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 is “the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device” in claim 2. This claim limitation finds structural recitation in paragraph 8 of the specification as well as figure 3 of the drawings. Paragraph 8 defines the first protruding portion as triangular, but figure 3 shows said protruding portion to be what seems to be a pentagonal shape. Due to the difference in shape, the examiner interprets said claim limitation to mean a polygonal shape that protrudes from the specified inner surface of the invention.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 to avoid it 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 recite sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 2, 5-10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn in view of Mitelberg et al (U.S. Patent Application Publication 2023/0181183, hereinafter “Mitelberg”). Mclawhorn teaches a cap for a medical device, comprising:
a cylindrical body (figure 7 element 115) including a central lumen (figure 7 element 114) extending longitudinally through the cylindrical body, wherein a radially-inward facing surface of the cylindrical body extends around the central lumen
McLawhorn fails to teach a cap for a medical device comprising a first protruding portion extending from the radially-inward facing surface, wherein the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device. Mitelberg teaches a cap for a medical device comprising a first protruding portion (figure 48 element 360 shown below) extending from the radially-inward facing surface, wherein the first protruding portion is configured to redirect fluid (paragraph 208 details element 360 being a wash deflector) supplied from a fluid lumen of the medical device. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the first protruding portion of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
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Regarding claim 2, Mclawhorn fails to teaches a cap wherein the first protruding portion is triangular. Mitelberg teaches a cap wherein the first protruding portion is triangular (figure 48 triangular portion element 360 shown above). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the triangular first protruding portion of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
Regarding claim 5, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap further comprising a second protruding portion extending circumferentially around the radially-inward facing surface of the cylindrical body (figure 5 element 122b pointed at below)
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Regarding claim 6, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap wherein the second protruding portion is configured to abut a distal face of the medical device (paragraph 39 “second portion 122 and connector such as a hinge portion 123 that connects the first and second portions 120, 122 and that allows the cap 100 to be positioned on the distal end 23 of the endoscope”).
Regarding claim 7, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap wherein the second protruding portion is positioned at a longitudinal midpoint of the cylindrical body (figure 6 see second protruding portion is situated at a longitudinal midpoint of the cylindrical body).
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Regarding claim 8, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap wherein the cylindrical body is configured to couple to a distal end of an endoscope (paragraph 39 “second portion 122 and connector such as a hinge portion 123 that connects the first and second portions 120, 122 and that allows the cap 100 to be positioned on the distal end 23 of the endoscope”).
Regarding claim 9, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap wherein the first protruding portion includes a first planar surface transverse from a central longitudinal axis of the cylindrical body (figure 5 see top surface or element 123 spanning transverse to the central longitudinal axis)
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Regarding claim 10, McLawhorn and Mitelberg combined teach the limitations of claim 1, and McLawhorn further teaches a cap wherein the first protruding portion further includes a proximal end surface substantially parallel to a distal end surface of the cylindrical body (figure 5 above opposite facing side (opposite meaning surface on the other side of the viewer facing surface of element 23) of element 123 faces proximally and is parallel to the distal end surface of the cylindrical body).
Regarding claim 16, McLawhorn teaches a cap for a medical device, comprising:
a cylindrical body (figure 7 element 115) including a central lumen extending longitudinally (figure 7 element 114) through the cylindrical body, wherein a radially-inward facing surface of the cylindrical body extends around the central lumen
the first protruding portion includes a living hinge structure (figure 6 element 123, paragraph 34 “the hinge portion described herein may be any type of hinge known to one skilled in the art, including, but not limited to hinges that pivot about a fixed axis of rotation, living hinges”) and is configured to rotate towards the radially-inward facing surface of the cylindrical body (hinge 123 hinges allows cap to go from open (figure 5) to closed (figure 7), and so rotates towards the inner surface of the cylindrical body).
