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 Invention I (claims 1-8) and Species A (Figs.1-6) in the response of 19 December, 2025 is acknowledged. Claims 9-20 are withdrawn, and claims 1-8 are examined.
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(s) is/are: coupling mechanism in claim 8.
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 § 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 1 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Riley (US 2005/0016886) in view of Saadat et al. (US 2006/0258909).
In regards to claim 1, Riley discloses a system for preventing leaks from an endoscope end of a tube set for use with an endoscope [this is a very general statement: the system of Riley could be used for such], the system comprising:
a storage case [10, Figs.1-3], the storage case comprising:
a base [82, Figs.6-7] including a plurality of wells [86, Fig.6];
an insert [88, Fig.7, para.54] disposed in each well of the plurality of wells; and
a lid [abstract, para.16, 57] configured to cover the base.
Riley further discloses wherein the storage case is adapted for modular medical instrument parts of different size and length, for the purpose of maintaining their sterility [para.10-12].
However, Riley does not positively disclose a cap having a housing extending from a first open end to a second closed end and defining a cavity between the first open end and the second closed end, the cap configured to be removably disposed within a well of the plurality of wells.
Saadat teaches a modular sterile endoscope cap [Figs.5-6, para.46-47] having a housing [44, Figs.5-6] extending from a first open end [“right” side of Fig.5a] to a second closed end [42, Figs.5-6, para.46, note that neither of these ends are positively claimed here] and defining a cavity [interior of 44, Fig.5a] between the first open end and the second closed end [note that the cavity is not positively claimed here]. Saadat teaches that this cap is provided for maintaining sterility within the interior of an endoscope [para.46].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the system of Riley to comprise the cap of Saadat removably disposed within a well of the plurality of wells. This would be done as Riley teaches the system is for packaging and maintaining the sterility of medical instrument parts of different sizes, and as this provides sterile packaging for the modular sterile endoscope cap of Saadat, both as taught above, and as Riley teaches that sterile packaging of modular medical parts in this fashion is known in the art.
In regards to claim 4, Riley in view of Saadat teaches the system of claim 1, wherein the insert comprises an embedded antibacterial or bacteriostatic material [Riley: para.22: plastics themselves have antibacterial and bacteriostatic properties to varying degrees. The examiner suggests much more specificity if the intended feature is to be claimed.].
In regards to claim 5, Riley in view of Saadat teaches the system of claim 1, further comprising an antiseptic disposed within at least one well of the plurality of wells [Riley: para.3-4, 54-55].
In regards to claim 6, Riley in view of Saadat teaches the system of claim 1, wherein the cap is configured to be disposed over an outer surface of an endoscope end of a tube set [Saadat: Figs.6a-b].
In regards to claim 7, Riley in view of Saadat teaches the system of claim 1, further comprising a sealing member disposed within the cavity of the cap [Saadat: 46, Fig.6b, para.46: sterility is maintained within the cap after the end of the endoscope is placed within the cavity of the cap].
In regards to claim 8, Riley in view of Saadat teaches the system of claim 7, wherein the cap further comprises a coupling mechanism [46, Fig.5a, para.46: This is equivalent to applicant’s “other releasable coupling mechanism”, para.66. This is 112 (f) interpretation of the term “coupling mechanism”.] configured to releasably couple the cap to an endoscope end of a tube set.
Allowable Subject Matter
Claims 2-3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, a system for preventing leaks from an endoscope end of a tube set for use with an endoscope, the system comprising:
a storage case having a base, an insert and a lid,
the base including a plurality of wells;
the insert disposed in each well of the plurality of wells;
the lid configured to cover the base;
a cap having a housing extending from a first open end to a second closed end and defining a cavity between the first open end and the second closed end, the cap configured to be removably disposed within a well of the plurality of wells,
(claim 2) the insert sized and shaped to conform to an inner surface of the cap
(claim 3) the insert comprises a perforated foam
Riley (US 2005/0016886) discloses the above except for the cap.
Saadat et al. (US 2006/0258909) discloses a modular sterile endoscope cap with a first open end, a second closed end, and a cavity therebetween.
In obvious combination, the above prior art teaches the above except for the particulars of claims 2-3.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795