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 .
Response to Amendment
Amendments to claims 1, 8, 35, 38, 43, 62, 64 of 4/15/2025 acknowledged and entered.
Cancellation of claim 7 of 4/15/2025 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 8/29/2025 have been fully considered but they are not persuasive.
Regarding p. 7, para. 4, applicant argues that the term “imaging instrument” connotes sufficient structure to one of ordinary skill in the art. Examiner is not in accordance. The term “imaging instrument” could be one of many embodiments common within the art from probes to full endoscopes or even capsule endoscopes. The claim language as recited presents the placeholder term, being “instrument”, with a functional description of being an instrument for “imaging”. Examiner maintains the standing USC 112f interpretation.
Applicant’s arguments, see p. 9, para. 1, filed 8/29/2025 , with respect to the rejection(s) of claim(s) 1, 43 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Qin.
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: imaging instrument in claim 1, biasing member in claims 7-8, locking member in claim 35, 62.
Regarding the imaging instrument of claim 1, the “imaging instrument” is a placeholder term with the function “configured to be slidably received within a lumen of the elongate device”. For the purposes of examination, the term will be interpreted as the imaging instrument 210 of para. [0042] or any functional equivalents.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7-8, 35, 43-45, 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 10201265 B2 to Dickhans (Hereinafter "Dickhans") in view of US 20200345212 A1 to Dreyer (Hereinafter "Dreyer") and Berci (US 20020072652 A1) and Qin (CN 105962877 B).
Regarding Claim 1, Dickhans teaches an imaging coupler comprising:
an elongate device connector configured to couple to an elongate device (Fig. 21-24, Element 511; col. 15 ln. 49 – col. 16, ln. 7);
a body portion (Fig. 1, Element 15) extending between the elongate device connector and the instrument connector (col. 7, ln. 34-49);
and a tubular member (Fig. 1, Element 96) coupled to the instrument connector and extending within the body portion (col. 7, ln. 50-64),
wherein the instrument connector is movable between a non-extended configuration and an extended configuration, wherein the instrument connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is coupled to the elongate device connector (col. 7, ln. 50-64).
Dickhans does not explicitly teach a coupler configured to receive an elongate device and the connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is received by the elongate device connector
wherein an instrument connector configured to couple to an imaging instrument,
the imaging instrument configured to be slidably received within a lumen of the elongate device, and wherein movement of the instrument connector along the longitudinal axis of the tubular member causes corresponding movement of the imaging instrument;
However, Dreyer teaches an instrument connector (Fig. 1, Element 200) configured to couple to an imaging instrument (Fig. 1, Element 500; para. [0034]),
the imaging instrument configured to be slidably received within a lumen (Fig. 6-7, Element 210) of the elongate device (para. [0034]);
However, Berci teaches a connector (fig. fig. 6, element 38, [0051], locking ring 38) wherein movement of the instrument connector along the longitudinal axis of the tubular member (fig. 6, element 10, [0051], apparatus 10) causes corresponding movement of the imaging instrument (fig. 6, element 52, [0051], endoscope 52) wherein the instrument connector is in a first position when the instrument connector is in the non-extended configuration, wherein the instrument connector is in a second position when the instrument connector is in the extended configuration, and wherein the second position is proximal to the first position ([0059], fig. 6 double arrow shows variability of shaft length, allowing for the proximal end to telescope away from the distal end, as moving the distal end deeper into the patient would cause traumatic introduction, causing connector 38 to the imaging instrument to move to a second proximal position).
However, Qin teaches a coupler (fig. 1, element 4, p. 4, para. 8, outer sleeve pipe 4) configured to receive an elongate device (fig. 1, element 15, p, 5, para. 1, endoscope through hole 15) and the connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is received by the elongate device connector (p. 5, para. 5, displacement of the endoscope relative to the guide device in the backwards direction drives the telescopic mechanism of the sleeve to stabilize the endoscope as it moves).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to be compatible with an imager as taught in Dreyer in order to increase the ease of use and maneuverability of imaging instruments (Dreyer [0026])
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to be extendable as taught in Berci in order to introduce the endoscope rapidly and non-traumatically (Berci [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to receive the elongate device as taught in Qin in order to stabilize the movement of the device (Qin p. 5, para. 5).
Regarding Claim 2, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dreyer further teaches a coupler wherein the tubular member includes an inner surface defining a lumen configured to slidably receive the imaging instrument (para. [0034]).
Regarding Claim 3, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dickhans further teaches a coupler wherein when the instrument connector moves in a proximal direction, a distal end of the imaging instrument moves in the proximal direction and is retracted within the lumen of the elongate device (col. 7, ln. 50-64 describes the telescoping capabilities of the connector, being capable of transitioning between an extended and retracted position).
