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 Objections
Claim 7 is objected to because of the following informalities:
Claim 7 contains typographical error: “wherein said at one additional channel and …”, which is considered to be “at least one”.
Claim 49 recites “… along a surface of body volume distal to and extending from …” is lacking a proper grammatical article.
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:
tissue support in claim 19;
tissue supporter in claim 40.
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 § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19, 40 and dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 19 and 40 relate to the recitation of “tissue support” and “tissue supporter”. The specification has been deemed as lacking proper written description for these elements because the terms are mentioned in the summary but do not appear in the detailed description. Additionally, there are multiple possible structures which might correspond to these claimed elements, but since they are similar in function, i.e. supporting tissue, the specification is considered to not sufficiently and specifically define these elements. The specification is considered to be lacking written description until this is rectified.
Claim Rejections - 35 USC § 112b
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 1, 5-8, 11, 19, 40, 47, and any dependent claims 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.
Claim 1 recites “a tool lumen”. It is unclear which of the potential lumens/channels this is. Possible candidates include working channel 4, working channel 5, or main working channel 3. Because claim 1 indirectly recites endoscope 2 by positively reciting the imagers of the endoscope, the main working channel 3 of the endoscope can also read on the tool lumen, making the claim indefinite. For this office action, it will be interpreted as given in the prior art rejection below.
Claim 5 recites “at least one additional channel within said body lumen and outside of said tool lumen”. It is unclear which element this is since it could be interpretated as at least two different possible channels. If “tool lumen” is taken to be compound working channel 5 for example (since it subtends at least 70 degrees), the one additional channel can be either compound working channel 4 or one of the wash/irrigation channels 8a, i.e. a channel located on the endoscope 2. This is because claim 1 interprets the scope of the invention as including the endoscope, but claim 5 apparently does not, i.e. presuming that the scope of the invention of claim 5 only includes the introducer 1 and the channels created therein, excluding the channels of the endoscope. Because claim 1 indirectly recites the endoscope 2 by positively reciting components thereon, it broadens the possible channels that read on the channels claimed in claim 5. For this office action, it will be interpreted as given in the prior art rejection.
Claim 6 recites “wherein said at least one additional channel and said tool lumen and said at least two imagers rotate separately from said body lumen”. It is unclear logically how this claim limitation is to operate. It is interpreted that the body lumen (considered to be the lumen of the cylinder/introducer 1 in fig 1A) rotate separately from the tool lumen (working channel 5) and imagers (6), but the body lumen, but as a cylindrical space within the introducer, it is unclear how the space rotates. The body lumen is a symmetrical cylinder space where it is unclear if it rotates with the rotation of the introducer 1 or stays stationary when the introducer 1 rotates. Either interpretation could be viable. It will be interpreted as given in the prior art rejection.
Claim 7 recites “wherein said at (least) one additional channel and said tool lumen and said at least two imagers rotate upon rotation of said body”. It appears these elements actually do not rotate upon rotation of the body, because when the body (being the outer cylinder/introducer 1 as seen in fig 2A, 2B) rotates the endoscope 2 is held stationary and the introducer 1 is rotated about endoscope 2. When this happens, the channel 4, tool lumen 5, and imagers do not rotate since they are fixed with respect to the endoscope 2 since it is the shape of the endoscope that define the channels. In order for the claim elements to rotate, the body must be stationary and the endoscope must rotate, not vice versa. For this office action, it will be interpreted as “… do not rotate upon rotation of said body”.
Claim 8 recites a brain surgery tool considered to be element 23, 24, or 25 (fig 8b, 8c, 8d), but requires that the tool rotate within the tool lumen. It appears claim 8’s definition of tool lumen is incongruent with parent claim 1. For claim 8, the rotation and extension of the brain surgery tool 23 within the tool lumen is considered to be represented in fig 8B, making the tool lumen the central channel in the diagram occupied by outer channel tube 20. This appears to differ from how claim 1 defines the tool lumen since in claim 1, the distal opening of the tool lumen “subtends at least 70 degrees”, suggesting that it is working channel 5 and not the main central working channel 3 as seen in fig 2B. As such, claim 8’s recitation of the elements is incongruent with respect to the parent claim 1 causing indefiniteness. For this office action, it will be interpreted as the tool rotating within the main working channel 3.
