DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/31/2025 has been entered.
Status of Claims
Claims 2 and 7-21 are pending. Claim 13 is withdrawn.
Priority
Instant application 17/416,577, filed 06/21/2021, claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendment filed 12/31/2025 has been entered. Applicant has amended claims 2 and 21
Claims 2, 7-12, and 14-21 were previously rejected under 35 U.S.C. 102(a)(1) as indefinite. In view of the amendment filed 12/31/2025, the rejection over claims 2, 7-12, and 14-21 is withdrawn.
Claims 2, 9, 12, and 14-21 were previously rejected under 35 U.S.C. 102(a)(1) over COT as evidenced by SOFTLY. In view of the amendment filed 12/31/2025, the rejection over claims 2, 9, 12, and 14-21 is withdrawn.
Claims 2, 9-12, and 14-21 were previously rejected under 35 U.S.C. 103 as being unpatentable over NEESBY in view of CANTINI, and further in view of SOFTLY. In view of the amendment filed 12/31/2025, the previous rejection under section 103 is withdrawn. A modified rejection necessitated by the amendment is presented below.
Claim 8 was previously rejected under 35 U.S.C. 103 as being unpatentable over NEESBY in view of CANTINI, and SOFTLY, and further in view of CHEN. In view of the amendment filed 12/31/2025, the previous rejection under section 103 is withdrawn. A modified rejection necessitated by the amendment is presented below.
Provisional nonstatutory double patenting rejections over copending Application Nos. 17/756,887; 17/595,629; 17/595,567; and 17/595,363 are withdrawn in view of the abandonment of those applications.
Claim Interpretation
Claim 2 recites “A method for treating or preventing an allergic disorder”. Therefore, according to the broadest reasonable interpretation, the method of independent claim 2 (and all claims depending therefrom) is being interpreted as including the prevention of the recited allergic disorders. Prevention of a disease or disorder by a composition in a subject is accomplished by prophylactic administration of that composition to a subject. Stated differently, the scope of the claims includes administering the recited compounds to a subject even if they are not identified as having one of the recited allergic disorders.
Claims 7, 19, and 21 recite the limitation “total triglycerides of the composition”. The compounds of Formulas (1), (2), (3), and (4) are recognized as triglycerides, and are therefore being interpreted as providing antecedent basis for the limitation “the total triglycerides” recited in the claims.
Claim 20 recites the limitation “total butyrate moiety containing triglycerides in the composition”. The compounds of Formulas (1), (2), (3), and (4) are recognized as triglycerides which contain either one or two “butyrate moieties”, and are therefore being interpreted as providing antecedent basis for the limitation “the total butyrate moiety containing triglycerides” recited in the claim.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 9-12, and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over:
NEESBY (US 4,735,967 A; 1988; cited previously) in view of
CANTINI (US 20080268094 A1; 2008; cited previously), and further in view of
FROEKJAER (WO 1991009597 A1; 1991; cited in IDS)
Applicant’s Invention
The present invention relates to compounds of Formula (1), (2), (3), and/or (4) as a dietary source of butyrate having improved organoleptic properties and methods for treating or preventing allergic disorders comprising administering such compounds. The compounds of Formula (1), (2), (3), or (4) are disclosed at page 3 of the specification.
Independent claim 1 recites:
The preparation of compounds of Formula (1) – (4) is disclosed in the specification as Example 1 (page 24 – 25). In particular, the triglycerides of the present invention were prepared by chemical interesterification between tributyrin and high oleic sunflower oil in the present of a catalyst such as sodium methoxide:
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Neesby
Neesby discloses a method for treatment of human food allergies by desensitizing the gastrointestinal tract comprising oral ingestion of a chemical composition of short chain fatty acids (SFCAs) having from 4 to 12 carbon atoms (title, abstract). In particular, Neesby discloses that the SFCA is preferably a butyrate (col. 1, lines 59-60). Neesby discloses that the beneficial effect of the butyrate may start at a dose of only one capsule/day (~500-600 mg); col. 5, lines 1-5). Neesby discloses that after regular administration of butyrate for one month, the immune system appeared to be improved as deemed by the % T cells and the % suppressor cells. In more than 80% of patients, a high degree of freedom of untoward reaction to foods was acquired (col. 7, lines 46-54). Neesby discloses the administration of butyrate to and treatment of various patients having food allergies to egg, peanut, rice, soy, corn, meat, etc. or inhalant allergies to weed pollen, pet dander, molds, dust mites, etc. (col. 7 to col. 12).
