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 .
DETAILED ACTION
2. Applicants’ arguments filed on 7/21/2025, have been fully considered. There is no amendment of the claims 1-23. However, examiner wants to address further additional 112 and to include missing claim with the addition of some paragraphs for better clarification. However, examiner is maintaining the identical prior arts of record. Therefore, the following action is made as non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-23 are pending in this office action.
Claims 1-23 have been rejected
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 1-23 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
6. Claim 1 recites at least the term “non-offending”. In specification, page 13, it recites “Correspondingly, non-offending sources of nutrition [022] are foods or sources of nutrition that have not been identified as offending [23]”. This can be interpreted broadly as any food(s) other than offending sources which is very broad and therefore, there is no meets and bounds of this term in the claims of the presently claimed invention. This makes independent claim 1 indefinite. Therefore, claims 1-23 have 112 second paragraph rejection.
Claim 1 also recites “ identifying pre-treatment offending sources of nutrition consumed by the person, each of said pre-treatment offending sources being one of either the purposefully fermented sources, the purposefully acidified sources, and both the purposefully fermented and the purposefully acidified sources;” It is unclear how to interpret claim 1. For example, “ one of either” can be interpreted as it can be any one, however, claim 1 also claims “and both the purposefully fermented and the purposefully acidified sources” should be considered. If applicants intend to mean “one or both” , applicants are advised to amend this portion of claim 1 into Markush format which is selected from the group consisting of “the purposefully fermented sources”, “the purposefully acidified sources” and combinations thereof”. Applicant’s may consider any other type of editing for better clarification to overcome 112 second paragraph rejection.
Claim 2 recites further the term “strength factor”. In specification, the strength factor is given values from 0 to 10, (Table C) corresponding to non-offending (considered as zero strength) (in specification, page 19, Table C), weak, medium, strong and extreme, respectively. As discussed above, the term ‘non-offending’ sources are indefinite, therefore, the evaluation of strength factor which corresponds to non-offending, weak, etc., is also unclear. Therefore, claim 2 is indefinite.
Claims 8-10 recite “first tier level”, “second tier level”, “third tier level” . Specification states about “strength factor”. However, it is not defined in the specification what is meant by these levels of Tier level from first to third with respect to the value and parameter to be taken into consideration. This depends on type of offending food also.
Claim 14 depends on claim 1. Claim 14 recites “wherein each of the purposefully fermented source”. However, claim 1 does not claim any one or more fermented sources from the groups of claim 14. Therefore, “wherein each of the purposefully fermented source” is confusing and is indefinite . Claim 14 depends on claim 1. Independent claim 1 recites “one of either” . Therefore, claim 14 should recite the phrase “wherein each of the offending sources being one of either the purposefully fermented source” selected from the group consisting of …….[which should be] in the format of Markush group in order to overcome 112 second paragraph rejection.
Claim 15 claims many fermented food from different groups like grains, vegetable, fruit, dairy, meat , tea etc. However, it is unclear whether all the fermented food sources are to be considered. Claim 15 depends on claim 14 which depends on claim 1. Independent claim 1 recites “one of either” . Therefore, claim 15 should recite the phrase “wherein each of the offending sources being one of either the purposefully fermented source” selected from the group consisting of …….[which should be] in the format of Markush group in order to overcome 112 second paragraph rejection.
Claim Rejections - 35 USC § 103
7. 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-AlA) 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.
8. The following is a quotation of 35 U.S.C. 103 that forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
9. 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:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
10. Claims 1-9, 13-20, 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Vijay Vad et al. (over “Arthritis RX: a cutting-edge program for a pain-free life” to Vijay Vad, M.D.; hereinafter "Vijay").
11. Regarding claim 1, it is to be noted that claim 1 claims “ A dietary method of treating arthritis for a person consuming sources of nutrition including non-offending sources of nutrition and offending sources of nutrition, said offending sources of nutrition being one of either purposefully fermented sources, purposefully acidified sources and both purposefully fermented and purposefully acidified sources, “said dietary method of treating arthritis comprising the steps and each step is discussed below.
Vijaya et al. discloses inflammation is also one cause of arthritis ( at least on page 67 last three lines). Vijaya et al. discloses anti-inflammatory and Pro-inflammatory sources of nutrition (at least on page 65) which can read on claimed non-offending and offending sources of nutrition of claim 1. Vijaya et al. discloses non-offending sources can be e.g. egg with vegetable omelet , salad, fruit etc. (at least on page 65, on chapter 7, pages 104-105), tuna fish, veg burger (pages 107-108). Vijaya et al. discloses the daily routine for breakfast, lunch and dinner daily (at least on pages 109, 111, 113, 117) to treat arthritis which includes non -offending plus offending source which is in reduced amount (at least on pages 62, 64, 65,66, 75 ) as “treatment base level containing offending source and discussed below.
