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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a one-way valve” (claim 9, lines 1-2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
In line 6, “The biasing member(s)” should be changed to “The at least one biasing member”
In line 9, “Movement” should be changed to “The movement”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-2 and 16-20 are objected to because of the following informalities:
In claim 1, line 15, “movement” should be changed to “the movement”.
In claim 2, lines 5-6, “a second length” should be changed to “the second length”.
In claim 16, line 8, “first and second materials” should be changed to “a first material and a second material”.
In claim 16, line 17, “the first volume” should be changed to “the first volume of the first section”.
In claim 17, line 3, “the second volume” should be changed to “the second volume of the second section”.
In claim 17, line 4, “the first volume” should be changed to “the first volume of the second section”.
In claim 18, line 10, “the first length” should be changed to “the first length of the first of the at least two biasing members”.
In claim 19, lines 14-15, “the receptacle of the end cap” should be changed to “the receptacle of the outer portion”.
In claim 20, line 4, “a tension” should be changed to “the tension”.
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 2-3 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.
In regards to claim 2, lines 4-6 recite: wherein, in a second configuration, “(d) the at least one biasing member has a second length greater than the first length, (e) the at least one biasing member has a second length greater than the first length”. It is unclear why the at least one biasing member having a second length greater than the first length is listed in two recitations instead of just one recitation. Claim 3 is rejected by virtue of being dependent upon claim 2.
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.
Claims 1-4, 6-8, 10-11, 14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lucas (US 4,738,660).
In regards to claim 1, Lucas teaches a medical device (Figures 1-2), comprising:
a handle (27/25), wherein the handle includes a first movable body (27) and a stationary body (25)
an end cap (11/20/18), the end cap comprising:
an outer portion (11)
an inner portion (20) disposed within the outer portion
at least one biasing member (18)
wherein the outer portion of the end cap defines a receptacle (22) configured to contain a material, wherein the inner portion is proximal to the receptacle within the outer portion (Figures 1-2), wherein the inner portion is coupled to the first movable body by at least one control element (23), wherein the at least one biasing member is disposed between a proximal face of the inner portion and a distal face of a proximal wall of the outer portion (Figure 1) such that movement of the first movable body relative to the stationary body moves the inner portion of the end cap relative to the outer portion of the end cap, and wherein movement of the inner portion of the end cap is configured to deliver the material (column 3, lines 68-69)(column 4, lines 24-27)
In regards to claim 2, Lucas teaches wherein, in a first configuration, (a) the at least one control element has a first tension, (b) the at least one biasing member has a first length, and (c) the inner portion is in a first position (Figure 1); and wherein, in a second configuration, (d) the at least one biasing member has a second length greater than the first length, (e) the at least one biasing member has a second length greater than the first length, and (f) the inner portion is in a second position (column 3, lines 68-69)(column 4, lines 24-27).
In regards to claim 3, Lucas teaches wherein, in the first configuration, the receptacle has a first volume (Figures 1-2), and wherein, in the second configuration, the receptacle has a second volume, wherein the second volume is less than the first volume (column 3, lines 68-69).
In regards to claim 4, Lucas teaches wherein the end cap further comprises:
a nozzle (distal portion of 42)
at least one tubular member (proximal portion of 42) extending distally from a distalmost face of the outer portion (Figure 2), wherein the at least one tubular member is fluidly connected to the nozzle and the outer portion (Figure 2), and wherein the material is delivered via the at least one tubular member and the nozzle (Figure 2)
In regards to claim 6, Lucas teaches wherein the receptacle includes at least a first section (22) and a second section (15), wherein at least the first section and the second section are partitioned by a wall (14), wherein the material is a first material (column 3, lines 35-36: injection liquid), and wherein the first section is configured to contain the first material (column 3, lines 35-36: liquid chamber 22 for an injection liquid), and the second section is configured to contain a second material (Figure 1).
In regards to claim 7, Lucas teaches wherein the first section of the receptacle has a first volume, and wherein the second section of the receptacle has a second volume different from the first volume (Figure 1).
In regards to claim 8, Lucas teaches wherein the end cap includes at least one port (Figure 2: of 21 where 40 exits) arranged on an external surface of the outer portion (Figures 1-2).
