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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 1/26/26, amended claim(s) 1-12 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Objections
Claim 2 is objected to because of the following informalities: “an at least one knurled section” (line 2) appears that it should be “at least one knurled section.”
Appropriate correction is required.
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.
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: “an actuation mechanism … configured to selectively advance and retract said retaining member relative to said tubular cutting member,” in claim 1, which is unclear what its corresponding structure is.
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.
Claim(s) 1-12 is/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.
For claim 1, the claim language “a second bend that orients a distal portion generally parallel to said longitudinal axis” is ambiguous. How parallel does the distal portion need to be oriented to be considered “generally” parallel? The claim is examined as meaning “a second bend that orients a distal portion parallel to said longitudinal axis.”
For claim 1, the claim language “an actuation mechanism … configured to selectively advance and retract said retaining member relative to said tubular cutting member” is ambiguous. Specifically, this claim language invokes 35 U.S.C. 112(f). However, there appears to be competing structures that could possible support and correspond to this claim language. First, para [0026] of Applicant’s specification as originally filed describes “a linear actuator, which may comprise a ledge adapted to the first end of the housing, a detachable tubular cutlass, which may comprise a first end that can adapt to the second end of the housing and a second end that may comprise a blade.” Since the claim uses the term “actuation member,” the corresponding structure appears that it could be this linear actuator. However, a “ledge” and “detachable tubular cutlass” don’t appear to perform the function recited in the claim of “selectively advance and retract said retaining member relative to said tubular cutting member.” Instead, that function appears to be accomplished by the “push button (200).” Specifically, Applicant’s specification states “[t]he push button (200), after receiving the downward force, may compress the spring (700) between the button lip (202) and the internal ledge (406), thus extending the claw assembly (600) of the cutting and capturing assembly (500, 600) through the through hole (504) of the cutting tip (500) and thereby the instrument body (400)” (see para [0080] of Applicant’s specification as originally filed) and “[o]nce the downward force is removed from the push button (200), the spring (700) may expand and push up against the button lip (202) of the push button (200) and the internal ledge (406) of the instrument body (400) simultaneously. The expansion of the spring (700) against the button lip (202) of the push button (200) can retract at least a portion of the cutting and capturing assembly (500, 600,) within the instrument body (400) in an upward motion through the through hole (504) of the cutting tip (500)” (see para [0079] of Applicant’s specification as originally filed). The claim is examined under the latter interpretation.
For claim 1, the claim language “an actuation mechanism mechanically coupled to said retaining member opposite said plurality of tines of said retaining member” is ambiguous. The claim doesn’t recite that the retaining member comprises anything other than the tines, so it is unclear what the metes and bounds of “opposite said plurality of tines” is since there is no other structure that they can be opposite to (and the claim doesn’t clarify another structure that they are opposite to). To be “opposite” of something it has to be in relation to another structure, the claimed “tines” cannot be opposite of themselves. The claim is examined as meaning that the tines extend in one direction and the actuation is mechanically coupled to the tines and extends in an opposite direction.
Dependent claim(s) 2-12 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-12 is/are rejected under 35 U.S.C. 112(b).
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.
Claim(s) 1, 3-8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2001/0007925 to Ritchart et al. (hereinafter “Ritchart”) in view of U.S. Patent Application Publication No. 2016/0166240 to Vetter et al. (hereinafter “Vetter”) and U.S. Patent Application Publication No. 2011/0230897 to Palermo et al. (hereinafter “Palermo”).
For claim 1, Ritchart discloses a sampling device for collecting a sample from an exposed surface (Abstract) comprising:
an elongated instrument body (98c) (Figs 31-34) (para [0092]) defining an internal axial passage (unlabeled, but as can be seen in Figs. 31-34) and having a distal end (distal end of 98c) and a proximal end (proximal end of 98c);
a tubular cutting member (152) (Figs. 31-34) (para [0092]) positioned at the distal end of said instrument body (as can be seen in Figs. 31-34), said tubular cutting member having a sharpened distal end defining a cutting opening (see Figs. 31-34);
a retaining member (150) (Figs. 31-34) (para [0092]) disposed at least partially within said tubular cutting member (see Fig. 32), said retaining member comprising a plurality of tines proximate said cutting opening (as can be seen in Fig. 32) and movable between a retracted position within said tubular cutting member (see Fig. 32) and a deployed position extending beyond said cutting opening (see Fig. 33), wherein said plurality of tines each comprises a first bend flaring radially outward a longitudinal axis of said tubular cutting member (unlabeled, but as can be seen in Figs. 31 and 33) and a second bend that orients a distal portion to said longitudinal axis (unlabeled, but as can be seen in Figs. 31 and 33), said plurality of tines are resilient, biased toward an expanded configuration, constrained in said retracted position while within said tubular cutting member (see Fig. 32) (see para [0092]), and configured to (Examiner’s Note: functional language, i.e., capable of) expand outwardly upon extending beyond said cutting opening in said deployed position (see Fig. 33) (see para [0092]);
an actuation mechanism (100c) (Figs. 31-34) (para [0092]) mechanically coupled to said retaining member (see Figs. 31-34) opposite said plurality of tines of said retaining member (100c extends proximally and tines extend distally, see Figs. 31-34), said actuation mechanism being configured to selectively advance and retract said retaining member relative to said tubular cutting member (see Figs. 32-34);
wherein, an advancement of said tubular cutting member cuts the sample and a deployment of said retaining member retains the sample within said instrument body for removal from the exposed surface (see Figs. 32-34).