Vijaya et al. discloses daily food has a portion with salad dressing with vinaigrette (page 109). However, salad dressing contains very small amount of vinegar (vinaigrette) (page 116) which can be considered as purposefully acidified “offending” food source can be considered to combine with the reduction of the amount with non-offending food source in order to avoid detrimental effect of “offending source as is evidenced by applicant’s specification (in PGPUB [0017]). Also, serving size can include about half the usual portion of meat (in Vijaya et al. at least on page 75), reduced fat (pages 65,66) and salad dressing with small amount of vinegar with total amount of food source to be consumed daily (page 109) contributes further very little vinegar (acid source) (page 109) which can be much less (<50%) acid to be consumed, therefore, it is permissible as evidenced by applicant’s specification (at least in PGPUB [0017]). Therefore, the reduction of offending source is at least about 50% (at least on pages 62, 64, 65,66, 75 ).
12. Claims 1 further claims the steps of (i)-(viii) discussed below.
All the steps are general steps , which can be performed using the teachings of Vijay et al. and is within the skill of one of ordinary skill in the art using the teachings of Vijay et al.
Regarding the claim limitation step (i) of claim 1, (i) identifying pre-treatment offending sources of nutrition consumed by the person, each of said pre-treatment offending sources being one of either the purposefully fermented sources, the purposefully acidified sources, and both the purposefully fermented and the purposefully acidified sources;”
Regarding the above claim limitation step (i) of claim 1, Vijay et al. discloses that some foods are “Not recommended” food (at least page 65, 109, 117 of Vijay et al.) because they are pro-inflammatory and inflammation causes arthritis (Vijaya et al. at least in pages 60, first paragraph and pages 67,75,80, 81) . This pretreatment offending source includes acidified source e.g. juice drinks, (i.e. acidic juice ), “Most commercial salads dressings” (i.e. having acidic component vinegar) , dairy product includes fermented yogurt (at least on page 65 under Pro-inflammatory food-Not Recommended). It is known that claim 1 recites alternative offending sources e.g. “one of either” fermented or acidified. Also, as mentioned above, red meat contains detrimental saturated omega -6 fatty acid (i.e. acid) which can be considered belonging to “offending source” because of the presence of omega -6 fatty acid (i.e. acid) (at least page 62 of Vijay et al.) and, therefore, serving size is reduced to about half the usual portion of meat (in Vijaya et al. at least on page 75) as discussed below. Therefore, not recommended juice etc. (i.e. acid food) as disclosed by Vijay et al. meets claim 1 (i). However, it is also to be noted that broadly claimed “fermented food” includes fermented acidic foods also. Therefore, it would have been obvious that one of ordinary skill in the art can “identify pre-treatment offending source” from the teaching of Vijay et al. which can be considered to be used in portions, reduced amount to treat arthritis patient. . It is also to be noted that the disclosed offending source as disclosed by Vijay et al. and discussed above, meets purposefully fermented source”, purposefully acidified source. The reason is and it is evidenced by applicant’s specification (in PGPUB [0017]), that the phrase “purposefully fermented source”, purposefully acidified source” as claimed in claim 1, is interpreted as the identifying offending foods consumed by the person belongs to the group which can be reduced in an amount from pre-treatment to treatment nutrition composition based on the designated strength factor (e.g. reduction of acidity etc.) to reduce the detrimental effect by using less than fifty percent (50%) of the patient/ person’s pre-treatment base level. Vijay et al. meets step (i) of claim 1.
13. Regarding step (ii) of claim 1, “ compiling a list of listed pre-treatment offending sources of nutrition for the person”, it is to be noted that it is within the skill of one of ordinary skill in the art to evaluate the diet chart of an individual consuming offended food sources e.g. “fermented food and/or acidic foods” who is prone to inflammation and followed by gradual development of arthritis pain , based on the discussion as discussed for step (i) above, which will be helpful to determine the treatment base level (discussed below) by reducing the desired amount of “offending source” to make it less detrimental as discussed below.
14. Regarding step (iii) of claim 1, “determining a pre-treatment base level for said listed pre-treatment offending sources of nutrition consumed by the person during a pre-treatment consumption time period;”, as discussed for steps (i) an (ii) above,
it is within the skill of one of ordinary skill in the art to determine the amount of acidity in vinegar (acid) used in salad dressing or the amount of red meat consumed which contributes amount of detrimental omega 6 fatty acid (page 62, 65) or amount of fat present in the “offending source of nutrition” (page 66 , fat is detrimental), and this step will help to decide the amount of reduction of this ‘offending source of nutrition’ is necessary to a desired amount to be considered as treatment base level and ‘treatment base level’ depends on the intensity of the disease, arthritis (i.e. pain) of an individual. It is to be noted that claim 1 is broad and the reduction of the amount of ‘offending source of nutrition’ depends on the amount of “offending ingredient” (e.g. acidic strength contributed by amount of vinegar or amount of fat etc.) and type of individual with pain. It is also to be noted that one of ordinary skill in the art can assay the amount of causative agent (e.g. acid from acid source) in the offending source and it can be assayed using any standard known method from literature in order to determine the pre-treatment base level.