Neesby therefore teaches a method for the treatment or prevention of an allergic disorder comprising administering butyrate to a subject in need thereof, wherein the allergic disorder is a food allergy to an allergen selected from those recited in claim 1. Neesby fails to disclose administering a compound of Formulas (1), (2), (3), and/or (4) or a composition thereof.
Cantini
Cantini discloses that glycerides of butyric acid can serve as a source of butyrate in animal feed, including triglycerides of Formulas (1) – (4) (title, abstract). In particular, Cantini discloses compositions for animal food comprising a mixture of glycerides of fatty acids, wherein the glycerides are mixtures of butyric acid and C18 unsaturated fatty acid glycerides (see, for example, claim 31). Cantini discloses that triglycerides can comprise up to 100% of the total mixture of glycerides (see, e.g., para. [0029]).
Cantini discloses that butyrate triglycerides offer advantages including the ability to simultaneously administer both butyric acid and the long chain fatty acids (e.g., palmitic, stearic, oleic, etc.) which are essential fatty acids not synthesized in the animal (para. [0048]). Further, Cantini discloses that butyrate triglyceride compositions solve problems associated with butyric acid, including unpleasant odor and volatility (para. [0017]); and allowing for passage through the stomach (gastric by-pass) and slow release in the intestine.
Cantini is therefore relied upon for its teaching of butyrate triglycerides as a source of butyric acid, and for teaching the advantages of butyrate triglycerides (improved organoleptic properties) over butyric acid.
Cantini does not disclose an exact butyrate triglyceride composition. However, butyrate triglyceride compositions comprising a combination of Formula (1) and Formula (2), and indeed all four of Formulas (1) – (4), were known in the prior art to the person having ordinary skill.
Froekjaer
Froekjaer is drawn to triglycerides with biological effects on the intestinal mucosa (title, abstract). Froekjaer is focused on solving certain problems associated with free fatty acids, such as butyric acid. Specifically, Froekjaer discloses that when free fatty acids (such as butyric acid) are used, these free fatty acids have the drawback that they exhibit a bad smell and a bad taste, and are subject to the so-called first pass effect, i.e. they are rapidly eliminated by the liver (page 1, lines 1-28). Thus, the purpose of Froekjaer’s invention is the provision of an agent with a biological effect on the intestinal mucosa, which have advantages over the free fatty acid equivalents, such as butyric acid (page 1, lines 1 – 28).
In particular, Froekjaer discloses triglycerides comprising one or more linear, saturated or unsaturated acyl groups containing 2 – 5 carbon atoms, and one or more linear, saturated or unsaturated acyl groups containing 16 – 24 carbon atoms (Abstract; page 2, lines 3 – 7; claim 1), having the formula:
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In Example 1 of Froekjaer, the synthesis of triglycerides comprising butyric acid and long chain fatty acids is disclosed, wherein the triglycerides are prepared by an interesterification reaction between high oleic sunflower oil and butyric acid (page 4, Example 1). The obtained product consisted of 100% triglycerides, i.e. no mono- or diglycerides were present (page 4, lines 9 – 10). The fatty acid composition of the lipid is shown below (page 4):
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As evidenced by the table above, the fatty acids were either butyric acid (C-4) or fatty acids having between 16 and 20 carbon atoms (such as C-18:1, oleic acid), as defined in the instant claims. Please note that the triglyceride of Example 1 in Froekjaer was prepared in a process which is similar to that of Example 1 of the instant application where interesterification between high oleic sunflower oil and tributyrin was performed. Froekjaer is considered to represent the closest prior art to applicant’s triglyceride composition disclosed in Example 1 of the instant specification.
