DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 02/12/2026 is acknowledged.
Status of Application
Applicant has elected Group I in response to restriction requirement and for the examination.
Due to restriction, based on election of Group I, claims 38-43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1,3-8,10-12,26-30, 38-43 are pending.
Claims 1,3-8,10-12,26-30 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,3-8,10-12,26-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and post-filing art, while being enabling for a method of increasing absorption of calcium and phosphorous in the digestive track of piglets and perhaps broiler chickens and cattle/cows with the administration of a composition comprising a) certain emulsifiers derived from ricinoleic acid like glyceryl polyethylene glycol ricinoleate, b) one or more mineral sources of calcium, c) one or more sources of silica in solid form, in combination with a dietary formulation; does not reasonably provide enablement for the breath claimed which is to any and all subjects/animal including humans and various poultry like Peking ducks, with any emulsifier derived from ricinoleic acid (the indefiniteness for the phrase is addressed below). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of increasing absorption of calcium and phosphorous in the digestive track of a subject with the administration of a composition comprising a) an emulsifier derived from ricinoleic acid, b) one or more mineral sources of calcium, c) one or more sources of silica in solid form, in combination with a dietary formulation. Thus, the claims taken together with the specification imply that the method is enabled to increase absorption of calcium and phosphorous in the digestive track of any and all subjects like humans and ducks and cows and sheep.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the prior art of Zeng et al. teaches administration of a dietary composition comprising glyceryl polyethylene glycol ricinoleate (also known as GPGR, PEGR, E484, PEG castor oil), dicalcium phosphate, calcium carbonate, bentonite (clay known to contain silica, see Wiginton) where while there was significant improvement in growth performance with the PreE diet (poultry fat, water, the emulsifier comprising GPGR, NC diet containing dicalcium phosphate, calcium carbonate, bentonite (clay with silica)); it did not have any significant effects on growth performance when there was only the direct addition of the emulsifier into the diet (GPGR, dicalcium phosphate, calcium carbonate, bentonite, no poultry fat, Page 5 second column last paragraph-Page 6 1st column 1st paragraph); and there was no significant difference (no statistically significant difference p>0.05) in calcium (Ca) utilization/absorption among the 4 groups - including with the glyceryl polyethylene glycol ricinoleate emulsifier (Nutrient Utilization – last sentence). Wherein the broad breath claimed is not enabled.
Post filing art by Decundo et al. addresses that glyceryl polyethylene glycol ricinoleate (GPGR) when incorporated in the diet for piglets showed improved epithelial morphology (greater villus height and intestinal absorption area), superior digestive enzyme activity, and a gut microbiome; and this effect had been previously described in pigs and can attribute to enhanced nutrient absorption – which would likely apply to calcium and phosphorous.
(5) The relative skill of those in the art:
The relative skill of one in the art is high
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided a disclosure for administering a composition comprising a) an emulsifier derived from ricinoleic acid, b) one or more mineral sources of calcium, c) one or more sources of silica in solid form, in combination with a dietary formulation; but has not provided guidance/examples or demonstrated a method of increasing absorption of calcium and phosphorous in the digestive track of a subject as claimed with the administration of a composition comprising a) an emulsifier derived from ricinoleic acid, b) one or more mineral sources of calcium, c) one or more sources of silica in solid form, in combination with a dietary formulation. The examples are to broilers, hens, and cattle which demonstrate an increase in weight gain in broilers and cattle and improvements in egg weight and crack occurrence in hens - but not that there was an increased absorption of calcium and phosphorous in the digestive track of broiler chickens with the administration of the exemplified feed composition, and the examples do not disclose what the emulsifier is- it only recites “Emulsifying oil” which does not disclose what the emulsifier is or what is in it – does it have calcium or silica? Or is it just an emulsifier and which one is it? It is noted that Table 5 is fuzzy and not readable. If there is calcium or phosphorous along with the emulsifier in the emulsifying oil then that would impact the nutritional content of the feed and impact the shell quality of the hens. The specification does not clearly demonstrate the claimed method, as a weight gain is correlated with calcium and phosphorus absorption in the intestine as seen by Zeng et al. where there was a significant improvement in growth performance (weight gain) with the PreE diet (poultry fat, water, the emulsifier – but there was no significant difference in calcium (Ca) utilization/absorption among the 4 groups - including with the glyceryl polyethylene glycol ricinoleate emulsifier. This also the case with the weight gain example of the cattle or increase in egg weight as it does not demonstrate an increase absorption of calcium or phosphorous from the intestine as a result of the administration of the composition, only weight gain.
The post filing art above appears to support for the piglet and perhaps the broilers and cattle/cows for a method of increasing absorption of calcium and phosphorous in the intestine with the administration of a composition comprising a) glyceryl polyethylene glycol ricinoleate (GPGR), b) one or more mineral sources of calcium, c) one or more sources of silica in solid form, in combination with a dietary formulation.