15. Regarding step (iv) of claim 1, “altering said listed pre-treatment offending sources of nutrition for the person to treatment sources of nutrition”;
Vijaya et al. also discloses the daily routine for breakfast, lunch and dinner daily (page 109) to treat arthritis. Even if Vijaya et al. discloses that not recommended (i.e. pre-treatment offending source) red meat containing saturated omega 6 fatty acid can be reduced to half the amount, (pages 62, 65, 75) , reducing fat content from fat containing food (page 66), salad with vinaigrette dressing (pages 108, 109, 117), having salad dressing containing little amount of vinegar (reduced acid) which can be considered as further little amount of original acidic vinegar with respect to total food consumption (page 118) and can be considered as permissible foods as it is much less (<50%) acid to be consumed, and fermented food e.g. beer, wine (page 76 e.g. giving up beer, wine is interpreted as at least 50% less which can be zero also), therefore, it is permissible as evidenced by applicant’s specification (at least in PGPUB [0017]).
Therefore, Vijay et al. discloses alterations of “listed pre-treatment offending sources of nutrition for the person to treatment sources of nutrition” of claim 1.
16. Regarding step (v) of claim 1 “identifying treatment offending sources of nutrition consumed by the person, each of said treatment offending sources being one of either the purposefully fermented sources, the purposefully acidified sources, and both the purposefully fermented and the purposefully acidified sources”,
it is to be noted that it is within the skill of one of ordinary skill in the art to identify from the disclosures of Vijay et al. as discussed above , to reduce its content to be considered as the treatment offending source e.g. which are acidic food, red meat with saturated omega-6 fatty acid food, high fat food etc. to be considered with the reduced amount to be consumed by an individual.
17. Regarding step (vi) of claim 1 (vi) compiling a list of listed treatment offending sources of nutrition for the person;
It is, therefore, within the skill of one of ordinary skill in the art to consider the teachings of Vijay et al. to compile the above identified list of pre-treatments offending sources by altering the offender source e.g. like milk in moderate amount or fat-free or low-fat milk , little amount of acidulants vinegar in salad dressing (e.g. oil and high fat component etc.) and less amount of meat as discussed above with the desired alteration (i.e. reduced amount) after determining the treatment level e.g. serving size can include about half the usual portion of offending source e.g. meat (in Vijaya et al. at least on pages 62, 65,66, 75, 109, 117). The amount to be reduced depend on the intensity of the offending ingredient” present in “offending source” and the person to be treated with pain for arthritis.
18. Regarding step (vii) of claim 1 (vii) determining a treatment base level for said listed offending sources of nutrition consumed by the person during a treatment consumption time period, said treatment base level being at least fifty percent less than said pre-treatment base level;
It is to be noted that and as discussed in steps (iv)-(vi) above, Vijay et al. discloses the use of reduced amount of the offending source by red meat about half the portion, by reducing detrimental saturated omega -6 fatty acid (i.e. acid) which can be considered belonging to “offending source” because of the presence of omega -6 fatty acid (i.e. acid) (at least page 62 of Vijay et al.), and, therefore, treatment base level is reduced to half to make serving size which is “treatment base level can include about half the usual portion of meat (in Vijaya et al. at least on page 75).
Vijay et al. also discloses the reduction of fat level ( 40-59% to 20-35%, in general ) as recommended by USDA and reduction of acid in salad dressing using little amount (at least pages 62, 65, 66, page 75, 109, 117 of Vijay et al.) . It is to be noted that it would have been obvious that fermented food and acidified food would be inherently “Offending source” as also evidenced by applicant’s specification (in PGPUB [0017], [0030], [0031]). Therefore, it meets “at least fifty percent” of claim 1 (vii). One of ordinary skill in the art can determine the amounts of acid, fat etc. using conventional routine method which is known in this art.
It is also to be noted that one of ordinary skill in the art can assay the amount of causative agent (e.g. acid from acid source) in the offending source and it can be assayed using any standard known method from literature in order to determine a treatment base level by evaluating the pre treatment base level and considering the desired treatment base level to be appropriate based on the intensity of the pain for arthritis patient by evaluating the amount of causative agent (e.g. acid from acid source).
