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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 22, 2026 has been entered.
Applicants' arguments, filed October 22, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections 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):
(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 – 15 and 17 – 19 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 requirements of the particle sizes in claim 1, from which all other claims depend, it’s not clear. The claimed compositions encompass a mixture of particles of different sizes. Depending on the intended non-mammalian monogastric animal, different particle size distributions are claimed. The same phrasing of “average particle size” precedes 4 different size ranges and for each range, a certain percentage of the particles must have an average particle size falling within the range. For example, for the solid composition for fish or monogastric crustaceans, 10% to 20% of the granules must have an average particle size from 50 µm to 250 µm and 45% to 55% of the granules must have an average particle size of 250 µm to 400 µm (emphasis added). Any given population of particles has a single average particle size that reflects the mathematical average of the particle size, although number and volume based averages can have different values for the same particle population. Different populations of particles can have the same average particle size even those the absolute size of the particles in the populations are completely different. A population of two particles that are 98 µm and 102 µm in diameter will have an average particle size of 100 µm, as will a population of two particles that are 1 µm and 199 µm in diameter. An average size of 100 µm does not mean that particles around 100 µm in absolute size are present in the sample which causes issues with the required particle size distribution as recited in the instant claims. The instant claims require the same population of granules to have 4 different average particle sizes but the average is a description of the entire population of particles or granules. How the claimed composition is actually four separate compositions, each with an average particle size, and how those four separate populations are defined are not discussed in either the claims or the specification particularly when the particles of size similar to the average particle size need not be present (e.g., 1 µm and 199 µm particle population has a 100 µm average size).
The percent of particles whose absolute size falls within a size range of 50 µm to 250 µm, 250 µm to 400 µm, etc. can be determined from the typical plots obtained showing number of particles on the y axis and the size on the x-axis (an overview of particle characterization from particleshape.com, accessed February 3, 2026 accompanies this action that may be helpful in showing how such data is displayed and common parameters reported). However, claim 1 is NOT worded to require that percentages of the granules in the formulation are based on the absolute size of the particles, e.g., that 10% to 20% of the granules have an absolute size of 50 µm to 250 µm for the fish or monogastric crustacean composition.
As the average particle size is a characteristic of a population or particularly defined subpopulation of particles and neither the claims nor the specification discloses how four different subpopulations are defined and the average particle size for each subpopulation then determined, the required characteristics of the size distribution cannot be determined.
Claim 1 also recites “wherein said lipid matrix is capable of providing a blood bioavailability of said at least one amino acid in a constant percentage over a period of time ranging from 2 hours to 24 hours” (emphasis added). This phrase does not require that the lipid matrix provide such a feature to the claimed composition as a whole but it must be capable of having such a feature whose metes and bounds also cannot be determined. The phrase “constant percentage” appears only once in the specification as originally filed with ¶ [0070] of the PGPub of the instant application indicating that “said (ii) lipid matrix is capable of providing a blood bioavailability of said (i.1) at least one amino acid at a constant percentage (as defined in the context of the present invention), over a period of time comprised from 2 hours to 24 hours.” However, no definition or other indication of the scope of “as defined in the context of the present invention” was located in the disclosure as originally filed and even if this a term of art, this phrasing seems to suggest that a different definition is set forth somewhere in the disclosure as filed. Two different definitions of bioavailability, one being the absolute bioavailability and one being the relative bioavailability are set forth at ¶¶ [0032] and [0033] of the PGPub of the instant application. Each mentions normalization which can result in a number that is a percent but which of the two possible definitions of bioavailability, and how the data is normalized (e.g., with different administration routes or comparison with a not defined comparison compound) is not discussed or linked to the claim language of a constant percentage. The claim language indicates something about the blood bioavailability being constant, apparently in comparison to something else, but the limitations of this wherein clause cannot be determined.
The dependent claims fall therewith.
Please clarify.
Claim Rejections - 35 USC § 112 – Written Description
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 – 15 and 17 – 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention the achieves the claimed results and do so by showing that that the applicant has invented species sufficient to support a claim to a functionally-defined genus.
