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 .
Election/Restrictions
Applicant’s election without traverse of Group I with Species A1, encompassing claims 1-5, and 7-10, in the reply filed on 8/10/2026 is acknowledged.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “a nitric oxide source … adapted to provide nitric oxide” in claims 1 and 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 2-5, and 8-10 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.
Each of the claims 2, 4, and 8-10 recites the limitation of “the nitric oxide source … adapted to provide nitric acid”. Each of the claims 1 and 7 requires “a nitric oxide source … adapted to provide nitric oxide”. It is not clear how “a nitric oxide source” could provide “nitric acid”. Appropriate correction/clarification is required. For the purpose of examination the above limitation will be interpreted as “the nitric oxide source … adapted to provide the nitric oxide”.
Note: some portions of the specification in the instant application describe “nitric acid”. The applicant is required to thoroughly review the specification for clear and concise description of the invention.
Due to the dependency of the parent claims, claims 3 and 5 are rejected.
Claim Rejections - 35 USC § 102
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 1-5, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gierke et al (“S-nitroso-N-acetyl-D-penicillamine covalently linked to polydimethylsiloxane (SNAP-PDMS) for use as a controlled release polymer”, cited in IDS).
Regarding claims 1 and 7, Gierke et al disclose an apparatus for releasing nitric oxide (ABSTRACT). The apparatus comprises a cell holder having a surface and a space to enclose SNAP films for releasing nitric oxide at various flux (i.e., a support …, and a nitric oxide source …, Figure 4, sections 2.4 - 2.5 and 3).
The limitation of “for sanitizing or sterilizing an article” is in preamble. It has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robie, 88 USPQ 478 (CCPA 1951).
Moreover, “for sanitizing or sterilizing an article” is a recitation for intended use, which does not differentiate the apparatus claim from the prior art (MPEP 2114).
The limitation of “an/the article” is material worked upon the device, which does not limit the apparatus claim from the prior art (MPEP 2115).
Furthermore, the limitation of “a nitric oxide source … adapted to provide nitric oxide” is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The instant specification discloses that the nitric oxide source includes S-nitroso-N-acetyl-D-penicillamine (SNAP, paragraphs [0062] & [0068]). Gierke teaches to utilize SNAP to release nitric oxide (sections 2.3 & 2.4), reading on “a nitric oxide source … adapted to provide nitric oxide”.
It should be noted that the limitation of “a predetermined rate/amount of time/dose” is not a structural limitation for the device, rather a process-limiting parameter which does not limit the apparatus claim from the prior art (MPEP 2114).
Regarding claims 2, 9, and 10, Gierke teaches that LED is provided within the cell holder for triggering the SNAP to release nitric oxide (sections 2.4 – 2.5).
Regarding claim 3, Gierke teaches that LED is provided within the cell holder for triggering the SNAP to release nitric oxide (sections 2.4 – 2.5).
Regarding claims 4 and 8, Gierke teaches that the SNAP is covalently linked to PDMS (section 2.3). The cited time period is related to a manner of operating the device which does not differentiate the apparatus claim from the prior art (MPEP 2114).
Regarding claim 5, Gierke teaches that the SNAP-PDMS film is disposed withing the cell holder (section 2.5).
Conclusion
Claims 1-5, and 7-10 are rejected, Claims 6, and 11-20 are withdrawn.
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/XIUYU TAI/Primary Examiner, Art Unit 1795
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