wherein the first protruding portion extends circumferentially about a central longitudinal axis of the cylindrical body (figure 7 hinge 123 extends circumferentially around the central longitudinal axis)
McLawhorn fails to teach a first protruding portion extending from the radially-inward facing surface. Mitelberg teaches a first protruding portion extending from the radially-inward facing surface (figure 48 element 360 shown below). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the first protruding portion of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
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Regarding claim 17, McLawhorn fails to teach a cap wherein the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device. Mitelberg teaches a cap wherein the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device (paragraph 208 details element 360 being a wash deflector). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the first protruding portion of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
Claims 3, 4, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn and Mitelberg in view of Saito (U.S. Patent Application Publication 2022/0248942). Regarding claim 3, McLawhorn and Mitelberg teach the limitations of claim 1, but fail to teach a cap further comprising a lateral lumen extending from a first opening at the radially-inward facing surface of the cylindrical body and a second opening at a radially-outward facing surface of the cylindrical body. Saito teaches a cap further comprising a lateral lumen extending from a first opening at the radially-inward facing surface of the cylindrical body and a second opening at a radially-outward facing surface of the cylindrical body (figure 8 element 53 “rectangular window”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhorn and Mitelberg with the lumen of Saito in order to allow for one insertion of the endoscopic tool to have a lateral view of the target area of the patient, reducing patient discomfort involved in reinserting the distal end of the endoscope at a new angle to look at the sides of the target region.
Regarding claim 4, McLawhorn and Mitelberg fail to teach a cap wherein the lateral lumen is longitudinally aligned with the first protruding portion. Saito teaches a cap wherein the lateral lumen is longitudinally aligned with the first protruding portion (figure 8 see window and first protruding portion element 451 are both aligned parallel to the longitudinal direction of the cap). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhorn and Mitelberg with the longitudinally aligned lumen and protruding portion of Saito in order to allow for one insertion of the endoscopic tool to have a lateral view of the target area of the patient, reducing patient discomfort involved in reinserting the distal end of the endoscope at a new angle to look at the sides of the target region.
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Regarding claim 20, McLawhorn teaches a cap for a medical device, comprising:
a cylindrical body (figure 7 element 115) including a central lumen (figure 7 element 115) extending longitudinally through the cylindrical body, wherein a radially-inward facing surface of the cylindrical body extends around the central lumen
and a second protruding portion (figure 5 element 122b pointed at below) extending circumferentially around the radially-inward facing surface, wherein the second protruding portion is configured to abut a distal face of the medical device (paragraph 39 “second portion 122 and connector such as a hinge portion 123 that connects the first and second portions 120, 122 and that allows the cap 100 to be positioned on the distal end 23 of the endoscope”)
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McLawhorn fails to teach a cap for a medical device, comprising:
a first protruding portion extending from the radially-inward facing surface, wherein the first protruding portion is triangular
a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body, wherein the lateral lumen is longitudinally aligned with the first protruding portion
wherein the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device
Mitelberg teaches a cap for a medical device, comprising:
a first protruding portion (figure 48 element 360 shown below) extending from the radially-inward facing surface, wherein the first protruding portion is triangular (element 360 is triangular in shape)
wherein the first protruding portion is configured to redirect fluid supplied from a fluid lumen of the medical device (paragraph 208 details element 360 being a wash deflector)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the first protruding portion of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
Mitelberg fails to teach a cap for a medical device, comprising a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body, wherein the lateral lumen is longitudinally aligned with the first protruding portion. Saito teaches a cap for a medical device, comprising a lateral lumen (figure 8 element 53 “rectangular window”) extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body, wherein the lateral lumen is longitudinally aligned with the first protruding portion (figure 8 see window and first protruding portion element 451 are both aligned parallel to the longitudinal direction of the cap). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhorn and Mitelberg with the longitudinally aligned lumen and protruding portion of Saito in order to allow for one insertion of the endoscopic tool to have a lateral view of the target area of the patient, reducing patient discomfort involved in reinserting the distal end of the endoscope at a new angle to look at the sides of the target region.
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Claims 11-14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn and Mitelburg in view of Busch (U.S. Patent Application Publication 2022/0133131). Regarding claim 11, McLawhorn and Mitelburg combined teach the limitations of claim 1 but fail to teach a cap wherein the first protruding portion includes an L-shaped cross-section and a first planar portion substantially perpendicular to a central longitudinal axis of the cylindrical body. Busch teaches a cap wherein the first protruding portion includes an L-shaped cross-section (figure 10 element 37 circled below, paragraph 95 “L-shaped cross-section”) and a first planar portion (figure 10 bottom surface of element 37 perpendicular to the longitudinal axis) substantially perpendicular to a central longitudinal axis of the cylindrical body. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhown and Mitelburg with the L-shaped protruding portion of Busch in order to prevent “undesired suction of air from the surroundings in the valve open state” as stated in paragraph 95, increasing suction control of the device and lessening room for error during surgical operations.