Therefore, it is within the skill of one of ordinary skill in the art to determine the levels of e.g. amount of omega-6 fatty acid in meat (page 62) amount of acid as vinegar in food, amount of fat in offensive food used during pretreatment time, which is a pretreatment base level and further reduction to a desired amount which is “treatment base level” (i.e. after reducing the offending source for treatment) of the offending source and the amount to be reduced to consider treatment base level depends on type of offensive food, level of offensive ingredient as pretreatment base level and intensity of the pain i.e. the disease for an arthritis patient. It is optimizable.
Absent showing of unexpected results, the determination of treatment base level depends on type of offensive food, level of offensive ingredient as pretreatment base level and intensity of the pain i.e. the disease for an arthritis patient. is not considered to confer patentability to the claims. As the type of offensive food, level of offensive ingredient as pretreatment base level and intensity of the pain i.e. the disease for an arthritis patient are variables that can be modified, among others, by adjusting the amount of reduction of the offensive sources, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of reduction of offensive source(s) in Vijay et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired reduction of arthritis pain for arthritis patient (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
19. Regarding step (viii) of claim 1 (viii) maintaining consumption of said treatment offending sources of nutrition by the person at or below said treatment base level”,
It is also to be noted that it is within the skill of one of ordinary skill in the art to maintaining consumption of said treatment offending sources of nutrition by the person at or below said treatment base level so long the improvement of the arthritis condition is achieved by considering the parameters like “pain reduction”, inflammation reduction etc. This is optimizable.
Absent showing of unexpected results, the claim limitation of “ maintaining consumption of said treatment offending sources of nutrition by the person at or below said treatment base level” is not considered to confer patentability to the claims. As the intensity of the pain i.e. the disease for an arthritis patient are variables that can be modified, among others, by adjusting the amount of reduction of the offensive sources, the precise amount of ‘maintaining consumption” would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the duration of the maintenance of consumption of said treatment offending sources of nutrition by the person at or below said treatment base level with a desired amount of reduction of offensive source(s) in Vijay et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired reduction of arthritis pain for arthritis patient (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
20. Regarding claims 2-4, Vijay teaches the dietary method of treating arthritis of Claim 1 but does not specifically teach “strength factor”. Although claims 2-4 have also 112 second paragraph issue, however, it is to be noted that it is within the skill of one of ordinary skill in the art to evaluate the strength factor of a food product based on its acid strength etc. by considering a base level as zero from corresponding non-offending food as evidenced by applicant’s specification (at least in Table C, page 19, Specification). Therefore, the rest of the claim limitations of claim 2 is simple mathematical calculation. One of ordinary skill in the art can perform it.
21. Regrading claim 3, the term “tiered strength factor” is defined as “a tiered or stepwise” implementation of” the strength factor as evidenced by applicant’s specification (at least in page 29, last few lines of the first paragraph). It is to be noted that sometimes the aggressive implementation with the most immediate benefit is difficult and may not bring good result. Therefore, it is within the skill of one of ordinary skill in the art to consider “tiered strength factor” for stepwise treatment approach, if an aggressive implementation with the most immediate benefit may not be possible because it is difficult and strenuous as evidenced by applicants’ own specification (at least in page 29, last few lines of the first paragraph).
22. Regarding claim 4, the duration of treating arthritis can be evaluated based on the good result. This is optimizable. It is within the skill of one of ordinary skill in the art to optimize the time of treatment in order to have the desired curing/improvement of the arthritis condition
Absent showing of unexpected results, the specific amount of treatment time duration is not considered to confer patentability to the claims. As the intensity of the disease, type of food, age of the person are variables that can be modified, among others, by adjusting the duration of treatment time, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the duration of treatment time in NPL Vijay to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired curing/improvement of the arthritis condition (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
23. Regarding claim 5, Vijay teaches the dietary method of treating arthritis of Claim 1, and wherein said pre-treatment base level is a pre- treatment base level numerical value and said treatment base level is a treatment base level numerical value, and said treatment base level numerical value is at or below 35 percent of said pre-treatment base level numerical value (pg. 75, Serving Size, para 1, ln 22-24, when it comes to fish, poultry, or meat, a serving consists of 3 ounces, or about half the usual portion; pg. 65, the anti-inflammatory diet, para 2, ln 1-3, total fat should make up 20 to 35 percent of calories (44 to 78 grams), the typical American diet gets 40 to 59 percent of calories from fat; pg. 62, para 2, ln 1-3, saturated omega-6 fatty acids, found in red meat and other animal products, promote inflammation. Hence, the determined treatment base level of the red meat is 3 ounces, which was altered from 6 ounces (pre-treatment base level). In addition, the determined treatment base level also includes Americans getting 20 percent of calories purely from fat instead of 59 percent (pre-treatment base level), including from sources such as red meat, and 20 percent of calories from fat is 33.9% percent of 59 percent of calories from fat).
