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, and Species B, corresponding to claims 1-6 and 8-18 in the reply filed on March 30th, 2026 is acknowledged. Claims 7, 19 & 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claim Interpretation
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.
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 1-6 and 8-17 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.
Claim 1 recites “a cleaning agent” in line 5 to line 6. However, Applicant has already recited “a cleaning agent” in line 3. Thus, it is unclear if the cleaning agent recited in line 5 to line 6 is the same cleaning agent as recited in line 3, or a different cleaning agent. As such, said claim is unclear. Appropriate action is required.
Claims 2-6 and 8-17 are rejected merely due to their dependency from claim 1.
Claim 4 also recites the limitation "periumbilical region of the subject" in line 2 to line 3. There is insufficient antecedent basis for the limitation “the subject” in the claim.
Claim 14 recites the limitation "the capsule" in line 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 9 is the first reference of a capsule, then claim 14 will be examined as though it depends from claim 9.
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 1-6 & 8-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haber et al. (U.S. Patent No. 5,558,874).
Regarding claims 1, 4, 5, 8 & 16-18, Haber discloses a navel cleaning device, comprising:
A cylindrical, semicylindrical, or planar deformable plastic housing (2) as set forth in column 4, lines 1-15;
An adhesive layer (82) comprising a pressure sensitive adhesive formulation, and configured to adhere and secure the navel cleaning device housing to a periumbilical region of a subject/patient (column 8, lines 8-30);
A soap cleaning agent (column 4, lines 30-55);
An applicator (24) configured to deliver the cleaning agent to a patient’s navel (column 4, line 66 to column 5, line 10); and
A dispensing mechanism (4/6/8/26) configured to be actuated to release the cleaning agent from the housing (column 5, line 35 to column 6, line 46);
Wherein the housing (2) comprises a deformable material, and wherein application of a compressive force can thereby release the cleaning agent to the applicator (24) as set forth in column 5, line 35 to column 6 line 46.
Concerning claim 2, Haber continues to disclose that the housing further comprises:
An aperture (21) configured to provide an exit for the cleaning agent from the housing (column 5, lines 1-10); and
A base (2/26) circumscribing the aperture (21) as shown in Figures 1, 2, 7 & 9.
With respect to claims 3 and 11-13, Haber further discloses that the applicator (24) comprises an absorbent, porous sponge that is flexible and configured to extend at least partially into a navel area of a patient during use (column 5, lines 1-5; Figures 2, 7 & 9).
Regarding claim 6, the reference also discloses a release liner (26) coupled to the adhesive layer (column 8, lines 8-30).
Concerning claims 9, 14 & 15, Haber further discloses that the dispensing mechanism (4/6/8/26) comprises a button (4/6/8) configured to rupture a frangible, plastic capsule upon application of a compressive force to the button (column 3, lines 60-67; column 5, line 35 to column 6, line 46).
With respect to claim 10, Haber also discloses that the button (4/6/8) includes an inner surface comprising one or more protuberances configured to receive the compressive force applied to the button (4/6/8) and convey said compressive force to the capsule (Figure 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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