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 .
Claims 1-15 are pending and under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
It is noted that throughout the specification and claims, the term “stoney” should read “stoney” so that it is not confused as to whether the term is an adjective or referring to an undefined class of corals. Throughout the specification, it refers to “small poly stoney corals”. It is presumed this is intended to read “small polyp stony corals”.
The specification references “Digitata montipora” and is presumed to intend to reference “Montipora digitata”.
Claim Objections
Claims 12 and 13 are objected to because of the following informalities: The term “comprises” at line 1 of each claim should read “is”. Appropriate correction is required.
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.
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 1-15 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 a method of increasing growth rate of a coral species, comprising growing the coral on a bioceramic hydroxyapatite material for a period of time wherein said increased growth rate is relative to the growth rate of control comprising the same coral species under the same growth conditions with exception that the control coral is grown on a control ceramic material, does not reasonably provide enablement for increased growth rate compared to growth on any substrate other than a control ceramic under otherwise identical conditions and does not enable a 100% increase in growth rate compared to control, an increased perimeter of 10cm/month, or a surface area increase of 50 cm^2/month.. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
MPEP §2164.01(a), 4th paragraph, provides that, “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 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
The nature of the invention relates to growth of coral on a hydroxyapatite surface that leads to increased growth rate compared to fired clay.
The claims are broad in that they fail to recite to what the increased growth rate is compared. Claim 6 recites that the growth rate increase can be about 100%, which is not supported by the Specification.
The art at the time of filing held that there are many factors that influence coral growth, These range from a carbonate source to light, carbon dioxide, inorganic nutrient level, food source, light, pH, and water flow (Osinga, Mar Biotechnol (2011) 13:658–671). The claims fail to require that the increased growth be relative to a controlled situation where the only variable between the compared growth rates is the substrate material used for growth.
The Specification teaches increased growth rate of 2 coral species when grown on hydroxyapatite compared to coral grown on fired clay (control ceramic). The Specification, at page 16, teaches that the hydroxyapatite can show up to 86% increased growth rate bit does not support a 100% increase. Table 3 falls short of supporting the claimed 10 cm/month recited in claim 8 as it shows just over 5.5 cm growth over 5.5 months. With regard to surface area (claim 9), the Specification does not give the starting size but given that the largest surface area at the end of the experiment was 28.53cm^2, the data does not support growth of 50cm^2/month. It appears most experiments were carried out for about 4 months. With regard to claim 100, no data is present to support increased volume. The Specification states, at page 22, “It is expected that similar results will be achieved with volumetric calculations.” An increase in perimeter and surface area would inherently lead to an increase in volume but the specification is silent with regard to any quantity and it would require undue experimentation to determine how much volume can be increased.
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 12 is 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 12 is unclear as to whether it encompasses all stony corals, all soft corals, and all members of the class Hexacorallia and the class Octocorallia or if it is limiting the stony and soft corals encompassed to those of the class Hexacorallia and the class Octocorallia. It is noted the Hexocorallia and Octocorallia are not species.
Claim 13 is similarly unclear as the class Hexacotallia includes species of soft corals as well as stony corals. Hexacorallia is not a species but is an Order that includes both stony and soft coral species.
Claims 14 and 15 are unclear because they are constructed to limit the structure of the hydroxyapatite but hydroxyapatite is, by definition Ca10(PO4)6OH2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632