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 .
Claim Status
Applicants’ amendments and arguments filed 03/09/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 4, 6, 13-14, 17-22, 25, 27, and 29 are canceled.
Claims 1 and 15-16 are amended.
Claims 9, 12, 15-16, 23-24, 26, 28, and 30-31 remain withdrawn.
Claim 32 is newly added.
Claims 1-3, 5, 7-8, 10-11, and 32 are examined on the merits.
New Rejections Necessitated by Claim 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.
Claims 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Larosa et al. (WO2009023803A2, published 02/19/2009, hereafter Larosa) in view of Roy et al. (Roy M, Sen S, Chakraborti AS. Action of pelargonidin on hyperglycemia and oxidative damage in diabetic rats: implication for glycation-induced hemoglobin modification. Life Sci. 2008 May 23;82(21-22):1102-10. doi: 10.1016/j.lfs.2008.03.011. Epub 2008 Apr 1. PMID: 18440560., hereafter Roy).
Larosa claims a modulated release formulation for delivery of one or more medicaments in which the formulations may be utilized as an aerosol or orally, such as in the form of tablets, capsules, granules or powders: sublingually: buccally: parenterals, such as by subcutaneous, intravenous, intramuscular, or intrasternal injection or infusion techniques (e.g., as sterile injectable aqueous or non-aqueous solutions or suspensions); nasally, including administration to the nasal membranes, such as by inhalation spray: topically, such as in the form of a cream ointment or as a patch: or rectalIy such as in the form of suppositories: in dosage unit formulations containing non-toxic, pharmaceutically acceptable vehicles or diluents (title and claims 1 and 38 and page 13, lines 5-10; according to the claim limitations of the instant claim 1). Larosa teaches the formulations are effective therapy for diabetes (page 1, lines 13-15; according to the claim limitations of the instant claim 1). Larosa claims the formulation has (a) one or more medicaments and (c) one of more binders which can be a polyphenol (claim 38; according to the claim limitations of the instant claim 1). Claim 47 of Larosa claims the medicament is selected from the group consisting of insulin, insulin analogs, GLP- 1 or GLP- 1 analogs (e.g.. truncated, elongated or recombinant GLP-I ), Apolipoproteins (e.g.. Apo-A l or ApoE proteins, analogs, truncated forms or recombinant forms thereof), amylin. amylin analogs, pramlintide. glucagon, leptin, PYY-3-36. conopeptides: immunomodulating peptides, interleukins, erythropoietins, thrombolytics, heparin, anti-proteases, antitrypsins, amiloride, rhDNase. antibiotics, antiinfectives, parathyroid hormones, LH-RH and GnRH analogs, nucleic acids, DDAVP, calcitonins, cyclosporine, hematopoietic factors, cyclosporins vaccines, immunoglobulins, vasoactive peptides, pegylated proteins and peptides, fusion proteins, gene, a gene analog, an antisense agent, an oligonucleotide, ribavirin and a small molecule organic compound, and pharmaceutically acceptable salts and solvates thereof, and mixtures thereof (according to the claim limitations of the instant claims 10 and 11). Claim 44 of Larosa claims the polyphenol binder is selected from a group to include anthocyanidins and pelargonidin (according to the claim limitations of the instant claim 1). Lastly, Larosa claims the concentration of binder is present in an amount in the range of about 0.00001-20% (claim 23; according to the claim limitation of the instant claim 1). While Larosa does not explicitly recite “able to increase permeability of the intestinal epithelium in a patient”, it is noted that, since the compound recited by Larosa is identical to that instantly claimed, it would possess the same property, absent evidence otherwise.
Although Larosa claims the concentration of pelargonidin in the formulation, Larosa fails to teach explicitly teach the pelargonidin dosage of instant claim 1.
