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 .
Response to Arguments
Applicant’s arguments, see pages 9-17, filed 12 June 2026, with respect to the rejection(s) of claim(s) 1, 3-4, 6-13, 18-24, 2729-33, 42, 52-54 under 35 USC§102, 35USC§103, and 35USC§112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is being made view of 35USC§112.
The previous 35 USC§112 rejection of claim 31 based solely on “about” has been withdrawn and replaced with the claim-31 rejection below, which is directed to the unclear association between the reducing agents and temperature ranges.
(New) Claim Rejections - 35 USC § 112
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.
Claim 31 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.
Claim 31 recites that reducing is performed:
> “(c) at a temperature in the range from about −10°C to about 30°C, or at about 0°C when the reducing agent is not Al(O-iPr)₃/iPrOH, or when the reducing agent is Al(O-iPr)₃/iPrOH from about 50 °C to about 90°C, or at about 80°C.”
The limitation is subject to more than one reasonable interpretation. Under one interpretation, the temperature range from about −10°C to about 30°C applies to each reducing agent recited in claim 1, while only the “about 0 °C” alternative is limited to a reducing agent other than Al(O-iPr)₃/iPrOH. Under another interpretation, both the range from about −10°C to about 30°C and the “about 0°C” alternative apply only when the reducing agent is NaBH₄ or LiBH₄. The phrase “or when the reducing agent is Al(O-iPr)₃/iPrOH from about 50°C to about 90°C” is also grammatically incomplete and does not clearly identify whether the stated temperature range is an alternative to the preceding temperature conditions or modifies another portion of the claim.
The specification describes these conditions as separate embodiments. Paragraph [0074] states that reduction with NaBH₄ or LiBH₄ may be performed from about −10°C to about 30°C or at about 0°C, whereas paragraph [0075] states that reduction with Al(O-iPr)₃/iPrOH may be performed from about 50°C to about 90°C or at about 80°C. Although the specification suggests the intended construction, the claim does not clearly associate each temperature range with the corresponding reducing agent. It is therefore unclear whether use of Al(O-iPr)₃/iPrOH at a temperature within the lower range satisfies the claim.
The rejection is not based on the use of the term “about.” Paragraph [0034] provides a standard for construing “about,” and a term of degree is not indefinite merely because it permits some variation. Rather, the rejection is based on the ambiguous grammatical relationship between the reducing agents and the several temperature alternatives. During examination, a rejection under § 112(b) is appropriate when claim language is susceptible to more than one reasonable interpretation and the boundaries of the claimed subject matter are unclear.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 71 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for supplying HMBi to a cow as a methionine source, does not reasonably enable the full scope of the claimed method without undue experimentation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 71 encompasses supplying a cow with an animal-feed composition containing any compound within Formula (I), wherein R¹ may be any C₁–₄ alkyl group, R² may be any C₁–₈ alkyl or C₄–₇ cycloalkyl group, and R³ and R⁴ may each independently be H, methyl, or ethyl. The claim requires that supplying the composition improve fertility, improve liver function, and/or increase energy. The claim alternatively encompasses the specific Formula (I-A) compound.
The specification defines the claimed results. Improved fertility may include shortening the interval between calving and reproduction or increasing fertilization during insemination; improved liver function may include reducing metabolic problems, improving very-low-density-lipoprotein levels, reducing blood ketosis, or reducing hepatic steatosis; and increased energy may result from increased rumen fermentation and digestible organic matter. The specification also describes exemplary animal-feed formulations containing HMBi. However, the specification contains no working animal example demonstrating improved fertility, improved liver function, or increased energy for Formula (I-A), much less for the full structural genus of Formula (I). The disclosed examples are directed to chemical synthesis and characterization rather than administration to cows and measurement of the claimed physiological results.
The factors relevant to whether the required experimentation would be undue are addressed as follows.
Breadth of the claims. Claim 71 encompasses a substantial genus produced by independent variation of four substituent positions, numerous animal-feed compositions, and three distinct physiological results. The claim does not limit dosage, frequency of administration, duration of treatment, age or physiological condition of the cow, background diet, or the amount of improvement required.
Nature of the invention. The claim concerns biological and nutritional responses in an animal. Fertility, liver function, and energy metabolism are affected by numerous interacting variables, including the structure and bioavailability of the administered compound, dosage, diet, stage of lactation, reproductive status, liver condition, and treatment duration.
State of the prior art and predictability. The record supports use of HMBi as a bioavailable methionine source, but does not establish that every compound within Formula (I) would be absorbed, metabolized, or converted to biologically available methionine in the same manner as HMBi. The specification does not disclose a recognized structure-function relationship from which the claimed physiological activity of the Formula (I) genus could be predicted.
