DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 9 May 2026. Claims 1-2, 4-6, 8, 10-12, 14-15 are now pending. The Examiner acknowledges the amendments to claims 1, 4, 6, 8, 14-15.
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)(5) because they do not include the following reference sign(s) mentioned in the description: “150”. Perhaps one of the reference signs “152” in new Fig. 8 should read –150--. 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.
Claim Objections
Claims 14, 15 is objected to because of the following informalities:
-Claim 14 recites “the second guide tube has a second pitch differs from” in line 3. Examiner recommends amending to –the second guide tube has a second pitch that differs from—
-Claim 15 recites “the dummy wire source” in line 2. Examiner recommends amending to –the dummy source wire—to remain consistent with verbiage in claim 10.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 15 recites “drive and control system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to extend the dummy wire from the cartridge. According to the specification the drive and control system includes wheels and a modular remote after loader (MRA) [0030 and 0031] and programmable logic controller [0054] and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 4, 6, 8, 10, 11, 12, 14, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thornton (U.S. 6048300).
Regarding Claim 1, Thornton teaches a cartridge that is configured to be received into a base defining a receptacle [Fig. 2, elements 20 (cartridge), 19 (receptacle and base)], the cartridge comprising: a radiation source [Abstract]—reference to radioactive sourcewire; a shield that is configured to receive the radiation source [Fig. 2, element 100 (source shield)]; a guidewire coupled to the radiation source [Col 6, lines 61-62]—reference to active sourcewire; and at least one motor that is configured to move the guidewire to thereby adjust a position of the radiation source [Fig. 2, element 42 (motor)] and [Fig. 5, element 66 (emergency retract motor)] and [Col 8, lines 12-17]—reference to the emergency retract motor retracting the sourcewire from the catheter in the patient, therefore adjusting the position of the source.
Regarding Claim 2, Thornton teaches further comprising: a housing [Col 5, line 21]—reference to a housing; a barrel that is coupled to the at least one motor so that rotation of the at least one motor causes the barrel to rotate within the housing about a rotational axis [Fig. 2, element 56 (active drive unit)] and [Col 10, lines 60]—drum having a rotational axis; a guide tube that is wrapped around the barrel and that is coupled to the housing so that it remains fixed within the housing as the barrel rotates [Fig. 2 elements 104 and 90 (tube) and take-off mechanisms)]; a carriage track that is coupled to the barrel so that the carriage track rotates around the rotational axis as the barrel rotates [Col 6, lines 64-67]—discloses the pivot blocks interpreted as the tracks, wherein the carriage track extends along the barrel in a direction that is parallel to the rotational axis [Col 6, lines 66-67]—describes the parallel passages and [Col 9, lines 61-64]—describes the pivot blocks and tubes guiding the structures in the helical groove in the drum which would include a direction parallel to the rotational axis; a carriage that is movable along the carriage track and simultaneously along the guide tube [Fig. 10, element 148 (slider)]; and a rotator that is housed within the carriage [Fig. 10, element 140 (rollers-low friction elements) so that the rotator is rotatable about an axis that is tangent to a direction of movement of the carriage, wherein the rotator is coupled to the guidewire so that as the carriage moves, the guidewire advances through the guide tube [Col 9, lines 23-26]—discusses advancement of the wire through the catheter (guide tube) and [Col 9, lines 46-51]—describes movement of the guidewire in a tangential axis to the periphery of the drum and slider.
Regarding Claim 4, Thornton teaches wherein the guide tube defines a helical groove [Col 9, lines 7-9].
Regarding Claim 6, Thornton teaches further comprising at least one encoder that is configured to measure a change in rotational position of the barrel [Col 8, lines 55-62]—refers to encoder and motor current sensor and [Col 10, lines 25-30]—describes adjusting angular position of the drive and drum system.
Regarding Claim 8, Thornton teaches further comprising a plurality of rollers that rotatably support an interior of the barrel [Fig. 10, elements 140 (rollers)]—also previously interpreted as “rotators” and [Col 9, lines 20-25]—describes the rollers surrounding the drum over the entire circumference and providing containment of the wire within supports.
Regarding Claim 10, Thornton teaches further comprising a dummy source wire [Col 6, lines 59-62]—reference to dummy wire.
Regarding Claim 11, Thornton teaches wherein at least a portion of the shield is removable and replaceable [Col 5, lines 18-27]—describes the shielding being contained within the cartridge and the cartridge being removable from the head of the device. Based on the interpretation of the limitations required by the claim, the shield meets the requirement of removal from the head as the limitation does not specify what reference structure the shield is removable or replaceable from.
