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 .
Status of Claims
Claims 1-20 are pending, claims 14 and 18-20 have been withdrawn from consideration due to the restriction requirement, and claims 1-13 and 15-17 are currently under consideration for patentability under 37 CFR 1.104.
Election/Restrictions
Applicant’s election of Group I and Species 1, readable on claims 1-13 and 15-17, in the reply filed on 04/30/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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: “an insertion device” in claim 7; “actuation element” in claim 17.
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 Objections
Claims 5-6 are objected to because of the following informalities: change “an open position” to “the open position” (i.e., previously recited in claim 1). Appropriate correction is required.
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 7-11 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.
Regarding claim 7, claim limitation “an insertion device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification recites both the insertion device as an endoscope ([0002]) and an insertion portion of an endoscope ([0032]). It is unclear what the structure of the insertion device is based on what is disclosed in the specification. Dependent claims 8-11 are rejected due to their dependency on claim 7. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claim 8, the limitation “a distal portion configured to extend distally of the distal portion of the insertion device” is unclear. First, it is unclear what feature “a distal portion” is referring to. Second, it is unclear how a distal portion can extend distally of the distal portion.
Regarding claim 9, the limitation “an endoscope” is unclear in view of how claim 7 is interpreted 35 USC 112f (i.e., “an insertion device” is described in the specification as both an endoscope and an insertion portion of an endoscope).
Regarding claim 9, the limitation “the cap comprises…an endoscope cap” is unclear. It is unclear how the cap can include another cap.
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.
Claim(s) 1-5, 7-9, 12, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray (US 2022/0054166).
Regarding claim 1, Murray discloses a medical device comprising: a handle (handle [0030]) comprising: a first arm operator (user interface at a proximal end of insertion device [0030]); and a second arm operator (user interface at a proximal end of insertion device [0030]); and a cap (see 202, figure 2) comprising: a body (connection portion 118, best seen with figure 1b | connection portion…[0042]) having a central lumen (cylindrical element [0032]) about a central longitudinal axis (see figure 1b); a first arm (210, figure 2) hingeably coupled to the body (pivotally connected [0032] | see 240, figure 2) and operably coupled to the first arm operator by a first wire (214, figure 2); and a second arm (210, figure 2 | two arms [0042]) hingeably coupled to the body (pivotally connected [0032] | see 240, figure 2) and operably coupled to the second arm operator by a second wire (see other 214, figure 2); wherein the first arm operator is moveable in the handle (wires may be movable to transition the configuration of arms [0042] | user interface at a proximal end of insertion device [0030]) to move the first arm between a closed position with the first arm generally parallel to the central longitudinal axis (see figure 2) and an open position with the first arm generally perpendicular to the central longitudinal axis (see figure 1b), the second arm operator is moveable in the handle (wires may be movable to transition the configuration of arms [0042] | user interface at a proximal end of insertion device [0030]) to move the second arm between a closed position with the second arm generally parallel to the central longitudinal axis (see figure 2) and an open position with the second arm generally perpendicular to the central longitudinal axis (see figure 1b).
Regarding claim 2, Murray further discloses the first arm and the second arm are semi-circular arms (see shape of 210, figure 2 | interpreted 210 to have a semi-circular shape).
Regarding claim 3, Murray further discloses the first wire is connected to the first semi-circular arm at an apex of the first semi-circular arm (see location of wire 214 with respect to 210, see figure 2 | the wire 214 is located at the apex of arm 210), and wherein the second wire is connected to the second semi-circular arm at an apex of the second semi-circular arm (see location of wire 214 with respect to 210, see figure 2 | the wire 214 is located at the apex of arm 210).
Regarding claim 4, Murray further discloses the first arm and the second arm comprise metal or a hard plastic material (arms may be formed of plastic, metal…[0036]).
Regarding claim 5, Murray further discloses the first arm and the second arm are biased toward an open position (arms may be biased toward closed or open configuration [0031] | figure 2 illustrates similar elements to medical system 100 [0041]).
Regarding claim 7, Murray further discloses the cap comprises a proximal portion (see 118, figure 1b | connection portion…[0042]) configured to overlap with a distal portion of an insertion device (this element is interpreted under 35 USC 112f as an insertion portion | see 112b rejection above | see distal portion of 204, figure 2).
