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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The instant application is a continuation-in-part (CIP) of US application no. 17/945,010 filed on 09/14/2022, which claims domestic benefit to US provisional application no. 63/356,389 filed on 06/28/2022, US provisional application no. 63/321,596 filed on 03/18/2022, US provisional application no. 63/309,205 filed on 02/11/2022, and US provisional application no. 63/244,105 filed on 09/14/2021.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The disclosure of the prior-filed application, US provisional application no. 63/244,105 (referred to as ‘105) filed on 09/14/2021, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The disclosed specification of ‘105 teaches a composition including a dispersion medium including: an aqueous solution and a dispersed phase including a population of particles, each particle including an active ingredient (see paragraph 0005). The specification of ‘105 further teaches means for encapsulating a variety of active components (see paragraphs 0015-0019 and paragraphs 0119-0123). However, there is no support provided in the disclosure for a particle comprising a recited nicotinamide adenine dinucleotide (NAD) precursor in the aqueous phase and for encapsulating the nicotinamide riboside chloride with an oil phase.
US provisional application no. 63/356,389 filed on 06/28/2022, US provisional application no. 63/321,596 filed on 03/18/2022, and US provisional application no. 63/309,205 filed on 02/11/2022 all provide support for the claimed composition. Therefore, the earliest effective filing date of the instant application is 02/11/2022.
Status of the Claims
The claim amendments and remarks filed on 01/23/2026 is acknowledged. Claim 1 is cancelled. Claims 2-21 are newly added.
Accordingly, claims 2-21 are pending and being examined on the merits herein.
Withdrawn Rejections
The cancellation of claim 1 renders the 35 USC 102 rejection over this claim moot.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
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) 2, 6, 13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892).
Erickson discloses compositions that can contain ethyl cellulose based coatings for microencapsulation of nicotinamide riboside and salts thereof such as chloride salt (NR-Cl) (Abstract and claims 1-2). Erickson discloses that the method of making their composition involve dispersing nicotinamide riboside, a salt thereof, or a solvate thereof, or a derivative thereof, in a matrix of ethyl cellulose and a solvent to produce a suspension; (b) homogenizing the suspension; (c) atomizing the homogenized suspension to produce particles of polymerized ethyl cellulose encapsulating nicotinamide riboside, a salt thereof, or a solvate thereof; and (d) drying the particles to provide ethyl cellulose coated particles of nicotinamide riboside, a salt thereof, or a solvate thereof, or a derivative thereof (claim 10).
Erickson discloses that NR, although hydrophilic, is particularly susceptible to hydrolysis, such that microencapsulation using an edible and biocompatible polymer provides physicochemical stability (paragraph 0002). Erickson discloses that a microencapsulated NR, or its derivatives, salts, or prodrugs thereof, would be useful in pharmaceuticals, food or beverages, or dietary supplements, e.g., to enhance NAD+ levels in cells, which would represent a useful contribution to the art (paragraph 0010).
Erickson discloses that the ethyl cellulose can be combined with edible oils such as fractionated coconut oil, medium chain triglycerides (MCT) oils, and others (paragraph 0077). Erickson discloses that the ethyl cellulose can also be combined with other biopolymers or semi-synthetic biopolymers for microencapsulation and include long chain fatty acids, chitosan, and others (paragraph 0073).
Erickson discloses that the NR-containing composition can be orally administered and suitable for use in human individuals, including reconstitutable powders, ready-to-drink liquids, parenteral (intravenous) formulations, and dilutable liquid concentrates, product forms which are all well known in the nutritional formula art (paragraph 0069). Erickson discloses nutraceutical embodiments comprising their NR compounds in combination with one or more vitamins (paragraph 0070), and further discloses other useful vitamins include vitamin D3, and others (paragraph 0071).
Erickson further discloses that oil-in-water emulsions may be better for oral use in infants because these are water-miscible, and thus their oiliness is masked (paragraph 0079). Erickson discloses that such emulsions are well known in the pharmaceutical sciences (paragraph 0079).
Erickson exemplifies in Example 1 the encapsulation of NR-Cl with ethyl cellulose and further demonstrates the retention of NR-Cl by adding water to the formulation at ambient temperature (paragraphs 0082-0085).
