DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: Applicant is requested to amend the first paragraph of the specification to indicate that parent applications 16/030,533 and 15/081,147 are now U.S. Patent Nos. 11,491,346 and 10,016,619, respectively.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 recites that the tandem has a longitudinal portion and an angled portion; claim 9 recites that at least one of the first and second ovoids is coupled to the angled portion. While the tandem is taught to have an angled portion, there is no disclosure whatsoever of this angled portion being coupled to one of the ovoids. It is noted that claim 9 does recite “the angled portion of the ovoid assembly.” Thus it is difficult to determine what the angled portion is in reference to, as claim 8 calls it part of the tandem. If claim 8 is meant to describe the ovoid assembly and not the tandem, than there would be sufficient written description for claim 9.
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 9, 13-16 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the angled portion of the ovoid assembly" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “corresponding first and second inflatable ovoids” in lines 2-3. It is not clear if this is intended to refer to the first and second inflatable ovoids previously recited in claim 1 or to separate ovoids.
Claim 15 recites the limitation "the respective first and second ovoids" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “first and second radiation transfer catheter shafts” in lines 1-2. It is not clear if this is intended to refer to the first and second radiation transfer catheter shafts previously recited in claim 1 or to separate shafts.
Claim 16 also recites the limitation "the respective first and second handles" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 14-16 are rejected by virtue of their dependence upon claim 13.
Claim 20 recites the limitation “wherein the radioactive source is configured to be positioned outside the patient to deliver.” There appears to be missing language at the end of the claim; it is not clear what is intended to be recited.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 recites “wherein the first retractor is adapted to be positioned to retract the bladder of the patient during treatment and the second retractor is adapted to be positioned to retract the rectum of the patient during treatment.” This limitation already appears in claim 1, so claim 18 fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 3, 7-13, and 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Isham (U.S. No. 8,500,618; cited in the IDS filed 07 November 2022), in view of Van’t Hooft (EP 1695740 A1). It is noted that Isham is a continuation-in-part of Application No. 12/209,200, which has a filing date of 11 September 2008. Thus, the disclosure of Isham that is supported by this application also has an effective filing date of 11 September 2008. Accordingly, only the disclosure of Isham that is supported by the ‘200 application will be relied upon infra.
Regarding claim 1, Isham discloses a system for treating cervical and/or uterine cancers in brachytherapy with an intracavitary brachytherapy applicator 10 (Abstract), comprising: a tandem 12 adapted for insertion into a cervix of a patient (col. 8, lines 1-4); an ovoid assembly comprising first and second ovoids 14/16 (col. 6, lines 11-12) and an ovoid support mechanism (col. 6, lines 12-19), the first and second ovoids each adapted for insertion within fornices of the patient (col. 6, lines 60-61; col. 8, lines 4-5); and first and second retractors 22/80 adapted to be coupled to the ovoid assembly, wherein the first retractor is adapted to be positioned to retract a bladder of the patient during treatment and the second retractor is adapted to be positioned to retract a rectum of the patient during treatment (col. 8, lines 14-25; the priority application teaches a balloon with two separate chambers, which are taken to be the first and second retractors); wherein the tandem and the first and second ovoids are adapted to be coupled to a radioactive source to deliver a radiation dose to respective radioactive source locations via the tandem and first and second radiation transfer catheter shafts suitable for cancer treatment at a cancerous cervical treatment site in the patient (col. 2, lines 21-39; col. 4, lines 50-52). Isham fails to disclose that the ovoids are inflatable and each consisting of an inflatable balloon, as well as that during delivery of the radiation dose the first and second inflatable ovoids are configured to cause respective radioactive source locations to be positioned away from respective surfaces of a vaginal mucosa of the patient. Van’t Hooft discloses a similar system (Abstract) comprising a tandem 3 and first and second ovoids 6 ([0012]), the ovoids being inflatable and each consisting of an inflatable balloon in order to allow the system to be more easily introduced (Fig. 4; [0017]; claim 2). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the invention of Isham with inflatable ovoids each consisting of an inflatable balloon, as taught by Van’t Hooft, in order to allow the system to be more easily introduced. It is submitted that such inflatable balloon, being connected to the radiation transfer catheter shafts, are configured to cause respective radioactive source locations to be positioned away from respective surfaces of a vaginal mucosa of the patient during delivery of the radiation dose, as they are positioned against internal surface(s) of the vagina, so the catheter shafts are positioned away from this surface when the balloons are inflated.