Froekjaer differs from instant claims 1 and 13 because Froekjaer does not specify an anti-allergy effect, but more broadly discloses a “biological effect on the intestinal mucosa”.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationales (B) and/or (G), it would have been prima facie obvious to substitute butyrate in the method of preventing or treating allergy taught by Neesby with the butyryl triglyceride composition taught by Froekjaer. A skilled artisan would have been motivated to make such a substitution in view of Cantini’s and Froekjaer’s teachings of the advantages of a butyryl triglyceride composition over free fatty acids (namely improved taste and smell; and avoiding the first pass effect). A skilled artisan would have reasonably predicted success because Cantini and Froekjaer teach that Froekjaer’s composition is an active alternative to butyric acid; and Neesby discloses that butyrate treats human food allergies and sensitivities.
With respect to claim 2, the combination of Neesby, Cantini, and Froekjaer teaches administering butyric triglycerides of Formulas (1) – (4) and compositions thereof to treat and/or prevent allergic disorders; and teaches that the compounds have improved organoleptic properties relative to butyric acid. The composition in Froekjaer comprises a combination of compounds reading on Formulas (1) – (4).
With respect to claim 9, the combination of Neesby, Cantini, and Froekjaer teaches food compositions, which are considered to read on the limitation “nutritional composition”.
With respect to claim 12, the method taught by the combination of Neesby, Cantini, and Froekjaer is considered to read on preventing an allergy to gluten in view of the Examiner’s interpretation of a “subject in need thereof”.
With respect to claim 14, the method taught by the combination of Neesby, Cantini, and Froekjaer reads on treating patients with inhalant allergies including pet dander and weed or tree pollen. Additionally, the method of Neesby, Cantini, and Froekjaer is considered to read on preventing allergies to other allergens listed in view of the Examiner’s interpretation of a “subject in need thereof”.
With respect to claim 15, the method taught by Neesby, Cantini, and Froekjaer reads on treating patients with food allergies including peanut allergies.
With respect to claims 16 and 18, the method taught by the combination of Neesby, Cantini, and Froekjaer reads on reducing or preventing allergic response to an allergen or a further allergen. Neesby teaches reducing allergic response in subjects having various food and inhalant allergies.
With respect to claim 17, Cantini and Froekjaer teach that butyric triglycerides have improved organoleptic properties relative to butyric acid which reads on “enhancing oral tolerance”.
With respect to claims 19-20, the Froekjaer composition comprises the compounds of formula (1), (2), (3), and (4) in at least 90% by weight of the total triglycerides in the composition (Froekjaer, page 4, lines 2-19).
With respect to claims 10 and 11, the combination of Neesby, Cantini, and Froekjaer teaches a triglyceride composition having oleic acid (C-18:1) as one of the long chain fatty acids. Oleic acid is a monounsaturated fatty acid.
With respect to claim 21, the composition in Froekjaer comprises a combination of compounds reading on Formulas (1) – (4). Froekjaer does not disclose the specific percentages of each compound in the composition, and identifies in the table at page 4, lines 14-19 that the composition is primarily comprised of triglycerides with C-4 (22.0 wt. %) and C-18:1 acids (70.6 wt. %).
However, differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the percentages of the individual triglycerides of Formulas (1) – (4) in the composition are result-effective variables which can be optimized by a person having ordinary skill in the art. The fatty acid composition can be modified by interesterifying tributyrin with different oils such as canola, cotton seed, soybean, etc. as taught by Froekjaer (page 3, 3rd para.). Absent a showing of criticality, optimizing result-effective variables is routine experimentation.
Response to Arguments
Applicant argues that the combination of Neesby and Cantini fails to teach the claimed method. Applicant asserts that Cantini relates to livestock and pets, whereas the instant claims are drawn to human subjects. Applicant argues (without evidence) that the skilled person would have no expectation that compounds of Formula (1)-(4) would provide an improved therapeutic source of butyrate (having e.g. improved gastric bypass and slow release in the intestines) in humans. Applicant argues that therefore the skilled person would have no motivation to replace the butyrate salts of Neesby with a triglyceride composition having compounds of Formula (1)-(4).
