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.
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:
The limitations encompassing the ‘members’ of claim(s) 1-6, 8, 11-14, 17, 18, and 20.
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 § 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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-6, 8, 9, 11-15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aghdam (US 20180078242 A1).
For claim(s) 1-3, 11-12, 15, and 18-19, Aghdam teaches
a sheath; [200]
a shaft [208] extending through a cavity of the sheath, the shaft being moveable relative to the sheath; [Fig(s). 1-2]
a cap [234] located at a distal end of the shaft, the cap being configured to seal a distal end of the sheath; [Fig(s). 2C]
a set of bristles [222] attached to the shaft;
and at least two members [224, 236] attached to the shaft at locations proximal to the cap, [each of 224 and 236 are proximal to a distalmost portion of 234 (e.g., the rounded portion of 234)]
the at least two members being configured to seal the cavity when located within the sheath, [Fig(s). 2C]
wherein a first member of the at least two members is attached to the shaft at a location distal to the set of bristles and a second member of the at least two members is attached to the shaft at a location proximal to the set of bristles [Fig(s). 2-6]
wherein the first member and the second member are located outside of the sheath when the shaft is moved distal to the sheath [Fig(s). 4]
wherein the first member and the second member are configured to wipe an inner surface of the sheath when the shaft is moved proximal to the sheath [¶57 ¶71]
(and a method of use comprising)
delivering the brush in a first state to a target location, [1204]
moving the shaft in a distal direction to a second state, [Fig. 1, Fig. 6B, ¶¶78-81]
collecting a tissue sample; [¶¶77-81]
and moving the shaft in a proximal direction to the first state. [via spring 900 in ¶¶45-47, end of ¶55]
For claim(s) 4-5 and 13, Aghdam teaches
a third member [stud 700] of the at least two members attached to the shaft at a location proximal to the second member
wherein the first member and the second member are located outside of the sheath and the third member is located within the sheath when the shaft is moved distal to the sheath. [Fig(s). 4]
For claim(s) 6 and 14, Aghdam teaches
a protrusion located towards a proximal end of the shaft, the protrusion being configured to prevent the third member from exiting the sheath when the shaft is moved distal to the sheath. [threads on stud 700 constitute(s), under BRI, a form of a protrusion for stud 700]
For claim(s) 8 and 17, Aghdam teaches
the sheath comprising a cutline [218] located proximal to the second member when the first member and the second member are located within the sheath.
For claim(s) 9, Aghdam teaches The brush of claim 1, comprising a locking mechanism [900, 218, 206] located at a proximal end of the brush, the locking mechanism being configured to prevent the shaft from moving relative to the sheath when the locking mechanism is in a locked state.
For claim(s) 20, Aghdam teaches
removing the brush from the target location; and cutting the brush at a cutline located proximal to the second member when the brush is in the first state. [¶81]
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aghdam in view of Parasher (US 5535756 A).
For claim(s) 7 and 16, Aghdam fails to teach a radiopaque marker.
Parasher teaches an invasive sampling device which has a radiopaque marker on a brush structure [end of col. 2 and throughout col. 3, col. 4 ll. 30-45]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the brush of Aghdam to incorporate the radiopaque marker of Parasher in order to aid in positioning of the device. As motivated by Parasher cols. 2-4.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aghdam in view of Erin (US 20120253115 A1).
For claim(s) 10, Aghdam fails to teach the brush configured for an endoscope.
Erin teaches a biopsy brush configured for an endoscope. [entire disclosure – see at least abstract]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the brush of Aghdam to be configured for use within an endoscope as taught by Erin in order to aid in inspection and sampling of the target anatomy. As motivated by Erin ¶3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
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