However, the specification does not provide for the broad breath claimed.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to the enablement with regards to the broad breath of subjects and breath of emulsifier derived from ricinoleic acid and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 1,3-8,10-12,26-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are directed to “an emulsifier derived from ricinoleic acid” but is indefinite as it unclear is encompassed by the term and given the form any number of emulsifiers given an infinite number of chemical reactions, the emulsifier and be anything and thereby it is unclear what is envisioned for the invention. For example, does the phrase embrace polysorbates or glycerol monolaurate as one can derive it from ricinoleic acid given an infinite number of chemical reactions. Or is it to emulsifiers where the fatty acid is ricinoleic acid like glyceryl polyethylene ricinoleate (also known as PEG castor oil, E484, Cremophor EL, Macrogolglycerol ricinoleate, PEG-35 castor oil, Polyoxyl-35 castor oil). It does not allow one of skill in the art to know the metes and bounds of the invention. For purposes of examination, either view applies.
Claims 1,3-8,10-12,26-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim recites the administration of an emulsifier composition and a dietary composition wherein it is unclear if the claim is in a product by process form as the administered composition can be the combination of the emulsifier composition (the emulsifier, silica, calcium) with the dietary formulation which is also claimed in claim 12 wherein it is unclear if it is a product by process as it recites a method of preparation, and the examples have the emulsifier composition combined with the feed, the components are not separate. Wherein it is unclear what the composition form is (i.e. one where the composition administered is a dietary formulation that contains (has incorporated) calcium, silica, and the emulsifier; or is it separate components wherein then claim 12 is unclear as it then one composition but contradicts the remaining claims. For purposes of examination, either view may apply.
Claims 3-5, 7 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.
The claim recites concentration for calcium and silica and the emulsifier but it is unclear if the amounts are for the component as separate compositions prior to the combination of the emulsifier with the dietary formulation which is a product by process or after as one feed composition as taught in the examples and as recited in claim 12 which appear to direct the independent claim to be a product by process. It does not allow one to ascertain the metes and bounds of the claim as written. For purposes of examination either view applies.
Claim 26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim recites the emulsifier derived from ricinoleic acid comprises a soap and polyol of ricinoleic acid which is indefinite as it is unclear how the emulsifier comprises a soap and a polyol of ricinoleic acid as an emulsifier contains a polyol that is in combination with the salt of fatty acids (i.e. ricinoleic acid, a salt of ricinoleic acid); wherein the soap could be a salt of ricinoleic acid but it is unclear how the polyol can be from ricinoleic acid as does not have the structure to be a polyol (doesn’t have the multiple hydroxyl groups). It does not allow one to ascertain the metes and bounds of the claim. For purposes of examination, the claim is treated where the fatty acid is ricinoleic acid and the emulsifier contains a polyol in combination with ricinoleic acid as the fatty acid base (i.e. the soap is a salt drawn from a form of ricinoleic acid).
Claim Rejections - 35 USC § 102
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, 8, 10-12, 26-28,30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roy et al. (Effects of Supplemental Exogenous Emulsifier on Performance, Nutrient Metabolism, and Serum Lipid Profile in Broiler Chickens).
It is noted that the claims are directed to the administration of a dietary formulation and a emulsifier composition containing an emulsifier derived from ricinoleic acid, a calcium source, and a silica; wherein the composition administered can be a dietary formulation containing an emulsifier derived from ricinoleic acid, a calcium source, and a silica; which appears to be reflective of the specification examples (as the emulsifying oil can be just the emulsifier).
Rejection:
Roy et al. teaches administering the emulsifier glyceryl polyethylene glycol ricinoleate (also known as PEG castor oil, E484, Cremophor EL, Macrogolglycerol ricinoleate, PEG-35 castor oil, Polyoxyl-35 castor oil)) with dicalcium phosphate (supplement for mineral calcium and phosphorus see Agcare Products (Dical Feed Phos)) with limestone (also known as calcium carbonate with silica, see ilc resources Safety Data Sheet) and soybean meal to broiler chickens. Glyceryl polyethylene glycol ricinoleate was added in the starter and finisher feeds at 350mg per kg feed and 280mg/kg feed in the E1 and 700mg and 560mg per kg feed in E2 (Page 2 Materials and Methods 2nd paragraph, all from about 50mg-2kg/ton of dietary formula, 1 ton=907.185kg, 1000g=1kg diet wherein 280mg/kg emulsifier is about 254g/ton=0.254kg/ton feed, 350mg/kg feed=317.5g/ton feed=0.3175kg/ton feed, 700mg/kg=about 635g/ton feed=0.635kg/ton feed, 560mg/kg feed=about 508g/ton feed=0.508kg/ton feed). There were no mortalities in the E2 dietary group and Ea and E2 had only 15% and 10% respectively of pasty vent comparted to 40% of birds in the control diet – where all the birds in E1 and E2 recovered but more than 18% of the control bird were still suffering from the condition (Results 2nd paragraph, Table 3); there was also an increase in the live weight of the birds in the E1 group, and Li et al. teaches that emulsifiers are documented to be a positive effect on nutrient digestibility in pigs, and there was a decrease in excretion of N (nutrients) decreased with the dose of emulsifier wherein the metabolized N intake tended to be higher with the dose of added emulsifier (60.5% and 42.1% in E1 and E2 groups over control). Li et al addresses that glyceryl polyethylene glycol ricinoleate can augment nutrient utilization and food conversion in broilers (see full document, specifically areas cited).
