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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “710” has been used to designate two different structures in figure 7.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…flexible material may enable the one or more positioning elements 330 to be inserted into the one or more holes 220 of the shaft 105 by a snap-fit and/or a form-fit…” in para.[64] needs to be corrected. A suggested correction is -- flexible material may enable the one or more positioning elements 330 to be inserted into the one or more holes 220 of the shaft 105 by a snap-fit and/or a form-fit coupling--. Alternative suggestion is –connection--.
“…flexible material may enable the one or more positioning elements 815 to be inserted into the one or more holes 720 of the base portion 125 by a snap-fit and/or a form-fit” in para.[64] needs to be corrected. A suggested correction is -- flexible material may enable the one or more positioning elements 815 to be inserted into the one or more holes 720 of the base portion 125 by a snap-fit and/or a form-fit connection-- needs to be corrected.
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 Objections
Following claims are objected to because of the following informalities:
Claim 20 recites “a source of radiation configured to be coupled to the plurality of connectors and to deliver radiation to a target location” which needs to be corrected. A suggested correction is -- a source of radiation configured to be coupled to the plurality of connectors [[and]] to deliver radiation to a target location--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 14-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 recites “A brachytherapy applicator for insertion into a body cavity… second plurality of projections configured to engage the second groove” which renders this claim unclear. More specifically, claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements and essential structural cooperative relationships of elements, such omission amounting to a gap between the elements and a gap between the necessary structural connections. See MPEP § 2172.01. The omitted elements and the omitted structural cooperative relationships are: the base portion and the base portion elements and base portion structural cooperative relationships with the shaft of the applicator that together form a brachytherapy applicator that can be inserted into a body cavity as also evidenced in instant application specification as-filed figures 1, 9-10, 12-13 and corresponding instant specification as-filed disclosure. Examiner suggests amending claim to include subject-matter in claim 17 such as the base portion and the base portion elements and base portion structural cooperative relationships with the shaft of the applicator to cure the noted issue. Dependent claims 15-16, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 15-16 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim 16 in lines 8-10 recites “the plurality of holes positioned circumferentially about the second central channel and configured to be coupled to the first plurality of lumens” which renders this claim unclear. More specifically, it is unclear as to which of preceding structures is configured to be coupled to the first plurality of lumens as recited in claim 16 line 10.
Dependent claims 17-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 17-20 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed paras. [0041-0049].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Contingently Allowable Subject-Matter
As per independent claim 14, independent claim 14 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 15-20, dependent claims 15-20 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 15-20, dependent claims 15-20 each is being 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 in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 14, the prior art of record fails to disclose or render obvious a brachytherapy applicator … comprising: a shaft … including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
Prior art US 20180085597 A1 to Isham et al. discloses a multi-channel cylinder brachytherapy applicator that is combined with real-time radiation sensor cables. More specifically, Isham discloses a brachytherapy applicator and radiation sensor device including a solid tubular body having a rounded distal end with the solid tubular body having a central hollow radiation lumen sized to receive an afterloader or a radiation source within 2 mm of a central hollow sensor lumen sized to receive a plastic scintillator detector cable; and the solid tubular body has one or more peripheral radiation lumens or radiation grooves sized to receive an afterloader or a radiation source, each within 2 mm of a peripheral sensor lumen or sensor groove sized to receive an PSD sensor cable. However, Isham does not disclose a brachytherapy applicator comprising a shaft including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
Prior art US 20110257459 A1 to Sutton et al. discloses brachytherapy applicators that is e radially and/or axially expandable to tailor the fit of the applicators to the surrounding gynecological tissues for delivering radiation therapy. More specifically, Sutton discloses brachytherapy applicators that comprise a modular support matrix that defines the arrangement of radiation source lumens within the brachytherapy applicator. The modular support matrix can be adjusted to position the radiation sources to obtain a certain dose and dose profile. A series of modular support matrices may be operably connected according to patient anatomy or dosing requirements. However, Sutton does not disclose a brachytherapy applicator comprising a shaft including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
