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 .
Response to Amendment
Applicant’s Amendments, filed 9/1/2026, to claims 1-6, 8-10 acknowledged by Examiner. Additionally, applicant cancelled claim 7.
Claims 1-6, 8-10 are now pending.
Response to Arguments
Applicant's arguments filed 9/1/2026 have been fully considered but they are not persuasive.
Applicant asserts that neither RPD nor Frohlich provide for the amended language of “wherein the handle is arranged such that no portion of the handle extends radially outward beyond an outer periphery of the cover member”. However, Examiner disagrees as seen in the updated rejection below. Regarding RPD, Annotated Fig. 1-3 shows wherein the indicated handle goes up from the cover member and does not extend radially past the edges of the outer periphery of the cover member therein. Regarding Frohlich, the handle 3 as shown in Fig. 1-4 has an outer edge/surface being flush with the outer periphery of the cover member 1 such that as shown the handle 3 does not extend radially outward beyond the outer periphery of the cover member.
Applicant asserts that the teachings provided for claim 10 do not establish that the claimed composition would have resulted from routine optimization. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. See the rejection below which clearly provides under Mansour the teachings for routine optimization of the molybdenum. Examiner notes that Applicant’s arguments do not appear to apply to the teachings of Miles Free which do not rely on routine optimization as seen in the rejection below.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
See previously attached pdfs for NPL references as cited.
Claim Objections
Claim 4 objected to because of the following informalities:
Claim 4 recites “a bottom of the coupling protrusion” should be -the bottom of the coupling protrusion- (claim 4 depends on claim 3 which recites “a bottom of the coupling protrusion”)
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radiation Products Design (Tungsten Eye Shield manual, device sold/disclosed on website in 2016) (see attached NPL document) (henceforth “RPD”) in view of Frohlich (US 20110004969 A1).
Regarding claim 1, RPD discloses a crystalline lens protector for radiation therapy (Annotated Fig. 1, see page 3, tungsten lens protector for protection from electron therapy being radiation therapy), comprising:
a shield member configured to be attached to a front surface of an eyeball comprising a lens to shield the eyeball against radiation from a radiotherapy machine (See Annotated Fig. 1-3, indicated shield member, and page 4 step 5, tungsten eye shield member placed directly onto the eye lens therein, page 3 protects from radiation capable of being from a radiotherapy machine); and
a cover member installed on an outer surface of the shield member to block radiation that is backscattered from the shield member to an eyelid (See Annotated Fig. 1-3, indicated cover member installed on the outer surface of the shield member, page 3, cover member being the aluminum cap that blocks radiation backscatter),
wherein the cover member has a handle formed on an outer surface of the cover member (Pages 3-4, handle is the knob, Annotated Fig. 1-3, indicated handle, being the outer surface of the cover member having the female threading therein, thus the handle being formed on an outer surface of the cover member, also see wherein the indicated handle/cover member cap sits on top of the other portion of the cover member being formed therein),
wherein the handle is arranged such that no portion of the handle extends radially outward beyond an outer periphery of the cover member (See Annotated Fig. 1-3, wherein the indicated handle goes up from the cover member and does not extend radially past the edges of the outer periphery of the cover member therein).
RPD does not disclose the handle protruding eccentrically and obliquely with respect to a center of the cover member.
However, Frohlich teaches an analogous eye protection device (Fig. 1-4) having an analogous cover member 1 and analogous shield member 14 (Fig. 3), wherein the cover member 1 has a handle 3 formed on its outer surface (Fig. 1-4, [0021], handle 3 formed on the outer surface of the cover member 1), and the handle 3 is formed to protrude eccentrically and obliquely with respect to a center of the cover member (Fig. 1-4, the handle protrudes eccentrically and obliquely from the center of the cover member as shown), and further analogously wherein the handle 3 is arranged such that no portion of the handle 3 extends radially outward beyond an outer periphery of the cover member 1 (See Fig. 1-4, wherein the handle 3 peripheral edge/surface is flush with the outer periphery of the cover member 1, and thus is arranged such that it is not extending radially outward beyond the outer periphery of the cover member 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the handle of RPD to have the shape/structure of the handle 3 such that the handle protrudes eccentrically and obliquely with respect to a center of the cover member as taught by Frohlich in order to provide a stable planar grasping surface for the eye shield to be easily moved/grasped/removed (Frohlich [0023]).
Regarding claim 2, RPD in view of Frohlich discloses the invention of claim 1 above.
