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 .
Election/Restrictions
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5-8-26.
Applicant's election with traverse of claims 1-14 in the reply filed on 5-8-26 is acknowledged. The traversal is on the ground(s) that that a search for one group is unlikely to not substantially overlap with the other and that it would be difficult to envision that a search for one group would not substantially overlap with that of the other. This is not found persuasive because the search for method claims requires the identification of processing steps, whereas the search for apparatus claims requires the identification of structural elements, which inherently involves difference considerations. As explained in MPEP 808.02, a serious search burden exists when the examiner demonstrates, with appropriate explanation, one of the following: (A) Separate classification thereof: This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search, (B) A separate status in the art when they are classifiable together, or (C) A different field of search. As, discussed on page 2 of the restriction requirement sent out 3-11-26, group I Claims 1-14 are drawn to a device, classified in A61B 90/70, group II Claims 15-21 are drawn to a method, classified in A61L 2/00. As further discussed in the restriction requirement, see page 3, the inventions have acquired a separate status in view of their different classification and the invention requires a different field of search (e.g., searching different class/subclasses or resources, or employing different search strategies or search quarries). Accordingly, the search for the two inventions are not equivalent and additional search would be required to examine the inventions in combination.
The requirement is still deemed proper and is therefore made FINAL.
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 1-14 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 refers to “the passage”, however “at least one passage”, encompassing multiple “passages” are earlier recited and it is uncertain as to which is being referenced in line 7 of claim 1, see MPEP 2173.05(e).
claim 4 recites “an aperture” after “at least one aperture” is defined in claim 1. It is unclear if the aperture in claim 4 is one of the at least one aperture of claim 1 or a separate aperture. Claim 4 further refers to “the apertures” it is unclear is the apertures are apertures of “the at least one aperture” or a different set of apertures.
Claim 8 recites the limitation "the first passage" in line 3 of claim 8. There is insufficient antecedent basis for this limitation in the claim. Further, claim 8 recites “an aperture” after “at least one aperture” is defined in claim 1. It is unclear if the aperture in claim 8 is one of the at least one aperture of claim 1 or a separate aperture.
Claims 2-11 are rejected as being dependent on an indefinite claim.
Claim 12 recites “an aperture” after “at least one aperture” is defined. It is unclear if the aperture in claim 8 is one of the at least one aperture of claim 1 or a separate aperture.
Claim 12 refers to “the passage”, however “at least one passage”, encompassing multiple “passages” are earlier recited and it is uncertain as to which is being referenced in line 8 of claim 12, see MPEP 2173.05(e).
Claims 13-14 are rejected as being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
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 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) 1-3 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weisenburgh, II et al. US 2010/0010310 (US’310).
Regarding claim 1, US’310 teaches a cleaning device for a surgical instrument (devices are provided for providing irrigation and/or suction to a surgical site and maintaining clear visibility through a lens of a scoping device during a surgical procedure, abstract), comprising:
a body (see annotated fig. 8 below);
at least one passage extending through the body from a first open end of the body to a second open end of the body (see annotated fig. 8 below),
the first and second open ends and the at least one passage being dimensioned to receive and guide a shaft of a surgical instrument during a cleaning procedure (see annotated fig. 8 below, the lumen 14 can be configured to receive a surgical instrument such as an endoscope 20 disposed at least partially therein, para. 43); and
at least one aperture in flow communication with a port and the at least one passage to define a cleaning fluid path from the port to the passage (see annotated fig. 8 below, para. 43-46 and 57).
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Regarding claim 2, US’310 teaches the cleaning device of claim 1. US’310 further teaches an end piece connected to the body of the cleaning device, wherein the at least one aperture is located in the end piece (distal section 134, see annotated fig. 8 above, para. 57).
Regarding claim 3, US’310 teaches the cleaning device of claim 2. US’310 further teaches wherein the end piece further comprises a plurality of apertures in flow communication with an interior of the cleaning device (see fig. 3, para. 46-57).