In regards to claim 10, Lucas teaches wherein the at least one control element is moveably disposed within a lumen of a sheath (45) (column 4, lines 18-19).
In regards to claim 11, Lucas teaches wherein the sheath is coupled to the outer portion of the end cap (Figures 1 and 3).
In regards to claim 14, Lucas teaches wherein the inner portion includes a proximal portion (19) and a distal portion (37), wherein the proximal portion is a rigid material (Figure 1), wherein the distal portion is a flexible material (column 2, lines 58-59), and wherein the distal portion of the inner portion forms a liquid-tight seal with the outer portion of the end cap (Figure 1).
In regards to claim 16, Lucas teaches a medical device (Figures 1-2), comprising:
an end cap (11/19/20), the end cap comprising:
a fixed portion (11)
a first movable portion (19)
a second movable portion (20)
wherein the fixed portion of the end cap includes a first section (15) and a second section (22) partitioned by a wall (14), wherein the first section and the second section are configured to receive first and second materials, respectively (Figure 1)
wherein the first movable portion is disposed within the first section and the second movable portion is disposed within the second section (Figure 1)
wherein, in a first configuration, the first movable portion is in a proximal position within the first section of the fixed portion, and the second movable portion is in a proximal position within the second section of the fixed portion, wherein each of the first section and the second section has a first volume (Figure 1)
wherein, in a second configuration, the first movable portion is in a distal position within the first section of the fixed portion such that the first section has a second volume, wherein the second volume is less than the first volume (Figure 2)
In regards to claim 17, Lucas teaches wherein, in the second configuration, the second movable portion is in a distal position within the second section of the fixed portion such that the second section has a second volume, wherein the second volume is less than the first volume (column 3, lines 68-69)(column 4, lines 24-27).
In regards to claim 18, Lucas teaches wherein the end cap includes at least two biasing members (17/18), wherein a first (17) of the at least two biasing members is disposed between a proximal face of the first movable portion and a distal face of a proximal wall of the fixed portion (Figure 1), wherein a second (18) of the at least two biasing members is disposed between a proximal face of the second movable portion and the distal face of the proximal wall of the fixed portion (Figure 1); wherein, in the first configuration, each of the at least two biasing members has a first length (Figure 1); and wherein, in the second configuration, the first of the at least two biasing members has a second length, wherein the second length is greater than the first length (Figure 2).
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.
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas, as applied to claims 4 and 8 above, and further in view of Livingstone (US 1,496,126).
In regards to claim 5, Lucas does not teach wherein the nozzle includes a plurality of internal threads. Livingstone teaches a medical device (Figure 1) wherein a nozzle (23) includes a plurality of internal threads (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the nozzle, of the device of Lucas, to include a plurality of internal threads, as taught by Livingstone, as such is adapted to receive a plug having a duct therein and a nipple adapted to receive the end of a hypodermic needle for discharging fluid or blood into a patient (page 1, line 111)(page 2, lines 16-29).
In regards to claim 9, Lucas does not teach wherein the at least one port includes a one-way valve. Livingstone teaches a medical device (Figure 1) wherein at least one port (7) includes a one-way valve (20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one port, of the device of Lucas, to include a one-way valve, as taught by Livingstone, as such will close preventing the entrance of air into the outer portion and eliminating the necessity of closing the end of the nozzle either by inserting it into the tissues or closing the orifice in the end of the nozzle (page 1, lines 103-108) while allowing fluid to be discharged into a patient (page 1, line 111).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas, as applied to claim 1 above, and further in view of Kim et al (CN 106031655).
In regards to claim 12, Lucas does not teach wherein the end cap is removably coupled to an endoscope by one or more fasteners, adhesives, or a friction fit. Kim et al teaches a medical device (Figures 1-3) wherein an end cap (300) is removably coupled to an endoscope (100) by one or more fasteners, adhesives, or a friction fit (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the end cap, of the device of Lucas, to be removably coupled to an endoscope by one or more fasteners, adhesives, or a friction fit, as taught by Kim et al, as such makes it possible to visually observe the afflicted part of human body (Description).
