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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/03/2025 has been entered.
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 11/03//2025, wherein independent claims 8 and 11 are amended.
Election/Restriction
Applicant elected without traverse of Group II (method for weight management), and combination species of compounds having formula (5) and (6) on 12/13/2024.
Status of Claims
Claims 1-20 are pending in the instant application.
Claims 1-7, 10, 13 remain withdrawn as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Claims 8, 9, 11, 12, 14-20 are currently under examination.
Action Summary
Applicant's arguments filed 11/03/2025 have been fully considered.
Applicant’s arguments regarding rejections under 35 U.S.C. § 112 (a) and 35 U.S.C. § 103 have been fully considered, but are NOT persuasive. Please see following Response to Argument.
Priority
This application 17/595,446 filed on 11/17/2021, is a national stage of international application No. PCT/EP2020/064077, filed on May 20, 2020, which claims priority to European Patent Application No. 19175540.4, filed on May 21, 2019.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of European Patent Application No. 19175540.4 was filed on 11/17/2021.
Claim interpretation
Instant claims are amended to a method for treating overweight and/or obesity in an individual in need thereof, comprising administering composition comprising a mixture of triglycerides having formula of (5), (6), (7), (8) and other triglyceride recited in claim 14 with common names. Instant specification discloses nomenclature of instantly claimed triglycerides (See page 20, Example 1).
Instant claimed triglyceride formula (5) ( CAS # 175878-34-9, entered STN on 05/02/1996), is also known as 1,3-dibutyryl-2-oleoyl glycerol, TG 4:0/18:1/4:0, 1,3-butyrin-2-olein (See STN searched note, Cayman catalog). Triglyceride formula (5), i.e. TG 4:0-18:1-4:0, comprises two butyrate short chain moiety and one unsaturated 18:1 moiety (SUS).
Instantly claimed compound of formula (6) (CAS # 145135-35-9, entered STN on 12/31/1992), is also known as 1,2-dioleoyl-3-butyryl glycerol, 1,2-olein-3-butyrin (See STN searched note).Triglyceride formula (6), i.e. TG (18:1-18:1-4:0), comprises two 18:1 unsaturated moiety and one butyrate short chain moiety( SUU or UUS).
Instantly claimed butyrate moiety containing triglycerides are a mixture of multiple triglyceride with variety of structures, wherein TG 4:0-18:1-4:0 is about 16.2-27%, TG 18:1-18:1-4:0 is about 23.3-25.8%(See page 20, Example 1, Table 1).
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It’s noted instant claimed butyrate moiety containing triglycerides was generated by chemical interesterification between tributyrin and high oleic sunflower oil in the presence of catalyst. Generally speaking, chemical interesterification are unpredictable due to a variety of factors, e.g. the catalyst, the ratio of oleic acid to tributyrin, etc., and different batch of oleic sunflower oil might generate triglyceride composition comprising different triglyceride at different ratio that are different from instant claimed composition.
Although instant claims recite formula (5) and formula (6) as the major component of butyrate moiety containing triglycerides, instant composition is a mixture of triglycerides comprising variety combination of different acid moiety (4:0, 16:0, 18:1, 18:2, etc.) at different positions. The alleged activity/ function of instant composition for use in treating obesity or overweight is construed as result of combination of butyrate moiety containing triglycerides that is NOT contributed/limited only by the properties of formula (5) and formula (6) alone.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Scope of enablement rejection
Claims 8, 9, 11, 12, 14-20 are rejected under 35 U.S.C. 112(a) first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification, while might be enabling for a method of providing a source of butyrate to an individual in need thereof with instantly claimed triglyceride comprising butyrate moiety, does not reasonably provide enablement for a method for treating overweight or obesity in an individual via administering instantly claimed triglyceride combination/mixture in full scope.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation" would have been needed to practice the claimed invention in full scope is not a single, simple factual determination.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons:
The Breadth of The Claims/ Nature of The Invention
Independent claims 8 and 11 are amended to a method for treating overweight and/or obesity in an individual in need thereof comprising administering composition comprising compounds having the formulas (5) and (6)… to an individual in need. Both instantly claimed formula (5) and (6) contain butyrate and oleoyl moiety. Instant specification discloses digestion profile of butyrate moiety containing triglyceride through in-vitro lipolysis assay (Example 5). Instant claims might be enabled for a method of providing a source of butyrate to a subject in need thereof with instantly claimed triglyceride comprising butyrate moiety. However, treating overweight or obesity is a very broad, umbrella term that involves many variable/factors, e.g. diet, disease, medications, physical exercise, etc. Different subject would have different response to the butyrate containing triglyceride. Please note instant claims are directed to triglycerides composition per se , not any butyrate that might be generated once digested that might be responsible for providing an effect relevant to weight control. Although instant specification disclosed digestion profile of instantly claimed composition, digestion is only small portion of butyrate diet which also involves absorption, distribution, metabolism, etc. The digestion profile does not necessarily correlate with weight loss and/or treating overweight. As such, instantly claimed method for treating overweight and/or obesity by administrating butyrate triglyceride in absence of sufficient evidence associated with weight loss data and dosage/administration regimen is extremely broad and not enabled for the full scope.
