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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a medical system comprising an imaging device, an instrument and a light source, classified in A61B1/05.
II. Claims 16-18, drawn to a method of treatment comprising releasing a light source into a patient’s body, classified in A61B90/30.
III. Claims 19-20, drawn to a method of treatment comprising using a chemiluminescent light source, classified in A61B2090/304.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case invention I could be used in a different process of use, for example insertion without release of the light source into the patient’s body, classified in A61B1/05.
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case invention II could be used in a different process of use, for example insertion without extending the instrument partially distal to a distal portion of the shaft, classified in A61B1/05.
Inventions II and III are directed to related methods. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed require different steps, for example invention II requiring release of a light source into a patient’s body, and invention III requiring use of a chemiluminescent light source. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
(a) the inventions require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the prior art applicable to one species would not likely be applicable to another invention.
(b) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Juan Gutierrez on 14 September, 2026 a provisional election was made without traverse to prosecute Invention I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claim 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-5, 8-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Avalos et al. (US 2023/0126325) in view of Barlow et al. (US 2007/0255100) and Bilitz (US 2003/0009176).
In regards to Claim 1, Avalos discloses a medical system comprising:
a medical device [102, Fig.1, para.17] comprising:
a shaft [body of 102, Fig.1] defining a plurality of working channels [104, “additional channel”, Fig.1, para.17-18], each working channel having a respective lumen with a respective distal opening [Fig.1], the distal openings positioned at a distal portion of the shaft [Fig.1]; and
an imaging device [as 102 is an endoscope, also see para.19, 27]
an instrument [the instrument comprising the “stone basket”, Fig. 1, para.12] movable through one or more of the working channels, wherein a distal portion of the instrument includes an end effector [“stone basket”, para.12]; and
a light source [108, Fig.1, para.12], wherein the light source is releasably positionable within the expandable end effector of the instrument, and
wherein the medical device does not comprise a light source [para.20].
However, Avalos does not positively disclose that the imaging device is positioned at the distal portion of the shaft,
or that the end effector is expandable.
Barlow teaches an analogous medical device with a releasable light source wherein an imaging device [6, Fig.2, para.48] is positioned at a distal portion of a shaft of the medical device [4, Fig.2, para.48].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the imaging device of Avalos to be positioned at the distal portion of the shaft in accordance with the teaching of Barlow. This would be done as Barlow shows that this is known in the art, as well as for the predictable result of image capture near working channel outlets [Barlow: Fig.2].
However, Avalos in view of Barlow does not positively teach that the end effector is expandable.
Avalos further discloses wherein the end effector is a basket [para.12] for passage through an endoscope working channel [para.12].
Bilitz teaches an instrument [90, Figs.1-5] comprising an expandable end effector [60, Figs.1-2, 4-5, para.35-36] which is a basket configured for passage through an endoscope working channel. Bilitz teaches that this expandability is done for the purpose of retrieving objects from a patient [para.37].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the end effector of Avalos in view of Barlow to be expandable in accordance with the teaching of Bilitz. This would be done for the purpose taught above, as well as for the predictable result of securing objects.
In regards to claim 2, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the medical device further comprises a handle [Avalos: proximal end of 102, Fig.1] positioned on a proximal end of the shaft, the handle comprising a port [Avalos: proximal end of 104 or channel accommodating the laser fiber, Fig.1] having a corresponding working channel of the plurality of working channels.
In regards to claim 3, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the instrument does not comprise an imaging device [Avalos: para.12]
In regards to claim 4, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the medical device is a ureteroscope [Avalos: Fig.1: advancing to the kidney].
In regards to claim 5, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the expandable end effector comprises an expandable basket [Avalos: para. 12, Bilitz: para.35-36].
In regards to claim 8, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the light source comprises a diameter less than a diameter of at least one of the plurality of working channels [Avalos: para.12].
In regards to claims 9-11, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, however does not positively teach
(claim 9) wherein a first working channel of the plurality of working channels comprises a first diameter, and wherein a second working channel of the plurality of working channels comprises a second diameter that is greater than the first diameter, or
(claim 10) claim 9, additionally wherein the first diameter is within a range of 0.02 to 0.04 inches, and wherein the second diameter is within a range of 0.05 to 0.07 inches, or
(claim 11) claim 9, additionally wherein the first diameter is 0.03 inches, and wherein the second diameter is 0.06 inches.
It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the working channels as taught by Avalos in view of Barlow and Bilitz with the above diameters, because Applicant has not disclosed that the above diameters provide an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the working channels as taught by Avalos in view of Barlow and Bilitz, because they provide access to light sources and instruments, and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Avalos in view of Barlow and Bilitz.
Therefore, it would have been an obvious matter of design choice to modify the working channel diameters of Avalos in view of Barlow and Bilitz to obtain the invention as specified in the claim(s).
In regards to claim 13, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the expandable end effector is configurable to releasably retain the light source and position the light source within a lumen of a body [Avalos: Fig.1, para.12-13].
In regards to claim 14, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, further comprising an additional instrument [Avalos: laser fiber, para.17-18] that is movable through an additional working channel of the plurality of working channels [Avalos: para.17-18].
In regards to claim 15, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, wherein the additional instrument is a laser fiber [Avalos: Fig.1, para.17-18].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Avalos et al. (US 2023/0126325) in view of Barlow et al. (US 2007/0255100), Bilitz (US 2003/0009176) and Honda et al. (US 2015/0265295).
In regards to claim 12, Avalos in view of Barlow and Bilitz teaches the medical system of claim 1, however does not positively teach wherein the medical device further comprises a pressure sensor positioned on the distal portion of the shaft.
Avalos further discloses wherein the medical device is a ureteroscope for operations in a patient’s kidney [Fig.1, para.19-20] and that the medical device may have a channel for irrigation [para.18].
Honda teaches that a device [131, Fig.19, para.77] for operations in a patient’s kidney may have a pressure sensor [145, Fig.19, para.77] in a distal region therein [Fig.19]. Honda teaches that this is done for the purpose of alerting an operator to stop irrigation [para.77].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the medical device of Avalos in view of Barlow and Bilitz to have a pressure sensor in accordance with the teaching of Honda. This would be done for the purpose taught above.
Allowable Subject Matter
Claims 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, a system comprising:
a medical device, an instrument and a light source
the medical device comprising a shaft having plural working channels, each working channel having a separate lumen with respective distal openings at a distal portion of the shaft, wherein an imaging device is positioned at the distal portion of the shaft, the medical device not comprising a light source,
the instrument movable through at least one of the working channels, a distal portion of the instrument comprising an expandable end effector,
the light source releasably positionable within the expandable end effector, and comprising an outer tube and an inner vial,
the outer tube and inner vial respectively containing first and second substances, wherein upon mixing, the first and second substances reacting in a chemiluminescent manner.
Avalos et al. (US 2023/0126325) discloses the above except for the positioning of the imaging device, that the end effector is expandable, or the composition of the light source.
Barlow et al. (US 2007/0255100) discloses the above except for having the medical device not comprise a light source, the light source being positionable within the end effector, and the composition of the light source.
Bilitz (US 2003/0009176) discloses a medical instrument with an expandable end effector.
In obvious combination, Avalos, Barlow and Bilitz teaches the above except for the composition of the light source.
Binmoeller (US 2005/0288555) discloses an endoscope comprising a chemiluminescent light source.
Honda et al. (US 2015/0265295) discloses an endoscopic instrument with a pressure sensor.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Binmoeller (US 2005/0288555)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