24. Regarding claim 6, Vijay teaches the dietary method of treating arthritis of Claim 5, and wherein said treatment base level numerical value is at or below 20 percent of said pre-treatment base level numerical value (pg. 75, Serving Size, para 1, ln 22-24, when it comes meat, a serving consists of 3 ounces, or about half the usual portion; pg. 68, para 2, ln 8-12, Red meat contains high levels of arachidonic acid, which increases inflammation, so removing meat from the diet decreases levels of pro-inflammatory compounds in the body; pg. 62, para 2, ln 1-3, saturated omega-6 fatty acids, found in red meat, promote inflammation; pg. 80, If You Must Eat Meat, ln 1-3, red meat is about the last thing you should eat in large quantities if you want to avoid inflammation and keep your weight down, as it is often loaded with omega- 6 fatty acids. Hence, the treatment base level of the treatment source (red meat) may be maintained at the 3 ounces instead of 6 ounces (pre-treatment base level), or the red meat may be completely excluded from the diet (0 ounces), which would evidently be below 20 percent of the pre-treatment base value of 6 ounces, as 0/6 is 0%).
25. Regarding claim 7, Vijay teaches the dietary method of treating arthritis of Claim 5, and wherein said treatment base level numerical value is at or below 5 percent of said pre-treatment base level numerical value (pg. 75, Serving Size, para 1, ln 22-24, when it comes meat, a serving consists of 3 ounces, or about half the usual portion; pg. 68, para 2, ln 8-12, Red meat contains high levels of arachidonic acid, which increases inflammation, so removing meat from the diet decreases levels of pro-inflammatory compounds in the body; pg. 62, para 2, ln 1-3, saturated omega-6 fatty acids, found in red meat, promote inflammation; pg. 80, If You Must Eat Meat, ln 1-3, red meat is about the last thing you should eat in large quantities if you want to avoid inflammation and keep your weight down, as it is often loaded with omega- 6 fatty acids. Hence, the treatment base level of the treatment source (red meat) may be maintained at the 3 ounces instead of 6 ounces (pre-treatment base level), or the red meat may be completely excluded from the diet (0 ounces), which would evidently be below 5 percent of the pre-treatment base value of 6 ounces, as 0/6 is 0%).
26. Regarding claim 8, Vijay teaches the dietary method of treating arthritis of Claim 1, and wherein said treatment base level is a first lower tier level (pg. 75, Serving Size, para 1, ln 22-24, when it comes to fish, poultry, or meat, a serving consists of 3 ounces, or about half the usual portion; pg. 65, the anti-inflammatory diet, para 2, ln 1-3, total fat should make up 20 to 35 percent of calories (44 to 78 grams), -- the typical American diet gets 40 to 59 percent of calories from fat; pg. 62, para 2, ln 1-3, saturated omega-6 fatty acids, found in red meat and other animal products, promote inflammation. Hence, the first lower tier level of the treatment base level of the red meat is 3 ounces, which was altered from 6 ounces (pre-treatment base level), showing an at least 50 percent reduction; see instant specification pg. 32, ln 3-5, the treatment base level of 50% of the pre-treatment base level is referred to as the first lower tier level).
27. Regarding claim 9, Vijay teaches the dietary method of treating arthritis of Claim 8, and further comprising the steps of: monitoring a determined level of arthritis pain and discomfort of the person when at or below said first lower tier level for a monitoring time period (pg. 75, Serving Size, para 1, ln 22-24, when it comes to fish, poultry, or meat, a serving consists of 3 ounces, or about half the usual portion; pg. 103, Chapter Seven, The Arthritis RX Plan: A Weekly Sampler, para 2, ln 1-4, you should notice minor improvements on a daily basis, but the full benefits of this plan begin to take effect after about eight weeks, you may experience mildly increased discomfort during the first two of three weeks of the plan; pg. 75, para 2, ln 8-12, Red meat contains high levels of arachidonic acid, which increases inflammation, so removing meat from the diet decreases levels of pro-inflammatory compounds in the body. Hence, levels of discomfort/inflammation are monitored after the first 2-3 weeks of the diet plan consisting of 3 ounces (first lower tier level) of the red meat); altering consumption of said treatment offending sources of nutrition for the person to at or below a second lower tier level when said determined level of arthritis pain and discomfort of the person remains above a desired level of arthritis pain and discomfort for the person (pg. 75, Serving Size, para 1, ln 22-24, when it comes meat, a serving consists of 3 ounces, or about half the usual portion; pg. 65, the anti-inflammatory diet, para 2, ln 1-3, total fat should make up 20 to 35 percent of calories (44 to 78 grams), the typical American diet gets 40 to 59 percent of calories from fat; pg. 62, para 2, ln 1-3, saturated omega-6 fatty acids, found in red meat, promote inflammation; pg. 80, If You Must Eat Meat, ln 1- 3, red meat is about the last thing you should eat in large quantities if you want to avoid inflammation and keep your weight down, as it is often loaded with omega-6 fatty acids; pg. 75, para 2, ln 8-12, Red meat contains high levels of