RPD further discloses the shield member has a coupling protrusion formed in a center of the outer surface of the shield member (See Annotated Fig. 1, shield member has a coupling protrusion extending from the center of the outer surface thereof);
the cover member has a coupling groove formed in a center of the inner surface of the cover member (See Annotated Fig. 1-3, wherein the cover member has an indicated coupling groove being a hole formed in its center that allows the coupling protrusion to pass therethrough, furthermore the indicated cover member cap/handle therein when assembled is formed on top of the cover member thereof and further contains a coupling groove formed at the center therein); and
the coupling protrusion has a male thread formed on an outer peripheral surface of the coupling protrusion (See Annotated Fig. 1, wherein the coupling protrusion has a male thread on its outer peripheral surface) and the coupling groove has a female thread formed on an inner peripheral surface of the coupling groove so that the shield member is screwed to the cover member (See Annotated Fig. 1, wherein the indicated cover member cap being part of the cover member groove has a female thread as seen therein formed on an inner peripheral surface so that the shield member coupling protrusion male threading can be screwed to the cover member, see page 4 for fastener/screwing instructions).
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Regarding claim 8, RPD in view of Frohlich discloses the invention of claim 1 above.
However, Frohlich further teaches wherein the handle 3 is in a form of a curved plate in which a widthwise middle part of the handle is convex outwardly relative to both ends of the handle (Fig. 1-4, the handle 3 is formed as a protruding plate shape, see Annotated Fig. 2, wherein the indicated widthwise middle part is convex outwardly from the two ends 16 on each side thereof).
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Regarding claim 9, RPD in view of Frohlich discloses the invention of claim 8 above.
RPD in view of Frohlich as combined is silent on wherein the handle has strap holes formed on both corners of a top of a handle for insertion of respective fixing straps thereinto.
RPD discloses providing a hole (strap hole) through a knob/handle for extending a suture string being a fixing strap for attaching the device to a patient’s forehead (Page 3).
Frohlich further teaches wherein the handle has two corners therein (Fig. 3, two corners at the top end of the handle).
Furthermore, Applicant specification lacks criticality/significant function on the placement of strap holes in corners of the handle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have placed strap holes as disclosed by RPD through the handle 3 both corners at the top of Frohlich for insertion of respective fixing straps thereinto as a matter of design choice, such a modification is held to be obvious since it has been held that "a mere rearrangement of parts was held to be an obvious matter of design choice" In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (See MPEP 2144.04 VI B). In the instant case Applicant's specification has not disclosed that placement of a strap hole at each of the corners of the handle provides an advantage, is used for a particular purpose, or solves a stated problem, and contrarily discloses that having strap holes formed on both corners is provided with the terminology of “may” thus not being significant to the function thereof (See specification [0085]). Therefore, the specific configuration is considered not critical to the functionality of Applicant's device and is considered to be a design choice obvious to one of ordinary skill in the art.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radiation Products Design (Tungsten Eye Shield manual, device sold/disclosed on website in 2016) (see attached NPL document) (henceforth “RPD”) in view of Frohlich (US 20110004969 A1) in view of Jones (US 5188495 A).
Regarding claim 3, RPD in view of Frohlich discloses the invention of claim 2 above.
RPD is silent on an O-ring made of elastic material on an outer periphery of a bottom of the coupling protrusion.
However, Jones teaches an analogous coupling protrusion 34 with male thread 36 (Fig. 1), wherein there may be provided an O-ring 22 made of elastic material (Col. 3 lines 8-24, Fig. 1, sealing ring 22 is an O-ring made from elastomeric material being elastic material) on an outer periphery of a bottom of the coupling protrusion (Fig. 1, O-ring 22 at a bottom of the coupling protrusion 34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the coupling protrusion of RPD to comprise the O-ring 22 and coupling protrusion structures therein as taught by Jones in order to provide sealing from dust/water/fluids from getting in between the shield and cover members therein (Jones Fig. 1).
Regarding claim 4, RPD in view of Frohlich and Jones discloses the invention of claim 3 above.
Jones further teaches wherein the O-ring is, at an inner periphery of the O-ring, inserted into and pressed against an undercut groove formed on the outer periphery of a bottom of the coupling protrusion (Fig. 1-4 of Jones, O-ring 22 and its inner periphery is inserted and pressed into the undercut groove 40 formed on the outer periphery of the bottom of the coupling protrusion 34).
Regarding claim 5, RPD in view of Jones discloses the invention of claim 4 above.
RPD in view of Jones further teaches wherein the O-ring is compressed between the shield member and the cover member (Jones Fig. 4 provides the O-ring being compressed between the analogous shield member 30 and the analogous cover member 12) (Annotated Fig. 1-3 of RPD, the shield and cover member in attachment are adjacent thus the provided O-ring placed therebetween would be compressed).