Applicants’ arguments have been fully considered but are not persuasive.
As an initial matter, please note that, as stated in MPEP 716.01(c), arguments cannot take the place of evidence in the record. Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. Therefore, applicant’s assertion of unexpected results must be supported by an appropriate affidavit or declaration to be of probative value as objective evidence.
The compositions comprising compounds of formula (1) – (4) were known sources of butyrate which could be used to deliver butyrate to the gut as taught by Cantini in view of Froekjaer. Butyrate was known to be useful for the treatment or prevention of allergies as taught by Neesby. Cantini teaches advantages of butyrate triglycerides over butyrate, including the advantages of avoiding unpleasant odor and volatility (para. [0017]); and allowing for passage through the stomach (gastric by-pass) and slow release in the intestine. One of ordinary skill in the art would have enjoyed a reasonable expectation of success in view of the combination of the references.
Applicant’s arguments have been fully considered but are not persuasive. Please note MPEP 2123(I), which states: “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”; and MPEP 2123(II), which states “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” Note also MPEP 2145, which states “[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…”
The improved organoleptic properties taught by both Cantini and Froekjaer serve as an explicit motivation for substituting butyrate, known to smell and taste bad to humans, with the triglyceride composition in humans. Cantini provides a broad teaching of the use of mono-, di-, and triglycerides comprising fatty acids from C1 to C22 and butyric acid (abstract, para. [0003], para. [0010], para. [0017], claim 31, claim 33). Cantini’s broader disclosure clearly establishes that butyrate triglycerides can serve as a source of butyric acid which avoid certain limitations of butyric acid, such as “the extremely unpleasant and persistent odor which also remains in some products in which it is contained (i.e. in the salts of butyric acid such as calcium or sodium butyrate)” (para. 0015]); and “the high costs of products which although containing butyric acid are odorless, but generally also very expensive, such as microencapsulated products.” (para. 0016]).
Similarly, Froekjaer discloses that when free fatty acids (such as butyric acid) are used, these free fatty acids have the drawback that they exhibit a bad smell and a bad taste, and are subject to the so-called first pass effect, i.e. they are rapidly eliminated by the liver (page 1, lines 1-28).
Both Cantini and Froekjaer clearly identify advantages of triglyceride sources of butyrate over butyric acid or butyrate salts. The person of ordinary skill would have recognized that these advantages extend to human subjects. Accordingly, the rejection is maintained.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over:
NEESBY (US 4,735,967 A; 1988) in view of CANTINI (US 20080268094 A1; 2008), and further in view of FROEKJAER (WO 1991009597 A1; 1991) applied to claims above, and further in view of
CHEN (US 20060141101 A1; published 29 June 2006; cited previously).
The teachings of Neesby, Cantini, and Froekjaer are disclosed above and at least those teachings are incorporated herein by reference. The combination of Neesby, Cantini, and Froekjaer teaches administering butyric triglycerides of Formulas (1) – (4) or compositions thereof to treat and/or prevent allergy in animals.
Neither Neesby, Cantini, nor Froekjaer disclose compositions comprising dietary fiber. However, compositions comprising dietary fiber and butyrate triglycerides are known in the prior art. For example, Chen discloses a delivery system for low calorie bulking agents coated with a lipid compound (title, abstract). The lipid layer can be an edible fat, such as a triglyceride prepared by interesterification of tributyrin with canola, soybean, cottonseed, or sunflower oil which contain SCFA and LCFA (para. [0022]; para. [0032]).
Applying KSR example rationale (A), it would have been prima facie obvious to combine the composition taught by the combination of Neesby, Cantini, and Froekjaer with dietary fiber as taught by Chen. A skilled artisan would have reasonably predicted that the combination would result in a composition which delivers a combination of both butyric acid and dietary fiber.
Response to Arguments
Applicant argues that the Chen fails to remedy the deficiencies of Neesby, Cantini, and Froekjaer. In particular, Applicant argues that Chen does not motivate an attempt to modify Neesby and/or Cantini to arrive at the claimed method.