In regards to claim 13, Lucas teaches wherein the end cap includes an aperture extending from a proximal end to a distal end (Figure 1: from 13 to 21); however, Lucas does not teach wherein the aperture is configured to receive a distal portion of a scope. Kim et al teaches a medical device (Figures 1-3) wherein an aperture (of 300) is configured to receive a distal portion of a scope (100) (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the end cap, of the device of Lucas, to be configured to receive a distal portion of a scope, as taught by Kim et al, as such makes it possible to visually observe the afflicted part of human body (Description).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lucas, as applied to claim 1 above, and further in view of Speer (US 4,040,420).
In regards to claim 15, Lucas is silent about wherein the handle includes at least one indicator, wherein the at least one indicator indicates a volume of the material disposed within the receptacle of the end cap. Speer teaches a medical device (Figures 1-3) wherein a handle (proximal portion of 22) includes at least one indicator (50), wherein the at least one indicator indicates a volume of a material disposed within a receptacle of an end cap (distal portion of 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the handle, of the device of Lucas, to include at least one indicator, as taught by Speer, as such will provide convenient graduations of volume (for example, cubic centimeters) for dispensing liquids in preselected ratios of volume (column 3, lines 36-41).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas, and further in view of Chu et al (US 2020/0352650).
In regards to claim 19, Lucas teaches a method, comprising:
delivering a medical system (Figures 1-2) to a treatment site, wherein the medical system includes:
a medical device (Figures 1-2), the medical device comprising:
a handle (27/25) having a first movable body (27) and a stationary body (25)
an end cap (20/11/18), the end cap comprising an inner portion (20), an outer portion (11), and at least one biasing member (18), wherein the inner portion is coupled to the first movable body of the handle by one or more control elements (23), wherein the outer portion defines a receptacle (22), wherein the at least one biasing member is disposed between a proximal face of the inner portion and a distal face of a proximal wall of the outer portion (Figure 1)
a material (column 3, lines 35-36: injection liquid), wherein the material is disposed within the receptacle of the end cap (column 3, lines 35-36: liquid chamber 22 for an injection liquid)
moving the first movable body relative to the stationary body by a first distance such that (a) a tension in the one or more control elements is decreased by a first amount and (b) the at least one biasing member is extended by a first amount to move the inner portion of the end cap relative to the outer portion of the end cap by a first distance (column 3, lines 68-69)(column 4, lines 24-27)
delivering a first amount of the material (column 3, lines 68-69)
Lucas does not teach wherein the medical system includes a scope, the end cap removably coupled to a distal end of the scope. Chu et al teaches a method, wherein a medical system (Figures 1-2) includes a scope (12), and an end cap (30) removably coupled to a distal end of the scope (Figure 1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Lucas, wherein the medical system includes a scope, the end cap removably coupled to a distal end of the scope, as taught by Chu et al, as such will allow for locating one or more stones and for positioning the medical device during a procedure (paragraph [0040]).
In regards to claim 20, in the modified method of Lucas and Chu et al, Lucas et al is silent about repositioning the medical system relative to the treatment site; moving the first movable body relative to the stationary body by a second distance such that (a) a tension in the one or more control elements is decreased by a second amount and (b) the at least one biasing member is extended by a second amount to move the inner portion of the end cap relative to the outer portion of the end cap by a second distance; and delivering a second amount of the material. Chu et al teaches repositioning the medical system relative to a treatment site (paragraph [0081]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Lucas and Chu et al, with repositioning the medical system relative to the treatment site, as taught by Chu et al, as such will allow for repositioning the medical device to another location within the body cavity and repeating method steps as many times as necessary to complete a stone removal procedure (paragraph [0081]).
Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Lucas and Chu et al, with moving the first movable body relative to the stationary body by a second distance such that (a) a tension in the one or more control elements is decreased by a second amount and (b) the at least one biasing member is extended by a second amount to move the inner portion of the end cap relative to the outer portion of the end cap by a second distance; and delivering a second amount of the material, as capable of the structure of the medical device of Lucas, as such will allow for delivering further treatment to the patient as needed within another location within the body cavity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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, Kevin C Sirmons can be reached at (571) 272-4965. 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.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights