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 .
Priority
The instant application is the national stage entry of PCT/IB2023/054724 filed 5 May 2023. Acknowledgement is made of the Applicant’s claim of foreign priority to application GB2206679.9 filed 6 May 2022.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 9-18 in the reply filed on 5 September 2026 is acknowledged. Claims 1-8 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of the Claims
Claims 1-20 are pending.
Claims 1-8 and 19-20 are withdrawn.
Claims 9-18 are rejected.
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 9-10 and 16-17 are rejected under 35 U.S.C. 102a1 as being anticipated by Bezzek (US 8,846,061) as evidenced by Khan et al. (US 2009/0117146).
Bezzek teaches a formulation comprising L-carnitine (4 g) and further comprising brown seaweed extract (claims 13, 15). Khan teaches that brown seaweeds are in the Phaeophyceae class [0062].
Regarding instant claim 16, the recited functional properties are inherent in the composition comprising L-carnitine and seaweed extract. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Moreover, “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unquantified property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 17, the limitation “seed treatment” is an intended use of the composition, does not result in a structural difference over the prior art, and is thus given minimal patentable weight (See MPEP 2111.02 (II)).
Claims 9-10 and 16-17 are accordingly anticipated by the prior art.
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 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bezzek (US 8,846,061) in view of Khan et al. (US 2009/0117146) in view of Drugs.com (https://web.archive.org/web/20210417060834/https://www.drugs.com/npc/seaweed.html; available online 17 April 2021).
Bezzek teaches a formulation comprising L-carnitine (4 g) and further comprising brown seaweed extract (claims 13, 15). The formulation may be prepared as a solid tablet, granule, or liquid (col 8, lns 18-19).
Bezzek does not teach the claimed species of seaweed extract. Bezzek does not teach a concentration of seaweed extract.
Khan teaches that brown seaweeds are in the Phaeophyceae class and can be selected as the species Ascophyllum nodosum [0062].
Drugs.com teaches that seaweed extracts are generally used in amounts ranging from 4-12g pre day (pg 2).
It would have been prima facie obvious to prepare the composition of Bezzek as granules, thus implying each component is a granule, wherein the composition comprises L-carnitine (4 g) and brown seaweed extract. The brown seaweed extract would have been obvious to select from Ascophyllum nodosum. Bezzek is non-specific on seaweed selection therefore it would have been obvious to look to Khan to make a selection as required in instant claims 9-11. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Regarding the claimed ratios of L-carnitine to seaweed extract, it would have been obvious to use 4 g of L-carnitine, as taught in Bezzek, and adjust the amounts of brown seaweed extract to the range of from 4-12 g, as recited by Drugs.com as a suitable dosage. As such, a 1:1 ratio by weight would have been obvious, addressing instant claims 12-14.
The composition can be in the form of a granule, thus implying granulation of each component of the composition, addressing instant claim 18. Alternatively, the formulation may be a liquid, according to Bezzek. The art does not teach a concentration, however, and the skilled artisan would be able to use any suitable liquid concentration to achieve a liquid formulation. That being said and in lieu of objective evidence of unexpected results, the concentration can be viewed as a variable which achieves the recognized result of successfully solubilizing and formulating a liquid dosage form. The optimum or workable range of concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of concentration nonobvious. As such, an amount of approximately 16-40 mL of solvent would achieve a concentration of 100-250 g/L of the reagents, addressing instant claim 15.
Regarding instant claim 16, the recited functional properties are inherent in the composition comprising L-carnitine and seaweed extract. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). Moreover, “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unquantified property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 17, the limitation “seed treatment” is an intended use of the composition, does not result in a structural difference over the prior art, and is thus given minimal patentable weight (See MPEP 2111.02 (II)).
Claims 9-18 are accordingly rejected as obvious in view of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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