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 .
Status of Claims
Claim 1 is pending. Claims 2-20 are canceled. Claim 1 is amended.
Claims 1 is examined based on its merits in light of the elected species of thiamine, pyridoxine, and quercetin.
Information Disclosure Statement
The Information Disclosure Statement filed 4/14/2025 has been reviewed.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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.
Rejections Maintained
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Kanaya et al. US 2013/0071525 (3/21/2013)(8/8/2022 IDS) in view of Bland et al. US 2007/0059378 (3/15/2007) (8/8/2022 IDS) is maintained.
Kanaya et al. (Kanaya) teaches a stable particulate composition using a fat composition having a solid fat content within a specific range as a matrix encapsulating a hydrophilic substance in high content and also controls the release in the intestinal tract. Kanaya teaches the applicability of its formulation in the medicinal context as well as foods and medicinal foods because of its high safety. (See [0018-0019]). In Kanaya the hydrophilic substance to be enclosed includes various substances such as vitamins given its usefulness for medical foods including thiamine diphosphate [0044] and the particulate composition may also contain hydrophobic flavonoids components including quercetin and curcumin together with the fat composition to be used as a matrix ([0033] –[0034]).
Quercetin is called for in instant claim 1. Curcumin is called for in instant claim 1. Thiamine is called for in instant claim 1. Kanaya also teaches the composition can be coated. (See [002, 0003, Abstract and throughout]). Kanaya also teaches that its composition is especially well suited for application as a medical food because of its safety. (See [0019]).
It would be prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine quercetin in order to have a flavonoid present in the medical food, thiamine in order to have a B1 vitamin present in the medical food and curcumin in order to have another flavonoid present along with other vitamins in the medical food.
Kanaya does not teach amounts of curcumin, amounts of thiamine, pyridoxine or its amounts or expressly teach a unit dose. This deficiency is made up for with the teachings of Bland et al.
Bland et al. teaches a pharmaceutical that can be in capsule form and contains curcumin and pyridoxine hydrochloride. (See Abstract and [0115]). Bland is directed to nutritional compositions for managing bodily processes, including ways of delivering nutrients via enteric pharmaceutical composition forms and capsules as medical food.. (See [0164]). Bland teaches that its preferred embodiments are directed to ways of delivering dietary fats to the body as a macronutrient. (See [0074]). Thus Bland is directed to fat as a macronutrient and means of delivering these fats. (See [0073-0074]). Bland is also directed to vitamins, water-soluble vitamins and fat-soluble vitamins. Bland at [0115] teaches that:
Pyridoxine (vitamin B-6) does not denote a single substance, but is rather a collective term for a group of naturally occurring pyridines that are metabolically and functionally interrelated: namely, pyridoxine, pyridoxal, and pyridoxamine. They are interconvertible in vivo in their phosphorylated form. Vitamin B-6 in the form of pyridoxal phosphate or pyridoxamine phosphate functions in carbohydrate, fat, and protein metabolism. Its major functions are most closely related to protein and amino acid metabolism. Pyridoxine is a part of the molecular configuration of many enzymes (a coenzyme), notably glycogen phosphorylase, various transaminases, decarboxylases, and deaminases. The latter three are used for the anabolism and catabolism of proteins. Pyridoxine is also aids in fat and carbohydrate metabolism; aids in the formation of antibodies; maintains the central nervous system; aids in the removal of excess fluid of premenstrual women; promotes healthy skin; reduces muscle spasms, leg cramps, hand numbness, nausea and stiffness of hands; and helps maintain a proper balance of sodium and phosphorous in the body. In the preferred embodiments, pyridoxine is preferably provided in the acid addition salt form as pyridoxine hydrochloride.
Pyridoxine is called for in instant claim 1. Pyridoxine can be present in an amount of 100 mg. (See Table 6). 100 mg falls within the from 10 mg to 2000 mg of pyridoxine called for in instant claim 1.