The State of the Prior Art and the Predictability or Lack Thereof in the Art
First, instant claimed butyrate moiety containing triglycerides was generated by chemical interesterification between tributyrin and high oleic sunflower oil in the presence of catalyst. Generally speaking, chemical interesterification are highly unpredictable due to a variety of factors, e.g. the catalyst, the ratio of oleic acid to tributyrin, etc., and different batch of oleic sunflower oil might generate composition of triglyceride comprising different triglyceride at different ratio that’s different from instantly claimed composition comprising formula (5) and (6).
Second, it’s well-known that weight control/ management is highly unpredictable wherein vast variety of factors have impact on the weight of individual, e.g. diet, physical exercise, disease, etc. The efficacy of treating overweight/obesity by dietary triglyceride are highly unpredictable due to a variety factors including chemical structures/ physical properties of the triglyceride composition, delivery/absorption/ digestion profile, individual conditions, etc.
Although some study report metabolic effect of butyrate source might be positively associated with weight control , the mechanism underlying the metabolic benefit of butyrate on weight control was still unclear and contradictory. The efficacies of controlling weight/treating obesity vary greatly due to a variety factors including chemical structures/ physical properties of the triglyceride composition, delivery/absorption digestion profile, individual conditions, etc. that are unpredictable. The efficacy/ effectiveness of specific triglyceride combination/composition needs to be evaluated/validated through in-vivo test/animal study to provide evidence for effective weight control, especially for the safety of infant formula.
Regarding butyrate triglyceride diet use for weight control, Liu (2018) reviews butyrate’s potential effects and mechanisms involved in intestinal health and obesity. Although butyrate plays an important role in gut health, the effect of butyrate on obesity remains controversial (See Introduction, page 21, right column, Table 2, Conclusion). Liu and its incorporated reference teaches short chain fatty acid SCFA/butyrate “ are rapidly assimilated into host carbohydrates and lipids and could contribute to the obese phenotype by providing ∼10% of our daily energy requirements… butyrate is able to increase lipid synthesis from acetyl-CoA or ketone bodies via the β-hydroxy-β-methylglutaryl-CoA pathway, which potentially contributes to obesity” (page 25, right column, Inducing obesity). “ In conclusion, although a large body of evidence has suggested the effect of butyrate on alleviating high fat diet–induced obesity and insulin resistance, a few studies showed an opposite effect. Therefore, additional investigations are
warranted to understand the apparently paradoxical effects of butyrate on obesity” (See page 26, left column). Liu concludes “The reason behind the paradoxical effect of butyrate on glucose and lipid metabolism, especially with regard to its role in obesity, remains elusive” (See Conclusions, page 26).
More generally, the invention is directed toward physiological activity in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The Amount of Direction Present and Presence or Absence of Working Examples
Instant specification discloses preparation of butyrate moiety containing triglyceride regioisomer profile (See page 20, Table 1, Example 1) comprising 4:0-18:1-4:0 (i.e. formula 5) and 18:1-18:1-4:0(i.e. formula 6), and variety of other triglyceride components comprising different acid moiety (4:0, 16:0, 18:1, 18:2, etc.) at different positions. Instant specification discloses digestion profile of butyrate moiety containing triglyceride through in-vitro lipolysis assay (Example 5).
Instant specification only discloses sodium methanoate as exemplary catalyst without ratio/amount in chemical interesterification (See Example 1). Instant specification does not disclose any assay associated with formula (5), or formula (6) alone or combination thereof. Instant specification does not disclose any assay/weight data of individual administered with instantly claimed formula (5) and formula (6). Although instant claims recite formula (5) and formula (6) as the major component of butyrate moiety containing triglycerides, instant composition is a mixture of triglycerides comprising variety combination of different acid moiety (4:0, 16:0, 18:1, 18:2, etc.) at different positions as seen from Table 1. The alleged activity/ function of instant composition for use in weight control is the result of combination of butyrate moiety containing triglycerides that is NOT contributed/limited only by the properties of formula (5) and formula (6) alone. Since different butyrate moiety containing triglyceride has different pharmacokinetic profile (absorption, digestion, etc.), an ordinary skilled in the art would not know how much butyrate is released from which butyrate-containing triglyceride component, formula (5), or formula (6), or other butyrate moiety containing triglycerides. An ordinary skilled in the art would not know what’s the specific contribution to C4 butyrate digestion profile are associated with formula(5) and formula (6). In absence of sufficient weight data associated with formula (5) and formula (6), instantly claimed composition comprising formula (5) and formula (6) for use in weight control is not fully established and enabled by instant disclosure. Please note the digestion profile does not necessarily correlate with weight loss and/or treating overweight. More importantly, instant claims are directed to triglycerides per se , not any butyrate that might be generated once digested that might be responsible for providing an effect relevant to weight control.