arachidonic acid, which increases inflammation, so removing meat from the diet decreases levels of pro-inflammatory compounds in the body. Hence, the treatment base level of the treatment source (red meat) may first be 3 ounces (first lower tier level), and then altered to be further lower than 3 ounces from the diet if monitored and determined discomfort/pain/inflammation persists (the desired level of discomfort of pain is no/minimal discomfort or pain), meaning that the treatment base level can be altered from 3 ounces to gradual decreasing amount which can avoid arthritis pain and lowering the inflammation (second lower tier level)); and, maintaining consumption of said listed treatment offending sources of nutrition for the person to at or below said second lower tier level (pg. 80, If You Must Eat Meat, ln 1-3, red meat is about the last thing you should eat in large quantities if you want to avoid inflammation and keep your weight down, as it is often loaded with omega-6 fatty acids; pg75, para 2, ln 8-12, Red meat contains high levels of arachidonic acid, which increases inflammation, so removing meat from the diet decreases levels of pro-inflammatory compounds in the body. Hence, the consumption of red meat for the person is maintained at further lower level than 3 ounces (second lower tier level) since the red meat may be excluded but does not specifically teach wherein the determined level of arthritis pain and discomfort is quantifiable. Based on the teachings of Vijay, it would have been obvious to one of skill in the art to employ and determine a quantifiable level of arthritis pain and discomfort during monitoring to optimally and accurately adjust the consumption of said listed treatment offending sources of nutrition to the second lower tier level to mitigate such pain and discomfort by routine experimentation.
28. Regarding claim 10, claim 10 claims “further altering consumption of said treatment offending sources of nutrition for the person to or below a third lower tier level” which can be addressed by further lowering from in between 3 and greater than zero (second lower tier level ) to zero ounces (third lower tier level) i.e. completely excluded from the diet if monitored and determined discomfort/pain/inflammation persists (the desired level of discomfort of pain is no/minimal discomfort or pain. This is applicable for other disclosed offending sources also e.g. fat, acidulant etc. in food composition. For example, one of ordinary skill in the art may consider low fat milk to non- fat milk to lower the tier level of this particular food. It is within the skill of one of ordinary skill in the art to optimize the respective tier levels of the offending source food with respect to arthritis pain reduction. It is optimizable.
Absent showing of unexpected results, the claim limitation of” further altering consumption of said treatment offending sources of nutrition for the person to or below a third lower tier level” is not considered to confer patentability to the claims. As the intensity of the pain i.e. the disease for an arthritis patient are variables that can be modified, among others, by further alteration of consumption of said treatment offending sources of nutrition for the person to or below a third lower tier level (i.e. adjusting the amount of reduction of the offensive sources), the precise amount of ‘below a third lower tier level ” would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the duration of the maintenance of consumption of said treatment offending sources of nutrition by the person at or below said treatment base level with a desired amount of reduction of offensive source(s) including third lower tier level in Vijay et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired reduction of intensity of arthritis pain for arthritis patient (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
29. Regarding claim 11, it is within the skill of one of ordinary skill in the art, to lower the tier levels of the offending source food with respect to arthritis pain by (i) reducing consumption and (ii) replacing with another similar equivalent alternative sources of nutritional product e.g. chicken in meal instead of red meat as disclosed by Vijay et al. (at least on (pages 65, 109), and, once evaluated the lowering of tier levels of the offending source food with respect to arthritis pain reduction.
30. Regarding claim 12, Vijay et al. discloses that (page 93, 94 e.g. consider shopping list and pages 99, last two paragraphs select ginger etc. as COX-2 inhibitor in the diet and chapter Seven and page 104, Under Daily Samples, and it recommends chapter five also and as discussed, few pages above). Also, it is within the skill of one of ordinary skill in the art to select a substitute non-offending source of nutrition and a substitute offending source of nutrition can be selected from the teaching of Vijay et al. (at least from the teachings from pages 62, 64, 65, 66, 75, 76, 80, 81, 103 and , specifically page 65 under “Pro-inflammmatory” (i.e. offending) and “Anti inflammatory (i.e. non-offending) : SEE Attachment B as filed by the applicants under Remarks on 7/21/2025) which specifies the portions of these pages ) with a reasonable expectation of success to control and to achieve desire result of reducing arthritis pain of a individual.
