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
A Species must be elected:
Species A: The hysteroscope system as discussed with reference to Figs. 1-3.
Species B: The hysteroscope system as discussed with reference to Figs.4-5
Species C: The hysteroscope system as discussed with reference to Fig. 6.
These species are independent or distinct because they have mutually exclusive characteristics, thus having a search and/or examination burden by requiring different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Further, the prior art applicable to one species would not likely be applicable to another species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are held to be generic. Further, applicants are required to point out which claims correspond with which species, including new or amended claims.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species 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)
(b) the species 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 inventions (ii) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143). and (iii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve 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 election of species 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 on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them 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 species 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 species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Stephen DiLorenzo on 22 September, 2026 a provisional election was made without traverse to prosecute Species B, Figs.4-5. Affirmation of this election must be made by applicant in replying to this Office action. Claims 2-21 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)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-6, 9, 11-16 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 11 of U.S. Patent No. 12,369,788 (henceforth ‘788). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Present claim 12 ‘788 claim 1 unless noted
A hysteroscopy system, comprising:
A hysteroscopy system, comprising:
a proximal housing;
an elongated tubular scope (the proximal portion of the elongated tubular scope could arbitrarily be considered a proximal housing)
an elongated tubular scope extending distally from the proximal housing and having an internal lumen extending longitudinally through the elongated tubular scope;
an elongated tubular scope having an internal lumen extending longitudinally through the elongated tubular scope; (non-proximal portions of the elongated tubular scope of ‘788 could be arbitrarily considered equivalent to this elongated tubular scope of the present claims
a wall extending across the elongated tubular scope to divide the internal lumen into a first portion having a first cross-sectional area and a second portion having a second cross-sectional area and fluidly isolated from the first portion, wherein the first portion defines an operative channel that fully occupies the first cross-sectional area; and
a wall extending across the elongated tubular scope to divide the internal lumen into a first portion and a second portion fluidly isolated from the first portion, wherein the first portion occupies a greater cross-sectional area of the internal lumen compared to the second portion, and wherein the first portion forms an operative channel that occupies a full cross-sectional area of the first portion of the internal lumen; and
a visualization device disposed within the second portion of the internal lumen, the visualization device occupying a cross-sectional area less than the second cross-sectional area such that the second cross-sectional area includes first and second free space portions that are not occupied by the visualization device, wherein the first free space portion is separate from the second free space portion,
a visualization device disposed within the second portion of the internal lumen and occupying less than a full cross-sectional area of the second portion of the internal lumen such that the second portion of the internal lumen includes a section on each side of the visualization device that is not occupied by the visualization device,
wherein the proximal housing and the operative channel are configured to receive a surgical tool inserted from a proximal end of the proximal housing through the proximal housing and through the operative channel.
wherein a device is configured for positioning within the operative channel (if the proximal housing is defined appropriately)
(claim 9) wherein the device is a rotary morcellator.
Independent claim 2 requires the same scope as Independent claim 12 except not requiring the second free space portion.
Claims 3-4 and 13-14 are anticipated by claim 1 of ‘788.
Claims 5-6 and 15-16 are anticipated by claims 1 and 9 of ‘788.
Claims 9 and 20 are anticipated by claim 11 of ‘788.
Claim 11 is anticipated by claim 1 of ‘788.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2-3, 7, 9, 11-13, 17-18 and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Muller et al. (US 5,807,240).
In regards to Claim 12, Muller discloses a hysteroscopy system, comprising:
a proximal housing [proximal portions of 48, 53, Figs.1b, 2-4; the proximal housing may be arbitrarily designated in this fashion];
an elongated tubular scope [remaining portions of 48, 53, Figs.1b, 2-4] extending distally from the proximal housing and having an internal lumen [56, 58, 68, 70, Figs.2-6] extending longitudinally through the elongated tubular scope;
a wall [66, wall between 56/68, 58, Figs.2-3, 5] extending across the elongated tubular scope to divide the internal lumen into a first portion [58 within 60, Figs.2-3, 5] having a first cross-sectional area and a second portion [area of 56, 68, Figs.2-3] having a second cross-sectional area and fluidly isolated from the first portion, wherein the first portion defines an operative channel [58 as seen in Fig.2] that fully occupies the first cross-sectional area; and
a visualization device [14, Fig.2, col.2 ll.26-45] disposed within the second portion of the internal lumen, the visualization device occupying a cross-sectional area less than the second cross-sectional area such that the second cross-sectional area includes first [left part of 68, Fig.2] and second free space [right part of 68, Fig.2] portions that are not occupied by the visualization device, wherein the first free space portion is separate from the second free space portion [these are different spaces occupying different coordinates, hence separate],
wherein the proximal housing and the operative channel are configured to receive a surgical tool [a surgical tool could be inserted into 70 and 58 through 46, Figs.1a-b, col.3 ll.25-30] inserted from a proximal end of the proximal housing through the proximal housing and through the operative channel.
Claim 2 requires the above, except for not requiring the second free space, hence is also anticipated by Muller.
Claim 11, depending from claim 2, additionally requires the second free space as disclosed by Muller above.
In regards to claims 3 and 13, Muller discloses the hysteroscopy system of claims 2 and 12, wherein the first cross-sectional area is different from the second cross-sectional area [Figs.2-3].
In regards to claims 7 and 18, Muller disclose the hysteroscopy system according to claims 2 and 12, wherein the visualization device includes fiber optics [col.2 ll.35-37] for illumination.
In regards to claims 9 and 20, Muller discloses the hysteroscopy system according to claims 2 and 12, wherein the elongated tubular scope is configured for simultaneous inflow and outflow of fluid through the internal lumen of the elongated tubular scope [title, col.1 ll.7-9, col.3 ll.27-50].
In regards to claim 17, Muller discloses the hysteroscopy system according to claim 12, wherein the visualization device is configured for illumination and image transmission [Fig.1a, col.2 ll.36-40].
Claims 2, 5, 11-12 and 15 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Watts et al. (US 2006/0149129).
In regards to claim 12, Watts discloses a hysteroscopy system [Fig.1, para.3-14: the device could be used in this fashion], comprising:
a proximal housing [12, Fig.1, para.31];
an elongated tubular scope [14, Fig.1, para.31] extending distally from the proximal housing and having an internal lumen [22a, 22c collectively, Figs.1, 3, para.33] extending longitudinally through the elongated tubular scope;
a wall [material between 22a and 22c, Fig.3, and including material extending to an other side of a cross-section of the elongate tubular scope] extending across the elongated tubular scope to divide the internal lumen into a first portion [22a, Fig.3, para.33] having a first cross-sectional area and a second portion [22c, Fig.3, para.33] having a second cross-sectional area and fluidly isolated from the first portion [Fig.1, 3], wherein the first portion defines an operative channel that fully occupies the first cross-sectional area [Figs.1, 3, para.33]; and
a visualization device [30, Figs.1, 3, para.36] disposed within the second portion of the internal lumen, the visualization device occupying a cross-sectional area less than the second cross-sectional area such that the second cross-sectional area includes first and second free space portions that are not occupied by the visualization device [Fig.3: the visualization device 30 is smaller than the second portion 22c, the free space remaining within 22c is arbitrarily dividable into first and second portions], wherein the first free space portion is separate from the second free space portion [the first and second free spaces are nonoverlapping, occupying different spaces],
wherein the proximal housing and the operative channel are configured to receive a surgical tool inserted from a proximal end of the proximal housing [22a, Fig.1, para.33] through the proximal housing and through the operative channel [22a, Figs.1, 3, para.33].
Claim 2 requires the above, except for not requiring the second free space, hence is also anticipated by Watts.
Claim 11, depending from claim 2, additionally requires the second free space as disclosed by Watts above.
In regards to claims 5 and 15, Watts discloses the hysteroscopy system according to claims 2 and 12, further comprising a surgical tool [para.33].
Claim Rejections - 35 USC § 102/103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10 and 21 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by Watts et al. (US 2006/0149129), or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Watts et al. (US 2006/0149129)
In regards to claims 10 and 21, Watts discloses the hysteroscopy system according to claims 2 and 12, wherein the proximal housing and the operative channel are capable of receiving a surgical tool having a diameter of 2.9 mm [Fig.3, para.33, 36: 22a and 22c being of the same diameter, and 22c handling a device of almost 4 mm diameter].