Regarding claim 3, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid assembly comprises a tandem connector adapted to releasably and adjustably couple the tandem to the ovoid assembly (col. 2, lines 37-39; col. 6, lines 17-19).
Regarding claim 7, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the first and second retractors are adapted to be releasably coupled to the ovoid assembly (col. 6, lines 24-25; col. 7, lines 1-4).
Regarding claim 8, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the tandem comprises a longitudinal portion and an angled portion disposed at an angle relative to the longitudinal portion (Figs. 1, 4; tandem is curved/angled at its distal end).
Regarding claim 9, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Van’t Hooft further discloses that the angled portion forms an angle with the longitudinal portion, wherein at least one of the first and second ovoids is coupled to the angled portion of the ovoid assembly (Fig. 4). This rejection assumes that the angled portion is actually supposed to be part of the ovoid assembly and not the tandem. If the angled portion is supposed to be part of the tandem, neither of these references teaches claim 9; however, as detailed supra, claim 9 would lack sufficient written description.
Regarding claim 10, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid support mechanism is adapted to support the ovoids and to allow for user manipulation to control a relative position of the ovoids for insertion of the ovoids within the fornices of the patient (ovoid arm handles are able to allow for such user manipulation).
Regarding claim 11, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid assembly is adapted to be pre-assembled as a single unit prior to insertion into a vagina of the patient (col. 6, lines 11-19; col. 6, lines 50-57; capable of being pre-assembled and shown to be such a single unit with the retractors uninflated before insertion).
Regarding claim 12, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid assembly is configured to be simultaneously inserted into the patient as integrated pieces of the single unit (connected pieces of the single unit; can be simultaneously inserted).
Regarding claim 13, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid support mechanism comprises first and second handles 28 configured to allow angular movement of corresponding first and second inflatable ovoids (handles attached to the arms that have the ovoids attached thereto).
Regarding claim 16, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the ovoid assembly further comprises first and second radiation transfer catheter shafts at least partially housed within the respective first and second handles (col. 2, lines 21-39; col. 4, lines 50-52; radioactively chargeable components including a central tubular tandem and two tubular ovoids as a gynecological brachytherapy applicator).
Regarding claim 17, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Van’t Hooft further discloses that the first and second inflatable ovoids are adjustably inflatable, having a deflated configuration for insertion into the patient and one or more adjustably inflated configurations for positioning the ovoid assembly during treatment ([0017]).
Regarding claim 18, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the first retractor is adapted to be positioned to retract the bladder of the patient during treatment and the second retractor is adapted to be positioned to retract the rectum of the patient during treatment (col. 8, lines 14-25).
Regarding claim 19, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the first and second retractors are adjustably inflatable, having a deflated configuration for insertion into the patient and one or more adjustably inflated configurations for retraction of tissue during treatment (col. 6, lines 50-57).
Regarding claim 20, the combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, and Isham further discloses that the radioactive source is configured to be positioned outside the patient to deliver (Fig. 4; most of the system is positioned outside the patient during treatment; the radioactive source is applied through the tubular portions from outside the patient).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Isham and Van’t Hooft as applied to claim 1 above, and further in view of Lebovic et al. (U.S. Pub. No. 2009/0234176 A1; hereinafter known as “Lebovic”). The combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, but fails to disclose that the tandem comprises an endoscopic viewing element to facilitate positioning of the tandem. Lebovic discloses a similar system (Abstract; Fig. 5) wherein the applicators may include an endoscopic viewing element to facilitate positioning via direct visualization of the anatomy ([0011]; [0046]; [0064]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of Isham and Van’t Hooft with an endoscopic viewing element as part of the tandem, as taught by Lebovic, in order to allow for direct visualization of the anatomy during positioning of the tandem.
