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
Claims 16, 22, 23, 25, 28, 29, 34, 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected –invention--, there being no allowable generic or linking claim. Cancellation of claims 3, 7, 9, 13, 17-21, 24, 27, 30-33 is acknowledged. Election was made with traverse in the reply filed on 12/1/25. Applicant’s election with traverse of Claims 1-2, 4-6, 8, 10-12, 14-15 in the reply filed on 12/1/25 is acknowledged.
Applicant's election with traverse of Group I in the reply filed on 1 December 2025 is acknowledged. The traversal is on the ground(s) that the claims include special technical features that are not included over the prior art reference Shani (U.S. 200902346126). The examiner maintains the Unity of Invention Restriction Requirement in regards to the special technical feature of “a cartridge that is configured to be received into a base defining a receptacle” due to the broad recitation and interpretation of configured to be received. This functional language is not required to be considered during the analysis of special technical features. Furthermore, the broad nature of this recitation would include any cartridge located within or adjacent to the base and lead box. The Shani reference discloses a cartridge, element 91, that is contained within the lead box or base, element 97, and fulfills the requirement of the limitation: “configured to be received into a base.”
Furthermore, the amendments to claim 34 to include language consistent with claim 1 do not overcome the grounds of the restriction because the amended claim 34 still remains consistent with the grouping restriction rationale associated with claim 16 due to the recitation of an “afterloader base.”
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “guide tube defines a helical notch,” “quarter toroid shape” and “dummy source wire” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 abstract of the disclosure is objected to because:
-Line 2 recites “brachy therapy”. Examiner recommends amending to –brachytherapy—
-Line 2 recites “the cartridge configured”. Examiner recommends amending to –the cartridge is configured—
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The use of the term “Varian Varisource” in [0045], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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
Claims 6, 14, 15 are objected to because of the following informalities:
-Claim 6 recites “claim 1s,” in line 1. Examiner recommends amending to –claim 1,--
-Claim 14 recites “wherein the second guide” in lines 2-3. Examiner recommends amending to –and wherein the second guide—
-Claim 15 recites “the dummy wire” in line 2. Examiner recommends amending to –the dummy source wire—
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 15 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 1 recites “the position of the radiation source” in line 6. There is insufficient antecedent basis for this limitation in the claim.
-Claim 4 recites “the guide tube” in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 6 recites “the barrel” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 6 recites “an angular displacement of the barrel” in line 2. It is unclear what displacement is measured in relation to. Further clarification should be provided to define whether this is measuring displacement from the rotational axis or a separate embodiment.
-Claim 8 recites “the barrel” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 14 recites “wherein…differs from the first guide tube in pitch” in lines 2-3. It is unclear what is meant by this recitation in terms of the difference between the first and second guide tube. Further clarification should be provided to identify whether this limitation requires that the pitch of each guide tube differs from one another, whether the pitch of an alternative structure separates the guide tubes or a separate embodiment.
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.
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.
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:
Claim(s) 1, 2, 4, 6, 8, 10, 11, 12, 14, 16 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 the 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 (guidetube) 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 notch [Col 9, lines 7-9].
Regarding Claim 6, Thornton teaches further comprising at least one encoder that is configured to measure an angular displacement 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 [Fig. 2, element 92 (first take-off tube)], 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)], wherein the second guide tube differs from the first guide tube in pitch [Col 6, lines 66]—refers to the guide tubes being spaced into separate, parallel passages within the shield by tubes 102, 104. It can therefore be understood that since the tubes are located within different guide passages, they differ from each other in terms of pitch.
Regarding Claim 15, Thornton teaches further comprising a drive and control system that is configured to extend the dummy wire 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].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Lamoureux (U.S. 20080009661)—describes an afterloader device with a removable shield
-Bueche (U.S. 5851172)-includes reference to an arcuate shielded compartment with tubular guide channels
-Sauerwein (U.S. 4631415)-references drive systems used within a shielding container that houses radiation sources and coupling elements that drive movement within cables and hose elements to promote movement.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at 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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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791