Claim 11 recites “wherein said guide or circuitry attached thereto generates an indication …”. The claim language implies the claimed “guide” and “circuitry” were previously recited. The “guide” has been previously recited but there is no previous recitation of “circuitry” causing possible lack of antecedent basis issues. The claim language should explicitly clarify antecedent basis, e.g. “where in said guide or a circuit/circuitry attached thereto …”.
Claim limitations:
“tissue support”, claim 19;
“tissue supporter”, claim 40;
invoke 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.
These terms are not mentioned in the details of the specification which should link the specific claim term to the structural description, and because of this, multiple different elements could be interpreted as these claimed elements, leading to indefiniteness.
Aside from the lack of these explicit claim terms, “tissue support” is mentioned three times in the specification but only with respect to functionality and not as a name for a specific structure: once with respect to “introducer 1” at page 37 (“introducer 1 may be advanced relative to the other system elements, e.g. in order to provide tissue support”) and additionally with respect to “scaffold 48” on pages 41 and 42, suggesting that either of these may be possible candidates for these claim terms, adding to further indefiniteness.
Additionally, at page 19, there is mention of “other supporting elements”, which may be potential candidates for these claim terms, one positioned distally and one laterally, and both extending distally and blocking tissue ingress, but neither are labelled as the specific claim terms. The details of claims 19 and 40 are also not enough to distinguish which of these elements distinctly read on the claimed elements. One of these supporting elements is also referred to as an “expandable element … also referred to herein as a scaffold or retractor scaffold” potentially causing confusion with the retractor element.
Another possible candidate might include retractor 40, but it does not appear that this element is described as performing “tissue support”, leading to another degree of indefiniteness. Also, the use of “retractor” as part of the scaffold, i.e. “retractor scaffold”, especially when the specification is not careful with specifically labelling claim terms, can lead to additional indefiniteness with respect to the described “retractor”.
These are potentially only a few of the aspects of indefiniteness.
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.
Claim 47 recites “… is flexible enough to move out of the way when contacted by said surgical tool” which is indefinite since it is unknown what measure of flexible qualifies as flexible enough in this context.
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, 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener-Irmakoglu US20180014842 (as Shener) and further in view of Ertas US20090147076 and Hermann US5421323.
Shener discloses for claim 1, “An endoscopic guide for brain surgery, comprising:
(a) a body (tube 120; fig 3A, 3B; 0042) having a body lumen (lumen of tube 120) with a distal side and a proximal side (fig 3A);
(b) a tool lumen (channel 128A; fig 3A, 3B; 0044) defined within said body lumen and sized for transfer of a brain surgery tool therethrough to a distal opening (opening of channel 128A; fig 3A) on the distal side of the body lumen; and
wherein the distal opening subtends at least 70 degrees of a total circumference surrounding each of the two distal-facing imagers (fig 3B shows the channel subtends greater than 70 degrees).
Shener does not disclose “(c) at least two distal-facing imagers”.
Ertas teaches in the same field of endeavor, providing two distal facing imagers with overlapping fields of view (figs 8, 11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Ertas into the invention of Shener in order to configure the endoscopic guide e.g. as claimed because it provides a larger field of view.
Shener does not disclose the at least two distal-facing imagers “positioned with respective fields of view each including, from a different respective circumferential position around the distal opening, a region surrounding an axis extending longitudinally along the tool lumen out of the distal opening”.
Hermann teaches in the same field of endeavor, positioning a camera’s field of view such that it has “a clear view of the treatment instrument” (2:28-31). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Hermann into the invention of Shener in order to configure the endoscopic guide e.g. as claimed because it ensures a clear view of the treatment instrument and the tissue location being treated (2:28-31).
