DETAILED ACTION
This action is pursuant to claims filed on 8/1/2025. Claims 1-6 are pending. A final action on the merits of claims 1-6 is as follows.
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 .
Claim Objections
Claims 4-6 are objected to because of the following informalities:
The claims state “securing means to secured the upper applicator housing shell”. This is written in the wrong tense. This should be corrected to –securing means to secure the upper applicator housing shell--.
Appropriate corrections are 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.
The following limitations are interpreted as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
Claims 3-6 utilize the limitation “securing means to secured the upper applicator housing shell”
The claim limitation uses the term “securing means” as a generic placeholder. Note that the generic placeholder lacks sufficient structure for performing the function and thus not limit the scope of the claim to any specific manner or structure for performing the claimed function.
The generic placeholder is modified by a functional language by the transition word “to”
The generic placeholder is modified by a functional language “secured the upper applicator housing shell” as opposed to a specific structure, material and/or acts that perform the function. Therefore, the claim limitation meets the 3-prong analysis.
For the purposes of this examination, the corresponding structures disclosed on pages 10 and 11 of the specification of the instant application, which state, “means are provided to secure the upper housing shell in treatment position, if desired, such as a catch to hold the upper applicator housing shell in position on the rails 68. The upper housing shell can also be secured in rest position.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fenn et al. (hereinafter ‘Fenn’, US 20040044385 A1) in view of Sun (US 20210339037 A1), and in further view of KR 101197568B1 (hereinafter ‘the ‘568 publication).
Regarding independent claim 1, Fenn discloses an electromagnetic energy applicator housing (100 in Fig. 7) for positioning an array of electromagnetic energy applicators (108) around an opening (300) adapted to receive a portion of a patient body ([0040], [0042], [0044] discuss treating the patient torso when the patient is inserted into the opening) having tissue therein in need of hyperthermia treatment ([0008]), wherein the electromagnetic energy applicator housing can move between an open condition (as broadly as claimed, the open position is simply a position prior to the treatment position that allows the patient to use the device; Fenn is capable of assuming said position [0039]: support member 400 can have a track or rails can guide the movement of the monopole array applicator 100 to traverse the patient positioning surface and improve positioning of the monopole antenna elements; this imparts the ability to move from one end of the tracks to another and movement to the most distal end of the track is interpreted as the open position as that is where the support surface would be exposed as in Fig. 11 which the patient then lies on) to directly receive a portion of the patient body having the tissue therein in need of hyperthermia treatment a closed condition for treatment (see Fig. 7 which displays the applicator housing 100 closed and surrounding the patient), comprising:
an elongate patient support surface (support 400 in Fig. 11 is elongated) for supporting the electromagnetic energy applicator housing and a patient to receive hypothermia treatment positioned in the electromagnetic energy applicator ([Claim 33]: the applicator support on which the waveguide rests; [Claim 34]: the apparatus comprises a non-conducting body support that is mounted to the waveguide aperture; Because the body support is mounted to the waveguide and the waveguide is mounted to the applicator support, the applicator support supports both the patient and the applicator);
a lower applicator housing shell (Fig. 7 upper housing shell which is the upper portion of shell 100) adjustably mounted on the patient support surface at a desired position along the elongate patient support surface ([0039]: support member 400 can have a track or rails can guide the movement of the monopole array applicator 100 to traverse the patient positioning surface and improve positioning of the monopole antenna elements for accurate heating of a tumor and the applicator ring is mounted on tracks), said lower applicator housing shell forming an inner lower substantially concave surface (see Fig. 7 with inner lower concave surface);
a lower bolus (lower portion of bolus 250 in Fig. 7) extending from the inner lower concave surface of the lower housing shell (see Fig. 7) and adapted to be filled with a dielectric fluid ([0040]: bolus is filled with water which is the dielectric fluid), said lower bolus having a lower bolus surface spaced from the inner lower concave surface when filled with a dielectric fluid (see the spacing in Fig. 7) and adapted to receive a portion of the patient body having tissue therein in need of hyperthermia treatment when the portion of the patient body having tissue therein in need of hyperthermia treatment is to be received in the electromagnetic energy applicator housing ([0040], [0042], [0044]: these paragraphs discuss treating the patient when the patient is inserted into the opening);