Guidance provided by the specification. The specification provides general feed compositions and identifies possible physiological endpoints, but does not instruct the skilled artisan which Formula (I) compounds produce each endpoint, the effective amount for those compounds, an appropriate treatment period, or a protocol for obtaining the claimed result.
Working examples. No working example administers a Formula (I) compound to a cow and measures fertility, liver function, or energy. There are also no comparative data demonstrating that variation of R¹, R², R³, or R⁴ retains the claimed activity.
Quantity of experimentation. To practice the full scope of claim 71, the skilled artisan would be required to prepare or obtain numerous Formula (I) species, determine their bioavailability and metabolism, establish safe and effective dosages, conduct controlled feeding studies, and separately evaluate reproductive, hepatic, and energy-related endpoints. Such experimentation would amount to a research program rather than routine verification of disclosed embodiments.
Level of skill. Although the ordinarily skilled artisan would understand animal-feed formulation and the measurement of the identified endpoints, that level of skill would not compensate for the absence of guidance identifying which members of the Formula (I) genus are operative and under what administration conditions.
Nature of the necessary experimentation. The experimentation would require animal studies involving multiple chemical species, doses, treatment periods, diets, and biological endpoints. The results could not be reliably predicted solely from the chemical formula or from the disclosure concerning HMBi.
Considering these factors as a whole, the specification does not enable the full scope of claim 71 without undue experimentation. The disclosure may enable a materially narrower claim directed to Formula (I-A), an adequately specified feed composition and dosage, and a particular physiological endpoint for which operative support is established. The enablement inquiry requires that the full scope of a claim be usable without undue or unreasonable experimentation, with the Wands factors providing the applicable framework.
Claims 23-24 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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 make and/or use the invention.
Claims 23 and 24 are rejected because the specification does not enable generating the thiolating reagent of Formula (B) from the metal thiolate of Formula (C) in the presence of an “acid catalyst,” as that term is expressly defined in the specification, without undue experimentation.
Claim 22 requires generating the thiolating reagent R¹–SH of Formula (B) from the metal thiolate R¹–S⁻M⁺ of Formula (C). Claim 23 requires that the generating be performed in the presence of an acid catalyst, and claim 24 limits the acid catalyst to acetic acid, p-toluenesulfonic acid, or sulfuric acid.
Paragraph [0030] defines an “acid catalyst” as an acid added in a substoichiometric amount that serves to catalyze the reaction. Paragraph [0069] repeats that Formula (B) may be generated from Formula (C) in the presence of an acid catalyst and identifies acetic acid, p-toluenesulfonic acid, and sulfuric acid, but does not provide a catalytic mechanism, acid-regeneration step, reagent quantity, or working example demonstrating the claimed catalytic generation.
The operative example does not demonstrate the claimed subject matter. In Procedure 2, one equivalent of aqueous sodium thiomethoxide is treated with two equivalents of sulfuric acid. That procedure uses a stoichiometric excess of acid and therefore does not demonstrate generation of the thiol using an “acid catalyst” as the term is defined in paragraph [0030].
Generation of R¹–SH from R¹–S⁻M⁺ ordinarily requires protonation of the thiolate. The specification does not explain how a substoichiometric quantity of the recited acid is regenerated or how it catalytically generates a useful amount of Formula (B). To determine how to practice the claimed scope, the skilled artisan would be required to investigate the amount and identity of acid, the presence of another proton source, solvent and water content, equilibrium conditions, the identity of M⁺, the identity of R¹, and whether Formula (B) must be isolated or generated in situ. The specification provides no guidance showing which combinations will operate with a substoichiometric quantity of acid.
The claimed scope extends to each Formula (C) compound incorporated through claim 18 and to each of the three acids recited in claim 24, while the only demonstrated procedure uses sodium thiomethoxide and a stoichiometric excess of sulfuric acid. On this record, practicing the claimed catalytic process over its full scope would require undue experimentation.
This rejection is narrower and less secure than the rejections of claims 31 and 71. It should be maintained only if “acid catalyst” is given the express definition in paragraph [0030]. If Applicant amends claim 23 to recite generation “in the presence of an acid” or “by acidification,” the principal enablement concern would be removed.
Allowable Subject Matter
Claims 1, 3-4, 6-13, 18-22, 27, 30, 32-33, 42, 52-54 are allowable over the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at 572-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH D CARR/ Primary Examiner, Art Unit 1691
Prosecution Insights