Ritchart does not expressly disclose that said tubular cutting member has a sharpened distal rim defining a cutting opening.
However, Vetter teaches a tubular cutting member having a sharpened distal rim defining a cutting opening (see Fig. 15) (para [0049]).
It would have been obvious to a skilled artisan to modify Vetter such that said tubular cutting member has a sharpened distal rim defining a cutting opening, in view of the teachings of Vetter, because such a modification would be the simple substitution of the sharpened end of Ritchart that would lead to the predictable result of being able to pierce the tissue, which is what Ritchart wants to do.
Ritchart and Vetter do not expressly disclose that the second bend orients a distal portion parallel to said longitudinal axis.
However, Palmero teaches a second bend that orients a distal portion parallel to a longitudinal axis (see “tongs 4402” in Fig. 48C).
It would have been obvious to a skilled artisan to modify Ritchart such that the second bend orients a distal portion parallel to said longitudinal axis, in view of the teachings of Palmero, because such a modification is the simple substitution of one geometry for another geometry that would lead to the predictable result of capturing tissue, which is what Ritchart wants to do.
For claim 3, Ritchart further discloses wherein said tubular cutting member and said retaining member collectively define a cutting and capturing assembly (see Figs. 31-34) (see para [0092]).
For claim 4, Ritchart further discloses wherein said retaining member is movable relative to said tubular cutting member along said longitudinal axis of said elongated instrument body (see Figs. 32-34).
For claim 5, Ritchart further discloses wherein said actuation mechanism is mechanically coupled to a proximal end of said retaining member and is operable to translate said retaining member relative to said tubular cutting member (see Figs. 32-34).
For claim 6, Ritchart further discloses wherein said retaining member is configured to displace the sample from a cut location and retain the sample within said elongated instrument body (see Figs. 32-34).
For claim 7, Ritchart further discloses wherein said tubular cutting member defines a first fixture comprising a tubular sharp-edged tool (see Figs. 32-34) (see para [0092]) and said retaining member comprises a second fixture comprising a capturing mechanism comprising at least two tines (see Figs. 32-34) (see para [0092]).
For claim 8, Ritchart further discloses wherein said retaining member is coupled to said actuation mechanism (see Figs. 31-34), and a spring (116) disposed within said elongated instrument body biases the retaining member toward said expanded configuration (para [0092]).
For claim 10, Ritchart, as modified, further discloses wherein in a first retracted state said retaining member is positioned fully within said tubular cutting member such that only said sharpened distal rim of said tubular cutting member is exposed (as can be seen in Fig. 32).
For claim 11, Ritchart further discloses wherein in a second actuated state said retaining member is advanced beyond said cutting opening such that said plurality of tines extend outwardly beyond said sharp distal rim of said tubular cutting member (as can be seen in Fig. 33).
For claim 12, Ritchart further discloses wherein in a third semi-actuated state said retaining member is partially advanced such that at least a portion of said plurality of tines extend beyond said cutting opening while remaining partially constrained by said tubular cutting member (as can be seen in Fig. 34).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritchart in view of Vetter and Palermo, and further in view of U.S. Patent Application Publication No. 2020/0214737 to Ian et al. (hereinafter “Ian”).
For claim 2, Ritchart, Vetter, and Palermo do not expressly disclose wherein the elongated instrument body comprises at least one knurled section disposed along an outer surface thereof.
However, Ian teaches wherein an elongated instrument body comprises at least one knurled section disposed along an outer surface thereof (para [0048] and [0129]).
It would have been obvious to a skilled artisan to modify Ritchart wherein the elongated instrument body comprises at least one knurled section disposed along an outer surface thereof, in view of the teachings of Ian, for the obvious advantage of improving the grip of the user on the device.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritchart in view of Vetter and Palermo, and further in view of U.S. Patent Application Publication No. 2015/0045665 to Lau.
For claim 9, Ritchart, Vetter, and Palermo do not expressly disclose wherein said tubular cutting member comprises a threaded section to releasably engage a corresponding threaded section at said distal end of said elongated instrument body.
However, Lau teaches wherein a tubular cutting member comprises a threaded section to releasably engage a corresponding threaded section at a distal end of an elongated instrument body (see 1/10 in Fig. 4 and 2 in Fig. 2, and “threaded screw interface” between 1 and 2 in para [0044]).
It would have been obvious to a skilled artisan to modify Ritchart wherein said tubular cutting member comprises a threaded section to releasably engage a corresponding threaded section at said distal end of said elongated instrument body, in view of the teachings of Lau, for the obvious advantage of making the tubular cutting member replaceable so a correct size may be used or a new sterile one may replace a used one.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 1/26/26.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791