In the alternative, Watts discloses the hysteroscopy system according to claims 2 and 12, however does not positively disclose wherein the proximal housing and the operative channel are capable of receiving a surgical tool having a diameter of 2.9mm.
Watts further teaches wherein a channel of the proximal housing and the internal lumen is capable of receiving a surgical tool having a diameter of 2.9 mm [Figs.1, 3, para.36].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the proximal housing and operative channel disclosed by Watts to be capable of receiving a surgical tool having a diameter of 2.9 mm in accordance with the teaching of Watts. This would be done as Watts teaches this is known in the art, and for the predictable result of handling a greater variety of tools.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Watts et al. (US 2006/0149129) in view of Kumar et al. (US 2008/0091074).
In regards to claims 6 and 16, Watts discloses the hysteroscopy system according to claims 5 and 15, further wherein the surgical tool type is not limited [para.33].
However, Watts does not positively disclose wherein the surgical tool is a morcellator.
Kumar teaches an analogous endoscopic system, comprising a proximal housing [proximal end of 4, Fig.1, para.22], an elongated tubular scope [remaining portions of 4, Fig.1, para.22] extending distally from the proximal housing and having an internal lumen [9, Fig.1] extending longitudinally through the elongated tubular scope, a visualization device [5, Fig.1, para.27] disposed within the internal lumen,
wherein the proximal housing and an operative channel [portion of 9 containing 6, Fig.1] of the internal lumen receive a surgical tool [6, Fig.1, para.28] inserted from a proximal end of the proximal housing through the proximal housing and through the operative channel,
wherein the surgical tool is a morcellator [para.28].
Kumar teaches that the morcellator is provided for the purpose of surgery in hysteroscopic or urologic procedures [para.28].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the surgical tool disclosed by Watts to be a morcellator in accordance with the teaching of Kuman. This would be done for the purpose taught above, and as Kumar shows that it is known in the art.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (US 5,807,240) in view of Sherner et al. (US 2005/0085695).
In regards to claims 8 and 19, Muller discloses the hysteroscopy system according to claims 2 and 12, however does not positively disclose a valve coupled to the proximal housing and disposed in fluid communication with the internal lumen of the elongated tubular scope.
Muller further discloses the proximal housing is coupled to an inflow port [44, Figs.1a-b, col.2 ll.55: indirectly] in fluid communication with the internal lumen of the elongated tubular scope.
Sherner teaches an analogous hysteroscopy system wherein an inflow port [175, Fig.1d] comprises a valve [175, Fig.1d, para.45]. Sherner teaches that this is done for the purpose of controlling fluid inflow.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the inflow port disclosed by Muller to have a valve in accordance with the teaching of Sherner. This would be done for the purpose taught above.
Allowable Subject Matter
Claims 4 and 14 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and if the double patenting rejections hereinabove are overcome.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, a hysteroscopy system comprising:
a proximal housing, an elongated tubular scope and a visualization device,
the scope extending distally from the proximal housing and comprising an internal lumen extending longitudinally through the scope, wherein a wall extends across the scope to divide the lumen into first and second portions having respective first and second cross-sectional areas, the first and second portions fluidly isolated from one another,
the visualization device in the second portion, occupying a cross-sectional area than the second cross-sectional area, leaving a part of the second cross-sectional area unoccupied by the visualization device,
wherein the proximal housing and first portion are configured to receive a surgical tool inserted from a proximal end of the proximal housing through the proximal housing and through the first portion,
wherein the first cross-sectional area is larger than the second cross-sectional area.
Buerger (US 1,958,656) discloses the above except for the first and second portions being fluidly isolated.
Kuboto (US 4,706,656) discloses the above except for the wall.
Muller et al. (US 5,807,240) discloses the above except for wherein the first cross-sectional area is larger than the second cross-sectional area.
Watts et al. (US 2006/0149129) discloses the above except for wherein the first cross-sectional area is larger than the second cross-sectional area.
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.
Buerger (US 1,958,656)
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
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