Regarding Claim 4, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dickhans further teaches a coupler wherein when the instrument connector moves, the elongate device remains stationary (col. 7, ln. 50-64 describes the telescoping capabilities of the connector, being capable of transitioning between an extended and retracted position; Col. 12, ln. 30-44 teaches the tool holder 330 is slidable along a railing, allowing movement of the tool relative to the stationary elongate device).
Regarding Claim 5, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dickhans further teaches a coupler wherein the tubular member includes a ring (Fig. 4, Element 129) at a distal end of the tubular member for preventing removal of the tubular member from the body portion (col. 10, ln. 56 – col. 11, ln. 3).
Regarding Claim 8, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dickhans further teaches a coupler wherein the tubular member is configured to be biased in a distal direction (col. 9, ln. 45-60, the locking pins are capable of engaging via the biasing members with either holes 126 or 128, which determine whether the instrument is in a retracted or extended (distal) direction).
Regarding Claim 35, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 1. Dickhans further teaches a coupler wherein a distal end of the instrument connector includes a lock (Fig. 4, Element 32), wherein a proximal end of the body portion includes a recess (Fig. 4, Element 126, 128) in a wall of the body portion, and wherein the lock is configured to be received by the recess (col. 9, ln. 45-60).
Regarding Claim 43, Dickhans teaches a system comprising:
the imaging coupler comprising: an elongate device connector (Fig. 21-24, Element 511; col. 15 ln. 49 – col. 16, ln. 7) configured to couple to the elongate device;
a body portion (Fig. 1, Element 15) extending between the elongate device connector and the instrument connector (col. 7, ln. 34-49);
and a tubular member (Fig. 1, Element 96) coupled to the instrument connector and extending within the body portion (col. 7, ln. 50-64),
wherein the instrument connector is movable between anon-extended configuration and an extended configuration, wherein the instrument connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is coupled to the elongate device connector (col. 7, ln. 50-64).
Dickhans does not explicitly teach a connector configured to receive an elongate device and the connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is received by the elongate device connector
an imaging instrument configured to be slidably received within a lumen of an elongate device;
and an imaging coupler including proximal and distal portions
an instrument connector configured to couple to the imaging instrument, and
and wherein movement of the instrument connector along the longitudinal axis of the tubular member causes corresponding movement of the imaging instrument;
However, Dreyer teaches an imaging instrument (Fig. 1, Element 500) configured to be slidably received within a lumen of an elongate device (para. [0056]);
and an imaging coupler (Fig. 1, Element 200) including proximal and distal portions (para. [0034]);
an instrument connector (Fig. 1, Element 200) configured to couple to the imaging instrument (para. [0034]);
However, Berci teaches a connector (fig. fig. 6, element 38, [0051], locking ring 38) wherein movement of the instrument connector along the longitudinal axis of the tubular member (fig. 6, element 10, [0051], apparatus 10) causes corresponding movement of the imaging instrument (fig. 6, element 52, [0051], endoscope 52) wherein the instrument connector is in a first position when the instrument connector is in the non-extended configuration, wherein the instrument connector is in a second position when the instrument connector is in the extended configuration, and wherein the second position is proximal to the first position ([0059], fig. 6 double arrow shows variability of shaft length, allowing for the proximal end to telescope away from the distal end, as moving the distal end deeper into the patient would cause traumatic introduction, causing connector 38 to the imaging instrument to move to a second proximal position).
However, Qin teaches a coupler (fig. 1, element 4, p. 4, para. 8, outer sleeve pipe 4) configured to receive an elongate device (fig. 1, element 15, p, 5, para. 1, endoscope through hole 15) and the connector is movable in parallel with a longitudinal axis of the tubular member while the elongate device is received by the elongate device connector (p. 5, para. 5, displacement of the endoscope relative to the guide device in the backwards direction drives the telescopic mechanism of the sleeve to stabilize the endoscope as it moves).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to be compatible with an imager as taught in Dreyer in order to increase the ease of use and maneuverability of imaging instruments (Dreyer [0026])
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to be extendable as taught in Berci in order to introduce the endoscope rapidly and non-traumatically (Berci [0059]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector of Dickhans to receive the elongate device as taught in Qin in order to stabilize the movement of the device (Qin p. 5, para. 5).
Regarding Claim 44, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 43. Dickhans further teaches a system wherein when the instrument connector moves in a proximal direction, a distal end of the imaging instrument moves in the proximal direction and is retracted within the lumen of the elongate device (col. 7, ln. 50-64 describes the telescoping capabilities of the connector, being capable of transitioning between an extended and retracted position).