As there is no specific patient condition/population recited, and the composition being administered contains the recited structural components (an emulsifier, calcium with silica (and also phosphorous) in the diet), the broilers would inherently have improved absorption of calcium and phosphorous and shell stability as the effects of administering the composition are inherent to the components of the composition and the mode of delivery. When the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as the absorption of nutrients like calcium and phosphorus, and eggshell quality as they are a direct result of the components of the composition and the mode of administration which are met by the art whereby the resulting properties and effects would inherently be met. It is noted that Li et al. addresses that emulsifiers are documented to be a positive effect on nutrient digestibility in pigs wherein “[T]he 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 unknown property which is inherently 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).
An inherent feature need not be recognized at the time of the invention.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. The fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al. (Effects of Supplemental Exogenous Emulsifier on Performance, Nutrient Metabolism, and Serum Lipid Profile in Broiler Chickens ) as applied to claims 1, 8, 10-12, 26-28,30 above, in view of Koutsos et al. (U.S. Pat. Pub. 2020/0196631).
Rejection:
The teachings of Roy et al. are addressed above.
Roy et al. does not expressly teach the recited amount of calcium carbonate/limestone but does teach its inclusion.
Koutsos et al. teaches that calcium sources like calcium carbonate is known to be in poultry feed compositions at 2-10%wt. feed composition and dicalcium phosphate at 2-10%wt.of the feed composition [12].
Wherein it would be obvious to one of ordinary skill in the art to incorporate the calcium carbonate at concentrations within the recited range along with additional calcium and phosphorus sources like dicalcium phosphate as Roy et al. contains similar calcium and phosphorus sources like calcium hydrogen phosphate as suggested by Koutsos et al. and produce the claimed invention; as it is prima facie obvious to incorporate the calcium sources like calcium carbonate at its known range for animal feed which overlaps the instant claimed range, and optimize within the range and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al. (Effects of Supplemental Exogenous Emulsifier on Performance, Nutrient Metabolism, and Serum Lipid Profile in Broiler Chickens ) as applied to claims 1, 8, 10-12, 26-28,30 above, in view of Yan et al. (CN 105661045A).
Rejection:
The teachings of Roy et al. are addressed above.
Roy et al. does not expressly teach the inclusion of diatomaceous earth but does teach the inclusion of limestone which contains calcium carbonate and silica in the animal feed.
Yan et al. teaches that diatomaceous earth can improve the quality and yield livestock and poultry, reduce feeding costs, promote aminal appetite and absorption and enhance their disease resistance and immunity [17]. The diatomaceous earth is applied to the feed for livestock and poultry at 1%-15%wt. of feed ([16], claim 4).
Wherein it would be obvious to one of ordinary skill in the art to incorporate the diatomaceous earth as suggested by Yan et al. and produce the claimed invention; as it is prima facie obvious to incorporate the diatomaceous earth in the feed as it has provides a host of benefits including improve the quality and yield livestock and poultry, reduce feeding costs, promote aminal appetite and absorption and enhance their disease resistance and immunity, with a reasonable expectation of success It is also prima facie obvious to incorporate it at its known range which overlaps the instant claimed range - and optimize within the range and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Roy et al. (Effects of Supplemental Exogenous Emulsifier on Performance, Nutrient Metabolism, and Serum Lipid Profile in Broiler Chickens ) as applied to claims 1, 8, 10-12, 26-28,30 above, in view of Wan et al. (U.S. Pat. Pub. 2018/0020696).
Rejection:
The teachings of Roy et al. are addressed above.
Roy et al. does not expressly teach the recited amount of glyceryl polyethylene glycol ricinoleate emulsifier but does teach its inclusion at around 0.028- 0.07%wt.
Wan et al. teaches that surfactants are known to be in dietary compositions for animal feed from about 0.01-about 20%wt. (claim 42, [3]) and the surfactants include glyceryl polyethylene glycol ricinoleate (polyglycerol polyricinoleate) E484 which is exemplified (Example 3, [175], claim 28).