Absent showing of unexpected results, the claim limitation of” further altering sources by substitute non-offending source of nutrition and a substitute offending source of nutrition is not considered to confer patentability to the claims. As the intensity of the pain i.e. the disease for an arthritis patient are variables that can be modified, among others, by further alteration of consumption of said sources, the precise substitution of non-offending source of nutrition and substitution of offending source” would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the substitution of non-offending source of nutrition and substitution of offending source by the person with the desired non-offending sources source(s) and offending sources and further reducing the desired amount of non-offending source during a treatment consumption time period , in Vijay et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired delayed/elimination of the disease with the reduction of intensity of arthritis pain for arthritis patient (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
31. Regarding claim 13, Vijay teaches the dietary method of treating arthritis of Claim 1, and wherein said purposefully fermented sources are one of either: a) deliberately fermented for more than one hour using one of either cultured microorganisms, cultured yeast and cultured bacteria (pg. 80, Dairy and Eggs, para 2, ln 1-2, some forms of dairy, including yogurt, milk, and cheese have some benefit as well when consumed in moderation; pg. 76, Nightshade Plants, para 1, ln 1-2, for others, the answer is giving up all dairy products or fermented foods such as soy sauce, beer, and wine; pg. 75, Serving Size, para 1, ln 22-24, when it comes to meat, a serving consists of 3 ounces, or about half the usual portion. Hence, fermented foods, including soy sauce, beer, and wine, are applicable purposefully fermented sources that have been deliberately fermented for more than one hour using cultured microorganisms, yeast, or bacteria; see instant specification Table A, Classification, Purposefully fermented sources of nutrition, Attribute, Deliberately fermented, one hour (cultured microorganisms, yeast, or bacteria), Examples, fermented bean foods group fermented grain foods group, fermented fruit foods group; see instant specification pg. 14, ln 4-15, as an example, foods and beverages that can be purposefully fermented include beans, grains, fruits, meat, bean-based foods that are purposefully fermented include the following group of foods: soy sauce, Grain-based foods that are purposefully fermented include the following group of foods: beer, Fruit-based foods that are purposefully fermented include the following groups of foods: wine).
32. Regarding claim 14, Vijay teaches the dietary method of treating arthritis of Claim 1, and wherein each of the purposefully fermented sources is from a purposefully fermented group including fermented bean foods, fermented grain foods, fermented vegetable foods, fermented fruit foods, fermented honey foods, fermented dairy foods, fermented fish foods, fermented meat foods and fermented tea foods (pg. 80, Dairy and Eggs, para 2, ln 1-2, some forms of dairy, including yogurt, milk, and cheese have some benefit as well when consumed in moderation; pg. 76, Nightshade Plants, para 1, ln 1-2, for others, the answer is giving up all dairy products or fermented foods such as soy sauce, beer, and wine; pg. 75, Serving Size, para 1, ln 22-24, when it comes to meat, a serving consists of 3 ounces, or about half the usual portion; see instant specification pg. 14, ln 4-15, as an example, foods and beverages that can be purposefully fermented include beans, grains, fruits, meat, bean-based foods that are purposefully fermented include the following group of foods: soy sauce, Grain-based foods that are purposefully fermented include the following group of foods: beer, Fruit-based foods that are purposefully fermented include the following groups of foods: wine).