Regarding claim 5, US’310 teaches the cleaning device of claim 1. US’310 further teaches a manifold located in an interior of the cleaning device, wherein the at least one aperture comprises a plurality of holes formed in the manifold, wherein the plurality of holes are in flow communication with a chamber of the manifold that is in flow communication with the port (annular manifold 36, illustrated in FIG. 3 and annotated fig. 8 above, para. 46-57).
Regarding claim 6, US’310 teaches the cleaning device of claim 5. US’310 further teaches wherein the plurality of holes are oriented at an angle relative to a radial direction of the cleaning device (see fig. 3 and annotated fig. 8 above, para. 46-57).
Regarding claim 7, US’310 teaches the cleaning device of claim 5. US’310 further teaches wherein the manifold has a substantially annular shape and comprises a central aperture that defines at least a portion of the at least one passage (annular manifold 36, illustrated in FIG. 3 and annotated fig. 8 above, para. 46-57).
Regarding claim 8, US’310 teaches the cleaning device of claim 1. US’310 further teaches a second passage configured to receive a cleaning fluid, wherein the at least one passage and the second passage are in flow communication via an aperture extending between the first passage and the second passage (annular manifold 36 include passages connected to the fluid passage via apertures, illustrated in FIG. 3 and annotated fig. 8 above, para. 46-57).
Regarding claims 9-10, US’310 teaches the cleaning device of claim 8. US’310 further teaches wherein the cleaning device comprises a first portion and a second portion provided as separate pieces divided by a parting line, with regard to claim 9 and wherein the first passage is partially formed in first portion and partially formed in the second portion so that the first portion and the second portion cooperatively form the first passage when the cleaning device is closed, with regard to claim 10 (passage 146 extends between proximal and distal sections 132 134, see fig. 8 para. 57).
Regarding claim 11, US’310 teaches the cleaning device of claim 8. US’310 further teaches wherein the first passage and the second passage are cylindrical passages extending from the first end of the cleaning device to the second end of the cleaning device, wherein the first end and the second end are opposite to one another (see fig. 1-3 the passages are cylindrical which together extend along the axis of the device from one end to the other, para. 46).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US’310.
Regarding claim 4, US’310 teaches the cleaning device of claim 8. US’310 further teaches an end piece including an aperture configured to be connected to an end of the body so the aperture of the end piece is in flow communication with the at least one passage (distal section 134 is coupled to the body, see fig. 8 para. 57).
US’310 does not teach multiple end pieces each including an aperture, wherein the end pieces are configured to be connected to the first and second ends of the body so the apertures of the end pieces are in flow communication with the at least one passage.
However, US’310 further teaches the distal section 134 is coupled to the proximal section 132 and is manually expandable and rotatable with respect to the proximal section 132 of the sheath 130, although in other embodiments the rotation and/or expansion can be mechanically and/or electronically actuated. distal end of a surgical instrument disposed in a lumen 146 of the sheath 130 can be angled for improved sideways viewing, the distal section can be correspondingly angled, and the rotatable feature can allow rotational alignment of the angled distal section with the angled distal end of the surgical instrument (para. 57). Therefore, it would have been obvious to add a second distal section so that each end can be angled for improving the viewing angles reachable by the endoscope.
It would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the device of US’310 to include multiple end pieces each including an aperture, wherein the end pieces are configured to be connected to the first and second ends of the body so the apertures of the end pieces are in flow communication with the at least one passage because US’310 teaches that it would improve the viewing angle reachable by the endoscope and the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see MPEP 2144.04 .VI. (B).
Claim Rejections - 35 USC § 102
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 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) 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weisenburgh, II et al. US 2010/0010310 (US’310).
