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
Election of Species and Status of the Claims
Applicant’s election without traverse of ‘an aqueous composition comprising 5% resveratrol’ as the single specific composition and ‘chicken’ as the subject receiving administration in the response filed on June 9th 2026 is acknowledged. Claims 28-47 are pending. Claims 35 and 44 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable (note that claims 35 and 44 require additional active ingredients other than resveratrol). Claims 28-34, 36-43, and 45-47 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on September 11th 2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Interpretation
The term “stilbene” as used throughout the claims will be interpreted as the class of compounds is commonly found in the art, to be a “compound containing at least a phenyl-ethene-phenyl scaffold.”
The claims recite a patient population of “a subject in need thereof of the improvement of gut health.” The patient population is not defined by the presence of any particular condition, but only the “need of improvement of gut health.” As the “improvement of gut health” is not defined by the specification, the patient population will be interpreted in the broadest reasonable interpretation, as “any subject where the improvement of gut health would be considered beneficial.” (i.e. all subjects with a gastrointestinal tract, whether healthy or not).
Claim 38 recites “the liquid solution,” in reference to claim 37. For the purpose of examination, the phrase will be read as “the liquid formulation.”
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39 and 46 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 39 and 46 are indefinite for the limitations, “wherein after administration of the stilbene composition the subject in need thereof…” and “wherein the effective amount of the stilbene composition is effective, in the subject, to…” respectively, because one of ordinary skill in the art could not reasonably determine how the phrase further limits the metes and bounds of the method of claim 28, nor the formulation of claim 43.
In case, the limitations amount to functional-descriptive language that appears to limit the results of administration of the composition, but no further limitations are described. Specifically, it is unclear how any of:
The compounds administered
The amounts administered
The method/route of administration
The patient population receiving administration
or any other limitation relating to the method of claim 28 or the formulation of claim 39 are further limited. Instead, only the results of said administration are described. This activity is described in the specification in identical language (Ex: Specification, pg. 2-4, 19-31), but at no point in the specification is it described how the method must be limited in order to achieve said activity.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 28-29, 33, 36-37, and 39-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juan (Juan et al., The Daily Oral Administration of High Doses of trans-Resveratrol to Rats for 28 Days Is Not Harmful, The Journal of Nutrition, Volume 132, Issue 2, 2002, Pages 257-260).
Claim 28 is directed towards a method for improving gut health via administration of a composition comprising one or more stilbenes, wherein 5-25 mg/kg BW of the stilbenes are administered. One such stilbene is resveratrol.
Juan teaches oral administration of 20 mg/kg resveratrol to rats (Juan, Abstract). As the ‘improvement of gut health,’ is considered non-limiting to the patient population (see the above claim interpretation), Juan anticipates claim 28.
Claim 29 limits the method of claim 28 to wherein the stilbene composition comprises resveratrol, and is anticipated by Juan for the same reasons as claim 28.
Claim 33 limits the subject in the method of claim 28 to a human or non-human animal. As Juan teaches administration to rats (Juan, pg. 4), Juan anticipates claim 33.
Claim 36 requires that the composition administered in claim 36 is administered orally, and is anticipated by Juan for the same reasons as claim 28.
Claim 37 limits the oral formulation of claim 36 to a liquid formulation. Juan teaches a liquid suspension of resveratrol (Juan, Materials and Methods, pg. 257), anticipating claim 37.
Claim 39 requires that the method of claim 28 results in a decreased food conversion ratio. Juan teaches a decrease in g weight gain/ g feed over the course of administration (Juan, pg. 258, Figure 1). As this is equivalent to the feed conversion ratio, Juan anticipates claim 39.
Claim 40 limits the stilbene administered in claim 28 to one isolated from a particular plant. This limitation amounts to a product-by-process limitation, limiting not the compound administered, but only its source. See MPEP § 2113. As the resveratrol remains identical regardless of its source, Juan anticipates claim 40.
Claim 41 is directed towards a formulation comprising a 5-25 mg/kg BW dosage of a stilbene, and a carrier. Juan teaches 20 mg/kg BW resveratrol administered in a liquid composition comprising carboxymethylcellulose as a carrier (Juan, pg. 257, Materials and Methods). Juan thereby anticipates claim 41.
Claim 42 requires the stilbene composition of claim 41 to contain resveratrol, and is anticipated by Juan for the same reasons as claim 41.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 28-34, 36-43, and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (Chen et al., Pterostilbene as a protective antioxidant attenuates diquat-induced liver injury and oxidative stress in 21-day-old broiler chickens. Poult Sci. 2020 Jun;99(6):3158-3167)
Claim 28 is directed towards a method for improving gut health via administration of a composition comprising one or more stilbenes, wherein 5-25 mg/kg BW of the stilbenes are administered.