Roy teaches that pelargonidin, an anthocyanidin, has been tested for its antidiabetic potential, specifically for diabetes mellitus, with emphasis on its role against pathological oxidative stress including hemoglobin-mediated free radical reactions (abstract). Roy teaches that pelargonidin counteracts hemoglobin glycation, iron release from the heme protein and iron-mediated oxidative damages, confirming glycated hemoglobin-associated oxidative stress in diabetes (abstract). Roy teaches treating rats with an injection of pelargonidin at 3mg/kg bodyweight (abstract and page 1103, experimental design, paragraph 2). Lastly, Roy teaches pelargonidin treatment counteracts hyperglycemia and relieves the oxidative stress including Hb-induced iron-mediated oxidative reactions by lowering the glycation level and free iron of Hb (page 1109, conclusion).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a diabetic formulation comprising pelargonidin and a therapeutic agent such as heparin or pramlintide as outlined by Larosa with the ready for improvement with the known technique of adjusting the dosage concentration of pelargonidin in diabetic therapy as outlined by Roy. Adjusting the forementioned components of a diabetic therapeutic formulation as claimed by instant claim 1 would yield predictable results thus making them obvious as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, it would be obvious to one skilled in the art before the effective filing date of the claimed invention to optimize the ranges of Larosa in view of Roy, as the MPEP 2144.05 states “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Claims 2-3, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Larosa et al. (WO2009023803A2, published 02/19/2009, hereafter Larosa) in view of Roy et al. (Roy M, Sen S, Chakraborti AS. Action of pelargonidin on hyperglycemia and oxidative damage in diabetic rats: implication for glycation-induced hemoglobin modification. Life Sci. 2008 May 23;82(21-22):1102-10. doi: 10.1016/j.lfs.2008.03.011. Epub 2008 Apr 1. PMID: 18440560., hereafter Roy), optionally, in view of Khoo et al. (Khoo, H. E., Azlan, A., Tang, S. T., & Lim, S. M. (2017). Anthocyanidins and anthocyanins: colored pigments as food, pharmaceutical ingredients, and the potential health benefits. Food & Nutrition Research, 61(1). https://doi.org/10.1080/16546628.2017.1361779, hereafter Khoo), and as evidenced by Liu et al. (Liu, Yongfeng et al. “Preparative separation and purification of lycopene from tomato skins extracts by macroporous adsorption resins.” Food Chemistry 123 (2010): 1027-1034., hereafter Liu).
The invention of Larosa in view of Roy is delineated above (see above).
Specifically regarding claims 2-3, 5, and 7-8 (and more generally regarding the remaining claims), Larosa and Roy do not specifically teach wherein pelargonidin prepared from a plant material, an extract of plant material, or a fruit, fruit skin, or flower that is retained on a hydrophobic resin in water and is eluted from the resin in ethanol. However, said limitations recite a product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Since Larosa teaches the same compound as those instantly claimed (i.e., pelargonidin), it effectively reads on the claims.
As evidenced by Liu, macroporous adsorption resins (MARs) are made by placing plant material in a resin then diluting it in ethanol (pages 1028-1029, paragraph 2.4).
Optionally additionally, Khoo teaches anthocyanidins, such as pelargonidin, are found in fruits and vegetables and result in red, blue, and purple colored plants (page 2, types of anthocyanin in plants). Khoo further teaches anthocyanidins are the major pigment in berries, red sweet potato, and corn (page 2, types of anthocyanin). Further, Khoo teaches the pelargonidin is red-colored pigment that gives orange hue to flowers and red to some fruits and berries (page 2, types of anthocyanin). Khoo provides a table with plants with their corresponding anthocyanidins to include pelargonidin being found in the whole fruit of a blackberry (page 7, table 1). Khoo teaches that macroporous adsorption is used in the purification of phenolic pigment (page 5, last paragraph). Lastly, Khoo teaches anthocyanidins and anthocyanins possess antioxidative and antimicrobial activities, improve visual and neurological health, and protect against various non-communicable diseases (abstract).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would claim a diabetic composition of pelargonidin and a therapeutic agent as outlined by Larosa and Roy with the ready for improvement with the known technique of using a macroporous adsorption resin method to purify pelargonidin from a raw plant such as blackberries as outlined by Khoo. Utilizing the forementioned method to obtain pelargonidin from a plant as claimed by instant claims 2-3, 5, and 7-8 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Larosa et al. (WO2009023803A2, published 02/19/2009, hereafter Larosa) in view of Roy et al. (Roy M, Sen S, Chakraborti AS. Action of pelargonidin on hyperglycemia and oxidative damage in diabetic rats: implication for glycation-induced hemoglobin modification. Life Sci. 2008 May 23;82(21-22):1102-10. doi: 10.1016/j.lfs.2008.03.011. Epub 2008 Apr 1. PMID: 18440560., hereafter Roy), and in view of Mounica et al. (Mounica, P., S. Pavani, and P. Mounica Rani. "A review on recent advances in enteric coating and enteric polymers." World J. Pharm. Res 7 (01/09/2018): 475-495., hereafter Mounica).