The level of one of ordinary skill in the art
The level of skill required to make and/or use the instant invention would likely require years of professional experience conducting research in the art (e.g., medicine, pharmaceutical science, biology, biochemistry, medicinal chemistry, and/or organic chemistry, etc.) as well as an advanced educational degree (e.g., M.D. and/or Ph.D.) commensurate in level with the advanced techniques involved in the preparation and/or use of the instant invention.
The quantity of experimentation needed
It would be a burden for one of ordinary skill in the art to carry out undue experimentation to use the claimed invention in full scope. First, an unduly amount of experimentation might be needed for one of ordinary skill in the art to develop inter-esterification protocols to generate instant claimed triglyceride composition at instant claimed ratio due to the unpredictability of inter-esterification. Second, an unduly extensive amount of experimentation would be required for one of ordinary skill in the art to test the effectiveness of instantly claimed method of treating overweight/obesity in an individual. In-vivo experiment on individual/subject would be needed to evaluate the efficacy of instantly claimed method of treating overweight/obesity in an individual. The effective amount may vary depending on many factors, such the physical properties, absorption profile of the triglyceride combination/mixture, individual conditions etc. More assay would be needed to evaluate the safety profile for instantly claimed use in infant formula.
Conclusion
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here with respect to the claimed method of treating overweight/obesity in an individual comprising administering compounds having the formulas (5) and (6), in view of the analysis above pursuant to In re Wands. In other words, one skilled in the art could not practice the claimed invention without undue experimentation.
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive.
Applicant argues that “Example 5 demonstrates that the composition undergoes complete
digestion to release three fatty acids per molecule, it likewise demonstrates that the compounds of
formula (5) and (6) release butyrate upon digestion. … The skilled artisan would understand that stimulation of energy expenditure (i.e., increased calorie burning) constitutes a direct therapeutic action against the underlying pathology of overweight and/or obesity. Therefore, the application provides evidence that butyrate, by inducing mitochondrial function and increasing energy expenditure, exerts a direct therapeutic effect relevant to the treatment of obesity...)(Remarks , page 8/17).
RESPONSE: It’s noted instant claimed total digestion was done by simulated digestion model back titration at pH 11.5 while many fatty acids are only partially ionized at pH 6.8(See [0173]). Thus, instant disclosed digestion profile is not considered as accurately representative or reflective of digestion in the normal pH of intestine as instant specification alleged (See [0174]).
The examiner does not dispute that butyrate might be associated with weight control according to some literature as Applicant argues. Although some evidence has suggested the effect of butyrate on alleviating high fat diet–induced obesity and insulin resistance, a few studies showed an opposite effect. Therefore, additional investigations are warranted to understand the apparently paradoxical effects of butyrate on obesity (Liu, Table 2; page 26, left column). Although Coppola et al. suggests oral butyrate supplementation may produce a reduction of BMI and exerts beneficial effects on glucose metabolism and inflammation in children with obesity, Coppola also noted randomized clinical trials with longer follow-up are needed to confirm findings which demonstrate the need of more assay data.
More importantly, instant claims are directed to triglycerides per se, not any butyrate that might be generated once digested that might be responsible for providing an effect relevant to weight control. Instant composition is a mixture of triglycerides comprising variety combination of different acid moiety (4:0, 16:0, 18:1, 18:2, etc.) at different positions as seen from Table 1. The alleged activity/ function of instant composition for use in weight control is the result of combination of butyrate moiety containing triglycerides that is NOT limited only by the properties of formula (5) and formula (6) alone. Since different butyrate moiety containing triglyceride has different pharmacokinetic profile (absorption, digestion, etc.), the lipolysis assay/ digesting profile does not necessarily correlate with weight control and/or treating overweight. An ordinary skilled in the art would not know how much butyrate is released from which butyrate-containing triglyceride component, formula (5) or formula (6), or other butyrate moiety containing triglycerides. Instant specification does not disclose any assay associated with formula (5), or formula (6) alone or combination thereof. Instant specification does not disclose any assay of weight data of individual with overweigh or obesity administered with instantly claimed formula (5) and formula (6). In absence of sufficient weight data/assay associated with triglycerides formula (5) and formula (6) directly, an ordinary skilled in the art would not know if formula (5) and formula (6) would exhibit any effect on weight control, and /or what’s the dosage regimen/amount for the alleged method of treating overweight/obesity with instant composition comprising mixture of other triglycerides. As such, instantly claimed composition comprising formula (5) and formula (6) for use in treating overweight/obesity is not fully established/ enabled by instant disclosure.
Claim Rejections - 35 USC § 103
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 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 8, 9, 11, 12, 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021), in view of Finley et al. ( US 2004/0086621 A1, Applicant’s IDS dated 08/10/2023) and Klemann et al.( US 2009/0123634 A1, Applicant’s IDS dated 11/17/2021).
Regarding combination/mixture of triglycerides, Wheeler teaches low calorie triglyceride comprising long residue (e.g. stearyl, oleoyl ) and short residues(e.g. acetyl, butyryl), composition/mixture of triglyceride having LSS, SLS, LLS, LSL components, and methods of using aforementioned low-calories triglycerides mixtures for reducing calories in food product (See abstract, Col. 5, lines 35-65; claims 1-31). (Please note instantly claimed formula (5) and (6) is SLS, LLS respectively).
