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 .
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 1-11 are 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. The claims comprise a limitation directed to the amount of gluconic acid or ester or salt thereof present in the composition:
“…the amount of gluconic acid or an ester or salt thereof in the composition provides a dosage in a range of…”
It is unclear what the dosage is of. Gluconic ester, acid and salt all have different molecular weights varying greatly depending on the type of salt of ester. Does the term dosage refer to the gluconate portion or to the full molecule.
It is unclear what amount of gluconic acid or ester or salt thereof is required in order to provide the claimed dosage.
Claim Rejections - 35 USC § 112(a)
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.
Claims 5-11 are 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 increasing colostrum production of a monogastric animal, increasing milk production of a monogastric animal, and increasing average daily gain of offspring of a monogastric animal by administering to the animal a composition comprising calcium gluconate, does not reasonably provide enablement for practicing the above listed methods by administering any other form of gluconate that is not a calcium salt. The specification does not enable any person 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.
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." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims:
The invention concerns increasing colostrum and/or milk production of a lactating monogastric animal (claim 5) and thereby increasing weight gain the offspring (claim 8). The invention is achieved by supplementing the feed of the monogastric animal with a source of gluconate in the form of gluconic acid, ester, or a salt.
State of the prior art and level of predictability in the art:
Art describes improvement in weight gain of an offspring of a lactating sow by supplementing the feed with calcium gluconate (CN108065079A; Examples). Art attributes the improvement to the presence of calcium in the feed.
Amount of direction provided by the inventor and existence of working examples:
Examples found in the specification all utilize calcium glutamate as a feed supplement. No other source of glutamate is exemplified.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention:
A skilled artisan would not be able to practice predictably practice the claimed invention without undertaking experimentation to determine whether it is calcium or glutamate, or the combination of the two that is responsible for the observed wight gain in sow offsprings. CN108065079A and the current examples administer the same compound calcium glutamate, but attribute the benefits of the treatment to different components of the salt. With undertaking experimentation to determine the mechanism by which calcium glutamate results in improved weight gain it is unpredictable whether other sources of glutamate will also result in the claimed improvement.
Thus, given these considerations, one of ordinary skill in the art clearly would not be able to practice the claimed method such that it can be used as contemplated in the specification without first engaging in substantial and undue experimentation. Therefore, the claims are rejected under 35 U.S.C. §112, first paragraph, as lacking and enabling disclosure.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by peg33 (www.pig333.com/swine_abstracts/hypocalcemia-and-calcium-gluconate-use-in-sows-at-parturition_7887/, published 11/22/2013).
In the first paragraph Pig333 discloses that calcium gluconate is administered to sows in the peri-parturent period, which encompasses gestational period.
Separately Pig33 discloses administering calcium gluconate to gestating sows (second paragraph).
Claim(s) 4-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al (CN108065079A; machine translation supplied by Examiner is referred to in this rejection).
In Examples 1-4 Huang describes a nutrient supplement for lactating sow comprising calcium gluconate.
In comparative analysis Huang describes points seen through result comparison and reports higher piglet weaning rate (point 3).
Huang does not attribute the improvement to presence of gluconate, however, since the disclosure of Huang discloses administration of the currently claimed agent (calcium gluconate) tot eh currently claimed population (lactating sows) the claimed method is anticipated.
Limitations directed to increase of colostrum production, increase in milk yield, improvement of offspring survival are inherently met by Huang. Administration of calcium gluconate to lactating sows is the only active step of the claimed process and Huang discloses this step.
Conclusion
Claims 1-11 are pending
Claims 1-11 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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