Prior art US 20070270627 A1 to Cutrer et al. disclose a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity. However, Cutrer does not disclose a brachytherapy applicator comprising a shaft including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
Prior art US 20200316402 A1 to Yang et al. discloses a catheter apparatus that includes a tubular member; multiple fluid-flow pipe members, each having a proximal end and a distal end, and being disposed along a first axial direction of the tubular member; multiple node members disposed along a first axial direction of the tubular member, wherein two adjacent node members form a segment; and a periphery member, wherein the periphery member wraps the multiple node members to form a space with the segment formed between the two adjacent node members. However, Yang does not disclose a brachytherapy applicator comprising a shaft including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
Prior art US 12685879 B1 to Rahimian discloses systems and methods for treating cervical and/or uterine cancers in brachytherapy with an intracavitary brachytherapy applicator. The system comprises a tandem adapted for insertion into a cervix of a patient. An ovoid assembly comprises first and second inflatable ovoids and an ovoid support mechanism. First and second retractors are adapted to be coupled to the ovoid assembly. The first retractor is adapted to be positioned to retract the bladder of a patient during treatment. The second retractor is adapted to be positioned to retract the rectum of a patient during treatment. The tandem and the first and second inflatable ovoids are adapted to be coupled to a radioactive source to deliver an implant radiation dose suitable for cancer treatment at a cancerous cervical treatment site in a patient. However, Rahimian does not disclose a brachytherapy applicator comprising a shaft including a top surface adjacent the first end of the shaft, the top surface defining a first groove and a second groove, the second groove circumscribing the first groove; and a cap configured to be coupled to the first end of the shaft, the cap including, a mating surface configured to be coupled to the top surface of the shaft, a first plurality of projections extending from the mating surface, the first plurality of projections configured to engage the first groove, and a second plurality of projections extending from the mating surface and circumscribing the first plurality of projections, the second plurality of projections configured to engage the second groove including all the other features, structures, specific arrangement and combination of features and structures as in independent Claim 14.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in independent device claim 14 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 15-20, dependent claims 15-20 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20180289978 A1 to Mahal et al. discloses a two-step tapered applicator, similar to that disclosed. More specifically, Mahal discloses brachytherapy applicator including an elongated cylindrical body having a proximal end, a distal end, and a longitudinal axis that connects the proximal and distal ends of the cylindrical body, wherein the cylindrical body is sectioned along a plane spanning the longitudinal axis into first and second hemi-cylindrical bodies, wherein the first and second hemi-cylindrical bodies can slide longitudinally with respect to each other along the sectioning plane; wherein the surfaces of the first and second hemi-cylindrical bodies along the sectioning plane are indented such that, wherein the proximal ends of the first and second hemi-cylindrical bodies are aligned and the distal ends of the first and second hemi-cylindrical bodies are aligned, at least one single-opening channel is formed in the cylindrical body, wherein the at least one channel is situated longitudinally along the cylindrical body and has its single opening to the proximal end of the elongated cylindrical body; wherein, in the aligned applicator, the diameter of the distal end is larger than the diameter of the proximal end, and the cylindrical body has a tapering point along the longitudinal axis, wherein the diameter of the cylindrical body between the distal end and the tapering point is approximately the same, and the diameter of the cylindrical body gradually decreases between the tapering point and the proximal end.
Prior art US 20090209802 A1 to Francescatti et al. discloses applicator into which the source of radiation is positioned similar to that disclosed. More specifically, Francescatti discloses applicator apparatus for brachytherapy treatment of tissue surrounding a resection cavity in a patient.
Prior art US 20140121443 A1 to Van Erp et al. discloses modular brachytherapy applicator similar to that disclosed. More specifically, Van Erp discloses brachytherapy treatment modular applicator including a central core and an outer sleeve, the central core being adapted with a fixation mechanism for affixing the outer sleeve to the central core, wherein the outer sleeve is manufactured from a substantially rigid or shapeable material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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