Claim 1 recites “wherein said lipid matrix is capable of providing a blood bioavailability of said at least one amino acid in a constant percentage over a period of time ranging from 2 hours to 24 hours” (emphasis added). Neither the claims nor the specification provides sufficient details as to what properties and/or structure the lipid matrix must possess in order to be capable of modulating the amino acid blood bioavailability to provide a constant percentage over the required 2 – 24 hour time period for at least one amino acid. Claim 1 does provide broad limitations for the actual structure of the lipid used in the matrix that are broad (e.g., a saturated or unsaturated, free or esterified fatty acid with 10 – 30 carbon atoms). Does the wherein clause at the end of claim 1 further limit the materials used for the lipid matrix beyond the structural limitations provided earlier in the claim? Are there implicit limitations on the thickness and/or additional ingredients that must be present in the matrix for the matrix to be capable of providing a constant percentage over a 2 – 24 hour time period for at least one amino acid? There are no examples or discussion in the specification as filed as to the structures (lipid materials themselves or the matrix as a whole) that can provide the claimed function, even if that function was clear (see above). Lipid matrices are known to provide controlled or sustained release of encapsulated materials (e.g., Ferket et al. and Mueller et al. cited in the obviousness rejection set forth below) but that alone does not appear sufficient to meet the claim limitation.
The dependent claims fall therewith.
Please clarify.
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.
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) 1 – 14, 14 and 17 – 19 were under 35 U.S.C. 103 as being unpatentable over Ferket et al. (WO 2018/089516; cited on IDS filed September 26, 2023) and Mueller (WO 2017/037157) in view of Chen et al. (US 2008/0220079, cited on IDS filed September 26, 2023). This rejection is MAINTAINED for the reasons of record set forth herein.
Ferket et al. discloses compositions containing nutrients encapsulated in a controlled release lipid matrix for feeding an animal (whole document, e.g., abstract). The controlled release lipid matrix can consist of at least one hydrogenated vegetable triglyceride selected from the group consisting of palm butter, sunflower oil, corn oil, rape oil (also known as rapeseed oil), peanut oil and soybean oil encapsulating nutrients selected from the group consisting of vitamins, amino acids, minerals and combinations thereof (¶ [0005]). By using the disclosed compositions in a composition for feeding an animal, the bioactive compounds are presented to the enteric ecosystem at more natural concentrations and release rates that are compatible with symbiotic microflora and the absorptive capacity and rates of the animal’s enteric mucosa, avoiding excessive amounts of nutrients being provided (¶ [0017]). Exemplified encapsulated amino acids include arginine, histidine, isoleucine, lysine, methionine, threonine, tryptophan, valine or any combination of the listed amino acids (¶ [0027]). The examples study the growth performance broiler chickens or male Ross X chickens (example 1 onward, beginning at ¶ [0039]), so the materials can be used as additives in poultry food. Encapsulation improved caloric and nutrient utilization even when the vitamins and minerals are provided at 30% of the industry standard dose (¶ [0091]) while the protection of the nutrients by hydrogenated fat encapsulation improved jejunum mucosal health (¶ [0092]) and altered the gut microflora towards a population distribution that is more symbiotic with the host (¶ [0093]).
Mueller et al. discloses a poultry feed additive composition comprising the phytocompound derivatives essential thyme oil that is microencapsulated and a saponin to improve the feed conversion efficiency in antibiotic-free poultry production (whole document, e.g., abstract). Essential thyme oil contains high amounts of the antioxidative phenolic compounds carvacrol and thymol (p 13, ln 13 – 18). Microencapsulated essential oil provides an oil component homogenously mixed with other dry substances and also provides for long-term bioavailability of the essential oil concomitant with the saponin compounds which are both released in a sustained manner (p 4, ln 4 – 15). Isolating the oils also provides other beneficial effects such as retarded evaporation and the release rate may be effectively controlled to provide an effects amount of the active components in the intestine (p 9, ln 5 – 16). Further excipients, optionally including bulking and anti-caking agents can also be present in the composition (p 3, ln 30 - 32) with SiO2 (silicon dioxide or silica) being specifically exemplified (e.g., p 5, ln 9 and p 11, ln 25). A wide range of materials can be used to encapsulate the active agents and the production process parameters such as spray drying are dictated by the desired physical characteristics of the final microencapsulated oil such as particle size (p 9, ln 17 – 34). The particles may have an average largest dimension of 250 – 500 µm, and the typical particulate materials has particles size of min 95% below 500 µm, indicating up to 5% has a particle size over 500 µm, and preferably the mean particle size is 100 – 350 µm (p 10, ln 20 -22).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition that contains microencapsulated amino acids as disclosed by Ferket et al. that also contains encapsulated phytogenic compounds that include thymol and carvacrol as discussed by Mueller. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because both materials are taught in the art for the inclusion in animal food such as for poultry to provide beneficial effects such as improved feed conversion, increased caloric and nutrient utilization in a sustained release form. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. The selection of the particular nutrients to be provided in microencapsulated form from those that are disclosed as suitable by the applied prior art is within the skill of one of ordinary skill in the art based on factors such as the particular type of feed being prepared and the nutritional needs (e.g., age of animal or type of animal). There is no evidence of record as to the criticality of the selected nutrients. Excipients can be added such as to provide anti-caking effects to the composition and the selection and use of such excipients is disclosed in the prior art as in within the knowledge of one of ordinary skill in the art. The amount of active components and lipid matrix will depend on any other materials that are encapsulated other than those recited in the claims that are being provided alongside the claimed active components and if excipients were added such as to prevent caking.
While Mueller discloses the desired particle size, rationale to alter the particle size is not disclosed.
Chen et al. discloses a sustained release-spherical or non-spherical pellets that comprise an active ingredient, a wax-like agent and a spheronizing agent that can be provided in oral dosage forms (whole document, e.g., abstract). The dissolution rate of the drug is directly proportional to the surface area of the mass such that conversion of a tablet into spheres 1 mm in diameter would reduce the release time from 24 hours to 0.8 hours (¶ [0018]). The sustained release barrier coating can enable slow release of the active ingredients (¶ [0019]). Herbs or other botanicals and amino acids are among the dietary supplement active ingredients that can be provided (¶ [0031]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to vary the particle size within the values disclosed by Mueller to provide the desired release rate of the microencapsulated phytogenic compounds and amino acids upon feeding to the desired non-mammalian monogastric animal. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Chen et al. discloses that smaller particles result in faster release of substances. Depending on the material(s) being delivered and the nutritional needs of the particular animal, different release rates may provide optimal effects by tuning the release rate for the intestinal system of the animal, such as the nutritional needs, natural concentrations in the animal’s diet, absorption capacity of the digestive system and microflora of the digestive system, all of which will affect the bioavailability and serum concentrations of the nutrients. This renders the particle size a results effective parameter that one of ordinary skill in the art would routinely optimize and Mueller provides information as to suitable sizes for poultry feed additives that encompass those of the instant claims and there is no evidence of record as to the criticality of the claimed particle sizes, rendering the claimed particle sizes prima facie obvious (see MPEP 2144.05).
Applicants traverse this rejection on the grounds that there are fundamental incompatibilities between the systems of Mueller and Ferket. A large section with significant emphasizing from Mueller is shown on page 13 and 14 of the Remarks filed October 22, 2025 that would be understood by a skilled person that the combination of microencapsulated essential oil component with the saponin in a flowable mixture is what functions to achieve improved feed conversion efficiency, potentially through synergistic effects on nutrient transport systems in the gut. The apparent citation to MPEP 2142, the legal concept of prima facie obviousness, after this statement is not clear to the Examiner. A citation from Ferket with considerable emphasis bridges p 14 and 15 of the Remarks filed October 22, 2025 which is stated to indicate that a key feature of the nutrients being encapsulated within the controlled release matrix. The cited passages discuss distinct features and operational principles, clearly indicating fundamental differences between Ferket’s integral lipid matrix and Mueller’s disparate system that would teach against the combination proposed. One skilled in the art would recognize that combining these disparate systems would likely frustrate the stated purpose of the systems in each of these references.
These arguments are unpersuasive. Mueller encapsulates amino acids in controlled release lipid mixture that can be used as an additive in poultry feed. Ferket also discloses a poultry feed additive of microencapsulated thyme oil and a saponin, wherein the microencapsulation of the thyme oil allows for homogenous mixing with other dry substances. The instant claims require the mixture of at least one amino acid and at least one phytocompound as defined in claim 1 to be embedded in the lipid matrix. As reiterated above, the rejection does not rely on the presence of the saponin within the same lipid matrix as the essential thyme oil that comprises carvacrol and thymol and the amino acid(s). The arguments of record do not establish that there is no reasonable expectation of success of changing from two separate poultry food additives of encapsulated amino acids in controlled release lipid mixture (Mueller) and microencapsulated thyme oil (Ferket) into a single poultry food additive in which both the at least one amino acid and essential thyme oil are encapsulated within a lipid mixture that provides controlled release. Such a material can be a free flowing material that can be mixed with other substances to provide a poultry food containing multiple additives that were known in the art to be beneficial, which is not frustrating the purpose of either reference as a microencapsulated nutrient material for use as a poultry food additive still results.
Applicants also argue that pellets of Chen describe a fundamentally different technology from Ferket and Mueller and that technology is incompatible with the monolithic lipid matrix with directly embedded nutrients of Ferket and Mueller’s flowable powder with separate microencapsulated oils and particulate plant powders. Indications from Chen such as the relationship between particle size and release rate would not be understood by a skilled person to be directly applicable to the materials of Ferket and Mueller.