Chen teaches administration of pterostilbene to chickens (Chen, Abstract) at an average dosage of 43.63 g pterostilbene per day (Chen, pg. 3161, Table 1). Chen also teaches that the chickens gained weight at an average rate of 32.68 g/day from days 1-20. If an approximate weight of zero grams is estimated for the chicken at day zero, the bodyweight of the chickens at day 20 can be estimated at 653.6 g, which estimates the pterostilbene dosage to 66.7 mg/kg BW.
While Chen’s pterostilbene dosage of 66.7 mg/kg lies outside of applicant’s claimed range, it lies close enough that one of ordinary skill in the art would have had a reasonable expectation of success in adjusting the dosage to within applicant’s claimed range. See MPEP § 2144.05(I):
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical)
Applicant’s stilbene range is thereby obvious. As the ‘improvement of gut health,’ is considered non-limiting to the patient population (see the above claim interpretation), claim 28 is thereby prima facie obvious.
Claim 29 requires the composition of claim 28 to include pterostilbene and is prima facie obvious for the same reasons as claim 28.
Claim 30 requires that the subject treated in the method of claim 28 is a bird, and is prima facie obvious for the same reasons as claim 28.
Claim 31 requires that the bird in claim 30 is poultry, and is prima facie obvious for the same reasons as claim 28.
Claim 32 limits the poultry of claim 31 to a chicken and is prima facie obvious for the same reasons as claim 31.
Claim 33 limits the subject of claim 28 to a human or non-human animal. Chen administers to a chicken, which is a non-human animal (Chen, Abstract). Claim 33 is thereby prima facie obvious for the same reasons as claim 28.
Claim 34 is directed towards the method of claim 28 wherein the pterostilbene concentration in the composition is 5-100 mg/ml (equivalent to 5-100 g/kg). Chen teaches a pterostilbene concentration of 400 mg/kg in chicken feed (Chen, Abstract). While Chen’s pterostilbene concentration lies outside of applicant’s claimed range, it lies close enough that one of ordinary skill in the art would have had a reasonable expectation of success in adjusting the concentration to within applicant’s claimed range. See MPEP § 2144.05(I). Applicant’s stilbene concentration range, and claim 34 are thereby prima facie obvious.
Claim 36 requires that the composition in claim 28 is administered orally. Chen’s pterostilbene was administered as part of the chicken feed (Chen, Abstract). Claim 36 is thereby prima facie obvious.
Claim 37 requires that, in the method of claim 36, the composition is administered in a feed. Claim 37 is prima facie obvious for the same reasons as claim 36.
Claim 38 requires that, in the method of claim 37, the liquid formulation is a water source for the subject. While Chen does not explicitly teach administration via a water source, one of ordinary skill in the art would recognize that, in administering the pterostilbene to chickens in an oral formulation, the two simplest methods (that would allow for the least amount of work via human intervention) would be:
Via the chickens’ feed
Via the chickens’ water
One of ordinary skill in the art would thereby find the administration via either of these two delivery methods obvious to try. As the administration of the pterostilbene to chickens via water source is obvious to try, claim 38 is prima facie obvious.
Claim 39 requires that the method of claim 28 results in increased bodyweight gain. Chen teaches increased bodyweight gain (Chen, pg. 3162, Figure 1). Claim 39 is thereby prima facie obvious.
Claim 40 requires that the stilbenes of claim 28 are isolated from a particular plant. As this limitation is a product-by-process limitation (see the above 102 rejection for claim 40), claim 40 is prima facie obvious for the same reasons as claim 28.
Claim 41 is directed towards a formulation comprising a 5-25 mg/kg BW dosage of a stilbene, and a carrier. As the pterostilbene dosage is obvious (see the above 103 rejection for claim 28) and Chen’s pterostilbene is administered using chicken feed as a carrier (Chen, Abstract), claim 41 is prima facie obvious.
Claim 42 requires that the formulation of claim 41 comprises pterostilbene and is prima facie obvious for the same reasons as claim 41.
Claim 43 is directed towards the method of claim 41 wherein the pterostilbene concentration in the composition is 5-100 mg/ml (equivalent to 5-100 g/kg). Chen teaches a pterostilbene concentration of 400 mg/kg in chicken feed (Chen, Abstract). While Chen’s pterostilbene concentration lies outside of applicant’s claimed range, it lies close enough that one of ordinary skill in the art would have had a reasonable expectation of success in adjusting the concentration to within applicant’s claimed range. See MPEP § 2144.05(I). Applicant’s stilbene concentration range, and claim 43 are thereby prima facie obvious.
Claim 45 limits the formulation of claim 43 to a feed. Claim 45 is thereby prima facie obvious for the same reasons as claim 43.
Claim 46 requires that the method of claim 43 results in increased bodyweight gain. Chen teaches increased bodyweight gain (Chen, pg. 3162, Figure 1). Claim 46 is thereby prima facie obvious.
Claim 47 requires that the stilbenes of claim 43 are isolated from a particular plant. As this limitation is a product-by-process limitation (see the above 102 rejection for claim 40), claim 47 is prima facie obvious for the same reasons as claim 43.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
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