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 .
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. Accordingly, the benefit of foreign priority under 35 U.S.C. 119(a)-(d) is obtained.
Claim Interpretation
In regards to claim 1, the claim recites “an other end of the operation sleeve is closed by a closure structure, and the closure structure is provided with a port for a hysteroscopic lens to pass through” [lines 2-4]. This other end is “closed” but is also open to an unknown degree as it has a port. Therefore, this clearly includes any proximal end to the operation sleeve that has a port (ie. an opening). Effectively, requiring the port negates the “closed” status of the operation sleeve because of the particular way it was claimed.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
In claims 1-20, the claims read “A dual-channel instrument guiding device for hysteroscope” [claim 1, line 1] or “The dual-channel instrument guiding device for hysteroscope” [claims 2-20, line 1]. It is clear that “a hysteroscope” or “hysteroscopes” was intended to be recited in this line instead of simply “hysteroscope”.
Claims 2, 5-6, 11, 15, 17 and 19 do not provide indentation where new items are provided. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP 6.08.01 (m).
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 7-9 and 15-20 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 7, the claim reads “the outer wall” [line 2]. There is insufficient antecedent basis for this limitation in the claim. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed this is a newly recited item.
In regards to claim 8, the claim reads “the outer wall” [line 2]. There is insufficient antecedent basis for this limitation in the claim. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed this is a newly recited item.
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 and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Nakao (US 2005/0085691).
In regards to Claim 1, Nakao discloses a dual-channel instrument guiding device for hysteroscope, comprising:
an operation sleeve [32, Figs.1-2], wherein one end of the operation sleeve is open [distal end of 32, Figs.1-2], an other end of the operation sleeve is closed by a closure structure [proximal end of 32, Figs.1-2, see the claim interpretation section hereinabove], and the closure structure is provided with a port [opening at proximal end of 32, Fig.1] for a hysteroscopic lens to pass through [para.11, Fig.1, and Scope 22, 38, Figs.1-3, para.24, 27 has distal lens 30 and may be used as a hysteroscope]; and
a cavity dividing piece [18, 20, Figs.1-3], wherein the cavity dividing piece is disposed in the operation sleeve and divides an interior of the operation sleeve into three channels [2 of 24, 26, and channel containing 22, Fig.2] isolated from one another, each of the channels extends in an axial direction of the operation sleeve, one of the channels is used as a lens channel for the hysteroscopic lens to pass through [para.11, Fig.1, and Scope 22, 38, Figs.1-3, para.24, 27 has distal lens 30 and may be used as a hysteroscope], and remaining two of the channels are used as instrument channels for surgical instruments to pass through [Fig.1, para.24, 26].
In regards to Claim 4, Nakao discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the operation sleeve and the cavity dividing piece are integrally formed [The device could be made in this fashion. Note that the applicant has not required they be one piece not detachable from each other during ordinary use. Note that after this office action, the applicant will have received examination on the art for claims 5-6 which requires these are detachable during ordinary use, and therefore if claim 4 is narrowed to be drawn to a different embodiment than claims 5-6, claim 4 will be restricted and withdrawn by rationale of original presentation.].
In regards to Claim 10, Nakao discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the closure structure and the operation sleeve are integrally formed [they could be formed in this fashion], the closure structure is an elastic closure structure [all material objects have the property of elasticity], and the port provided in the closure structure is a cut [the port could be manufactured in this fashion].
Claims 1-2, 4, 7, 10-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Qi (US 2016/0120395).
In regards to claim 1, Qi discloses a dual-channel instrument guiding device for hysteroscope, comprising:
an operation sleeve [2, Figs.1-2, 6, para.36, 42], wherein one end of the operation sleeve is open [Figs.1-3, 6, para.36, 42: optically open for the scope channel, physically open for the tool channels], an other end of the operation sleeve is closed by a closure structure [5-7, Figs.1, 8, 10 and 12-13, note 5 is unlabeled in Fig.8, further note the claim interpretation section hereinabove], and the closure structure is provided with a port [rear end of 7, Figs.1, 10, 12-13, para.36, 38] for a hysteroscopic lens to pass through [Fig.13, para.36, 44, note the hysteroscope and hysteroscopic lens are not positively claimed and a hysteroscope with a distal lens could be used here]; and
a cavity dividing piece [26 and internal structure of 2, Fig.6, para.36, 42], wherein the cavity dividing piece is disposed in the operation sleeve and divides an interior of the operation sleeve into three channels [21 and left and right instances of 23, Fig.6, para.42] isolated from one another, each of the channels extends in an axial direction of the operation sleeve, one of the channels is used as a lens channel for the hysteroscopic lens to pass through [para.36, 44, see above discussion of the lens], and remaining two of the channels are used as instrument channels for surgical instruments to pass through [para.42].