Even though Erickson discloses an oral compositions such as the oil-in-water emulsion which can comprise the microencapsulated NR-Cl along with other vitamins such as vitamin D3 using ethyl cellulose and other materials such as medium chain triglycerides and/or chitosan, Erickson does not disclose that the mean diameter of the microencapsulated particles are 300-900 nanometers.
Abbaspoor discloses the synthesis and characterization of ethyl cellulose micro/nanocapsules using solvent evaporation method (Abstract).
Abbaspoor discloses that ethyl cellulose has a variety of properties allowing it to be used in a wide range of applications (first paragraph left column page 1509). Abbaspoor discloses that it is a suitable material being used in different coating applications because of its physical and mechanical properties and further discloses that ethyl cellulose has received considerable attention in the pharmaceutical industry because of its environmentally friendly and physiological inert character, and in many pharmaceutical applications, it is used as a coating material for drug delivery systems due to its controlled release properties caused by the porous structure of its forming films, where the drugs may be absorbed at the surface of the ethyl cellulose nanoparticles as the carries or encapsulated within the ethyl cellulose carriers in form of the micro/nanocapsules (first paragraph left column page 1509).
Abbaspoor discloses that the study of ethyl cellulose in the form of nano-carriers is still limited. Therefore, Abbaspoor discloses that their study involved the preparation of ethyl cellulose micro/nanocapsules containing linseed oil as the core material at different sizes using solvent evaporation method and sought to determine factors in the capsule synthesis process that may influence the characteristics and average diameter size of ethyl cellulose microcapsules such as the drug-polymer ratio and the agitation speed (see left column second and third paragraph page 1510).
Abbaspoor discloses that their ethyl cellulose micro/nanocapsules were prepared using an emulsification-solvent evaporation process. Here, the ethyl cellulose was dissolved in benzene and ethanol and then mixed with the linseed oil as well as an aqueous solution contain PEG and SDS. The mixtures then underwent mechanical stirring at various agitation speeds (see section “Preparation of micro and nano capsules” page 1510).
Abbaspoor discloses the preparation of a sample N1, in which the preparation was mechanically stirred at 10000 rpm (see second paragraph right column page 1510), and further discloses that this sample had a mean particle size in the range of 375.23 to 518.63 nm (see first paragraph right column page 1511 and also see Fig. 2 page 1512). Abbaspoor concludes that all of their samples successfully encapsulated the linseed oil, and that the size distribution of capsules was successfully controlled by controlling emulsion agitation rate (see left and right paragraph page 1513).
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the microencapsulated NR-Cl of Erickson using the method of Abbaspoor to produce a mean particle size in the range of 375.23 to 518.63 nm as disclosed in Abbaspoor to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both Erickson and Abbaspoor disclose the encapsulation of active ingredients using ethyl cellulose as well as similar methods to produce the encapsulated particles using a solvent-mixing based process.
Claim(s) 3 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claim 2 above, and further in view of Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claim 2 as discussed above.
The combined references, however, do not disclose the composition further comprising PGPR or sodium alginates.
Tepsongkroh discloses the influence of PGPR and biopolymers (gelatin and sodium alginate) on the stabilization of water-in-oil emulsions was investigated to improve the encapsulation efficiency (EE) of water-in-oil-in-water (W/O/W) emulsions containing mango seed kernel extract (MSKE) (Abstract).
Tepsongkroh discloses that bioactive compounds in the form of crude extract such as MKSE are unstable under environmental conditions and it is essential to encapsulate them to protect and preserve their stability, bioactivity, and bioavailability (first paragraph left column page 1127). Tepsongkroh discloses that PGPR was used because it is an effective hydrophobic emulsifier in W/O emulsions and has been used in several studies concerning W/O/W emulsions and further discloses that alginate is a hydrophilic, colloidal carbohydrate extracted using dilute alkali from various species of brown seaweed (Phaeophyceae) and is of interest as a potential biopolymer film or coating component because of its unique colloidal properties, which include thickening, stabilizing, suspending, film-forming, gel producing, and emulsion-stabilizing (first paragraph right column page 1127).
