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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 04/04/26, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112, (Indefiniteness)
The following is a quotation of 35 U.S.C. 112(b):
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 13 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 pre-AIA the applicant regards as the invention. Regarding claim 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 3-14, 22-24 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (US PG Pub. 2019/0090507) in view of Svoboda et al. (J Insect Physiology Vol 26, issue 5, pages 291-294, 1980).
Wright et al. discloses Bee nutrition, see title. Wright et al. teaches methods and compositions of providing nutrition to insects such as bees, honey bees, honey bee colonies and bumbles bees (invertebrates and insects), see abstract, [0001], [ 0013], [0038] and claim 58. The composition provides a correct balance of nutrients for bees and provides a pollen-substitute which does not require the addition of floral pollen, see [0048]. The “bee” refers to the family Apidae, honey bee refers to members of the eusocial group of bees and bumblebee refers to genus bombus, see [0045].
Wright et al. teaches that the composition can comprise at least one sterol, wherein: (a) the at least one sterol is selected from one or more of 24-methylene cholesterol, campesterol, β-sitosterol and cholesterol; (b) the at least one sterol is a plurality of sterols, wherein the plurality of sterols comprises at least two sterols selected from 24-methylene cholesterol, campesterol, β-sitosterol and cholesterol; (c) the composition comprises 24-methylene cholesterol; (d) the sterol is derived from addition of or extraction from Echium sp. Oil (seed oil) or Borago officianalis oil (a borage seed oil) or other oils or marine organisms; or (e) the at least one sterol is provided in the composition in a concentration selected from between about 0.01% and about 4% and between about 0.5% to 2% by dry weight of the composition, see claim 13 and [0144].
Figure 2 shows food consumed by honey bees was in the form of a patty and within hives, see [0037]. The composition can be in the form of a liquid, patty or biscuit, see [0193]. The composition comprises vitamins and minerals, see [0147] and ][0148]. The composition can be an aqueous composition, see claim 55. The composition product can be solid or powdered, see claim 56.
While Wright et al. teach inclusion of various sterols into the pollen-substitute composition to be administered to insects like honey bees, Wright et al. do not teach use of the claimed sterols such as isofucosterol, fucosterol or a mixture thereof into the pollen-substitute composition.
Svoboda et al. discloses that isofucosterol are important sterols in the nutrition of Apidae, in particular honey bees (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized isofucosterol as taught by Svoboda et al. into the pollen substitute of Wright et al. to be fed to honey bees (invertebrates). One of ordinary skill would have been motivated to do so because Wright et al. teaches providing nutrition to insects such as honey bees by administering a nutritional composition comprising sterols or group of sterols and Svoboda et al. teaches that isofucosterol are important sterols in the nutrition of Apidae, in particular honey bees. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
Regarding claim 22, Wright et al. teaches that the composition comprises at least one component which is a source of protein, at least one source of fatty acid and at least one component which is a source of carbohydrate, see paragraphs [0050] to [0053]. In an embodiment, the at least one source of carbohydrate is provided in the concentration of between about 20% to about 90% weight of the composition e.g. about 50% to about 90% by dry weight of the composition, see [0059]. In an embodiment, the source of protein ranges from about 10 to about 50% by total dry weight of the composition, see [0066]. In an embodiment, a source of fatty acid is provided in a composition wherein the amount ranges from 1% to 10%, see [0131] and claim 7. Since the art teaches the generic amounts of the sources of protein, carbohydrate and fatty acids, it would be within skill of an artisan to have optimized the amounts for providing optimum nutritional benefits to the insects or honey bees taught by Wright et al.
Regarding the dosage amount of isofucosterol or fucosterol that is included in the feed or administered to the honey bees/insects/invertebrates as claimed, Wright et al. as discussed above teaches that at least one sterol is provided in the composition in a concentration selected from between about 0.01% and about 4% and between about 0.5% to 2% by dry weight of the composition. While the reference does not teach the exact amounts and dosage regimen of the sterols or pollen-substitute composition to the honeybees, the objective of Wright et al. as taught however, is to provide a mixture of micronutrients and micro-nutrients as found in naturally-occurring floral pollen that provides the correct balance of nutrients for honeybees. Therefore, it would have been obvious to one of ordinary skill to have manipulated the amounts of various components of the composition in order to provide optimum nutritional benefits to the honeybees.
Claims 15-17 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (US PG Pub. 2019/0090507) in view of Svoboda et al. (J. Insect Physiology Vol 26, issue 5, pages 290-294, 1980) and further in view of Lan Phuong et al. (Processes 2019, 7, 456, pages 1-11).
The references discussed above do not teach that the source of isofucosterol or the sterols to be a plant species.
Lan Phuong et al. teaches extraction and identification of sterols including beta-sitosterol from Fabaceae plant seeds, see title and abstract.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the plant Fabaceae species and extracted isofucosterol or fucosterol because lan Fuong teaches extraction of various sterols including beta-sitosterol from such plant species.
Claims 18-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (US PG Pub. 2019/0090507) in view of Svoboda et al. (J Insect Physiology Vol 26, issue 5, pages 290-294, 1980) and further in view of El Syed et al. (Studies on the constituents of the green alga Ulva Lactuca, Chemistry of natural compounds, Vol. 47, July 2011, pages 335-338).
The references discussed above do not teach that the source of isofucosterol or the sterols to be an algal species.
El Syed et al. teaches isofucosterol was isolated from green alga Ulva Lactuca, see title and abstract.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized green alga Ulva Lactuca as a source of isofucosterol and utilized it the bee nutritional composition of Wright et al. as El Syed et al. teaches alga to be the source of isofucosterol.
Applicant argues that obviousness is not provided by the combined teachings of the references used in the rejections. According to applicant wright does not teach use of isofucosterol and Svoboda also does not teach use of isofucosterol or fucosterol in he diet for invertebrates or aquaculture. Applicant submits that there is no motivation, suggestion or reason to combine the teachings of Wright and Svoboda and use isofucosterol as an essential nutrient and/or that its addition to a diet would be beneficial, other than excessive hindsight.
Applicant’s arguments and the declaration is fully considered but is not persuasive to overcome the rejections. The rationale for using Svoboda’s reference is discussed above. Svoboda et al. discloses that isofucosterol are important sterols in the nutrition of Apidae, in particular honey bees. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant submits that as further evidence that the claimed invention provides unexpected results, several Examples from the application are presented. (Declaration (pages 10-12, part V). As even further evidence, the scientific community has recognized Dr. Bogaert's contribution in peer-review publications. (See, Declaration, pages 12-15 and Exhibit 1 attached to the Declaration.)
The examiner notes the unexpected benefits demonstrated in the declaration and specification. However, the independent claim does not commensurate with the scope of the declaration because no effective amounts of isofucosterol or fucosterol are recited in independent claim 1 (as recited in instant claim 4/demonstrated in specification or declaration). Once unexpectedness has been established, the probative value of the evidence as compared to the invention as claimed must be determined, i.e., claims must be “commensurate in scope” with the showing. See MPEP 716.02(d). And the Examiner does not consider the claimed invention to be commensurate in scope with the showing. (It is also suggested that independent claim 1 recites that the administration step is to invertebrates or aquaculture organisms).
Action is final
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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