In response, Applicant's arguments have been fully considered but they are not persuasive. Chen is not relied upon to motivate an attempt to modify Neesby and/or Cantini. Chen is relied upon for teaching the combination of edible fat, such as a triglyceride prepared by interesterification of tributyrin with canola, soybean, cottonseed, or sunflower oil which contain SCFA and LCFA, with dietary fiber.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Copending Application No. 18/990,008
Claims 2, 7-12, and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/990,008 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites a method of treating or preventing an allergic disorder in a subject, comprising administering to the subject an infant formula comprising a compound having Formulas (1) – (4).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/756,872
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/756,872 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘872 application claims a method for use in recovery from antibiotic mediated gut microbiota disturbance and/or preventing and/or treating gastrointestinal infections, comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘872 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘872 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/756,871
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/756,871 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘871 application claims a method for use in promoting immune response and/or preventing and/or treating bacterial and/or viral infections, comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘871 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘871 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US 12,317,913 B2
Claims 2, 7-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US 12,317,913 (reference patent) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The reference patent claims a method for the prevention or treatment of bone disorders associated with bone growth impairment comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The reference patent claims fail to recite treating or preventing an allergy.
However, the compounds of the reference patent, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
Copending Application No. 17/595,581
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/595,581 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘581 application claims a method for the prevention or treatment of cardiovascular disorders comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘581 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘581 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/595,516
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/595,516 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘516 application claims a method for the prevention and/or treatment of non-alcoholic fatty liver disease comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘516 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘516 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/595,451
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/595,451 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘451 application claims a method for the prevention or treatment of metabolic disorders comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘451 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘451 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/595,446
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/595,446 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘446 application claims a compound of the same formula (1)-(4) as the instant application, for use in weight management.
The ‘446 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘446 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/413,991
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/413,991 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘991 application claims a method for the prevention or treatment of dehydration comprising administering to a subject in need of same a compound having the same formula (1)-(4) as the instant application.
The ‘991 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘991 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 17/044,684
Claims 2, 7-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/004,684 (reference application) in view of Neesby (US 4,735,967 A; published 05 April 1988) in view of Cantini (US 20080268094 A1; published 30 August 2008).
The ‘684 application claims a method for providing a source of butyrate to an individual comprising administering a compound having the same formula (1)-(4) as the instant application.
The ‘684 claims fail to recite treating or preventing an allergy.
However, the compounds of the ‘684 application, having the same formula (1)-(4) as the instant application will provide a source of dietary butyrate in the method of treating allergy taught by Neesby in view of Cantini. See the rationale further below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Finding of prima facie obviousness
The teachings of Neesby in view of Cantini are disclosed above and at least those teachings are incorporated herein by reference and applied to the instant claims. Neesby in view of Cantini teaches a method for the treatment or prevention of an allergic disorder comprising administering compositions comprising butyrate triglycerides to a subject in need thereof, wherein the allergic disorder is a food allergy to an allergen selected from those recited in claim 1.
Applying KSR prong (B), it would have been prima facie obvious to substitute the diseases for treatment in the claims of the above copending applications or issued patent with an allergic disorder, such as the food and inhalant allergies of Neesby, to arrive at a method of the instant claims. A skilled artisan would have reasonably expected that administering the butyrate source of formulas (1) – (4) recited in the claims of the above copending applications or issued patent to a subject would result in the treatment or prevention of the allergy, because Neesby teaches that butyrate results in generation of regulatory T-cells, and this results in accelerated tolerance acquisition to various foods; and Cantini teaches that glycerol esters of butyric acid are sources of butyrate that solve problems associated with butyric acid, including unpleasant odor and volatility (para. [0017]); and allowing for passage through the stomach (gastric by-pass) and slow release in the intestine.
Response to Arguments
In response to the nonstatutory double patenting rejections, Applicant requests that the nonstatutory double patenting rejections be withdrawn or held in abeyance until claims are allowed in the present application.
In response, the nonstatutory double patenting rejections are still deemed proper and are maintained.
Conclusion
Claims 2, 7-12, and 14-21 are rejected. Claim 13 is withdrawn.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621