DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claims and remarks filed 8/8/2025 have are acknowledged.
Claims 1-21 and 37 are cancelled.
Claims 22-36 and 38-42 are included in the prosecution.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 8/8/2025 have been fully considered and are persuasive in overcoming the previous rejection under 112(b) and 112(a) which are hereby withdrawn.
However, after further consideration of the claims, examiner has made another rejection under 112(a).
Since the new grounds of rejection are not necessitated by amendment, this action is made NON-FINAL.
Claim Rejections - 35 USC § 112
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.
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.
Scope of Enablement
Claims 22-36 and 38-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for the full scope simultaneously cooling and agitating the partially solid mixture until the partially solid mixture transitions to a fully solid state comprising the coconut oil in a solid state and the aloe vera extract distributed with the coconut oil in the solid state; wherein the simultaneously cooling and agitating comprises cooling with one or more of a refrigerated environment or forced cooled air; and wherein the simultaneously cooling and agitating comprises constantly agitating until the partially solid mixture transitions to the fully solid state. The instant specification discloses, “aloe vera plant extract is a liquid at room temperature or at common refrigeration temperatures” [0014]. 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.
The claims are directed to a method comprising: preparing a mixture comprising coconut oil and aloe vera extract; warming the mixture to generate a liquid mixture comprising liquid coconut oil and liquid aloe vera extract; partially cooling the liquid mixture until a portion of the liquid coconut oil transitions to a solid state to form a partially solid mixture; and simultaneously cooling and agitating the partially solid mixture until the partially solid mixture transitions to a solid state comprising the coconut oil in a solid state and the aloe vera extract distributed with the coconut oil in the solid state.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). 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 USPQ2sd 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). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are directed to a method of manufacturing wherein simultaneously cooling and agitating the partially solid mixture until the partially solid mixture transitions to a solid state comprising the coconut oil in a solid state and the aloe vera extract distributed with the coconut oil in the solid state.
Thus, the claims taken together with the specification imply that combining only coconut oil and aloe vera extract together and then simultaneously cooling and agitating the mixture produces coconut oil and aloe vera extract in a solid state, but guidance is lacking as to how this is possible when there is no possession or data to support this. The scope of claims 22, 41, and 42 are drawn to a method of manufacturing a composition comprising coconut oil and aloe vera extract in a solid state. The specification does not discuss or mention any use of an emulsifier, thus the specification provides inadequate guidance to allow the skilled artisan to determine, given the nature of the invention and in the absence of working examples, how aloe vera extract which is an aqueous liquid can mix with coconut oil which is an oil based substance in the absence of an emulsifying agent.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art is replete in terms of combining aqueous components with oil based components with the presence of an emulsifier; however, the state of the art is silent regarding combining aqueous components with oil based components without the presence of an emulsifier.
It is unpredictable to one of ordinary skill in the art to know to how to arrive at a solid state of aloe vera extract from simultaneously cooling and agitating when there is no possession or parameters to do so.
(5) The relative skill of those in the art:
One of skill in the art would typically have a graduate degree in the field of endeavor such as M.D. or a PhD. MPEP 2141.03 states (in part), "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. At 1396, 82 USPQ2d at 1396. The "hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988).
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
There is nothing in the specification that would indicate repeat success how aloe vera extract which is an aqueous liquid can mix with coconut oil which is an oil based substance in the absence of an emulsifying agent. Guidance is lacking and the specification does not provide any evidence of a working example of producing a coconut oil and aloe vera extract mixture in a solid state from simultaneously cooling and agitating in the absence of an emulsifying agent. The scope of claim 22, 41, and 42 are drawn to a method of manufacturing a composition comprising coconut oil and aloe vera extract in a solid state. The specification does not discuss any emulsifying agents, thus the specification provides inadequate guidance to allow the skilled artisan to determine, given the nature of the invention and in the absence of working examples, how aloe vera extract which is an aqueous liquid can mix with coconut oil which is an oil based substance in the absence of an emulsifying agent. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art.
(8) The quantity of experimentation necessary:
A burdensome amount of research would be required by one of ordinary skill in the art to determine what else is required in simultaneously cooling and agitating coconut oil and aloe vera extract that it is unreasonable to believe, on its face, that it is possible to arrive at a mixture of coconut oil and aloe vera extract in a solid state from simultaneously cooling and agitating, when there is no possession or parameters to do so. One of ordinary skill in the art would have to conduct a myriad number of experiments comprising guessing what additional steps are required to successfully produce coconut oil and aloe vera extract mixture in a solid state from simultaneously cooling and agitating. Consequently, a burdensome amount of research would be required by one of ordinary skill in the art to bridge this gap. The amount of experimentation is HUGE, the guidance is lacking, the correlation of any measurements are lacking, etc.
Given the complete lack of direction in applicant's instant disclosure, the amount of experimentation required to realize the full scope of claims 22-36 and 38-42 is clearly undue. Applicants have not described how one would know what else is required in simultaneously cooling and agitating aloe vera extract to arrive at aloe vera extract in a solid state, in such full, clear, concise, and exact terms as to enable any person skilled in the art to do so.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615