In regards to claim 2, Qi discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the cavity diving piece comprises:
a cylindrical guide tube [26, Figs.6, 8, para.35-36, note that 26 is unlabeled in Fig.8], wherein the cylindrical guide tube is sleeved with the operation sleeve and arranged in the axial direction of the operation sleeve, both ends of the cylindrical guide tube are open, and the lens channel [21, Fig.6, para.36, 42] is arranged in the cylindrical guide tube;
the cylindrical guide tube and the operation sleeve are tangential and connected at a tangent point [Fig.6: connected at least slidably], and an annular cavity channel [channels 23, Fig.6: this is a singular channel in the same sense as the applicant’s disclosed annular cavity channel (which is also divided). While the applicant is entitled to be their own lexicographer, this language should be changed.] is formed between an outer wall of the cylindrical guide tube and an inner wall of the operation sleeve; and
a cavity separating plate [the bridge beneath 26 arcing across the interior of 2, Fig.6], wherein the cavity separating plate is disposed in the annular cavity channel and arranged in the axial direction of the operation sleeve, so as to separate the annular cavity channel into two instrument channels [“left” and “right” 23, Fig.6] isolated from each other in a circumferential direction of the annular cavity channel.
In regards to claim 4, Qi discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the operation sleeve and the cavity dividing piece are integrally formed [The device could be made in this fashion. Note that the applicant has not required they be one piece not detachable from each other during ordinary use. Note that after this office action, the applicant will have received examination on the art for claims 5-6 which requires these are detachable during ordinary use, and therefore if claim 4 is narrowed to be drawn to a different embodiment than claims 5-6, claim 4 will be restricted and withdrawn by rationale of original presentation.].
In regards to claim 7, Qi discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the outer wall, close to the other end that is closed, of the operation sleeve is provided with two instrument inlets [Where 22 meets 2, Fig.8, para.42, note that 2 is not labeled in this figure. Further note that as separate channels 23 run the length of 2, that their inlets at the proximal end of 2 within 5 will likewise be separate.], and the two instrument inlets are communicated with the two instrument channels, respectively.
In regards to claim 10, Qi discloses the dual-channel instrument guiding device for hysteroscope according to claim 1, wherein the closure structure and the operation sleeve are integrally formed [they could be manufactured in a fashion comprising this step], the closure structure is an elastic closure structure [all material objects have the property of elasticity], and the port provided in the closure structure is a cut [the port could be manufactured in this fashion].
In regards to claims 11 and 15, Qi discloses the dual-channel instrument guiding device for hysteroscope according to claims 4 and 7, respectively, wherein the cavity diving piece comprises:
a cylindrical guide tube [26, Figs.6, 8, para.35-36, note that 26 is unlabeled in Fig.8], wherein the cylindrical guide tube is sleeved with the operation sleeve and arranged in the axial direction of the operation sleeve, both ends of the cylindrical guide tube are open, and the lens channel [21, Fig.6, para.36, 42] is arranged in the cylindrical guide tube;
the cylindrical guide tube and the operation sleeve are tangential and connected at a tangent point [Fig.6: connected at least slidably], and an annular cavity channel [channels 23, Fig.6: this is a singular channel in the same sense as the applicant’s disclosed annular cavity channel (which is also divided). While the applicant is entitled to be their own lexicographer, this language should be changed.] is formed between an outer wall of the cylindrical guide tube and an inner wall of the operation sleeve; and
a cavity separating plate [the bridge beneath 26 arcing across the interior of 2, Fig.6], wherein the cavity separating plate is disposed in the annular cavity channel and arranged in the axial direction of the operation sleeve, so as to separate the annular cavity channel into two instrument channels [“left” and “right” 23, Fig.6] isolated from each other in a circumferential direction of the annular cavity channel.
