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
Claim Objections:
Claims 4, 6-9, 22, 26, 28, 29 and 30 are objected to for reciting the limitation “pollen substitute composition”, whereas claim 1 to which the claims are dependent upon recites “non-pollen” composition. Applicant is suggested to replace “pollen substitute” to “non-pollen” to be consistent throughout the claims. Claim 15 is objected to for reciting “barks and fruits and combinations thereof”. The correct format of the markush group is “barks, fruits and combinations thereof”, see MPEP2117. I. and 2173.05(h). Claim 16 is objected to for reciting “extract, an oil or refinement of a non-pollen tissue of one or more of a plant species or a combination thereof”. The correct format is suggested to be “extract, an oil, refinement of a non-pollen tissue of one or more of a plant species or a combination thereof”. Claim 17 is objected to for being grammatically incorrect. The claim is suggested to be recited as “wherein the source of the isofucosterol, fucosterol or a mixture thereof is a non-pollen tissue of one or more plant species selected from the group consisting of Solanaceae, Poaceae, Ranunculaceae, Fabaceae and Corylacaceae.” Claim 18 is objected to for missing a semicolon at the end of “Ulva Lactuca”.
Applicant is advised that should claim 19 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1, 3-24 and 26-30 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 pre-AIA the applicant regards as the invention.
Claims 1, 22-23, 28 recites the limitation “preferably”, “more preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The recitation of "preferably" in this context improperly provides for preferences within the subject claims and thereby renders confusion over the intended scope of the claim term. See MPEP § 2173.05(d). Applicant should amend to remove all occurrences of improper preferences throughout the claims.
Claims 13 and 18 recite the limitation “in particular” 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 13 recites the limitations “Apini”, “Bombini” and “Meliponini” within parenthesis and also recite narrow and broad limitations as “honey bees (Apini), bumble bees (Bombini) and stingless honey bees in a single claim which makes the claim indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation Apini , Bombini and Meliponini, and the claim also recites honey bees, bumble bees and stingless honey bees which is the narrower version of the tribe Apini, Bombini and Meliponini. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 14 and 18-20 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 27 recites inclusion of a bee inducing constituent to be pollen. However, the independent claim 1 recites administering a non-pollen composition. Inclusion of pollen is therefore contradictory to the limitations of the independent claim thereby making the claim indefinite. Claim 24 recites the limitation “wherein the composition is essentially free of pollen” which makes the claim indefinite because claim 1 recites the composition to be non-pollen. It is not clear as to what level of pollen is within the scope of the term “essentially free” when the claim it depends on already recites the composition to be non-pollen in nature.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 27 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 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 27 recites inclusion of a bee inducing constituent to be pollen. However, the independent claim 1 recites administering a non-pollen composition. Inclusion of pollen is therefore broadening of 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 § 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 (or Non-pollen composition as claimed).
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 or non-pollen composition 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 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 18-21 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.
Nonstatutory double patenting rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-24 and 26-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-11, 14-23, 25 and 27-38 of copending Application No. 18/580,901. (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims recite a method for feeding invertebrates or aquaculture organisms comprising: providing a non-pollen composition comprising a nutritionally effective amount of isofucosterol, fucosterol or a mixture thereof, and administering the non-pollen composition to invertebrates; wherein the invertebrates are pollen eating insects, preferably insects of the orders Hymenoptera and Coleoptera, more preferably honeybees, bumblebees, black soldier flies, hoverflies, or ladybirds; and the aquaculture organisms are plankton and algae eating aquaculture organisms, preferably fish, fish larvae, oysters, clams, molluscs, gastropods, or crustacea. Claim 4 recites wherein the nutritionally effective amount of isofucosterol, fucosterol or a mixture thereof is from 10 w% to 60 w% of the total amount of sterols of the group of isofucosterol, fucosterol, cholesterol, 24-Methylenecholesterol, campesterol, stigmasterol and beta-silosterol in the total diet of the invertebrates or aquaculture organisms or the pollen substitute composition.
The copending claims recite a method for feeding invertebrates aquaculture organisms comprising: providing a pollen substitute composition comprising a nutritionally effective amount of isofucosterol, fucosterol or a mixture thereof; and administering the pollen substitute composition to invertebrates or aquacultural organisms; wherein the pollen substitute composition comprises a nutritionally effective amount selected from (a) or (b), and wherein (a) and (b) are: (a) at least one further sterol selected from the group consisting of cholesterol, 24-Methylenecholesterol, campesterol, stigmasterol and beta-sitosterol or a physiologically available conjugate thereof in a weight-ratio of isofucosterol, fucosterol, or a mixture thereof to the sum of at least one further sterol is from 2:100 to 100:2 and (b) at least two further sterols, selected from the group consisting of cholesterol, 24-Methylenecholesterol, campesterol, stigmasterol and beta-sitosterol or a physiologically available conjugate thereof in a weight-ratio of isofucosterol, fucosterol, or a mixture thereof to the sum of the at least two further sterols is from 2:100 to 100:2 each as compared to the total weight of the pollen substitute composition. The copending claims reciting a method of feeding invertebrates or aquaculture organisms comprising providing a pollen substitute reads on the instantly claimed administering non-pollen composition comprising isofucosterol, fucosterol or a mixture thereof, wherein the nutritionally effective amount of isofucosterol, fucosterol or a mixture thereof is from 10 w% to 60 w% of the total amount of sterols of the group of isofucosterol, fucosterol, cholesterol, 24-Methylenecholesterol, campesterol, stigmasterol and beta-sitosterol in the total diet of the invertebrates or aquaculture organisms or the pollen substitute composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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