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Regarding butyrate moiety, Wheeler teaches various low calorie triglycerides comprising butyrate moiety(See Example 51, Col. 51 to Col. 54):
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Wheeler teaches butyryl-stearoyl glyceride mixture comprising dibutyryl-stearoyl glyceride and butyryldistearoyl glyceride, e.g. 1, 3-dibutyryl-2-stearoyl glycerides, 1, 2-dibutyryl-3-stearoyl glyceride, 1-butyryl-2, 3-distearoyl glyceride, 2-butyryl-1, 3-distearoyl glyceride, and mixture/combination thereof (See Col. 13, line 42; Col. 27, Example 5, 6, 8, 14-18). It’s noted 1, 3-dibutyryl-2-stearoyl glyceride read on instantly claimed other triglyceride recited in instant claim 14.
Wheeler teaches reduced calorie fat mixtures are prepared by inter- esterifying hydrogenated canola oil with tributyrin in the presence of 0.2 to 0.3% sodium methoxide (See Example 20, 21 and 28. ). Wheeler also teaches inter-esterifying safflower oil with tributyrin (See Example 31-32).
Regarding method for weight control, Wheeler teaches correlation of calories ingested and animal body weight gain, and in-vivo test wherein low calorie triglycerides were administered to rats and weight gain were measured (See Col. 37, Example 26).
Regarding the percentage limitation recited in claims 8-9, 11-12 and 19-20, Wheeler teaches low calorie triglycerides generally contain 33 to 67 % short acid residues, up to 20% of unsaturated long fatty acid and the functional properties of triglyceride can be tuned/modified by selection of S and L groups and by the ratio of SSS, SLS, SSL, LLS, LSL components in the mixture (See Col. 8, line 15-16; Col 9, line 13 to Col. 10, line 44), For example, the percentage of LLS in the mixture can range from 0-40%, the percentage of SLS in the mixture can range from 15-85% (See Col. 6, lines 28-34; Col. 10, lines 24-35). Wheeler teaches butyryl-stearoyl glyceride mixture of LSS, SLS, LLS, LSL, comprising 56.4% SSL/SLS, 30% LSL/LLS (See Example 8, 14-18, 21; Col. 27, Col. 31, lines 9-10).
Regarding limitation of nutritional composition recited in claims 15-16, Wheeler teaches low-calorie triglyceride can be formulated into variety of food products, nutrient, etc.(See Col. 13, lines 15-35). Wheeler teaches medium chain triglycerides have been employed in premature infant formulas and in the treatment of several malabsorption syndromes (See Col. 4, lines 56-62)
Regarding limitation of carbohydrate source recited in claims 17-18, Wheeler teaches embodiments comprising low-calorie butyrate-containing triglyceride further comprising sugar /starch component, e.g. dextrose and the like in food (See Col. 23, lines 40- 56; Example 44-45). A skilled artisan would have known lactose is a commonly known sugar/carbohydrate.
Wheeler collectively teaches a method for reducing calories in food composition comprising low calorie triglycerides bearing butyrate moiety and long chain fatty acid moiety, whereas the low calorie triglyceride has dietary benefit for body weight control.
The difference of butyrate moiety containing triglyceride taught by Wheeler(e.g. Example 5, 8, etc.) with instant application is the saturated stearyl group (18: 0) compared with unsaturated oleoyl group (18:1). However, Wheeler also teaches inter-esterifying safflower oil with tributyrin (See Example 31-32). Wheeler teaches long chain fatty acid residue R can incorporate unsaturated acid moiety (e.g. oleic, linoleic, etc.) from non-hydrogenated high oleic sunflower oil (See Col. 8, line 54-55), wherein the low calorie triglyceride contain up to 20% unsaturated fatty acid residue(See Col. 12, line 34; claims 29, 31). Wheeler teaches oleic acid moiety provides advantageous property compared with saturated stearyl group , e.g. better absorption, lower melting point for formulation (See Col. 2, lines 16-20, 42-45).
Finley teaches triglyceride compositions comprising unsaturated long chain fatty acid moiety(e.g. oleic acid) and short chain acid (e.g. butyric acid) with reduced calorie for promoting weight loss (See abstract, [0012]-[0017]; claims 1-21).
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Finley teaches examples of unsaturated long chain fatty acids are oleic acid, linoleic acid and linolenic acid, and short chain fatty acids are selected from acetic acid, propionic acid, and butyric acid (See [0017], claim 2-10, 14-20). Finley teaches triglyceride embodiment comprising oleoyl moiety and butyrate moiety (See claim 5, 10, 17, 21) and preferred embodiment, 1, 3-dioleyl-2-butyrylglycerol (See [0017]. It’s noted 1,3-di(oleoyl)-2-butyroyl-glycerol is regioisomer of instantly claimed formula (6) which also reads on instantly claimed triglyceride having formula (7) recited in instant claim 10.