Tepsongkroh discloses that W/O emulsions were prepared under different treatments by varying the concentrations of PGPR in the oil phase and varying the type and concentration of biopolymers in the inner aqueous phase (second paragraph, right column page 1129). Tepsongkroh demonstrates in Tables 1 and 2 (pages 1131-1132) that 6-8 wt% PGPR and 0.5-15 wt% sodium alginate had the highest EE values. Tepsongkroh concludes that their results indicate the potential of using gelatin or sodium alginate and PGPR in combination to improve the EE of MSKE in multiple emulsions (first paragraph left column page 1133).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above the PGPR and the sodium alginate as disclosed by Tepsongkroh to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include PGPR and sodium alginate because Tepsongkroh discloses that this combination of increased the encapsulation efficiency in water / oil emulsions.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined teachings of Erickson and Abbaspoor described above as well as Tepsongkroh disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
Furthermore, even though the combined references described above do not explicitly teach that the PGPR is in the oil phase and the sodium alginate is in the inner aqueous phase of the recited composition, the PGPR and sodium alginate would be necessarily present in their respective recited phases due to their chemical properties.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II states that “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Claim(s) 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892) and Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), as applied to claims 2-3 above, and further in view of Vergallo (Nanomaterials, 2020 in PTO-892).
The combined teachings of Erickson, Abbaspoor, and Tepsongkroh are as described above and teach the composition of claims 2-3 as discussed above.
The combined references, however, do not disclose the composition further comprising lecithin and a polysorbate.
Vergallo discloses nutraceutical vegetable oil nano formulations (Abstract).
Vergallo discloses that vegetable oil is a rich source of nutraceuticals, playing pivotal role in human health and nutrition (second paragraph page 2). However, Vergallo discloses that there are challenges using vegetable oil-based nutraceuticals which are common to all nutraceuticals such as when they are administered through the oral route, namely formulation, bioavailability, stability and/or permeation of the bioactive in the gastrointestinal tract (GIT), labile nature, oral absorption and target ability (last paragraph page 2). Therefore, Vergallo discloses that the advent of nanotechnology for pharmaceutical applications has opened up a new avenue for enhancing stability, solubility, and/or permeation with promising results (last paragraph page 2 and first paragraph page 3).
Vergallo discloses that lecithin is used in in a vast range of foods, feed, pharmaceutical and technical applications as a natural emulsifier and surface-active agent, to change the properties of viscosity and crystallization (first paragraph page 8). Vergallo discloses that lecithin is also derived from sunflower seed and rapeseed oils, and further discloses vegetable de-oiled lecithins, as derived from soybean, sunflower seed and rapeseed, have the disclosed phospholipid and FA compositions (first paragraph page 8).
Vergallo discloses several nanoformulations that have been developed to encapsulate vegetable oil-based nutraceuticals and bioactives extracted from vegetable oils (page 12 and Figure 3).
Vergallo discloses oil-in-water nanoemulsions that were effective in improving the solubility and stability of various compounds (pages 12-14). Here, Vergallo discloses an oil-in-water nanoemulsion containing black seed oil as the dispersed phase and distilled water as the continuous phase that was prepared using emulsifying agents, including lecithin and tween 80 (polysorbate 80) dissolved in the oil phase and aqueous phase, respectively (first paragraph page 13). Vergallo discloses that the wound healing and radioprotective activity on monkey-kidney-fibroblast-like cells (Vero) and HaCaT keratinocytes had greater bioactivity than pristine oil, suggesting that these nanoemulsions are a product to include in dermal cosmetics or food supplements with therapeutic efficiency, especially after radio- or chemotherapy (first paragraph page 13).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson, Abbaspoor, and Tepsongkroh described above the lecithin and tween 80 as disclosed by Vergallo to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Erickson, Abbaspoor, and Tepsongkroh described above as well as Vergallo disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
Furthermore, even though the combined references described above do not explicitly teach that the lecithin is in the oil phase and the tween 80 is in the inner aqueous phase in the recited composition, the lecithin and tween 80 would be necessarily present in their respective recited phases due to their chemical properties.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II states that “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
In regards to instant claim 5, it would have also been prima facie obvious before the effective filing date of the claimed invention to have used de-oiled sunflower lecithin as disclosed by Vergallo for the lecithin in the composition as disclosed by the combined teachings of Erickson, Abbaspoor, Tepsongkroh, and Vergallo described above to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because Vergallo provides guidance that that lecithin is used in in a vast range of foods, feed, pharmaceutical and technical applications as a natural emulsifier and exemplifies de-oiled lecithin derived from sunflower seed.