Bland teaches that curcumin can be present in an amount of 200 mg. (See Table 13). 200 mg falls within the from 10 mg to 2000 mg of curcumin called for in instant claim 1. Bland teaches that a medical food designed for nutritional support of women with symptoms associated with hormone cycles can have curcumin be present in amount of 200 mg. (See [0185-0186]).
Bland teaches that chromium is a trace element where lack of sufficient chromium in the diet leads to impairment of glucose utilization, and in experimental studies chromium as a supplement can produce benefits in conditions such as diabetes and weight control. (See [0133]).
Bland teaches quercetin and that quercetin can block the spread of cancer cells in the stomach. (See [0079]). Thus, quercetin is taught to be a results-effective variable and it would be no more than routine experimentation to experiment to arrive at the claimed amount in claim 1.
Bland teaches thiamine and that thiamine plays a role in the body’s metabolic cycle for generating every, aids in the digestion of carbohydrates, is used for the normal functioning of the nervous system, stabilizes the appetite and promotes growth and good muscle tone. (See [0118]). Thus, thiamine is taught to be a results-effective variable and it would be no more than routine experimentation to experiment to arrive at the claimed amount in claim 1.
It would be prima facie obvious for a skilled artisan before the effective filing date of the invention making the Kanaya composition to add 100 mg pyridoxine hydrochloride and chromium as taught by Bland in order to have a more complete and convenient medical food with a preferred form of pyridoxine that can increase metabolism and to promote healthy skin and muscles as taught by Bland and as a more complete medical food can produce benefits in conditions such as diabetes and weight control as taught by Bland.
It would be prima facie obvious for a skilled artisan before the effective filing date of the invention making the Kanaya composition to have the curcumin be present in amount of 200 mg as taught by Bland in order to have a more complete and convenient medical food that provides nutritional support of symptoms related to hormone cycles as taught by Bland.
With respect to the language of “for the prevention of complications of diabetes mellitus induced by AGEs at micro and macrovascular level and metabolic syndrome” this is only a statement of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Merely discovering and claiming a new benefit of an old process cannot render the process again patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2USPQ2d 1051, 1054 (Fed.Cir.), cert. Denied, 484 U.S. 827 (1987). In re Woodruff, 16 USPQ2d 1934.
Response to Arguments
Applicants remarks filed April 14, 2025 have been fully considered and are found to be unpersuasive for the following reasons.
Applicants note that the amendment to the claim has moved the purpose or effect of the composition out of the preamble and into the body so as to render the purpose or effect of the composition as a material limitation of the claim such that the combination of references in the obviousness rejection must address the purpose or effect, which they do not.
With respect to the obviousness rejection Applicants assert that there is no prima facie case of obviousness because the rationale to combine the references is based on conclusory statement and is made with hindsight. Applicants reiterate the and incorporate by reference the arguments raised in its October 8, 2024 response to the obviousness rejection, believing them to remain on point.
Additionally, Applicants assert that the rationale provided to support the combination of Bland with Kanaya does not work because relying on a dosing regimen for curcumin for treating women experiencing hormonal issues says nothing about treating complications from diabetes mellitus. Applicants assert that Bland only mentions diabetes once and assert that this is insufficient to motivate a person of ordinary skill in the art to incorporate a trace metal for the purposes of treating diabetes.
Applicants argue that the rational of having a more complete and convenient medical food is abstract and unspecific and do not support any particular reasons to combine. Applicants take issue with the first stated rationale of increasing metabolism and to promote healthy skin and muscles as taught by Bland and assert that it is inapplicable to the express medical treatment in amended claim 1. Applicants assert that to say that body systems overlap and are interrelated is over generalized and is not articulated reasoning with some rational underpinning to support obviousness.
Applicants argue that for the treatment of complication of diabetes mellitus is not a statement of intended use because the intended use is recited in the body of claim 1 and must be considered.
Applicants argue that for the treatment of complication of diabetes mellitus is not a statement of intended use because the intended use is recited in the body of claim 1 and must be considered.