Modified Shener discloses for claim 4, “The endoscopic guide according to claim 1, wherein a distance between each of said at least two imagers and said tool lumen is less than 3 mm (Hermann: 2:25-28 describes the viewing element and the instrument channels can be adjacent to each other to help obtain a clear view of the instrument)”.
Shener discloses for claim 5, “The endoscopic guide according to claim 1, comprising at least one additional channel within said body lumen and outside of said tool lumen (channel 128B; fig 3B)”.
Shener discloses for claim 6, “The endoscopic guide according claim 5, wherein said at least one additional channel and said tool lumen and said at least two imagers rotate separately from said body lumen (the claim is interpreted herein as requiring the additional channel, tool lumen, and two imagers rotate when the endoscope is rotated within the guide; as such, when member 124 rotates within tube 120, the channels created by the member 124 and the modified imagers thereon rotate as required by the claim)”.
Shener discloses for claim 7, “The endoscopic guide according to claim 5, wherein said at (least) one additional channel and said tool lumen and said at least two imagers [do not] rotate upon rotation of said body (fig 3B shows the relationship between the tube and the member/endoscope where the endoscope elements rotate with the rotation of the endoscope but do not rotate with the rotation of the tube)”.
Claim(s) 8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, and Hermann as applied to claim 1 above, and further in view of Ito US20190201149.
Shener does not disclose for claim 8, “The endoscopic guide according to claim 1, further comprising said brain surgery tool, said brain surgery tool comprising one or more of suction, electrical cauterization and tissue cutting wherein said brain surgery tool rotates within the tool lumen, and comprises a bending region through which it bends; and extends longitudinally along a longitudinal axis of a portion of the brain surgery tool positioned distally beyond the bending region”. Ito teaches in the same field of endeavor, an articulating brain surgery tool (surgical tool 1 with end effector 22 with jaws; fig 3, 7) that can extend and retract. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Ito into the invention of Shener in order to configure the endoscopic guide e.g. as claimed because it provides for a manner to manipulate the subject tissue.
Modified Shener discloses for claim 10, “The endoscopic guide according to claim 8, wherein said brain surgery tool retracts proximally along a path including a path portion along the longitudinal axis of the portion of the brain surgery tool positioned distally beyond the bending region, and a path portion passing through the bent bending region (fig 3 and 7 show the extending and retracting including through a bending portion via guide tubes 11)”.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, Hermann, and Ito as applied to claim 8 above, and further in view of Atarot US20150238276.
Shener does not disclose for claim 11, “The endoscopic guide according to claim 8, wherein said guide or circuitry attached thereto generates an indication when a tip of said tool extends outside of a predefined region distal to and extending from the distal side of said body lumen”. Atarot teaches in the same field of endeavor tracking and determining the position of a surgical tool which includes a tip position and when the tool is located within permissible and non-permissible regions (0071). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Atarot into the invention of Shener in order to configure the endoscope guide e.g. as claimed because it provides safety constraints for the physical location of the surgical tool.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, and Hermann as applied to claim 1 above, and further in view of Bendory US20150289754.
Shener does not disclose for claim 19, “The endoscopic guide according to claim 1, comprising a tissue support, sized and shaped to reduce ingress of surrounding tissue into a body volume within a region distal to and extending from the distal side of said body lumen”. Bendory teaches in the same field of endeavor, adjustable tissue support (102, 104, 106; fig 1A-1D generally with specific embodiment e.g. fig 17A-C; 0086) as the claimed tissue support extendable distally from a lumen (figs 2A-F); with work tools which can be any of a camera, optical fibers, suction, surgery tool, ultrasound, etc. 0099. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Bendory into the invention of Bendory in order to configure the endoscopic guide e.g. as claimed because it allows manipulation of subject tissue to help facilitate imaging and also provides work tool functionality including but not limited to suction via a suction port.
Claim(s) 21, 29, 35, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, Hermann, and Bendory as applied to claim 19 above, and further in view of Schara US20030092966.
