or it could be drawn to a product. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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 1-12 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.
Claims 1-12 provide for the use of 2’-fucosylllactose and/or lacto-N-neotetraose or a composition comprising either or both active agents, but, since the claim does not set forth any steps involved in the method/process of use, it is unclear what method/process of use applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. For the purpose of prosecution claims 1-12 are being examined as drawn to a composition comprising 2’-fucosylllactose and/or lacto-N-neotetraose and the additional components as in claims 6, 9 and 11-12.
Claim 9 contains the trademark/trade name Orlistat. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the additional agent and, accordingly, the identification/description is indefinite.
Claim 9 recites the limitation "additional agent" in claim 6. There is insufficient antecedent basis for this limitation in the claim. It is examined as dependent from claim 8. Claim 9 recites Bupropion/Naltrexone. It is interpreted as a combination of both agents.
Claim 11 recites ‘selected from the group comprising’. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. The recitation of the term comprising is open-ended. It is unclear what other alternatives are intended to be encompassed by the claim. See also MPEP § 2111.03.
Claim 12 recites ‘a food additive of supplement’. Does applicant intend ‘a food additive or supplement’?
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 10-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vigsnaes et al (US2021/0393657 A1).
Vigsnaes et al teaches a composition for treating CVD in overweight individuals, which may comprise single HMO or a mixture of two or more HMOs. At least one of the selected HMO is 2’-FL and at least one of selected HMO is lacto-N-neotetraose (LNnT). One of the preferred embodiments is a mixture consisting essentially of 2’-FL and LNnT (paras 0057-0060, limitations of claims 1-3). The composition can be eaten (para 0082-limitation of claim 4). The composition can be a pharmaceutical composition and can further contain a pharmaceutically acceptable carrier and excipient (paras 0067, 0087-0088-limitations of claims 5-6). The composition can be in the form of a tablet, capsule, powder, granules, syrup, aqueous suspension or solutions (para 0089-as in claim 7). The composition can be in the form of food such as a nutritional bar or yoghurt (para 0085-as in claims 10-11).
Therefore, Vignaes et al anticipates claims 1-7 and 10-11.
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.
Claim(s) 8-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vigsnaes et al (US2021/0393657 A1) in view of Lin et al (Frontiers in Endocrinology, 06 September 2021, 12, 1-9).
The teachings of Vigsnaes are set forth above. Vigsnaes does not teach the limitations of claims 8-9 and 12 and some of the limitations of claim 11.
Vigsnaes et al teaches that its composition is used in a method of treating obesity and the HMOs of its disclosure can be co-administered to an individual who is also receiving a standard-of-care medication for obesity (paras 0108, 0123, 0131).
Lin et al teaches the use of orlistat and Naltrexone/Bupriopion as anti-obesity medications (page 5, right col. last para through page 6 left col; limitations of claims 8-9).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, 2’-FK and LNnT composition and orlistat, naltrexone/bupropion combination are known in the art to be used for reducing obesity. Thus, it is obvious to arrive at the claimed composition. This also renders obvious the use of the other two agents recited in claim 8 as components in the composition. Since Vigsnaes teaches that the composition can be in the form of food such as a nutritional bar or yoghurt, it would be obvious to include the HMOs in the food compositions as in claim 11 and also provide it in the form of a food additive or supplement as in claim 12.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art will be motivated to make the claimed composition since the HMOs, 2’-FL and LNnT, and the additional agents will reduce the risk of, prevent or treat CVD or CVD-associated pathological condition or disease in human preferably in an overweight or obese human individual (para 0008).
Conclusion
Pending claims 1-12 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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