These arguments are unpersuasive. Applicants seem to be arguing that the pellets of Chen are so dissimilar in structure from the encapsulated materials in Ferket and Mueller that the teachings regarding the functional relationship between particle size and the release rate of embedded materials in such particles would not be expected to apply to the particles or powders of Mueller and Ferket. However, while pellet, powder and particles are not exact synonyms of each other, each applied prior art reference describes individual structures comprising a wax like or lipid material encapsulating at least one substance whose release rate is modified by virtue of being encapsulated with the surface area of the final material altering the release rate. Surface area necessarily changes are particle size changes even for particles of the same shape. A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton (MPEP 2141(II)(C). Obviousness takes into consideration not only the explicit teachings of the applied prior art but also the implicit and inherent teachings of the prior art and the knowledge of one of ordinary skill in the art before the effective filing date of the claimed invention. The general statements of record do not establish that such an artisan would not expect the size of the materials described by Ferket et al. and Mueller to alter the release rate in a manner analogous to that discussed by Chen et al.
Applicants also argue that the specific functional outcome achieved by the claimed invention would still not have been obvious as the cited references fail to suggest the unique controlled release profile resulting from the claimed combination of the specific lipid matrix and the precisely defined particle size distribution. Portions of the specification with significant emphasis added are presented in the remarks discussing the digesting of different particle sizes in the intestine and in vitro experiments based on simulated intestinal pH conditions of granules of different sizes, showing earlier release of larger amounts of active ingredient from smaller particles. The specification explicitly described the mechanism enabled by the combination of lipid matrix embedding of a mixture of active compounds with the particle size distribution optimized for general sustained release and is experimentally supported by Table 2 from the specification [the table showing in vitro in a buffer simulating the intestinal pH conditions]. Progressive release along the entire intestine represents an unexpected improvement over the general concepts of controlled or sustained release as mentioned in Ferket and Mueller. Chen does not describe the specific distribution of multiple particle sizes. The functional outcome is constant blood bioavailability of 2 to 24 hours is a direct result of this non-obvious structural feature. The result is not merely sustained release but sustained release optimized for continuous absorption along the gut. The unexpected results stem directly from the unique combination of claimed matrix properties and the specific, engineered particle size distribution.
These arguments are unpersuasive. As discussed in greater detail above, the claims encompass populations of particles that somehow possess four different average particles sizes defined by an average particle size even though a sample having an average particle size within a range need not contain particles whose absolute size also falls within the claimed range with a lipid matrix that just must be capable of providing a constant percentage of blood bioavailability for at least one amino acid over the claimed time period. The instant application presents no data as to any type of blood bioavailability in an organism. Table 2 does not state the organism whose intestinal pH was being simulated and/or of the pH used varied over time. As shown in the Figure, pH varies as a function of time in Diplodus sargus, a fish, although it is no clear if this is for a single part of the intestinal tract and/or the transit of a material through the intestinal tract takes 24 hours and this is the pH that material would be exposed to at that time of day. Table 1 references transit times and the various pH values of what appears to be the digestive system of birds/poultry which possess a gizzard and at most the entire transit time would be 280 minutes or about 4.7 hours with pH values ranging from 2.5 to 8.0. Even if in vivo date demonstrating a constant blood bioavailability was actually demonstrated, evidence in support of unexpected results must be reasonably commensurate in scope with the claims. The criticality for poultry, a genus that would reasonably include at least chickens and turkeys and for fish and monogastric crustaceans, a genus that also would seem to include multiple types of crustaceans, would need to be demonstrated. One of ordinary skill in the art would be motivated to provide a composition whose particle sizes were optimized to provide more natural concentrations and release rates compatible with symbiotic microflora discussed by Ferket et al. and there is no evidence of record of unexpected results arising from administration of a composition have a particle size distribution percentage as claimed.
Claim(s) 13 was rejected under 35 U.S.C. 103 as being unpatentable over Ferket et al., Mueller and Chen et al. as applied to claims 1 – 12, 14 and 17 – 19 above, and further in view of Schultz et al. (US 2016/0304410). This rejection is MAINTAINED for the reasons of record set forth herein.
Ferket et al., Mueller and Chen et al. are discussed above.
While the use of excipients such as the anti-caking agent silicon dioxide is disclosed, none of the specific materials in claim 13 are disclosed.
Schultz et al. discloses coatings and additives comprising a fatty acid or salt of fatty acid for application to granules such as animal feed (whole document, e.g., abstract). To alleviate the caking tendencies, a flow additive is added and can be animal feed certified sodium stearate or other metal or mineral salts such as calcium stearate or magnesium stearate and in certain embodiments, it can provide a secondary nutrient or micronutrient source (¶ [0032]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a fatty acid salt such as calcium stearate or magnesium stearate as a flow additive in the compositions of Ferket et al., Mueller and Chen et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because both Mueller and Schultz et al. discuss the inclusion of anti-caking agents to assist in the flow of granular compositions such as those for animal feed. Calcium stearate or magnesium stearate can provide such functionality while also providing the (micro)nutrients calcium or magnesium as part of the composition.
No specific arguments relating to Schultz et al. are set forth for the Examiner to address herein.
Terminal Disclaimer
The terminal disclaimer filed on October 22, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent to issue from Application No. 17/631,182 has been reviewed and is accepted. The terminal disclaimer has been recorded. In view of the accepted terminal disclaimer and abandonment of the ‘182 application since the mailing of the last Office Action in this case, the provisional nonstatutory double patenting rejection has been withdrawn.
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.
Due to the abandonment of Application No. 17/265,769 since the mailing of the previous Office Action in this case, the provisional nonstatutory double patenting rejection based on that application has been withdrawn.
Claims 1 – 15 and 17 – 19 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 19 of copending Application No. 17/921,094 in view of Ferket et al. (WO 2018/089516; cited on IDS filed September 26, 2023) and Mueller (WO 2017/037157) in view of Chen et al. (US 2008/0220079, cited on IDS filed September 26, 2023) and optionally Schultz et al. (US 2016/0304410) This rejection is MAINTAINED for the reasons of record set forth herein.
The claims of US’094 recite compositions and methods relating to such a composition that contains thymol embedded or incorporated into a controlled release lipid matrix of the same materials as in instant claim 1 and at least one pharmaceutically acceptable pharmaceutical or food grade additive and/or excipient (claim 1 of US’094). The compositions can be administered to various humans or animals to treat various conditions (e.g., claims 2 and 11) and can be a feed or feed additive (claim 19).
The presence of at least one amino acid and the particle sizes are not claimed.
Ferket et al., Mueller and Chen et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition that contains microencapsulated amino acids as disclosed by Ferket et al. that also contains encapsulated phytogenic compounds that include thymol and carvacrol as claimed by US’094. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because both materials are taught in the art for the inclusion in animal food to provide beneficial effects such as improved feed conversion, increased caloric and nutrient utilization in a sustained release form. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. The selection of the particular nutrients to be provided in microencapsulated form from those that are disclosed as suitable by the applied prior art is within the skill of one of ordinary skill in the art based on factors such as the particular type of feed being prepared and the nutritional needs (e.g., age of animal or type of animal). There is no evidence of record as to the criticality of the selected nutrients. Excipients can be added such as to provide anti-caking effects to the composition and the selection and use of such excipients is disclosed in the prior art as in within the knowledge of one of ordinary skill in the art. The amount of active components and lipid matrix will depend on any other materials that are encapsulated other than those recited in the claims that are being provided alongside the claimed active components and if excipients were added such as to prevent caking.
It also would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to vary the particle size to provide the desired release rate of the microencapsulated phytogenic compounds and amino acids upon feeding to the desired animal. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Chen et al. discloses that smaller particles result in faster release of substances. Depending on the material(s) being delivered and the nutritional needs of the particular animal, different release rates may provide optimal effects by tuning the release rate for the intestinal system of the animal, such as the nutritional needs, natural concentrations in the animal’s diet, absorption capacity of the digestive system and microflora of the digestive system. This renders the particle size a results effective parameter that one of ordinary skill in the art would routinely optimize and Mueller provides information as to suitable sizes for poultry feed additives that encompass those of the instant claims and there is no evidence of record as to the criticality of the claimed particle sizes, rendering the claimed particle sizes prima facie obvious (see MPEP 2144.05).
While the use of excipients is claimed, none of the specific materials in instant claim 13 are claimed.
Schultz et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a fatty acid salt such as calcium stearate or magnesium stearate as a flow additive in the compositions of US’094, Ferket et al., Mueller and Chen et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because both Mueller and Schultz et al. discuss the inclusion of anti-caking agents to assist in the flow of granular compositions such as those for animal feed. Calcium stearate or magnesium stearate can provide such functionality while also providing the (micro)nutrients calcium or magnesium as part of the composition.
This is a provisional nonstatutory double patenting rejection.
Applicants do not present any specific arguments regarding this double patenting rejection other than requesting reconsideration.
As discussed above, even as amended the claims of the instant application are not patentably distinguished over those of US’094.
Conclusion
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618