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 .
Status of the Claims
Claims 1-5 are currently pending.
Response to Amendments
Applicant’s amendments filed 11/12/2025 have been entered.
Claims 1 and 2 have been amended.
The Section 102 rejections have been updated to reflect Applicant’s amendments.
Claim Rejections - 35 USC § 102
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirkpatrick et al. (US 2008/0123810 A1).
Regarding claims 1-3,
Kirkpatrick teaches a bolus forming material (Kirkpatrick: abstract). Kirkpatrick is silent towards the bolus forming material having a 30°C rubber hardness A of 20 degrees or more, and a 70°C rubber hardness E of 60 degrees or less and 10 degrees or more, and can shift a peak of a percentage depth dose for electron beams and X-rays in a direction of a beam source by 0.8 to 1.2 times a thickness thereof.
However, Kirkpatrick teaches the bolus forming material comprises: a rubber composition including a styrene-ethylene/propylene-styrene thermoplastic elastomers (a rubber composition that includes ethylene-propylene rubber as a main material with a temperature sensitive material, such as styrene, as ethylene-propylene would be 70% of the composition and styrene would be about 30%); a filler, such as silica, (a reinforcing agent that is a type that is utilized in Applicant’s specification); an oil, such as a mineral oil, (a softening agent where a mineral oil is a type of oil utilized in Applicant’s specification) (Kirkpatrick: par. 0025-0029, 0041, 0050). The filler may be added to adjust the density of the bolus material to be about 1.0 g/cm3 which is within the desired range of 0.9 to 1.2 g/cm3 in the specification (Kirkpatrick: par. 0029; Applicant’s Specification: par. 0047). The bolus material mimics the certain characteristics of human tissue when exposed to increasing dosage of radiation (Kirkpatrick: par. 0024).
As such, as the bolus material of Kirkpatrick is composed of substantially similar materials that are listed in Applicant’s specification resulting in a bolus material with similar structure such as having the same density and the desire to match the bolus material radiation characteristics to human tissue, it would be expected that the bolus material of Kirkpatrick would possess the same properties when tested in the claimed manner, such as the bolus forming material having the claimed hardness and would shift peak of a percentage depth dose for electron beams and X-rays when tested in the claimed manner. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01.
Regarding claim 4,
Kirkpatrick teaches the bolus forming material required by claim 1. Kirkpatrick teaches the thickness of the bolus material may be about 1.05 to about 1.1 cm (10.5 to 11 mm) which is within the claimed range of 0.1 mm to 50 mm (Kirkpatrick: par. 0042). The bolus may be shaped into any desired shape with Fig. 1 showing a plate-like shape (Kirkpatrick: Fig. 1; par. 0041 and 0042).
Regarding claim 5,
Kirkpatrick teaches the bolus forming material required by claim 1. Kirkpatrick is silent towards the bolus forming material having a transparency that allows one to confirm a marking at a treatment site through the bolus forming material during heating. However, as noted in the rejection of claims 1-4 above, Kirkpatrick teaches the claimed and disclosed material that would be expected to have the same properties. Additionally, Kirkpatrick teaches the bolus material is clearly transparent (Kirkpatrick: par. 0027). As such, the bolus material would be expected to allow one to confirm a marking to some degree at a treatment site through the bolus forming material during heating. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01.
Response to Arguments
Applicant’s arguments filed 11/12/2025 have been fully considered but they are not found persuasive.
Applicant argues that Kirkpatrick could not render the claimed rubber hardness A and peak depth dose for electron beams and X-ray properties inherent as the bolus forming material of Kirkpatrick is not a “rubber composition” and argues that the styrene-ethylene/propylene-styrene composition is a thermoplastic elastomer (TPE), which is not a rubber composition.
The argument is not found persuasive as the composition of Kirkpatrick is a rubber composition. Kirkpatrick explicitly teaches “bolus materials” mean a soft, “rubbery material” and TPEs are polymeric materials that demonstrate both elastomeric (rubbery) and thermoplastic properties at room temperature (Kirkpatrick: par. 0018 and 0031). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 I.
Applicant further argues that the bolus forming material an oil gel and thus not identical.
The argument is not found persuasive as the bolus material of the disclosed invention may also have an oil (Applicant’s specification: par. 0044 and 0050-0053). Additionally, Applicant has not provided evidence or proven beyond conclusionary statements, that the combination of the same compositions and additives as taught by Kirkpatrick would not form the claimed bolus material. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 2145 I.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Travis M Figg whose telephone number is (571)272-9849. The examiner can normally be reached M-F 9am-5pm.
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/TRAVIS M FIGG/Primary Examiner, Art Unit 1783
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