Finley collectively teaches the technical feature/benefit of employing oleic acid as long chain fatty acid in low calorie triglycerides, its role to reduce fat calories for weight loss and a preferred embodiment 1, 3-dioleyl-2-butyrylglycerol comprising two oleoyl moieties and butyrate moiety.
Klemann also teaches mixture of edible low calorie triglycerides comprising butyrate moiety and unsaturated long chain fatty moiety U (e.g. oleic acid) for use in weight control (See abstract, [0086], claims 1-7). Klemann teaches lipid triglyceride compositions/mixture comprising a variety combinations of triglycerides comprising short triglyceride moieties (S), medium triglyceride moieties (M), long unsaturated triglyceride moieties (U) and long saturated triglyceride moieties (L)(See [0025]-[0026], [0040]), such that the structured lipid component has the capacity to simultaneously provide dietary and other health benefits, e.g. calorie reduction, weight control (See [0001], [0027],[0038]). Klemann discloses short triglyceride moieties (S) derived from butyric acid, acetic acid, propionic acid or mixtures thereof, medium triglyceride moieties (M) derived from caproic acid, caprylic acid, capric acid, lauric acid, or mixtures thereof, and long unsaturated triglyceride moieties (U) present derived from palmitoleic acid, oleyl acid, vaccenic acid, linoleic acid, alpha-linolenic acid, gamma linolenic acid, gadoleic acid, arachidonic acid, eicosapentaenoic acid, erucic acid, docosahexaenoic acid, or mixtures thereof, (See [0027]).
Klemann teaches various combination of triglycerides USU, SSU, USS structures etc. comprising butyrate moiety (See 0025]. For example, Klemann teaches triglyceride composition comprising 12% of 1,3-di(oleoyl)-2-butyroyl-glycerol and 40% of 1-stearoyl-3-oleoyl-2-butyryl glycerol (See Example 1, [0086]). It’s noted 1,3-di(oleoyl)-2-butyroyl-glycerol is regio-isomer of instantly claimed formula (6) which also reads on instantly claimed triglyceride having formula (7) recited in instant claim 10. 1-stearoyl-3-oleoyl-2-butyryl glycerol is the regio-isomer of instantly claimed 1-stearoyl-2-oleoyl-3-butyrylglycerol recited in instant claim 14.
Regarding the limitation of carbohydrate/sugar limitation of new claims 17-18, Klemann also teaches food product comprising low calorie triglycerides further comprises starch component , sweetener, e.g. sugar, etc.(See [0079])
Klemann collectively teaches nutritional composition comprising mixture/combinations of low calorie triglyceride comprising butyrate moiety and oleoyl moiety, and amount/percentage thereof, having highly desirable dietary benefits for weight control.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of instant invention to modify the low-calorie triglycerides comprising butyrate moiety and stearyl moiety taught by Wheeler, with oleoyl moiety taught by Finley and Klemann, further explore fatty acid moiety combination and percentage thereof based on general knowledge of nutritional triglyceride, and arrive at the instant application with reasonable expectation of success. At the time the invention was made, it was already known that low-calorie triglyceride combination/mixture comprising butyrate moiety and stearyl moiety can be used for weight control as taught by Wheeler. Finley collectively teaches the technical feature/benefit of employing oleic acid as long chain fatty acid in low calorie triglycerides, its role to reduce fat calories for weight control and embodiment comprising two oleoyl moieties and butyrate moiety. Klemann also teaches low-calorie triglyceride comprising butyrate moiety and unsaturated long chain fatty moiety (e.g. oleoyl moiety) for weight control . Both Finley and Klemann teach 1,3-di(oleoyl)-2-butyroyl-glycerol, regioisomer of instant formula (6) and Klemann further teaches percentage of 1,3-di(oleoyl)-2-butyroyl-glycerol (12%).
A skilled artisan would be motivated to explore more low-calorie triglyceride by replacing the stearyl moiety of triglyceride taught by Wheeler with an oleoyl group as the long chain fatty acid because both Wheeler and Finley teach the advantage of unsaturated fatty acid over saturated fatty acid. Finley teaches diets high in saturated fat is associated with increased risk of heart disease and it’s desirable to provide reduced-fat triglyceride made primarily of unsaturated fatty acid([0006]). It’s well known that unsaturated fatty acid also provides other health benefit compared with saturated fatty acid. 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. MPEP 2144.05. The modification of triglycerides comprising stearyl moiety with oleoyl moiety based on combined teaching of prior art, together with exploration /optimization based on general knowledge of nutritional triglyceride, would provide alternative nutritional low-calorie triglyceride combination/mixture comprising butyrate moiety and oleoyl moiety, having lower melting point for easier formulation and better absorption/digestion for potential use in controlling calorie intake and weight control.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teaching of prior art and optimization based on general knowledge of nutritional triglyceride. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues different mechanism/rationale of instantly claimed method: “The core concept of the claimed inventions is that these compounds deliver butyrate in vivo, and that the direct action of the released butyrate modulates metabolic processes to provide a therapeutic effect to treat
overweight and/or obesity... the present claims are distinguished from Wheeler, Klemann and
Finley alone or in combination at least because in Wheeler, Klemann and Finley, it is the triglycerides per se (not any butyrate that might be contained therein) that are responsible for providing an effect relevant to weight control. This is by virtue of the fact that triglycerides disclosed therein are stated as being low-calorie alternatives to standard lipids. It follows that the low-calorie alternatives disclosed in Wheeler, Klemann, and Finley are presented only as preventative measures to limit weight gain--rather than as treatments capable of reducing existing obesity (i.e., promoting fat loss). Wheeler, Klemann, and Finley do not teach or suggest achieving a direct therapeutic effect through enhancement of energy expenditure and induction of mitochondrial function(Remarks, page 11-12/17).