an upper applicator housing shell (Fig. 7 upper housing shell which is the upper portion of shell 100) movably mounted on the patient support surface (as broadly as claimed the upper housing is movable because the system is movable [0039]: support member 400 can have a track or rails can guide the movement of the monopole array applicator 100 to traverse the patient positioning surface and improve positioning of the monopole antenna elements; this imparts the ability to move from one end of the tracks to another) to be moved from a rest position along the elongate patient support surface (as broadly as claimed, the rest position is interpreted as a position prior to the treatment position that allows the patient to use the device; Fenn is capable of assuming said position [0039]: support member 400 can have a track or rails can guide the movement of the monopole array applicator 100 to traverse the patient positioning surface and improve positioning of the monopole antenna elements; this imparts the ability to move from one end of the tracks to another and movement to the most distal end of the track is interpreted as the rest position as that is where the support surface would be exposed as in Fig. 11 which the patient then lies on) to a treatment position over the lower applicator housing shell (the treatment position is interpreted as the closed position described above where the device is over the patient which is the target body of Fig. 11; additionally, the upper housing is always above the lower housing as they are connected and the claim does not require them to be separate parts), said upper applicator housing shell forming an inner upper concave surface (see inner upper concave surface in Fig. 7) that faces the inner lower concave surface to create an opening between the upper housing shell and the lower housing shell when the upper applicator housing shell is in treatment position over the lower applicator housing shell (the upper and lower concave surfaces face each other to form an opening when in the treatment position as seen in Fig. 7);
an upper bolus (upper portion of bolus 250 in Fig. 7) extending from the inner upper concave surface of the upper applicator housing shell (Fig. 7) and adapted to be filled with a dielectric fluid ([0040]: bolus 250 is filled with dielectric fluid which is the water disclosed);
a plurality of electromagnetic energy applicators (electromagnetic applicators 104/108) positioned on the inner lower concave surface of the lower housing shell and the inner upper concave surface of the upper housing shell (see Fig. 7 which displays applicators 108 positioned on the upper and lower concave surfaces) so as to create, when the upper housing shell is in treatment position over the lower housing shell, at least one ring of a plurality of electromagnetic energy applicators around the opening between the lower housing shell and the upper housing shell adapted to receive the portion of the patient body therein for hyperthermia treatment (see ring of applicators 108 in Fig. 7; [0033], [0042]).
However, Fenn does not disclose the upper and lower housing shells as two separate pieces or the specific details of how the upper and lower housing shells are movably mounted to the patient support.
Sun teaches a targeted hyperthermia system for tumor therapy and a control method thereof ([Abstract]). The hyperthermia apparatus body of Sun is used to provide a stable supporting surface for the patient and to provide mounting sites for related function devices ([Abstract]). Sun teaches two embodiments for the hyperthermia apparatus. The first teaches an apparatus where the treatment frame is entirely circular where the lower section and upper section are connected ([0107]). However, in this embodiment of Sun, the bed moves through the treatment area ([0107]). The second embodiment teaches two annular sections each mounted to its own set of sliding blocks ([0106]). The first annular section 6 is arc-shaped and mounted to the first sliding blocks at two ends, and the second annular section 7 is arc-shaped and mounted to the second sliding block 15 ([106]). It can be clearly seen in Fig. 5 that the upper portion of the mounting frame 5 connects to sliding blocks 13 to form the first section and the second section 7 is connected to the rail 14. Each section is mounted to its own set of sliding blocks which are disposed in their own sets of sliding rails ([0106]). Utilizing a system in which two separate annular sections are each mounted on the patient support allows for the application of radiation at any position on the human body from any direction without having to adjust the support body ([0106]). As seen in Figs. 4 and 5, the utilization of the second embodiment allows for the support system to support both the patient and the treatment device. The sliding blocks allow for the device to slide along the sliding rails ([0026]). This imparts the functionality that the treatment apparatus can be moved to the end of the support so the patient can enter and then apparatus can move over the patient for treatment. It would be of routine skill in the art to combine the second embodiment of Sun with that of Fenn such that the lower and upper housing shells were each mounted on slidable rails as they are both for the same treatment and operate in very similar manners. Additionally, it would maintain the operability of Fenn and allow for adjustments to be made without moving the patient support. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the second embodiment of sun with that of Fenn such that the lower and upper housing shells are separate entities each mounted on rails that allow for movement of the device along said rails without having to adjust the patient support.
Sun is acceptable prior art as it is used to teach limitations that were not previously disclosed in the provisional application filed 6/22/2015 or application 15/190,098 filed 6/22/2016 and was filed before the instant application.
However, the Fenn/Sun combination does not disclose that the upper housing shell moves independently away from the lower housing shell to form the rest or patient receiving position.
The ‘568 publication teaches a bed for the functional stimulation of the body which can include hyperthermia treatment ([0001]). As seen in Fig. 3, there are two independent applicators 50 and 60 that are each slidable relative to the patient. Warmer 50 is mounted on the rail 282 for slidable movement ([0044]) and emitter 60 is movable via the rotation of the screw 64 ([0046]). The invention of the ‘568 publication allows for a more comfortable user experience ([0014]). Furthermore, modifying the system of Sun such that the upper and lower applicators could move independently is of routine skill in the art as it simply requires applying power to one rail while holding the other still. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drive system of the Fenn/Sun combination such that the lower applicator and the upper applicator can move independently as taught by the ‘568 publication such that the upper applicator housing can be moved to one end of the bed to form an open, rest position and back over the lower applicator for a closed, treatment position to facilitate increased patient comfort prior to and during use.