Applicants note that the objective of the prior art is different than the claimed invention. Kanaya invention is different from the objective of the instant invention. Kanaya’s objective is to provide a particulate composition that uses a fat composition as a matrix that can encapsulate a hydrophilic substance and control its release in the intestinal tract. Bland describes medical compositions to provide a natural approach to controlling bodily processes involving S-adenosylmethionine and symptoms related to a hormonal cycle. The objective of the Bland invention is different from the objective of the instant invention.
Applicants assert that Bland teaches away from the claimed treatment composition because a history of diabetes was an exclusion criteria for the clinical study of the Bland composition and further Bland was focused on healthy hormonal cycles.
Applicants also argue that Bland is not combinable with Kanaya without fundamentally changing its underlying principles because the primary reference Bland only mentions diabetes once and Bland excludes subjects with a history of diabetes.
Applicants further assert that neither Kanaya nor Bland are analogous art to the claimed invention. Applicants repeat their assertion that the combination of the references in the obviousness rejection is based on hindsight.
Applicant’s arguments have been fully considered but they are still not found to be persuasive. Applicants reiterate and incorporate by reference their earlier arguments and the response to these arguments is reiterated and incorporated by reference as well, although it is further explained below.
As an initial matter, moving the purpose of an invention from the preamble of a claim into the body of the claim does not, in and of itself, make the language limiting in the claim. If the language in the preamble provides structural or functional limitations, than the preamble can be considered limiting and this language will remain limiting when it is moved to the body of the claim. However, when the language in the preamble simply states the intended purpose or use of the invention, this is not limiting because it does not provide a structural or functional limitation and this will be the case whether the language is in the preamble or in the body of the claim.
However, for treating diabetes does not describe a method or process step and provides no structural or functional limitations. Claim 1 is directed to a unit dose stable pharmaceutical physicochemical composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Merely discovering and claiming a new benefit of an old process cannot render the process again patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2USPQ2d 1051, 1054 (Fed.Cir.), cert. Denied, 484 U.S. 827 (1987). In re Woodruff, 16 USPQ2d 1934. The inclusion of the statement of intended use in the body of the claim does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02.
Applicants’ previously asserted arguments that the stated rationales to combine the teachings of the prior art references are abstract and non-specific is still not found to be persuasive because increasing metabolism and promoting healthy skin and muscles is very specific and is directly relevant to treating diabetes melitis. A healthier body and faster metabolism is directly relevant to treating diabetes. This is a powerful motivation to incorporate a vitamin or mineral into the composition.
Applicants’ issue with the second rationale of providing nutritional support related to hormone cycles as taught by Bland as being inapplicable to the medical treatment in amended claim 1 remains confusing because diabetes mellitus is at its heart a hormonal disruption with insulin, so nutritional support for properly functioning hormones in the body would appear to be relevant and potentially helpful to treating diabetes mellitus. As interdependent as hormonal systems in the body are, it would appear that nutritional support for one hormonal systems would indirectly (or directly) benefit the proper functioning of other hormonal systems. Additionally, Bland expressly teaches that chromium is beneficial in conditions like diabetes and weight control.
Also remaining unpersuasive is Applicants’ argument that there is no incentive in any of the references to add pyridoxine to the composition of Kanaya to obtain the claimed composition due to the differing objectives of Kanya and Bland because the objectives of the prior art inventions do not negate the teachings of the claimed elements or eliminate the motivation to combine those teachings.
As described in the rejection it would be prima facie obvious for a skilled artisan before the effective filing date of the invention making the Kanaya composition of quercetin, thiamine and curcumin to add 100 mg pyridoxine hydrochloride and chromium as taught by Bland in order to have a more complete and convenient medical food with a preferred form of pyridoxine that can increase metabolism and to promote healthy skin and muscles as taught by Bland and as a more complete medical food can produce benefits in conditions such as diabetes and weight control as taught by Bland.
It would be prima facie obvious for a skilled artisan before the effective filing date of the invention making the Kanaya composition of quercetin, thiamine and curcumin to have the curcumin be present in amount of 200 mg as taught by Bland in order to have a more complete and convenient medical food that provides nutritional support of symptoms related to hormone cycles as taught by Bland.
