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 1-7, drawn to an endoscopic system, classified in A61B1/05.
II. Claims 8-12, drawn to a method of intrauterine access, classified in A61B1/303.
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 introduction without advancement of a dilator sheath, classified in A61B1/05.
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 Sanjay Bagday on 25 August, 2026 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention, and claims 1-7 are examined.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1 reads “a maximum cross-sectional dimension of 2.5 mm or less” [lines 3-4] where it is clear this was instead intended to read “a maximum cross-sectional diameter of 2.5 mm or less”.
Claim 6 reads “a maximum cross-sectional dimension of 2.5 mm or less” where it is clear this was instead intended to read “a maximum cross-sectional diameter of 2.5 mm or less”.
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 1-7 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 pre-AIA the applicant regards as the invention.
In regards to claim 1, the claim reads “an elongate optical guide member extending about an axis having a maximum cross-sectional dimension of 2.5mm or less with a flexible distal tip portion” [lines 3-4]. This could be interpreted to mean the elongate optical guide member has the maximum dimension and flexible tip portion. Alternatively, the axis has the maximum dimension and flexible tip portion.
Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed that the former is the case.
In regards to claim 1, the claim reads “a first connector with electrical contacts at a proximal end of the elongate optical guide member for coupling” [lines 6-7]. This could be interpreted to mean the electrical contacts are at the proximal end of the elongate guide member, or that the first connector is at the proximal end of the elongate guide member. This could be interpreted to mean the first connector is for coupling, or that the electrical contacts are for coupling. Therefore the claim is unclear.
For the purposes of prosecution, it will be assumed the coupler is both at the proximal end of the guide member and for coupling.
Allowable Subject Matter
Claims 1-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include 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 uretroscope system comprising:
a handle, an elongate guide member, an elongate introducer sleeve and a hub,
the handle comprising a second connector,
the guide member having a maximum diameter of 2.5mm or less, having a flexible distal tip having an image sensor and light emitter, and having a first connector at a proximal end,
the first connector comprising electrical contacts, the first connector for coupling to the second connector,
the sleeve having an interior passageway configured to receive both the guide member and a fluid flow,
the hub at the proximal end of the sleeve, the hub comprising a fitting configured to couple to a fluid source to deliver the fluid flow into the interior passageway of the sleeve.
Renaud (US 4,984,563) discloses an endoscope having an insertion portion with a flexible distal tip, the insertion portion having a maximum diameter of 2.5mm or less.
Witta et al. (US 5,313,934) discloses the above sleeve and hub, used with a flexible endoscope.
Schneider et al. (US 2009/0225159) discloses the above except for the sleeve and the hub, and that the maximum diameter of the guide member is 2.5mm or less.
Dejima et al. (US 2017/0007105) discloses the above sleeve and hub, except for that the sleeve is configured to accept a non-flexible endoscope.
Wake et al. (US 2018/0084974) discloses the above except for the diameter of the guide member, the first and second connectors, and that the sleeve supplies a fluid through the interior passageway, instead disclosing the sleeve supplies a vacuum through the interior passageway.
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.
Renaud (US 4,984,563)
Witta et al. (US 5,313,934)
Schneider et al. (US 2009/0225159)
Dejima et al. (US 2017/0007105)
Wake et al. (US 2018/0084974)
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (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