Shener does not disclose for claim 21, “The endoscopic guide according to claim 19, comprising an ultrasound transducer positioned on a distal portion of the tissue support, and oriented to image in a proximal direction from its position”, i.e. does not specify a viewing direction. Schara teaches in the same field of endeavor the ability to view in a proximally oriented direction (fig 1A). Since Shener fails to disclose the nature of the viewing direction, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable viewing direction known in the art, including the one taught by Schara, to achieve the predictable result of providing a viewing direction for an imager.
Modified Shener discloses for claim 29, “The endoscopic guide according to claim 19, wherein said tissue support is sized to insert through an auxiliary channel within said body lumen (Bendory: figs 2A-F shows tubular structure of the tissue support capable of insertion into a common working channel)”.
Modified Shener discloses for claim 35, “The endoscopic guide according to claim 19, wherein said tissue support defines at least one suction aperture facing away from said body volume (Bendory: work channel recess 736; fig 17A; 0175)”.
Shener discloses for claim 39, “The endoscopic guide according to claims 19, wherein said tissue support is positionable to prevent contact of said brain surgery tool with sensitive tissue outside of said body volume (Bendory: e.g. figs 4B, 4E shows the tissue support bendable and therefore creating 3D separation space from the surrounding tissue, preventing contact with an inserted tool)”.
Claim(s) 40, 42, 47, 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, and Hermann as applied to claim 1 above, and further in view of Utley US20020115992.
Shener does not disclose for claim 40, “The endoscopic guide according to claims 1, comprising at least one narrow tissue supporter extending distally from said body lumen”. Utley teaches in the same field of endeavor, providing a wire basket structure 56, fig 6 for use with an ultrasound probe (0072, 0081). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Utley into the invention of Shener in order to configure the endoscopic guide e.g. as claimed because it provides support for an ultrasound transducer (0072).
Modified Shener discloses for claim 42, “The endoscopic guide according to claim 40, wherein said at least one narrow tissue supporter comprises two separate wires or is in the form of a loop, with each of two sides of the loop extending distally out of the body lumen (Utley: fig 8 shows basket 56 with wire spines 58 forming loops)”.
Modified Shener discloses for claim 47, “The endoscopic guide according to claim 40, wherein said at least one narrow tissue supporter is flexible enough to move out of the way when contacted by said surgical tool (0071 describes the molded plastic material and flexibility of the material capable of manipulating tissue)”.
Modified Shener discloses for claim 48, “The endoscopic guide according to claims 40, wherein said at least one narrow tissue supporter is re-positionable to mark a tumor or other tissue to be removed or to mark a tissue to be avoided, while the distal opening remains in place (0071 describes the deployable nature of the basket disclosed as formed from molded plastic and therefore capable of marking tissue with applied pressure)”.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shener, Ertas, Hermann, and Utley as applied to claim 40 above, and further in view of Bendory.
Shener does not disclose for claim 49, “The endoscopic guide according to claim 40, comprising a tissue support having a base extending axially along a surface of body volume distal to and extending from the distal side of said body lumen; and wherein said at least one narrow tissue supporter lies on an opposite side of said body volume from said base and extends to rest against said base; wherein said tissue support restricts axial movement of said at least one narrow tissue supporter and thereby converts axial movement thereof into lateral and/or circumferential movement thereof”. Bendory teaches in the same field of endeavor, adjustable tissue support (102, 104, 106; fig 1A-1D generally with specific embodiment e.g. fig 17A-C; 0086) as the claimed tissue support extendable distally from a lumen (figs 2A-F); with work tools which can be any of a camera, optical fibers, suction, surgery tool, ultrasound, etc. 0099. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Bendory into the invention of Bendory in order to configure the endoscopic guide e.g. as claimed, specifically configuring Bendory’s tissue support (shaft) at the distal hub 60 of Utley, thereby restricting motion, because it allows manipulation of subject tissue to help facilitate imaging and also provides work tool functionality including but not limited to suction via a suction port.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/13/26