The objective of the claimed invention, for the treatment of diabetes mellitus induced by AGEs at micro and macrovascular level and metabolic syndrome, is still only a statement of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Merely discovering and claiming a new benefit of an old process cannot render the process again patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2USPQ2d 1051, 1054 (Fed.Cir.), cert. Denied, 484 U.S. 827 (1987). In re Woodruff, 16 USPQ2d 1934. The inclusion of the statement of intended use in the body of the claim does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02. The claims are directed to a unit dose stable pharmaceutical physicochemical composition. In this case, Kanaya in view of Bland teach making the Kanaya composition and adding 100 mg pyridoxine hydrochloride and chromium as taught by Bland in order to have a more complete and convenient medical food with a preferred form of pyridoxine that can increase metabolism and to promote healthy skin and muscles and to have a more complete medical food that can produce benefits in (i.e. treat) diabetes and weight control as taught by Bland.
Bland does not teach away from the claimed invention. It does not constitute a teaching away that that a history of diabetes was an exclusion criteria for the clinical study of the Bland composition and that Bland was focused on healthy hormonal cycles. Bland mentions diabetes in its discussion of its invention and exclusion criteria for its clinical study is just that – the Examples of its invention should not be construed to be limiting of its invention. Bland expressly states at [240] that the Examples are not meant to be limiting:
Although the invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof. Accordingly, the invention is not intended to be limited by the specific disclosures of preferred embodiments herein, but instead by reference to claims attached hereto.
Furthermore Bland does not teach away from the claimed invention because a teaching away must be clear. Significantly, there is absolutely no discouragement or disparagement of a composition with the claimed elements recited in the instant claim. A teaching away must be clear. See MPEP Sec. 2143.03 (VI). There is no discouragement of using a medical food to treat diabetes, indeed, quite the opposite. Specifically, at paragraph [0133] Bland expressly teaches that chromium as a supplement in a medical food can produce benefits in diabetes and weight control. There is an express teaching of using a more complete medical food that includes chromium to treat diabetes in Bland.
Since there is an express teaching of using chromium to treat diabetes in Bland, the prior art is analogous art. It should also be noted that chromium is incorporated into the composition of Kanaya along with the pyroxidine hydrochloride in order to make it a more complete medical food with the ability to effect weight control and treat diabetes as taught by Bland.
Applicants’ arguments that Bland and Kanaya are not analogous art is still not found to be persuasive. Kanaya teaches a composition that is a medical food or nutritive food and is especially well suited for this application because of its safety. (See Kanaya [0002], [0019]). The claimed invention is a pharmaceutical composition for treating diabetes, which is also a medical food.
Kanaya’s purpose is not defeated with the combination of Kanaya and Bland. Kanaya teaches a composition that is a medical food and is especially well suited for this application because of its safety. (See Kanaya [0002], [0019]). Bland expressly teaches that chromium as a supplement can produce benefits in diabetes and weight control. There is a teaching of using a more complete medical food or nutritive food that includes chromium to treat diabetes in Bland. Bland is also directed to using the medical food to treat or prevent hormonal disorders, but this additional teaching does not defeat the purpose of Kanaya as providing a safe nutritive food or medical food. The claimed invention is a pharmaceutical composition for treating diabetes which is also a medical food.
Respectfully, Applicants’ assertion that hindsight has been employed in making the obviousness rejections is incorrect and unpersuasive. Hindsight has not been used in making any obviousness rejections; this is evident in that all of the claimed elements are taught or suggested in the prior art references themselves and so is the motivation to combine them. Significantly, all of the reasons for combining the teachings of Kanaya and Bland are based on the express teachings of the references themselves.
Additionally, the rationale for combining the teachings of the references are not conclusory and are very specific. They are specific to the teachings of the references and would be highly motivating to one or ordinary skill in the art. A person of ordinary skill in the art would be very interested in having a more complete medical food that can increase metabolism, promote healthy skin and muscles and can produce benefits in (i.e. treat) diabetes and weight control as taught by Bland.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619