RESPONSE: Applicant’s argument is NOT persuasive. Please note instant claims are directed to triglycerides composition per se , not any butyrate that might be generated once digested that might be responsible for providing an effect relevant to weight control. Instant specification only disclosed digestion profile releasing butyrate that might be associated with method of treating overweight/obesity. Instant specification does NOT disclose any assay/working example wherein instant claimed composition comprising formula (5) and (6) was administered to subjects with existing obesity and achieved direct therapeutic effect of weight control data. Please note the intended result and function/mechanism as low-calorie food and/or weight loss/reducing obesity by releasing butyrate, are property of the compounds formula (5) and (6) ,which does not further limit the step of administering the triglycerides composition. It’s common knowledge that low-calorie food are generally associated with weight loss/reducing obesity as taught by Finley.
Applicant argued against the reference individually: “ the skilled person would not consider using compounds (5) and (6) as required by independent Claims 8 and 11 as low-calorie triglycerides, because Wheeler, Finley and Klemann explicitly teach away from this subject matter”(Remarks, page 12-13/17).
IN RESPONSE to applicant's arguments against the references individually, 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). The test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.
Regarding Wheeler reference, Applicant argues “ no data is provided as to whether the compounds are low calorie in comparison to a control” . Applicant also argues against Wheeler Example 26, “the butyryl-stearoyl glycerides (highlighted above) provide the highest calorie count of all compounds listed... presumably why Wheeler explicitly states that the "Short chain" fatty acid is preferably
selected from acetic and propionic acids as opposed to butyric” (Remarks, page 13).
RESPONSE: It’s a general knowledge dietary fat is the most concentrated source of energy supplying 9 kcal/gram as taught by Wheeler(See Col. 1, line 25). Wheeler’s butyrate-containing triglycerides having about <4.4 kcal/g is at least half of regular fat, thus is effective low-calorie control for weight control.
Regarding the preferred embodiment , MPEP 2123(I) and (II) provides the following guidance. MPEP 2123(I): “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also UpsherSmith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component)”. MPEP 2123(II):“Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) ….. "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”.
Wheeler teaches reduced calorie fat mixtures are prepared by inter-esterifying canola oil with tributyrin in the presence of 0.2 to 0.3% sodium methoxide (See Example 20, 21 and 28). Wheeler also teaches inter-esterifying safflower oil with tributyrin(See Example 31-32). It’s noted high oleic sunflower oil taught by Wheeler was used in instant Example 1 for preparing instantly claimed triglycerides. Although Wheeler dose not explicitly disclose the lipid profile of safflower oil/Tributyrin comprising 18:1 oleic moiety, a skilled artisan would have known safflower oil comprise high content of unsaturated acid, e.g. oleic acid, thus safflower oil /tributyrin triglyceride taught by Wheeler would comprise instantly recited compound of formula(5) and Formula (6) comprising 18:1 moiety from the oleic acid.
In alternative, Wheeler teaches long chain fatty acid residue R can incorporate unsaturated acid moiety (e.g. oleic, linoleic, etc.) from non-hydrogenated source, e.g. high oleic sunflower oil (See Col. 8, line 54-55), wherein the low calorie triglyceride contain up to 20% unsaturated fatty acid residue(See Col. 12, line 34; claims 29, 31). Wheeler teaches oleic acid moiety provides advantageous property compared with saturated stearyl group , e.g. better absorption, lower melting point for formulation (See Col. 2, lines 16-20, 42-45). It would be obvious for a skilled artisan to incorporate the high oleic sunflower oil as the source for inter-esterifying with tributyrin for better adsorption and easier formulation as taught by Wheeler.
Regarding Finley reference, Applicant argues “Finley is directed to triglycerides that are LSL, that is triglycerides with a long chain fatty acid present being present in the 1 and 3 positions, and a short chain fatty acid being present in the 2 position … the key difference between compounds ( 5) and ( 6), and those disclosed in Finley is that the claimed compounds contain a short chain fatty acid in the 1 and/or 3 position, whereas the compounds of Finley do not” . Applicant further argues about Finley’s preference and “Finley do not promote fat storage owing to their absence of short chain triglycerides at the 1 and 3 positions” (Remarks, page 13/17).