Claim(s) 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claim 2 above, and further in view of Meyer et al. (US20210069083A1 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claim 2 as discussed above.
The combined references, however, do not disclose the composition further comprising xanthan gum and agar.
Meyer discloses a method for improving skin whitening power of a skin whitening agent in a cosmetic or dietary supplement composition comprising or consisting of the following step: (a) providing a cosmetic composition comprising at least one skin whitening agent selected form the group consisting of kojic acid and phenylethyl resorcinol, beta- and alpha-arbutin, hydroquinone, nicotinamide, dioic acid, Mg ascorbyl phosphate and vitamin C and its derivatives, mulberry extract, Bengkoang extract, papaya extract, turmeric extract, nutgrass extract, licorice extract (containing glycyrrhizin), alpha-hydroxy-acids, 4-alkylresorcinols, 4-hydroxyanisole and mixtures thereof, and (b) adding a working amount of sclareolide to said composition (claim 16).
Meyer discloses that their compositions can be administered orally and that the compositions are typically encapsulated by means of a solid covering material, which is selected from agar-agar, xanthan gum, and other substances (paragraph 0205). Meyer discloses microcapsules and nanocapsules which contain at least one solid or liquid core surrounded by at least one continuous membrane (paragraph 0207). Meyer discloses that the micro/nanocapsules are finely dispersed liquid or solid phases coated with film-forming polymers, in the production of which the polymers are deposited onto the material to be encapsulated after emulsification and coacervation or interfacial polymerization (paragraph 0207).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included the agar-agar and xanthan gum of Meyer into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Erickson and Abbaspoor described above as well as Meyer disclose the encapsulation of active ingredients including nicotinamides using similar biopolymer based compounds.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892) and Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), as applied to claims 2 and 9-10 above, and further in view of Fundueanu et al. (International Journal of Pharmaceutics, 1998 in PTO-892).
The combined teachings of Erickson, Abbaspoor, and Tepsongkroh are as described above and teach the composition of claims 2 and 9-10 as discussed above.
The combined references, however, do not disclose the composition further comprising calcium ions associated with the sodium alginate and that calcium ions are provided by calcium chloride (CaCl2).
Fundueanu discloses the preparation and characterization of Ca-alginate microspheres obtained by a new procedure from alginic acid, treated with an excess of NaOH and subsequently with a very concentrated solution of CaCl2 (Abstract).
Fundueanu discloses that alginate microencapsulation requires strict control of a number of parameters including the alginate used and the type (i.e. the alginate characteristics affect the capsule geometry), and molecular weight and concentration of the cations used for the gelation process (right column page 11 through left column page 12). Fundueanu further discloses that the amount of calcium ions appeared to be a critical parameter with certain concentrations destabilizing the emulsion system and forming irregular polymer aggregates (second paragraph left column page 18).
Fundueanu discloses their produced Ca-alginate microspheres showed a relative dense and homogenous internal structure in comparison with previously reported alginate microcapsules (Abstract). Fundueanu discloses that their microspheres have good stability, and despite very low degree of swelling, they have good solvents regain, and an excellent ionic binding capacity of cationic drugs (Abstract). Fundueanu further discloses and demonstrates the encapsulation of an antitumor aromatic tetramidine and discloses its in vitro release (Abstract and Fig. 6 page 17). Fundueanu concludes based on their data that Ca-alginate microspheres are particularly interesting for biomedical applications, and that their TAPP-Br loaded microspheres could be proposed for the experimental therapy of tumors by following subcutaneous or chemoembolization administration procedures (left column page 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the sodium alginate in the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson, Abbaspoor, and Tepsongkroh described above by including calcium ions provided by calcium chloride as disclosed by Fundueanu to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Fundueanu discloses that their Ca-alginate microspheres have good stability, and despite very low degree of swelling, they have good solvents regain, and an excellent ionic binding capacity of cationic drugs.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined teachings of Erickson, Abbaspoor, and Tepsongkroh described above and Fundueanu disclose the use of sodium alginates to encapsulate active compounds.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claim 2 above, and further in view of Zidan et al. (International Journal of Nanomedicine, 2016 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claim 2 as discussed above.