33. Regarding claim 15, Vijay teaches the dietary method of treating arthritis of Claim 14, and wherein each of said fermented bean foods is from a bean group including cheonggukjang, doenjang, fermented bean curd, miso, natto, soy sauce, stinky tofu, tempeh, oncom, soybean paste, Beijing mung bean milk, kinama and iru (pg 76, Nightshade Plants, para 1, ln 1-2, for others, the answer is giving up all dairy products or fermented foods such as soy sauce, beer, and wine); each of said fermented grain foods is from a grain group including batter made from rice and lentil (Vigna mungo), amazake, beer, bread, chou Jiu, gamju, injera, kvass, makgeolli, murri, ogi, rejuvelac, sake, sikhye, sourdough, sowans, rice wine, malt whisky, grain whisky, idli, dosa, Bangla vodka, boza and chichi (pg. 76, Nightshade Plants, para 1, ln 1-2, for others, the answer is giving up all dairy products or fermented foods such as soy sauce, beer, and wine); each of said fermented vegetable foods is from a vegetable group including kimchi, pickles, sauerkraut, Indian pickle, gundruk, and tursu, among others (pg. 93, ln 1-2, served with radish, wasabi, and pickled ginger. Hence, pickled ginger includes pickles); each of said fermented fruit foods is from a fruit group including wine, vinegar, cider, perry, brandy, atchara, nata de coco, burong mangga, asinan, viinata, chocolate and rah -- (pg. 76, Nightshade Plants, para 1, ln 1-2, for others, the answer is giving up all dairy products or fermented foods such as soy sauce, beer, and wine); each of said fermented dairy foods is from a dairy group including cheese, kefir, ryazhenka, buttermilk, kumis, shubat, quark, filmjolk, creme fraiche, smetana, skyr and yogurt (pg. 80, Dairy and Eggs, para 2, ln 1-2, some forms of dairy, including yogurt, and cheese have some benefit as well when consumed in moderation) but does not specifically teach wherein each of said fermented honey foods is from a honey group including mead and metheglin, wherein each of said fermented fish foods is from a fish group including bagoong, faseekh, fish sauce, Garum, Hakarl, jeotgal, rakfisk, shrimp paste, surstromming and shidal, wherein each of said fermented meat foods is from a meat group including chin som mok, chorizo, salami, sucuk, pepperoni, nem chua, som moo and saucisson, and wherein each of said fermented tea foods is from a tea group including pu-erh tea and kombucha. However, Vijay teaches wherein fermented honey may incorporated (pg. 70, last para, ln 1-3, if you are looking for reliable, slow-burning energy, maybe a natural sweetener such as honey; see instant specification pg. 14, ln 4-5, as an example, foods that can be purposefully fermented include honey). Vijay also teaches wherein fermented tea may be incorporated (pg. 78, para 2, ln 11-13, a study concluded that drinking 4 or more of green tea a day could help prevent rheumatoid arthritis or reduce symptoms in individuals already suffering from the disease; see instant specification pg. 14, ln 4-6, as an example, beverages that can be purposefully fermented include tea). Based on the teachings of Vijay, it would have been obvious to one of skill in the art to incorporate fermented honey such as mead and/or metheglin and fermented teas such as pu-erh and/or kombucha to optimize the efficacy of the dietary method for treating arthritis. Vijay also teaches wherein a fermented meat may be incorporated (pg. 75, Serving Size, para 1, ln 22-24, when it comes to meat, a serving consists of 3 ounces, or about half the usual portion; see instant specification pg. 14, ln 4-5, as an example, foods and beverages that can be purposefully fermented include meat) and wherein fermented fish may be incorporated (pg. 75, Serving Size, para 1, ln 22-24, when it comes to fish, a serving consists of 3 ounces, or about half the usual portion; see instant specification pg. 14, ln 4-5, as an example, foods and beverages that can be purposefully fermented include fish; pg. 93 ln 1-2, raw tuna, salmon, yellowtail, shrimp served with radish, wasabi, and pickled ginger). Hence, it would have been obvious to one of skill in the art to incorporate fermented fish such as bagoong, faseekh, fish sauce, Garum, Hakarl, jeotgal, rakfisk, shrimp paste, surstromming, and/or shidal, and fermented meat such as chin som mok, chorizo, salami, sucuk, pepperoni, nem chua, som moo, and/or saucisson to further optimize the efficacy of the dietary method for treating arthritis by routine experimentation.
34. Regarding claim 16, Vijay teaches the dietary method of treating arthritis of Claim 1, and wherein the purposefully acidified sources are deliberately acidified using an acidifying agent (pg. 75, Serving Size, para 1, ln 22-24, when it comes to meat, a serving consists of 3 ounces, or about half the usual portion; pg. 107, para 1, The longer the tomatoes and other ingredients sit in the vinaigrette, the tastier they get, the beauty of balsamic vinegar is that just a few drops makes a tasty salad that isn’t overly acidic. Hence, the chicken in the salad may be acidified with vinegar; see instant specification Table A, Examples of Deliberately acidified foods using an acid include chicken sausages with vinegar added).
35. Regarding claim 17, Vijay teaches the dietary method of treating arthritis of Claim 16, and wherein said acidifying agent is from an acidifying agent group including citric acid, fumaric acid, lactic acid, acetic acid, ascorbic acid, folic acid, malic acid, sorbic acid, erythorbic acid, stearic acid, tartaric acid and phosphoric acid, and diluted solutions thereof (pg. 107, para 1, ln 4-5, the beauty of balsamic vinegar is that just a few drops makes a tasty salad that isn’t overly acidic. Hence, vinegar is also known as diluted acetic acid; see instant specification pg. 15, ln 18-19, Acids that are most commonly added to foods or sources of nutrition include acetic acid (vinegar is diluted acetic acid).
36. Regarding claim 18, Vijay teaches the dietary method of treating arthritis of Claim 17, and wherein each of the purposefully acidified sources has a pH level, and said acidifying agent reduces said pH level of each of the purposefully acidified sources to below a pH level of about 5 (pg. 107 ln 4-5, the beauty of balsamic vinegar is that jus