Claims 4-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Isham and Van’t Hooft as applied to claim 1 above, and further in view of Kumar (U.S. No. 4,331,131; cited in the IDS filed 07 November 2022). The combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, but fails to disclose a tandem connector adapted to allow for translational motion of the tandem relative to the ovoid assembly prior to insertion into a vagina of the patient but adapted to limit translational motion of the tandem thereafter, or adapted to limit rotational movement of the tandem about a longitudinal axis of the tandem. Kumar discloses a similar system (Abstract; Fig. 5) comprising a tandem connector 30/45 that is adapted to allow for translational motion of a tandem relative to an ovoid assembly prior to insertion into a vagina of a patient but adapted to limit translational motion of the tandem thereafter, and adapted to limit rotational movement of the tandem about a longitudinal axis of the tandem, in order to properly position and install the ovoid assembly relative to the tandem (col. 3, lines 46-60). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of Isham and Van’t Hooft with such a tandem connector as taught by Kumar in order to properly position and install the ovoid assembly relative to the tandem.
Claims 14 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Isham and Van’t Hooft as applied to claim 13 above, and further in view of Benson (U.S. Pub. No. 2010/0286465 A1). The combination of Isham and Van’t Hooft discloses the invention as claimed, see rejection supra, but fails to disclose that the ovoid assembly further comprises first and second inflation lumens at least partially housed within the respective first and second handles for inflating the respective first and second ovoids. Van’t Hooft does not expressly teach how its inflatable ovoids are inflated; it teaches elsewhere a supply tube guided along the catheters for inflating a different inflatable body. Benson discloses a similar system (Abstract) that incorporates both an inflation lumen and a radiation dosing lumen within a shaft ([0019]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of Isham and Van’t Hooft by incorporating the first and second inflation lumens within the respective first and second handles so that the lumens are at least partially housed within the handles, as taught by Benson, in order to reduce the number of tubes extending from the system, making it easier to manipulate and control and easing insertion/retraction.
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 1-7 and 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, and 9-16 of U.S. Patent No. 9,295,491. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claims 1 and 2 of the issued patent include all of the limitations of present claim 1; while the issued patent claims do not expressly call the ovoids a balloon, the inflatable ovoids recited by these claims may be reasonably taken to encompass a balloon. Claim 1 of the issued patent also includes the limitations of present claims 2-7 and 10-20; claims 3, 4, 6, 7, and 9-16 of the issued patent also include many of these limitations.
Claims 1-7 and 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-23 of U.S. Patent No. 9,295,856. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claim 3 of the issued patent includes all of the limitations of present claim 1; while the issued patent claim does not expressly call the ovoids a balloon, the inflatable ovoids recited by this claim may be reasonably taken to encompass a balloon. Claims 4-9 of the issued patent map to present claims 2-7; claim 3 of the issued patent also includes the limitations of present claims 10-20; claims 10-23 of the issued patent also include many of these limitations.
Claims 1-7 and 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-18 of U.S. Patent No. 10,016,619. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claim 3 of the issued patent includes all of the limitations of present claim 1; while the issued patent claim does not expressly call the ovoids a balloon, the inflatable ovoids recited by this claim may be reasonably taken to encompass a balloon. Claims 4-9 of the issued patent map to present claims 2-7; claim 3 of the issued patent also includes the limitations of present claims 10-20; claims 10-18 of the issued patent also include many of these limitations.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,491346. Although the claims at issue are not identical, they are not patentably distinct from each other because they recite essentially identical limitations such that they would not meet a one-way test for distinctness. Claim 1, 8, and 15 of the issued patent each include all of the limitations of present claim 1; claims 2-7 of the issued patent map to present claims 2-7; claims 1 and 8 of the issued patent include the limitations of present claim 8; claim 19 of the issued patent maps to claim 9; claim 1 of the issued patent also includes the limitations of present claims 10-20; claims 9-14, 16-18, and 20 of the issued patent also include many of these limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791