Wherein it would be obvious to one of ordinary skill in the art to incorporate the glyceryl polyethylene glycol ricinoleate at concentrations within the recited range as suggested by Wan et al. and produce the claimed invention; as it is prima facie obvious to incorporate the glyceryl polyethylene glycol ricinoleate E484 at its known range for animal feed which overlaps the instant claimed range, and optimize within the range and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claims 1, 5-8, 10-12, 26-27, 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. (U.S. Pat. Pub. 2018/0020696) in view of Yan et al. (CN 105661045A).
It is noted that the claims are directed to the administration of a dietary formulation and a emulsifier composition containing an emulsifier derived from ricinoleic acid, a calcium source, and a silica; wherein the composition administered can be a dietary formulation containing an emulsifier derived from ricinoleic acid, a calcium source, and a silica; which appears to be reflective of the specification examples (as the emulsifying oil can be just the emulsifier).
Rejection:
Wan et al. teaches the administration of a dietary composition comprs8ing a fatty acid and surfactant and at least one feed material for a ruminant like cattle/cows wherein the surfactant includes glyceryl polyethylene glycol ricinoleate (polyglycerol polyricinoleate) E484 which is exemplified (Example 3, [175, 17, 38, 98], claim 28). The composition can improve the digestibility of nutrients [77-78, 120, 149]. the amount of surfactant is about 0.01-about 20%wt.and the feed is about 50-about 99%wt (abstract, [3]). The composition can include feed material like corn and wheat and soy meal [33-34], a nutritional agent comprising a mineral like calcium like the exemplified calcium carbonate and phosphorous (Table 2, barley is known to have phosphorus, [9-10, 13, 175]). The dietary composition can improve various aspects of the ruminant like milk production or growth; and can be in various forms like dry particles or pellets ([72], see full document specifically areas cited). While Wan et al. does not recite the product by process recitation of addition the emulsifier components at the feed (i.e. 50mg-2kg/ton of feed), the product by process recitation is treated as a product (i.e. the dietary composition with the emulsifier calcium and silica) absent evidence that the process limitations yield a different product.
Wan et al. does not expressly teach the inclusion of diatomaceous earth but does teach the administration of a dietary composition for an animal like a cow.
Yan et al. teaches that diatomaceous earth can improve the quality and yield of livestock, reduce feeding costs, promote aminal appetite and absorption and enhance their disease resistance and immunity [17]. The diatomaceous earth is applied to the feed for livestock at 1%-15%wt. of feed ([16], claim 4).
Wherein it would be obvious to one of ordinary skill in the art to incorporate the diatomaceous earth as suggested by Yan et al. and produce the claimed invention; as it is prima facie obvious to incorporate the diatomaceous earth in the feed as it has provides a host of benefits including improve the quality and yield livestock, reduce feeding costs, promote aminal appetite and absorption and enhance their disease resistance and immunity, with a reasonable expectation of success It is also prima facie obvious to incorporate it at its known range which overlaps the instant claimed range - and optimize within the range and arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values. As there is no specific patient condition/population recited, and the composition being administered contains the recited structural components (an emulsifier, calcium with silica (and also phosphorous) in the diet), the animal like a cow would intrinsically have improved absorption of calcium and phosphorous; particularly as there is improved nutrient digestibility (all more absorption of the diet and nutrients like calcium and phosphorous).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. (U.S. Pat. Pub. 2018/0020696) in view of Yan et al. (CN 105661045A) as applied to claims 1, 5-8, 10-12, 26-27, 29-30 above, further in view of Wei et al. (CN 107333984A).
Rejection:
The teachings of Wan et al.in view of Yan et al. are addressed above.
Wan et al.in view of Yan et al. does not expressly teach the instant claimed amount of calcium carbonate but does teach its inclusion.
Wei et al. teaches that calcium carbonate is known to be useful in ruminant compositions for animal feed from 7-10%wt. (claim 1, [11] falling within the breath instantly claimed of about 10-about 30%).
Wherein it would be obvious to one of ordinary skill in the art to incorporate the calcium carbonate at 7-10% as suggested by Wei et al. and produce the claimed invention; as it is prima facie obvious to incorporate the calcium carbonate in its known useful amounts in animal feed with a reasonable expectation of success.
Double Patenting
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 182-184 of copending Application No. 19/113337 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a method of feeding an animal a feed source and a nutritional supplement that comprise an emulsifier solution with an emulsifier of formula I which includes ricinoleic acid and optionally one or more carriers that would be silica or calcium, and the aminal has the same or enhance level of calcium or phosphorus to the control while have less calcium and phosphorus I the feed.(more absorption) wherein the breath of the copending claims read upon the breath of the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1,3-8,10-12,26-30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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