Regarding Klemann reference, Applicant argues Klemann discloses that triglycerides containing " ... medium or short chain acid residues in the 2 position ...are burned rather than stored as fat.. not the claimed compounds which are SLS and SLL (i.e., compounds have a long chain fatty acid in the 2 position)” (Remarks, page 15).
RESPONSE: Please note Finley and Klemann are teaching reference that mixture/combinations of low calorie triglyceride comprising butyrate moiety and oleoyl moiety were already known and had been made. Finley collectively teaches the technical feature/benefit of employing oleic acid as long chain fatty acid in low calorie triglycerides, its role to reduce fat calories for weight loss and a preferred embodiment 1, 3-dioleyl-2-butyrylglycerol comprising two oleoyl moieties and butyrate moiety. Instant claimed formula (6) is an isomer of Finley compound. As noted in preceding Claim Interpretation section, although instant claims recite formula (5) and formula (6) as the major component of butyrate moiety containing triglycerides, instant claimed composition is a mixture of triglycerides comprising variety combination of different acid moiety (4:0, 16:0, 18:1, 18:2, etc.) at different positions. The alleged activity/ function for use in treating overweight/obesity is the result of combination of butyrate moiety containing triglycerides comprising different acid moieties at different positions which is NOT limited by formula (5) and formula (6) only. Finley collectively teaches the technical feature/benefit of employing oleic acid as long chain fatty acid in low calorie triglycerides, its role to reduce fat calories for weight control and a preferred embodiment 1, 3-dioleyl-2-butyrylglycerol comprising two oleoyl moieties and butyrate moiety. Klemann collectively teaches nutritional composition comprising mixture/combinations of low calorie triglyceride comprising butyrate moiety and oleoyl moiety, and amount/percentage thereof, having highly desirable dietary benefits for weight control. It’s well known that unsaturated fatty acid provides health benefit compared with saturated fatty acid as taught by Wheeler. It would have been obvious to one of the ordinary skill in the art before the effective filing date of instant invention to modify low-calorie triglycerides comprising butyrate moiety and stearyl moiety taught by Wheeler, with oleoyl moiety taught by Finley and Klemann, further explore fatty acid moiety combination and percentage thereof based on general knowledge of nutritional triglyceride, and arrive at the instant application with reasonable expectation of success.
Applicant argues unexpected results based on the alleged different mechanism/discovery: "[s]urprisingly, it was seen that butyrate moiety containing triglycerides generated via interesterification of C4 with long chain fatty acids (C4-C18:1) decreases the extent of gastric lipolysis of C4 fatty acids." These new and unexpected results suggest that interesterification of C4 with long chain fatty acids (C4-C18:1) modulates the release of butyric acid within the stomach to later in the intestine following digestion, and that the design of structured lipids alter the timing (but not extent) of short chain fatty acid delivery in the gastrointestinal tract” (Remarks, page 15-16/17).
RESPONSE: Applicant’s argument is fully considered, but NOT persuasive. It’s noted instant claimed total digestion was done by simulated digestion model back titration at pH 11.5 while many fatty acids are only partially ionized at pH 6.8(See [0173]). Thus, instant disclosed digestion profile is not considered as accurately representative or reflective of digestion in the normal pH of intestine as instant specification alleged (See [0174]).
It’s noted instant claimed formula (6) is an isomer of Finley preferred compound and a skilled artisan would reasonably expect similar activity/function for the isomers. Wheeler, Finley and Klemann all teach nutritional composition comprising mixture/combinations of low calorie triglyceride comprising butyrate moiety having highly desirable dietary benefits for weight management. Wheeler and Klemann not only teach the butyrate containing triglycerides as low calorie alternative for weight management, Wheeler, Klemann and their incorporated reference also teach the digestibility/ metabolism of tributyrin and potential mechanism of tributyrin use for weight control, for example, tributyrin is readily cleaved by pancreatic lipase in in vitro digestibility studies, lower body weight gains were observed in animals fed tributyrin in two experiments, tributyrin was hydrolyzed more readily by human milk bile salt-activated lipase (See Wheeler Col.3 and Col 4; ). Both pancreatic lipase and bile lipase emulsify fats more in intestine compared with stomach. As Liu (2018) teaches, variety of different mechanisms have been proposed to explain the effects of butyrate on alleviating obesity Thus, instantly alleged different mechanism of direct action of butyrate providing control of weight management by modulating metabolic processes is NOT novel and NOT unexpected over prior art.
Further, the digestion profile of composition comprising butyrate triglyceride is the property /direct result of administrating the lipid to the subject in need thereof weight control which does not necessarily further limit the step of administering instant composition. Even if prior art is silent about the digestating profile, by practicing the method made obvious by the prior art of administering butyrate moiety containing triglyceride to the obese or overweight subjects in need of reducing weight , one would also be practicing weight control by release of butyrate in the intestine following digestion.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 11-15, 17-22, 25-27 of copending Application No. 17/044,684 (US 20210038554 A1), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021).