Regarding Claim 12, Thornton teaches further comprising a loading port [Fig. 2, element 7 (catheter receiver assembly)], wherein at least a portion of the loading port is removable and replaceable [Col 7, lines 30-33]—describes the catheter being received in the assembly and attaching to the cartridge, therefore, being removable and replaceable.
Regarding Claim 14, Thornton teaches wherein the guide tube is a first guide tube having a first pitch [Fig. 2, element 92 (first take-off tube)] See annotated Fig. 2 below, wherein the cartridge is configured to receive a second guide tube in place of the first guide tube [Fig. 2, element 94 (second take-off tube)], and wherein the second guide tube has a second pitch differs from the first guide tube [Col 6, lines 66]—refers to the guide tubes being spaced into separate, parallel passages within the shield by tubes 102, 104 and See annotated Fig. 2 below which depicts the differing pitch/tilt of the guide tubes relative to one another.
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Regarding Claim 15, Thornton teaches further comprising a drive and control system that is configured to extend the dummy wire source from the cartridge [Cols 9 and 10, lines 65-3]—describes the active drive unit using the take-off tube to extend the wire through the tube into the catheter receiver as well as mentioning that the dummy drive unit (element 54) operates in the same manner.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thornton (U.S. 6048300) in view of Chi Sing (U.S. 20120108881).
Regarding Claim 5, Thornton is silent on wherein the shield has a quarter toroid shape. Chi Sing teaches wherein the shield has a quarter toroid shape [0055]—describes the supports including shielding that are shaped to a predetermined arcuate shape.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include certain structural elements with an arched shape as taught by Chi Sing to include in the design of the shielding element as suggested by Thornton, as Thornton discusses the object of the described invention as providing a fail-safe wire storage and delivery mechanism for retaining wire of the storage drum which is of a circular shape [Col 3, lines 37-45] and with Chi Sing because Chi Sing teaches the use of this shape to create rigid and bias within the elongate members of the applicator supports [0052].
Response to Arguments
Applicant's arguments filed 9 April 2026 with respect to the specification and abstract objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 9 April 2026 with respect to the drawing objections have been fully considered and are persuasive however, a new objection is presented in light of the newly added Fig. 8.
Applicant's arguments filed 9 April 2026 with respect to the claim objections have been fully considered and are persuasive however, new objections are presented in light of the amendments for claims 14 and 15.
Applicant's arguments filed 9 April 2026 with respect to claim interpretation under 35 U.S.C. 112(f) have been fully considered but are not persuasive. The examiner contends that one of ordinary skill in the art would be able to identify the structure for deploying the active source. The examiner contends that drive and control system embodies many forms of both drive systems and electrical control systems. For example this recitation could be referring to the motor, the controller, computer or processing units, the arms or shafts connected to the drive system, or any aspect of the drive and/or control system associated with extending the sources from the cartridge. In view of the foregoing, the examiner maintains claim interpretation of “drive and control system.”
Applicant's arguments filed 9 April 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive in light of the amendments.
Applicant’s arguments filed 9 April 2026 with respect to the rejection of
claims 1, 2, 4, 6, 8, 10, 11, 12, 14 and 16 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Regarding Claim 1, Applicant contends that the motor is external to the cartridge and separate from the cartridge in reference to the cited Fig. 2. While the applicant argues the emphasis placed between the mechanical couplings of the cartridge and the motor of the head, the examiner presents that the claim as presented does not define the motor of the cartridge requiring inclusion internally. The motor is electrically connected to the cartridge via electrical connections through the head and afterloader and therefore, provides the cartridge the ability to provide the required function of moving the guidewire to thereby adjust a position of the radiation source. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps MPEP 2111.03 Transitional Phrases. Therefore, the term comprising does not limit the structure to be located internal to or external to the recited apparatus. In view of the foregoing, the previously presented rejections for claims 1, 2, 4, 6, 8, 10, 11, 12, 14, and 16 citing Thornton are maintained.
Applicant’s arguments filed 9 April 2026 with respect to the rejection of claim 5 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Regarding claim 5, Applicant contends that Chi Sing does not teach “wherein the shield has a quarter toroid shape.” Specifically the applicant states that the supports do not comprise a shield and that these supports do not possess a quarter toroid shape in reference to Fig. 1, element 40 (supports). The reference provided by the examiner also cites paragraph [0055] which states that “the supports 40 may provide shielding” and that the supports are in “a predetermined arcuate shape.” The arcuate shape described in [0055] and shown in Fig. 1 are representative of a quarter toroid shape where the quarter toroid is interpreted to be the arcuate shape or apex of the elongate members that are expanded outwardly. In view of the foregoing, the previously presented rejections for claim 5 citing Thornton in view of Chi Sing are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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