(the texts of claims 11 and 15 are identical to claim 2, except for depending from different claims)
Allowable Subject Matter
Claims 2, 5-6 and 12-14 would be allowable if rewritten to overcome the claim objections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 8-9 and 16-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action, to overcome the claim objections 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 hysteroscope and instrument guiding device, comprising:
a sleeve, wherein one end of the sleeve is open, the other end has a closure structure, the closure structure having a port for a lens of the hysteroscope to pass through,
a divider, the divider disposed in the sleeve such as to divide an interior of the sleeve into three channels isolated from one another, each of the channels extending in an axial direction of the sleeve,
one of the channels being a lens channel for the hysteroscope lens to pass through,
remaining two of the channels being instrument channels for surgical instruments to pass through,
(claims 3, 12 and 16, which have identical texts except for depending from different claims) wherein the divider comprises a guide tube and separating plate,
the guide tube being cylindrical, is sleeved in the sleeve and arranged in the axial direction of the sleeve, both ends of the guide tube being open, and the lens channel being in the guide tube,
the guide tube and sleeve being tangential and connected at a tangent point, the instrument channels formed between an outer surface of the guide tube and an inner surface of the sleeve, the instrument channels being isolated from one another in a circumferential direction by a cavity separating plate within the sleeve and outside the guide tube,
the cavity separating plate being a flat plate, where the two instrument channels are symmetrically distributed on both sides of the plate,
(claim 5) the guide tube being cylindrical, is sleeved in the sleeve and arranged in the axial direction of the sleeve, both ends of the guide tube being open, and the lens channel being in the guide tube,
the guide tube and sleeve being tangential and connected at a tangent point, the instrument channels formed between an outer surface of the guide tube and an inner surface of the sleeve, the instrument channels being isolated from one another in a circumferential direction by a cavity separating plate within the sleeve and outside the guide tube,
wherein the guide tube is detachably connected to the inner wall of the sleeve via a rail-and-groove system,
(claim 6) the guide tube being cylindrical, is sleeved in the sleeve and arranged in the axial direction of the sleeve, both ends of the guide tube being open, and the lens channel being in the guide tube,
the guide tube and sleeve being tangential and connected at a tangent point, the instrument channels formed between an outer surface of the guide tube and an inner surface of the sleeve, the instrument channels being isolated from one another in a circumferential direction by a cavity separating plate within the sleeve and outside the guide tube,
wherein the cavity separating plate is detachably connected to the guide tube and inner wall of the sleeve via a rail-and-groove system,
(claim 8) an outer wall of the sleeve, near the end of the outer sleeve at the closure structure, has a water inlet and a water return connector, the water inlet and water return connectors communicated respectively with the two instrument channels.
Nakao (US 2005/0085691) discloses the above except for:
(claims 3, 5-6, 12 and 16) the arrangement of the instrument channels, the cavity separating plate, and the underlined specifics discussed in regards to the specific claims,
(claim 8) the outer wall of the sleeve having the water inlet and water return connectors.
Qi (US 2016/0120395) discloses the above except for:
(claims 3, 5-6, 12 and 16) the underlined specifics discussed in regards to the specific claims,
(claim 8) the outer wall of the sleeve having the water inlet and water return connectors, or the water inlet and return connecters being communicated respectively with the two instrument channels.
Sherner (US 2005/0085695) discloses a hysteroscope system with a sleeve that, in cooperation with a divider defines four separate channels: one that holds a hysteroscope, one for fluid outflow, one for fluid inflow, and one for pressure sensing.
Sahney et al. (US 2012/0078038) discloses a hysteroscope system with a sleeve cooperating with a divider therein to create two fluid flow channels and a channel for a hysteroscope.
Germain et al. (US 2017/0055811) discloses a hysteroscope with a guide tube configured to go on an outside of the operation sleeve, the guide tube having instrument or water channels therein.
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:
Sherner (US 2005/0085695)
Sahney et al. (US 2012/0078038)
Germain et al. (US 2017/0055811)
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