The combined references, however, do not disclose the particles having an average absolute value of zeta potential greater than 10 or 20 mV.
Zidan discloses nicotinamide polymeric nano emulsified systems (Abstract).
Zidan discloses that nicotinamide has a short biological half-life of hours with significant fluctuations in its plasma levels and serious adverse actions such as nausea, vomiting, hepatotoxicity, tremor and convulsions, sedation, and coma (first paragraph left column page 1502). Therefore, Zidan discloses that a controlled release formulation would be a crucial factor in the effective management of its antimicrobial activity such as scaffolds and lipid carriers to improve efficacy, however Zidan discloses that the particle growth, unpredictable precipitation tendency, burst release, and drug expulsion limit its practical usefulness and there is a need for alternative drug delivery system for nicotinamide (first paragraph left column page 1502).
Zidan discloses that the objective of their study was to understand the formulation and process variabilities affecting the preparation of nicotinamide-loaded polymeric nano emulsified particles (Abstract). Zidan prepared 12 formulations of nicotinamide-loaded polymeric nano-emulsified particles using Eudragit S100 and 2-hydroxypropyl-beta-cyclosdextrin polymer materials and an oil-in-water emulsification technique with eight different chemical and physical factors (second paragraph left column through right column page 1502). Zidan discloses the formulations were characterized by entrapment capacity (EC), entrapment efficiency (EE), particle size, polydispersity index, zeta potential, transmission electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, powder X-ray diffraction, in vitro drug release, and their antibacterial activity against bacterial scrums (Abstract).
Zidan discloses and demonstrates in Table 3 (page 1507) that their formulations have zeta potentials ranging from 9.5 to 53.5 mV (last paragraph right column page 1511). Zidan discloses that the significant factors affecting surface charge intensity of the prepared polymeric nano emulsified particles were Eudragit S100 and drug-loading concentrations, and volume of aqueous phase (last paragraph right column page 1511 as well as Table 4 and Figure 3, page 1509). Zidan discloses that multiple regression analysis revealed a significant positive effect of Eudragit S100 loadings and significant negative effects of both drug-loading concentration and volume of aqueous phase on the recorded zeta potentials (last paragraph right column page 1511). Zidan discloses that the magnitude of the zeta potential indicates the degree of electrostatic repulsion between adjacent, similarly charged particles in dispersion and further discloses that a value of ±30 mV was reported to assure good stability of nano-dispersed systems (last paragraph right column page 1511).
It would have been prima facie obvious before the effective filing date of the claimed invention to have routinely optimized the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above to have a zeta-potential of ±30 mV as disclosed by Zidan to arrive at the claimed invention.
One of ordinary skill in the art would have performed routine optimization to a zeta-potential of ±30 mV because Zidan discloses that that a value of ±30 mV was reported to assure good stability of nano-dispersed systems and that the zeta potential can be tuned by adjusting the coating material and drug-loading concentrations as well as volume of aqueous phase, which indicates that an ordinary skilled artisan would have recognized that adjusting these parameters in the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above is a result-effective variable to have a zeta potential of ±30 mV. See MPEP 2144.05 II.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claims 2 and 18 above, and further in view of Bishop et al. (US20190358169A1 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claims 2 and 18 as discussed above. Furthermore, Erickson discloses that the NR-containing composition can be orally administered and suitable for use in human individuals, including reconstitutable powders, ready-to-drink liquids, parenteral (intravenous) formulations, and dilutable liquid concentrates, product forms which are all well known in the nutritional formula art (paragraph 0069). Erickson discloses nutraceutical embodiments including nutritional and sports drinks comprising their NR compounds in combination with one or more vitamins (paragraph 0070), and further discloses other useful vitamins include vitamin D3, B6, and others (paragraph 0071).
The combined references, however, do not disclose the inner aqueous phase further comprising ionic zinc.