Regarding claim 6, RPD in view of Jones discloses the invention of claim 4 above.
RPD in view of Jones further teaches wherein the O-ring is configured such that a bottom of the O-ring is pressed against a flat surface formed around the coupling protrusion of the shield member (Jones Fig. 1-4, the O-ring 22 bottom pressed against a flat surface around the coupling protrusion 34) and a top of the O-ring is pressed against a portion around an entrance of the coupling groove of the cover member (Jones Fig. 1-4, top of the O-ring placed against adjacent structure 12 having an analogous entrance 18 of the analogous coupling groove 16 therein).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radiation Products Design (Tungsten Eye Shield manual, device sold/disclosed on website in 2016) (see attached NPL document) (henceforth “RPD”) in view of Frohlich (US 20110004969 A1) in view of Mansour et al (see attached pdf “Feasibility of polymer-based composite materials as radiation shield”).
Regarding claim 10, RPD in view of Frohlich discloses the invention of claim 1 above.
RPD does not explicitly disclose wherein the shield member comprises 89 to 90 wt % of tungsten (W), 6.5 to 6.8 wt % of nickel (Ni), 2.7 to 2.9 wt % of iron (Fe), 0.1 to 0.2 wt % of copper (Cu), and 0.15 to 0.2 wt % of molybdenum (Mo).
However, RPD does disclose wherein the shield member comprises
89 to 90 wt % of tungsten (W) (Page 5, tungsten shield member comprises 90% tungsten),
6.5 to 6.8 wt % of nickel (Ni) (Page 5, tungsten shield member comprises 0-10% nickel),
2.7 to 2.9 wt % of iron (Fe) (Page 5, tungsten shield member comprises 0-10% iron),
0.1 to 0.2 wt % of copper (Cu) (Page 5, tungsten shield member comprises 0-10% copper).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have found the percentage composition of Tungsten/Nickel/Iron/Copper obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
RPD does not disclose the shield member comprises 0.15 to 0.2 wt % of molybdenum (Mo).
However, Mansour et al teaches an analogous shielding member material being formed with a concentration of 5-15% of molybdenum (Mo) as a known additive material for radiating shielding (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided molybdenum to the shielding member of RPD in order to increase the radiation shielding of the material therein (Mansour Abstract). RPD and Mansour does not explicitly provide the wt% being 0.15 to 0.2% of molybdenum. However, it would have been obvious to find the % composition as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05. and as RPD as combined with Monsour et al provides molybdenum into the mixture of metals of RPD finding the optimum % of 0.15 to 0.2 wt % would be obvious to one of ordinary skill through routine experimentation therein.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radiation Products Design (Tungsten Eye Shield manual, device sold/disclosed on website in 2016) (see attached NPL document) (henceforth “RPD”) in view of Frohlich (US 20110004969 A1) in view of Miles Free (see attached pdf “4 Contributions to Steel” by Miles Free, published 2022).
Regarding claim 10, RPD in view of Frohlich discloses the invention of claim 1 above.
RPD does not explicitly disclose wherein the shield member comprises 89 to 90 wt % of tungsten (W), 6.5 to 6.8 wt % of nickel (Ni), 2.7 to 2.9 wt % of iron (Fe), 0.1 to 0.2 wt % of copper (Cu), and 0.15 to 0.2 wt % of molybdenum (Mo).
However, RPD does disclose wherein the shield member comprises
89 to 90 wt % of tungsten (W) (Page 5, tungsten shield member comprises 90% tungsten),
6.5 to 6.8 wt % of nickel (Ni) (Page 5, tungsten shield member comprises 0-10% nickel),
2.7 to 2.9 wt % of iron (Fe) (Page 5, tungsten shield member comprises 0-10% iron),
0.1 to 0.2 wt % of copper (Cu) (Page 5, tungsten shield member comprises 0-10% copper).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have found the percentage composition of Tungsten/Nickel/Iron/Copper obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
RPD does not disclose the shield member comprises 0.15 to 0.2 wt % of molybdenum (Mo).
However, Miles Free teaches that molybdenum can be added to metal alloys (such as steel) for improving hardenability, reducing embrittlement, enhancing creep strength, and adding corrosion resistance by adding molybdenum in the weight% range of 0.1-0.6% (page 2 of pdf).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided molybdenum 0.1-0.6 wt% to the shielding member metal composition of RPD in order to for improving hardenability, reducing embrittlement, enhancing creep strength, and adding corrosion resistance, wherein the range of 0.15 to 0.2 wt % of molybdenum is found obvious since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05.
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 KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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