Regarding claim 12, US’310 teaches a surgical instrument cleaning system (devices are provided for providing irrigation and/or suction to a surgical site and maintaining clear visibility through a lens of a scoping device during a surgical procedure, abstract), comprising:
a first cleaning device comprising: a body (see annotated fig. 8 below);
at least one passage extending through the body from a first end to a second end of the body (see annotated fig. 8 below),
the at least one passage being dimensioned to receive and guide a shaft of a surgical instrument during a cleaning procedure (see annotated fig. 8 below, the lumen 14 can be configured to receive a surgical instrument such as an endoscope 20 disposed at least partially therein, para. 43); and
at least one aperture in flow communication with a port and the at least one passage to define a cleaning fluid path from the port to the passage (see annotated fig. 8 below the cleaning can follow a path from the aperture through the port and to the passage, which reads on flow communication)
and a second cleaning device (see annotated fig. 8 below) comprising:
a first passage for the surgical instrument to be inserted within; and a second passage configured to receive the cleaning fluid (see annotated fig. 8 below cleaning fluid path),
wherein the first passage and the second passage are in flow communication via an aperture extending between the first passage and the second passage (see annotated fig. 8 below, the first passage and the second passage are in flow communication for defining a path for the cleaning fluid).
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Regarding claim 13, US’310 teaches the cleaning device of claim 12. US’310 further teaches a spray gun (Generally, in an exemplary embodiment, the fluid system 64 can include the irrigation source 32, the vacuum source 34, a handpiece 66 having a fluid outlet 68. The handpiece 66 can be configured to alternatively switch between the irrigation source 32 and the vacuum source 34, such as by using first and second valve buttons 84, 86. In this way, fluid can flow proximally or distally through the passageway 26 to, respectively, provide fluid aspiration and irrigation para. 53-54, see fig. 1, wherein a handheld fluid source that activates the on/off state of the fluid flow reads on a spray gun).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US’310 as applied to claim 12 above, and further in view of Patel US 4,815,450 (US’450).
Regarding claim 14, US’310 teaches the cleaning device of claim 12. US’310 further teaches a surgical instrument (endoscope 20, see fig. 1 para. 43)
US’310 does not teach the surgical instrument comprising: a shaft extending from a proximal end to a distal end; and a manifold disposed at the proximal end and in flow communication with an interior of the shaft, the manifold comprising a port configured to be coupled to a cleaning fluid supply.
US’450 teaches an improved endoscope of the variety which includes an endoscope slideably nested inside of a guiding tube, including an improvement that renders on demand either the guiding tube more flexible than the endoscope or the endoscope more flexible than the guiding tube. The improvement may be one of several embodiments, namely: (a) channels in a thermosensitive guiding tube or endoscope for circulating warm or cold fluid therein (abstract). he operator of the improved endoscope of the instant invention has control over the flexibility of the guiding tube or the endoscope relative to when it will become more flexible and when it will become less flexible, the guide tube or the endoscope, has a wall made from thermosensitive plastic. Such plastic is adapted to be rendered more flexible when brought into contact with a heated fluid medium (heated water for example) and less flexible when brought into contact with a cooled fluid medium (cooled water for example) (see fig. 4, col. 1-2 and 4-5). The channels in the guiding tube read on a manifold that directs water to the interior of the guide tube/shaft. Although the water is not described as a cleaning fluid, it would be able to perform this function since the water is directed to flow along the surface of the endoscope though the guide.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of US’310 to include the surgical instrument comprising: a shaft extending from a proximal end to a distal end; and a manifold disposed at the proximal end and in flow communication with an interior of the shaft, the manifold comprising a port configured to be coupled to a cleaning fluid supply because US’450 teaches that it can be included to control the flexibility of the endoscope and use of known technique to improve similar methods in the same way is obvious, see MPEP 2141 III (C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN FLANAGAN BERGNER whose telephone number is (571)270-1133. The examiner can normally be reached M-F 8:00-5:00.
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, Joshua Allen can be reached at 571-270-3176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN F BERGNER/Primary Examiner, Art Unit 1713
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