Bishop discloses nanometer sized water clusters comprising or consisting essentially of ultrapure water that encapsulate a solute, wherein the water clusters have a median diameter of between about 2 to about 400 nanometers and uses thereof (Abstract).
Bishop discloses their particles can encapsulate various solutes including electrolytes and others and is advantageous for various applications, including medical and agricultural applications, based, for example, on the improved bioavailability, solubility, and/or stability of water clusters comprising or consisting essentially of ultrapure water, and solutes encapsulated in water clusters comprising or consisting essentially of ultrapure water (paragraph 0033).
Bishop discloses their invention include oral formulations in which the water clusters are used to encapsulate a solute in a hydration, sports, or energy drink (paragraph 0035). Bishop discloses that various electrolytes as the encapsulated solute including zinc ions and others (paragraph 0012) as well as vitamins such as vitamin B6 and D3 (paragraph 0017).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above additional electrolytes such as zinc ions as disclosed by Bishop to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Erickson and Abbaspoor described above as well as Meyer disclose the encapsulation of similar active ingredients as well as same oral formulations such as drinks comprising the encapsulated particles.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claim 2 above, and further in view of Mu et al. (Journal of Controlled Release, 2002 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claim 2 as discussed above.
The combined references, however, do not disclose the aqueous continuous phase further comprises vitamin E TPGS.
Mu discloses the used of vitamin E TPGS as an emulsifier in the solvent evaporation/ extraction technique for fabrication of PLGA nanospheres for controlled release of paclitaxel (Abstract).
Mu discloses that various drug delivery systems such as liposomes, micelles, emulsions, polymeric micro/nanoparticles have shown much promise in controlled and targeted drug delivery, and that these techniques are capable of controlling the rate and duration of drug delivery and/or targeting the drug to the cell or tissue. Mu further discloses that nanospheres of biocompatible and biodegradable polymers have showed remarkable progress (first paragraph left column page 130).
Mu discloses that polymeric nanospheres are usually produced by the solvent evaporation/extraction technique. In such a process, a number of fabrication parameters can affect the nature of the nanospheres obtained. One of the most important parameters involves the emulsifier, which is necessary as surfactant stabilizer in the process to form nanospheres. Emulsifier plays a key role in separation of the two (oil/water) phases to form the emulsion or particles (second paragraph left column page 130).
Mu discloses that vitamin E TPGS is an amphiphilic compound and is used as a solubilizer, absorption enhancer and as a vehicle for lipid-based drug delivery formulations (first two paragraphs left column page 131).
Mu discloses that in comparison with the traditional chemical emulsifier PVA, the TPGS could significantly improve the encapsulation efficiency of the drug in the PLGA nanospheres, which could be as high as 100% (Abstract). Mu further concludes that vitamin E TPGS could be an ideal and effective emulsifier (Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above the vitamin E TPGS as an emulsifier as disclosed by Mu to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include vitamin E TPGS because Mu discloses that vitamin E TPGS can significantly improve the encapsulation efficiency of a drug in similar polymer based PLGA nanospheres, which could be as high as 100%.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined teachings of Erickson and Abbaspoor described above as well as Meyer disclose the encapsulation of active ingredients using similar emulsifying and coating materials.
Claims 21 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et al. (US20220241305A1 in PTO-892) in view of Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), as applied to claim 2, and further in view of Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), Vergallo (Nanomaterials, 2020 in PTO-892), Meyer et al. (US20210069083A1 in PTO-892), and Zidan et al. (International Journal of Nanomedicine, 2016 in PTO-892).
The combined teachings of Erickson and Abbaspoor are as described above and teach the composition of claim 2 as discussed above.
Even though the combined references teach including medium-chain triglycerides, the combined references, however, do not disclose the composition further comprising polysorbate 80, xanthan, agar, PGPR, de-oiled lecithin, and a particle having a zeta potential greater than 10 mV.
The independent teachings of Tepsongkroh, Vergallo, Meyer, and Zidan are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above the PGPR and the sodium alginate as disclosed by Tepsongkroh, the de-oiled lecithin and tween 80 as disclosed by Vergallo, the agar-agar and xanthan gum of Meyer, and routinely optimize to have a zeta-potential of ±30 mV as disclosed by Zidan to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include PGPR and sodium alginate because Tepsongkroh discloses that this combination of increased the encapsulation efficiency in water / oil emulsions.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined teachings of Erickson and Abbaspoor described above as well as Tepsongkroh disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
One of ordinary skill in the art would have combined known prior art elements according to known methods to include de-oiled lecithin and tween 80 to yield predictable results and would have a reasonable expectation of success in doing so because the combined teachings of Erickson and Abbaspoor described above as well as Vergallo disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
One of ordinary skill in the art would have combined known prior art elements according to known methods to include to the agar-agar and xanthan gum to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Erickson and Abbaspoor described above as well as Meyer disclose the encapsulation of active ingredients including nicotinamides using similar biopolymer based compounds.
One of ordinary skill in the art would have performed routine optimization to a zeta-potential of ±30 mV because Zidan discloses that that a value of ±30 mV was reported to assure good stability of nano-dispersed systems and that the zeta potential can be tuned by adjusting the coating material and drug-loading concentrations as well as volume of aqueous phase, which indicates that an ordinary skilled artisan would have recognized that adjusting these parameters in the NR-Cl encapsulation composition as disclosed by the combined teachings of Erickson and Abbaspoor described above is a result-effective variable to have a zeta potential of ±30 mV. See MPEP 2144.05 II.
Furthermore, even though the combined references described above do not explicitly teach that the PGPR and de-oiled lecithin are in the oil phase, and the tween 80, xanthan, and agar are in the aqueous phase in the recited composition, these compounds would be necessarily present in their respective recited phases due to their chemical properties.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II states that “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Response to Arguments
Applicant’s arguments filed on 01/23/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that the new claims are allowable over the previously cited Dihora. However, the new rejections above do not cite Dihora, rendering Applicant’s argument moot.
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.
Claims 2, 6, 8-10, 13-15, and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/944,985 (‘985) in view of Erickson et al. (US20220241305A1 in PTO-892) and Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892)
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘985 recites a bead for use in food or a beverage, the bead comprising: a core comprising: a continuous phase comprising: a lipophilic carrier and a wax; a dispersed phase comprising: one or more particles, wherein each particle comprises: a first active ingredient; and a first polymer; and a first shell surrounding the core. Claim 16 of ‘985 recites the first active ingredient can be nicotinamide riboside chloride. Claim 3 of ‘985 recites that the first polymer can be ethyl cellulose, and claim 21 of ‘895 recites the first polymer can be sodium alginate, calcium alginate, agar, guar gum, and xanthan gum. Claim 1 of ‘985 recites that the zeta potential has a magnitude of at least 30 mV, and that the bead further comprises lipophilic carriers such as triglycerides (claim 22) and an emulsifying agent (claim 22).
The claims of ‘985 do not recite a mean diameter of the particles are 300-900 nanometers.
The independent teachings of Erickson and Abbaspoor are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the composition recited in the claims of ‘985 according to Erickson and further modifying the method to produce a mean particle size in the range of 375.23 to 518.63 nm as disclosed in Abbaspoor to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘985 and Erickson recite the encapsulation of nicotinamide riboside using ethyl cellulose and other lipid/polymer materials, and both Erickson and Abbaspoor provides further guidance of similar methods to produce the encapsulated particles using a solvent-mixing based process.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-10, 13-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/944,985 (‘985) in view of Erickson et al. (US20220241305A1 in PTO-892), Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), Vergallo (Nanomaterials, 2020 in PTO-892), and Meyer et al. (US20210069083A1 in PTO-892).
The combination of the claims of ‘985 and the teachings of Erickson and Abbaspoor are as described above and recite the composition of instant claim 2 as discussed above.
The combined references, however, do not recite the composition, except the MCT oil, the zeta potential, and the chitosan, the additional components recited in instant claim 21.
The independent teachings of Tepsongkroh, Vergallo, and Meyer are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by the combination of the claims of ‘985 and the teachings of Erickson and Abbaspoor described above the PGPR and the sodium alginate as disclosed by Tepsongkroh, the de-oiled lecithin and tween 80 as disclosed by Vergallo, and the agar-agar and xanthan gum of Meyer to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include PGPR and sodium alginate because Tepsongkroh discloses that this combination of increased the encapsulation efficiency in water / oil emulsions.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above as well as Tepsongkroh disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
One of ordinary skill in the art would have combined known prior art elements according to known methods to include de-oiled lecithin and tween 80 to yield predictable results and would have a reasonable expectation of success in doing so because the combined references described above as well as Vergallo disclose oil / water based emulsions as well as the encapsulation of active ingredients using similar oil and biopolymer based compounds to protect their stability.
One of ordinary skill in the art would have combined known prior art elements according to known methods to include to the agar-agar and xanthan gum to yield predictable results and would have a reasonable expectation of success in doing so because both the combined references described above as well as Meyer disclose the encapsulation of active ingredients including nicotinamides using similar biopolymer based compounds.
Furthermore, even though the combined references described above do not explicitly teach that the PGPR and de-oiled lecithin are in the oil phase, and the tween 80, xanthan, agar, and sodium alginate are in the aqueous phase in the recited composition, these compounds would be necessarily present in their respective recited phases due to their chemical properties.
MPEP 2112 section I states that "[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”. Furthermore, MPEP 2112.01 section II states that “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2 and 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/944,985 (‘985) in view of Erickson et al. (US20220241305A1 in PTO-892), Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), Vergallo (Nanomaterials, 2020 in PTO-892), Meyer et al. (US20210069083A1 in PTO-892), and Fundueanu et al. (International Journal of Pharmaceutics, 1998 in PTO-892).
The combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer are as described above and recite the composition of instant claims 2 and 9-10 as discussed above.
The combined references, however, do not recite wherein the particles further comprise calcium ions associated with the sodium alginate as well as calcium ion provided by calcium chloride.
The teachings of Fundueanu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the sodium alginate in the NR-Cl encapsulation composition as disclosed by combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer described above by including calcium ions provided by calcium chloride as disclosed by Fundueanu to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Fundueanu discloses that their Ca-alginate microspheres have good stability, and despite very low degree of swelling, they have good solvents regain, and an excellent ionic binding capacity of cationic drugs.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Fundueanu disclose the use of sodium alginates to encapsulate active compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/944,985 (‘985) in view of Erickson et al. (US20220241305A1 in PTO-892), Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), Vergallo (Nanomaterials, 2020 in PTO-892), Meyer et al. (US20210069083A1 in PTO-892), and Bishop et al. (US20190358169A1 in PTO-892).
The combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer are as described above and recite the composition of instant claims 2 and 18 as discussed above.
The combined references, however, do not recite the inner aqueous phase further comprising ionic zinc.
The teachings of Bishop are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer described above additional electrolytes such as zinc ions as disclosed by Bishop to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined references described above as well as Meyer disclose the encapsulation of similar active ingredients as well as same oral formulations such as drinks comprising the encapsulated particles.
Claims 2 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/944,985 (‘985) in view of Erickson et al. (US20220241305A1 in PTO-892), Abbaspoor et al. (Colloid and Polymer Science, 2018 in PTO-892), Tepsongkroh et al. (Journal of Dispersion Science and Technology, 2015 in PTO-892), Vergallo (Nanomaterials, 2020 in PTO-892), Meyer et al. (US20210069083A1 in PTO-892), and Mu et al. (Journal of Controlled Release, 2002 in PTO-892).
The combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer are as described above and recite the composition of instant claim 2 as discussed above.
The combined references, however, do not recite the aqueous continuous phase further comprising vitamin E TPGS.
The teachings of Mu as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the NR-Cl encapsulation composition as disclosed by combination of the claims of ‘985 and the teachings of Erickson, Abbaspoor, Tepsongkroh, Vergallo, and Meyer described above the vitamin E TPGS as an emulsifier as disclosed by Mu to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include vitamin E TPGS because Mu discloses that vitamin E TPGS can significantly improve the encapsulation efficiency of a drug in similar polymer based PLGA nanospheres, which could be as high as 100%.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above as well as Meyer disclose the encapsulation of active ingredients using similar emulsifying and coating materials.
Response to Arguments
Applicant’s arguments filed on 01/23/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that the new claims are different from the claims of co-pending ‘985. However, the new double patenting rejections above establish obviousness to arrive the claimed invention as discussed above.
Conclusion
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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