Regarding claim 8, Murray further discloses a distal portion (see 112b rejection above) configured to extend distally of the distal portion of the insertion device (see figure 2).
Regarding claim 9, Murray further discloses the insertion device is an endoscope (endoscope [0028]), and wherein the cap comprises: an endoscope adaptor (see 118, figure 1b | connection portion…[0042]); and an endoscope cap (see 210, figure 2) for capping a shaft (see 204, figure 2) of the endoscope.
Regarding claim 12, Murray further discloses the first wire is surrounded by a first tube (212, figure 2), wherein the second wire is surrounded by a second tube (212, figure 2), and wherein proximal ends of the first tube and the second tube are connected to the handle (tubes extend along the entire length of the insertion device…connecting to a handle [0030]).
Regarding claim 16, Murray discloses a cap (see 202, figure 2) for an insertion device (204, figure 2) comprising: a body (connection portion 118, best seen with figure 1b | connection portion…[0042]) having a central lumen (cylindrical element [0032]) about a central longitudinal axis (see figure 1b); a first arm (210, figure 2) hingeably coupled to the body (pivotally connected [0032] | see 240, figure 2) and operably coupled to a first wire (214, figure 2); and a second arm (210, figure 2) hingeably coupled to the body (pivotally connected [0032] | see 240, figure 2) and operably coupled to a second wire (214, figure 2); wherein the first arm is moveable between an open position with the first arm generally perpendicular to the central longitudinal axis (see figure 1b) and a closed position with the first arm generally parallel to the central longitudinal axis (see figure 2), and the second arm is moveable between an open position with the second arm generally perpendicular to the central longitudinal axis (see figure 1b) and a closed position with the second arm generally parallel to the central longitudinal axis (see figure 2).
Regarding claim 17, Murray further discloses the first arm is operably coupled to a first arm operator (user interface at a proximal end of insertion device [0030]) in a handle (handle [0030]) by a first actuation element (this element is interpreted under 35 USC 112f as a wire, cable, thread, strand, etc. | 214, figure 2); the second arm is operably coupled to a second arm operator (user interface at a proximal end of insertion device [0030]) in the handle by a second actuation element (this element is interpreted under 35 USC 112f as a wire, cable, thread, strand, etc. | 214, figure 2); the first arm operator is moveable in the handle to move the first arm (movably positioned…[0031]); and the second arm operator is moveable in the handle to move the second arm (movably positioned…[0031]).
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.
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) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 2022/0054166) as applied to claim 5 above, and further in view of To (US 2011/0098531).
Regarding claim 6, Murray discloses all of the features in the current invention as shown above in claim 5. Murray is silent regarding the first arm is biased toward an open position by a first spring in the handle that biases the first arm operator, and wherein the second arm is biased toward an open position by a second spring in the handle that biases the second arm operator.
To teaches a retractor cannula device (100, figure 1) with a handle structure (118, figure 1) and an atraumatic retractor assembly (116, figure 1) comprising two jaws (308 and 310, figure 3c). The device has a steering mechanism (120, figure 8) with a lever (122, figure 8). The lever is attached to two control members (192, figure 8) that are slidable located along the length of the shaft and are attached at a distal location of the shaft ([0108]). One or more posts (191, figure 8) may be provided against the control members ([0108]). The ends of the control members are secured to the lever, where the movement range and force may be augmented by one or more bias members (198, figure 8) acting upon the lever ([0108]). The bias members may comprise helical springs ([0108]).
It would have been obvious to modify the device of Murray with the lever (122, figure 8), posts (191, figure 8), and bias members (198, figure 8) as taught by To. Doing so would augment the movement range and force of the lever ([0108]). The modified device would have the first arm is biased toward an open position (biased toward the open configuration [0031]; Murray) by a first spring in the handle (198, figure 8 | helical springs [0108]; To) that biases the first arm operator, and wherein the second arm is biased toward an open position (biased toward the open configuration [0031]; Murray) by a second spring in the handle (198, figure 8 | helical springs [0108]; To) that biases the second arm operator.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over
Murray (US 2022/0054166) as applied to claim 9 above, and further in view of Smith (US 2016/0038133).
Regarding claim 10, Murray further discloses the endoscope cap is made of a plastic material (arms formed of plastic…[0036]; Murray). Murray is silent regarding the endoscope adaptor is made of an elastic material.