The invention of Larosa in view of Roy is delineated above (see above).
Further, Larosa claims the addition of a fluid carrier and teaches the fluid carrier exhibits a physical slate of either a liquid or gas or mixture of both, in which medicaments are incorporated for delivery of various dosage forms (claim 30 and page 5, lines 15-17). Also, it is again noted, Larosa teaches the composition is used orally such as in the form of tablets, capsules, granules or powders (title and claims 1 and 38 and page 13, lines 5-10).
Although Larosa discloses a carrier and the composition in the form of an oral tablet or capsule, it fails to teach the composition comprising an enteric coating.
Mounica teaches a review for enteric coatings (title). Mounica teaches enteric coated means a tablet or capsule or other form of oral medication which is layered with a defensive coating (abstract). Mounica teaches this coating is used to fortify the stomach from unwanted effects or detrimental effects of a medication (abstract).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify an oral composition, specifically a tablet or capsule, comprising a therapeutic agent, and up to 40 mg/kg of pelargonidin as outlined by Larosa in view of Roy by addition of an enteric coating as outlined by Mounica under TSM, see MPEP 2143(G). As outlined by Mounica, adding an enteric coating fortifies the stomach from unwanted or detrimental effects of a medication which would motivate someone skilled in the art to advantageously combine an enteric coating with the composition of Larosa in view of Roy as it would have a reasonable expectation of success.
Response to Applicant’s Arguments
Applicant’s arguments filed on 03/09/2026 have been fully considered by the examiner.
In regards to Applicant’s arguments against the 35 USC § 103 rejections, Applicant first argues that Larosa is directed to and focuses on aerosol formulations, while the present claims as amended are directed to an oral dosage form. Applicant further argues that Larosa provides no evidence that the aerosol formulation can be configured for an oral dosage form and that Roy and Liu do not remedy this deficiency. Secondly, Applicant argues that Larosa discloses the inclusion of anthocyanidins only as binders and is not concerned with intestinal permeability as the instant application. Lastly, Applicant argues that Roy is similarly not concerned with intestinal permeability or an oral dosage and is limited to intraperitoneal injections.
In regards to Applicant’s argument against Larosa being directed toward aerosols, it is first noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, it is noted that Larosa teaches the composition is a modulated release formulation for delivery of one or more medicaments in which the formulations may be utilized as an aerosol or orally, such as in the form of tablets, capsules, granules or powders (title and claims 1 and 38 and page 13, lines 5-10). Therefore, Larosa teaches the composition can be used orally as required by the instant claims. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Secondly, in regards to Applicant’s arguments that Larosa does not explicitly recite “able to increase permeability of the intestinal epithelium in a patient”, it is noted that, since the compound recited by Larosa is identical to that instantly claimed, it would possess the same property, absent evidence otherwise. Applicant is reminded this is a composition/product claim and the prior art teaches an oral dosage comprising a therapeutic agent with a size of 1,000 Da to 150kDS, and an anthocyanidin comprising up to 40mg/kg of pelargonidin, thereby since a product is not separable from its physical properties then it necessarily teaches the composition is effective to increase permeability of intestinal epithelium of a patent. Applicants observation that it also is ‘effective to increase permeability of intestinal epithelium’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
Lasty, in regards to Applicant’s argument that Roy is similarly not concerned with intestinal permeability, Applicant is again reminded, since the compound recited by Larosa is identical to that instantly claimed, it would possess the same property, absent evidence otherwise. Applicant is reminded this is a composition/product claim and the prior art teaches an oral dosage comprising a therapeutic agent with a size of 1,000 Da to 150kDS, and an anthocyanidin comprising up to 40mg/kg of pelargonidin, thereby since a product is not separable from its physical properties then it necessarily teaches the composition is effective to increase permeability of intestinal epithelium of a patent. Applicants observation that it also is ‘effective to increase permeability of intestinal epithelium’ does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable. Further, it is again noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant is reminded that Roy is a secondary reference, cited solely remedy Larosa deficiency of common dosage to a patent which Roy outlines the commonly known dosage to a patient is pelargonidin at 3mg/kg bodyweight (abstract and page 1103).
In summary, the examiner is not persuaded by Applicant’s arguments. The rejections are maintained and updated for claim amendments.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611