Regarding claim 2, the Fenn/Sun/’568 combination discloses the electromagnetic energy applicator housing according to claim 1. The combination further teaches the elongate patient support surface includes opposite elongate sides (elongate sides highlighted below) and additionally including rails along the opposite elongate sides of patient support surface (Sun [0106]: sliding rail 12 is disposed at two opposite side walls of the support) and the upper applicator housing shell is configured to rest on and move along such rails between its rest position and its treatment position (Sun [0106]: the first annular section is connected to sliding blocks 13 at the two ends and the first sliding blocks are disposed in the first sliding rails 12; in the combination as described above the upper housing shell can move independently from a rest to treatment position).
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Regarding claim 3, the Fenn/Sun/’568 combination discloses the electromagnetic energy applicator housing according to claim 2, additionally including securing means to secured the upper applicator housing shell in treatment position when moved into treatment position (Fenn [0039]: Magnetic locks, for example, can be employed to maintain the physician selected treatment position of the monopole array applicator – magnetic locks are interpreted as being a type of catch as they form a catch to hold the applicator in place).
Regarding claim 4, the Fenn/Sun/’568 combination discloses the electromagnetic energy applicator housing according to claim 3, additionally including securing means to secured the upper applicator housing shell in rest position when moved into rest position (Fenn [0039]: Magnetic locks, for example, can be employed to maintain the physician selected treatment position of the monopole array applicator – magnetic locks are interpreted as being a type of catch as they form a catch to hold the applicator in place; additionally the use of multiple locks, which is disclosed by the plurality of “magnetic locks”, imparts the ability to have multiple positions, one of which can be the most distal, rest position since the applicator traverses the entire patient positioning surface as described in [0039] – the magnetic locks are capable of holding the applicator in the rest position).
Regarding claim 5, the Fenn/Sun/’568 combination discloses the electromagnetic energy applicator housing according to claim 1, additionally including securing means to secured the upper applicator housing shell in treatment position when moved into treatment position (Fenn [0039]: Magnetic locks, for example, can be employed to maintain the physician selected treatment position of the monopole array applicator – magnetic locks are interpreted as being a type of catch as they form a catch to hold the applicator in place).
Regarding claim 6, the Fenn/Sun/’568 combination discloses the electromagnetic energy applicator housing according to claim 5, additionally including securing means to secured the upper applicator housing shell in rest position when moved into rest position (Fenn [0039]: Magnetic locks, for example, can be employed to maintain the physician selected treatment position of the monopole array applicator – magnetic locks are interpreted as being a type of catch as they form a catch to hold the applicator in place; additionally the use of multiple locks, which is disclosed by the plurality of “magnetic locks” imparts the ability to have multiple positions, one of which can be the most distal, rest position since the applicator traverses the entire patient positioning surface as described in [0039] – the magnetic locks are capable of holding the applicator in the rest position).
Response to Arguments
Applicant’s arguments, see page 4, filed 8/1/2025, with respect to the drawing objections have been fully considered and are persuasive. The objections of the drawings have been withdrawn.
Applicant’s arguments with respect to claim 1 regarding Fenn not disclosing separable upper and lower housings have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 8/1/2025 regarding Sun have been fully considered but they are not persuasive. While Sun is not used to teach independently moving housing pieces as the new claim requires, Sun does teach two separate portions for the mounting frame 5. Sun teaches the first annular section 6 is arc-shaped and mounted to the first sliding blocks at two ends, and the second annular section 7 is arc-shaped and mounted to the second sliding block 15 ([0106]). It can be clearly seen in Fig. 5 that the upper portion of the mounting frame 5 connects to sliding blocks 13 to form the first section and the second section 7 is connected to the rail 14. Each section is mounted to its own set of sliding blocks which are disposed in their own sets of sliding rails ([0106]). Because the two sections are not integral to each other and reside on their own set of sliding blocks, it would be of routine skill in the art to modify the drive system such that the upper portion can move independently of the bottom portion as taught by the ‘568 publication. Therefore, because it would be an obvious modification of Sun to make the portions of the frame 5 move independently allowing for an open, rest position and a closed position over the lower portion, the rejection is maintained.
Response to Amendment
The amendment of claim 2 rectifies the 112b rejection noted in the Non-Final Rejection dated 5/1/2025. The 112b rejections of claims 2, 3, and 4 have been withdrawn.
The amendment of claim 3 rectifies the claim objection of claim 3 noted in the Non-Final Rejection dated 5/1/2025. The objection of claim 3 has been withdrawn.
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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
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