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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Currently, no claim limitation is being interpreted as invoking 35 U.S.C. 112(f).
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 1-3, 6-8, 11-14, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,284,621 to Kaufman (Kaufman).
Regarding claims 1 and 11, Kaufman discloses a pharmaceutical waste disposal assembly and method for disposing of raw pharmaceutical waste (title/abstract), the pharmaceutical waste disposal assembly comprising: a receiver body (10) that is configured to receive the pharmaceutical waste (waste is added to chamber 10), the receiver body including a body interior wall (wall(s) that form chamber 21) that defines a body interior (chamber 21 is placed inside chamber 10, forming a body interior); and a first reaction agent (xerogel composition) that is positioned within the body interior (the xerogel composition is stored inside chamber 21) so that the first reaction agent contacts the body interior wall prior to receiving the pharmaceutical waste (the xerogel composition is in contact with the body interior wall prior to receiving pharmaceutical waste; see Figs. 4, 5 and 7); wherein the first reaction agent chemically reacts with the pharmaceutical waste so that the pharmaceutical waste is rendered unrecoverable (col. 12, lines 1-4).
Regarding claims 2 and 12, Kaufman discloses the receiver body receives one or more of fluid pharmaceutical waste (abstract) and solid pharmaceutical waste.
Regarding claim 13, Kaufman further discloses adding a fluid into the body interior (fluid binders added to chamber 21; see col. 7, lines 65-66), the fluid mixing with the first reaction agent so that the first reaction agent chemically reacts with the pharmaceutical waste so that the pharmaceutical waste is rendered unrecoverable (col. 8, lines 4-9 and col. 12, lines 1-4).
Regarding claims 3 and 14, Kaufman discloses the first reaction agent includes at least one of a denaturant (the xerogel serves to solidify the waste and is therefore a denaturant) and a deterrent.
Regarding claims 6 and 17, Kaufman further discloses further comprising a second reaction agent (in addition to the xerogel, binders and disinfectant are added) positioned within the body interior (these are also within chamber 21), the pharmaceutical waste reacting with the second reaction agent to change the pharmaceutical waste in one of a chemical and physical manner so that the pharmaceutical waste is rendered unrecoverable, the second reaction agent being different than the first reaction agent (both the xerogel and the binder/disinfectant react with the pharmaceutical waste to render it unrecoverable).
Regarding claims 7 and 18, Kaufman discloses one of the reaction agents is adapted to solidify following contact with a liquid (col. 4, lines 1-5).
Regarding claims 8 and 19, Kaufman discloses the first reaction agent is adapted to solidify following contact with a liquid (col. 4, lines 1-5).
Claim Rejections - 35 USC § 103
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 4-5, 9-10, 15-16 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman in view of US Patent Application Publication 2012/0088951 to Deryck et al. (Deryck).
Regarding claims 4 and 15, Kaufman discloses the pharmaceutical waste disposal assembly and method of claims 1 and 11, and further discloses the first reaction agent includes a denaturant (the xerogel serves to solidify the waste and is therefore a denaturant), but does not disclose a deterrent. Deryck teaches a drug disposal kit which includes a reaction agent having both a denaturant and a deterrent (see abstract and [0027]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a deterrent in the reaction agent of Kaufman to further aid is safe disposal of the pharmaceutical waste as taught by Deryck.
Regarding claims 5 and 16, Kaufman discloses the pharmaceutical waste disposal assembly and method of claims 1 and 11, but does not disclose the first reaction agent includes activated charcoal. Deryck teaches a drug disposal kit which includes a reaction agent having activated charcoal ([0027] and [0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included activated charcoal in the reaction agent of Kaufman to further aid is safe disposal of the pharmaceutical waste as taught by Deryck.
Regarding claims 9-10 and 20-21, Kaufman discloses the pharmaceutical waste disposal assembly and method of claims 1 and 11, but does not disclose a fluid absorber positioned within the body interior, the fluid absorber absorbing and retaining the pharmaceutical waste; and wherein the pharmaceutical waste reacts with the first reaction agent prior to being absorbed and retained by the fluid absorber, wherein the fluid absorber converts the pharmaceutical waste to one of a gelatinous material and a solid material. Deryck teaches a drug disposal kit which includes a fluid absorber (58) positioned within the body interior, the fluid absorber absorbing and retaining the pharmaceutical waste; and wherein the pharmaceutical waste reacts with the first reaction agent prior to being absorbed and retained by the fluid absorber, wherein the fluid absorber converts the pharmaceutical waste to one of a gelatinous material and a solid material (see [0030]-[0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a fluid absorber in the body interior of Kaufman to further aid is safe disposal of the pharmaceutical waste as taught by Deryck.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and claimed invention.
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/NICOLAS A ARNETT/Primary Examiner, Art Unit 3753 March 6, 2026