Regarding Claim 45, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 43. Dickhans further teaches a system wherein when the instrument connector moves, the elongate device remains stationary (col. 7, ln. 50-64 describes the telescoping capabilities of the connector, being capable of transitioning between an extended and retracted position; Col. 12, ln. 30-44 teaches the tool holder 330 is slidable along a railing, allowing movement of the tool relative to the stationary elongate device).
Regarding Claim 62, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 43. Disckhans further teaches a system wherein a distal end of the instrument connector includes a lock (Fig. 4, Element 32), wherein a proximal end of the body portion includes a recess (Fig. 4, Element 126, 128) in a wall of the body portion, and wherein the lock is configured to be received by the recess (col. 9, ln. 45-60).
Claim(s) 36-41, 63, 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickhans in view of Dreyer and Berci and Qin as applied to claims 35, 62 in further view of US Patent 20120253127 A1 to Yamane (Hereinafter "Yamane").
Regarding Claim 36, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 35.
Dickhans and Dreyer and Berci and Qin do not explicitly teach a coupler wherein the instrument connector is configured to be rotated in a first rotational direction to couple the instrument connector and the body portion,
and wherein the instrument connector is configured to be rotated in a second rotational direction to decouple the instrument connector and the body portion.
However, Yamane teaches a coupler wherein the instrument connector is configured to be rotated in a first rotational direction to couple the instrument connector and the body portion (para. [0056] teaches rotation in a first direction for locking),
and wherein the instrument connector is configured to be rotated in a second rotational direction to decouple the instrument connector and the body portion (para. [0067] teaches rotation in a second direction for releasing and removal.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking mechanism of Dickhans to have a boss-groove mechanism as taught in Yamane in order to increase the ease of decoupling (Yamane [0019]).
Regarding Claim 37, Dickhans in view of Dreyer and Berci and Qin and Yamane teach the coupler of claim 36. Yamane further teaches a coupler wherein the first rotational direction is a clockwise direction (para. [0048]),
and wherein the second rotational direction is a counterclockwise direction (para. [0048]).
Regarding Claim 38, Dickhans in view of Dreyer and Berci and Qin teaches the coupler of claim 35.
Dickhans and Dreyer and Berci and Qin do not explicitly teach a coupler wherein the lock includes an elongate portion
and a hook portion extending from the elongate portion.
However, Yamane teaches a coupler wherein the locking member includes an elongate portion (Fig. 4, Element 31)
and a hook portion (Fig. 4, Element 33) extending from the elongate portion (para. [0051]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking mechanism of Dickhans to have a boss-groove mechanism as taught in Yamane in order to increase the ease of decoupling (Yamane [0019]).
Regarding Claim 39, Dickhans, Dreyer, and Berci and Qin and Yamane teach the coupler of claim 38. Yamane further teaches a coupler wherein the recess includes an entry recess (Fig. 4, Element 25)
and a locking recess (Fig. 4, Element 36),
and wherein the hook portion is configured to be received within the locking recess (para. [0055]).
Regarding Claim 40, Dickhans in view of Dreyer and Berci and Qin and Yamane teach the coupler of claim 39. Yamane futher teaches a coupler wherein the hook portion is configured to be received within the locking recess when the instrument connector is rotated in a clockwise direction (para. [0056]).
Regarding Claim 41, Dickhans in view of Dreyer and Berci and Qin and Yamane teach the coupler of claim 39. Yamane further teaches a coupler wherein when the hook portion is received within the locking recess, the imaging coupler is in a locked configuration (para. [0056]).
Regarding Claim 63, Dickhans in view of Dreyer and Berci and Qin teaches the system of claim 62.
Dickhans and Dreyer and Berci and Qin do not explicitly teach a system wherein the instrument connector is configured to be rotated in a first rotational direction to couple the instrument connector and the body portion,
and wherein the instrument connector is configured to be rotated in a second rotational direction to decouple the instrument connector and the body portion.
However, Yamane teaches a system wherein the instrument connector is configured to be rotated in a first rotational direction to couple the instrument connector and the body portion (para. [0056] teaches rotation in a first direction for locking),
and wherein the instrument connector is configured to be rotated in a second rotational direction to decouple the instrument connector and the body portion(para. [0067] teaches rotation in a second direction for releasing and removal.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking mechanism of Dickhans to have a boss-groove mechanism as taught in Yamane in order to increase the ease of decoupling (Yamane [0019]).
Regarding Claim 64, Dickhans in view of Dreyer and Berci and Qin and Yamane teach the system of claim 63. Yamane further teaches a system wherein the locking member includes an elongate portion (Fig. 4, Element 31)
and a hook portion extending from the elongate portion (Fig. 4, Element 33; para. [0051]),
wherein the recess includes an entry recess (Fig. 4, Element 25) and a locking recess (Fig. 4, Element 36),
and wherein the hook portion is configured to be received within the locking recess (para. [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795