Smith discloses a resection device (100, figure 1) with a distal end (106, figure 1) removably coupled to a hood (110, figure 1). The hood (200, figures 2) has an attachment section (220, figures 2) and semi-cylindrical sections (208 and 210, figure 2), where the proximal portion of the semi-cylindrical sections are attached to the attachment section ([0056]). Pull wires (212 and 214, figures 2) move the sections between a closed and open state ([0056]). The attachment section may be formed of a flexible material, such as elastic or rubber, which may expand radially to allow the hood to fit over a range of elongate members ([0050]). The hood may also be made of rigid or semi-rigid materials, such as metals, polymers, resins, super elastic materials, or plastics ([0088]). Smith also teaches rubber, silicon, synthetic plastic, and metal alloys to be material that can be included ([0105]).
It would have been obvious to modify the device of Murray, specifically the endoscope adaptor, to be made of a flexible material as taught by Smith ([0056]). Doing so would allow the endoscope adaptor to expand radially to allow it to fit over a range of elongate members ([0050]). The modified device would have the endoscope adaptor is made of an elastic material (elastic [0050]; Smith).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 2022/0054166) and Smith (US 2016/0038133) as applied to claim 10 above, and further in view of Smith (US 2016/0038133) and Moktali (US 2020/0237200).
Regarding claim 11, Murray and Smith disclose all of the features in the current invention as shown above in claim 10. They are silent regarding the endoscope adaptor is made of silicone, and wherein the endoscope cap is made of a clear material including ABS plastic, polycarbonate, or a similar plastic.
Smith also teaches rubber, silicon, synthetic plastic, and metal alloys to be material that can be included ([0105]).
Moktali teaches a device (100, figure 1) with a cap (105, figure 1). The cap can be made of a clear, transparent polycarbonate or any material that can provide full transparency ([0026]).
It would have been obvious to modify the endoscope adaptor to be made of silicone as taught by Smith ([0105]). Doing so would be an obvious alternative to using elastic or rubber ([0050]). It would have been obvious to modify the endoscope cap to be made of a clear polycarbonate as taught by Moktali ([0026]). Doing so would provide a cap that can provide full transparency ([0026]). The modified device would have the endoscope adaptor is made of silicone (silicon [0105]; Smith), and wherein the endoscope cap is made of a clear material including ABS plastic, polycarbonate ([0026]; Moktali), or a similar plastic.
Claim(s) 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 2022/0054166) as applied to claims 1 and 12 above, and further in view of Mulcahey (US 2017/0311789).
Regarding claim 13, Murray discloses all of the features in the current invention as shown above in claim 12. Murray is silent regarding the first tube and the second tube are each made from a plastic extrusion.
Mulcahey teaches a cap (102, figures 1) connected to the sleeve (126, figures 1) of an endoscope (112, figures 1). The cap is connected to a purging fluid supply mechanism (306, figures 3), which is formed as a multilumen or single lumen extrusion ([0060]). The purging fluid mechanism may be extruded or molded from PVC, Pebax 6333, or similar material ([0059]).
It would have been obvious to modify the first and second tubes to be extruded as taught by Mulcahey ([0060]). Doing so would provide another method for creating the first and second tubes (extruded or molded [0059]; Mulcahey). The modified device would have the first tube and the second tube are each made from a plastic extrusion (extrusion [0060] | PVC [0059]; Mulcahey).
Regarding claim 15, Murray discloses all of the features in the current invention as shown above in claim 1. Murray is silent regarding the cap includes one or more vent holes through the body of the cap.
Mulcahey teaches a cap (102, figures 1) connected to the sleeve (126, figures 1) of an endoscope (112, figures 1). The cap is connected to a purging fluid supply mechanism (306, figures 3), which is formed as a multilumen or single lumen extrusion ([0060]).
It would have been obvious to modify the body to have a purging fluid supply mechanism (306, figures 3) as taught by Mulcahey. Doing so would provide the purging fluid ([0060]). The modified device would have the cap (202, figure 2; Murray) includes one or more vent holes through the body of the cap (see lumens in 306, figures 3; Mulcahey).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Chu (US 2022/0133383) has two jaws; Saadat (US 2014/0228875) has two leaflets that open and close.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
June 16, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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