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Regarding claim 12, McLawhorn, Mitelberg, and Busch combined teach the limitations of claims 1 and 9, and McLawhorn further teaches a cap wherein the first protruding portion includes a living hinge structure (paragraph 34 “the hinge portion described herein may be any type of hinge known to one skilled in the art, including, but not limited to hinges that pivot about a fixed axis of rotation, living hinges”).
Regarding claim 13, Mclawhorn, Mitelberg, and Busch combined teach the limitations of claims 1, 11, and 12, and McLawhorn further teaches a cap wherein the first protruding portion is configured to rotate toward the radially-inward facing surface of the cylindrical body (hinge 123 hinges allows cap to go from open (figure 5) to closed (figure 7), and so rotates towards the inner surface of the cylindrical body).
Regarding claim 14, Mclawhorn, Mitelberg, and Busch combined teach the limitations of claims 1, 11, and 12, and McLawhorn further teaches a cap wherein the first protruding portion is curved and extends circumferentially around a central longitudinal axis of the cylindrical body (figure 7 see hinge element 123 is curved and extends around the central longitudinal axis of the cylindrical body when the cap is in the closed configuration).
Regarding claim 18, McLawhorn and Mitelberg teach the limitations of claims 16 and 17, but fail to teach a medical device wherein the first protruding portion has an L-shaped cross-section. Busch teaches a medical device wherein the first protruding portion has an L-shaped cross-section (figure 10 element 37 circled below, paragraph 95 “L-shaped cross-section”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhown and Mitelburg with the L-shaped protruding portion of Busch in order to prevent “undesired suction of air from the surroundings in the valve open state” as stated in paragraph 95, increasing suction control of the device and lessening room for error during surgical operations.
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Claims 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mclawhorn, Mitelburg, and Busch in view of Saito. Regarding claim 15, Mclawhorn, Mitelburg, and Busch combined teach the limitations of claims 1, 11, 12, and 13, and McLawhorn futher teaches a cap further comprising:
a second protruding portion extending circumferentially around the radially-inward facing surface of the cylindrical body (figure 5 element 122b pointed at below)
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McLawhorn fails to teach a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body, wherein the lateral lumen is positioned distal from the first protruding portion and the second protruding portion and wherein the first protruding portion is configured to direct fluid from a fluid lumen of the medical device towards the lateral lumen.
Mitelberg teaches a cap further comprising a first protruding portion configured to direct fluid from a fluid lumen of the medical device towards the lateral lumen (paragraph 208 details element 360 being a wash deflector, figure 48 below shows fluid path from deflector towards lateral lumen element 340 circled below). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the cap of McLawhorn with the first protruding portion and fluid direction of Mitelberg in order to angle a flow of fluid within the treatment area. This lowers the potential for damage to be done within the patient, as the fluid may now reach areas at an angle to the longitudinal direction of the distal tip, reducing need to readjust the entire tip within the patient’s body.
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Mitelberg fails to teach a cap further comprising:
a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body
wherein the lateral lumen is positioned distal from the first protruding portion and the second protruding portion
Saito teaches a cap further comprising:
a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body (figure 8 element 53 “rectangular window”)
wherein the lateral lumen is positioned distal from the first protruding portion and the second protruding portion (figure 8 below see window is positioned distal to first protruding portion element 451 and second protruding element)
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It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhorn and Mitelberg, and Busch with the lumen and protruding portion configuration of Saito in order to allow for one insertion of the endoscopic tool to have a lateral view of the target area of the patient as close to the distal tip as possible, reducing patient discomfort involved in reinserting the distal end of the endoscope at a new angle to look at the sides of the target region or reinserting the distal end deeper to be able to see with a viewing window located more proximal along the shaft.
Regarding claim 19, McLawhorn, Mitelberg, and Busch combined teach the limitations of claims 16, 17, and 18, but fail to teach a medical device further comprising a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body. Saito teaches a medical device further comprising a lateral lumen extending from the radially-inward facing surface to a radially-outward facing surface of the cylindrical body (figure 8 element 53 “rectangular window”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the caps of McLawhorn and Mitelberg with the lumen and protruding portion configuration of Saito in order to allow for one insertion of the endoscopic tool to have a lateral view of the target area of the patient as close to the distal tip as possible, reducing patient discomfort involved in reinserting the distal end of the endoscope at a new angle to look at the sides of the target region or reinserting the distal end deeper to be able to see with a viewing window located more proximal along the shaft.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 to 5:00 PM Mondays through Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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