Reference claims are directed to a method for providing a source of butyrate comprising administering combination of butyrate containing triglycerides. Reference claims 14-15, 18 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims 8-9, 11-12. Reference claim 27 recites butyrate containing triglycerides that read on instant claim 14. Reference claims 21-22, 25-26 recite nutritional composition, infant formula, a follow-on formula or a dietary supplement that read on instant claims 15 and 16.
The reference claims do not recite a method of treating overweight/obesity. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. Instant claims do not recite any dosage regimen/ or specific administration limitation that are different from reference claims. By administering compounds of the reference claims, having the same formula (5) and (6) as the instant claims, one will also be practicing instantly claimed method of managing weight, since the same triglyceride composition comprising formula(5) and (6) are being administered to the same subjects.
Further, as elaborated in preceding 103 rejection, Wheeler collectively teaches a method for reducing calories in food composition comprising low calorie triglycerides bearing butyrate moiety and long chain fatty acid moiety, whereas the low calorie triglyceride has dietary benefit for body weight control. It would have been obvious for one of ordinary skilled in the art to produce the claimed invention with reasonable expectation of success, based on combined teaching of reference claims, Wheeler and optimization based on general knowledge of nutritional triglyceride,.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8, 9, 11, 12, 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 14-16 of copending U.S. Patent Application No. 17/413,991 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for prevention / treatment of dehydration comprising administering combination of butyrate containing triglycerides. Reference claims 14-15, explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims. Reference claim 16 recites nutritional composition, infant formula, a follow-on formula or a dietary supplement that read on instant claims 15, 16.
The reference claims do not recite a method of treating overweight/obesity. However, by administering compounds of the reference claims having the same formula (5) and (6) as instant claims, one will also be practicing instantly claimed method of managing weight, since the same triglyceride composition comprising formula(5) and (6) are being administered to the same subjects. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10, 13-14,16, 18-19 of copending U.S. Patent Application No. 17/595,451(reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for reduction of frequency and/or occurrence and/or severity and/or duration or treatment of metabolic disorders, comprising administering combination of butyrate containing triglycerides. Reference claims 9-10, explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims 8-9, 11-12. Reference claim 16 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 18-19 recites nutritional composition, infant formula, a follow-on formula or a dietary supplement that read on instant claims 15, 16.
The reference claims do not recite a method of treating overweight/obesity. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-16 of copending U.S. Patent Application No. 17/595,516 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for prevention and/or treatment of non- alcoholic fatty liver disease, comprising administering combination of butyrate containing triglycerides. Reference claims 8-9, 11-12, explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims. Reference claim 14 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 15-16 recites nutritional composition, infant formula, a follow-on formula or a dietary supplement that read on instant claims 15, 16.
The reference claims do not recite a method of treating overweight/obesity. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-11, 15-16, 18, 23-24 of copending U.S. Patent Application No. 17/595,539 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for treating a bone disorder, comprising administering combination of butyrate containing triglycerides. Reference claims 10-11, 15-16 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims. Reference claim 18 recites butyrate containing triglycerides that read on instant claim 14.
The reference claims do not recite a method of treating overweight/obesity. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 of copending U.S. Patent Application No. 17/595,567 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for promoting and/or accelerating myelination, comprising administering combination of butyrate containing triglycerides. Reference claims 9-10, 12-13 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims. Reference claim 15 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 17-18 recites nutritional composition, infant formula, a follow-on formula or a dietary supplement that read on instant claims 15, 16.
The reference claims do not recite a method of treating overweight/obesity. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-11, 15-16, 18, 21 of copending U.S. Patent Application No. 17/595,629 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for treating a bone disorder, comprising administering combination of butyrate containing triglycerides. Reference claims 10-11, 15-16 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims 8-9, 11-12. Reference claim 18 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 21 recites nutritional composition that read on instant claims 15.
The reference claims do not recite a method of treating overweight/obesity. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending U.S. Patent Application No. 17/756,871 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for promoting immune response and/or preventing and/or treating bacterial and/or viral infections , comprising administering combination of butyrate containing triglycerides. Reference claims 8-9, 11-12 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims. Reference claim 14 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 15-16 recite nutritional composition that read on instant claims 15-16.
The reference claims do not recite a method of treating overweight/obesity. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Claims 8, 9, 11, 12, 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending U.S. Patent Application No. 17/756,872 (reference application), in view of Wheeler et al.(US 5662953, Applicant’s IDS dated 11/17/2021). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for preventing and/or treating gastrointestinal infections , comprising administering combination of butyrate containing triglycerides. Reference claims 8-9, 11-12 explicitly teaches composition comprising instantly claimed formula (5) and formula (6) with similar weight ratio limitation as instant claims 8-9, 11-12. Reference claim 14 recites butyrate containing triglycerides that read on instant claim 14. Reference claim 15-16 recite nutritional composition that read on instant claims 15-16.
The reference claims do not recite a method of treating overweight/obesity. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. The rationale of combining reference claims and Wheeler for a method of treating overweight/obesity is similar as elaborated in preceding nonstatutory double patenting rejections.
Conclusion
No claims are allowed.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628