DETAILED ACTION
Claim Objections
Claim 1 is objected to as it should recite “A personalized eye protection block” to provide antecedent basis to the claim.
Claim 2 is objected to because it should recite “A production of a personalized eye protection block”
Claim 2 is objected to because of the following informalities:
Claim 2 has a period at the end of clause “c”. MPEP 608.01 (m) recites “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations”.
Appropriate correction is required.
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 acrylic outer coating 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 lacks written description for requiring each step a)-b) and d)-e) in the production method. Specifically, the instant specification merely reiterates the same results of mixing, making a mold, creating a reverse mold, cleaning the unwanted particles and covering the eye protection with a very thin layer of acrylic (dental jaw prosthesis material” see page 2. However, there is no detailed disclosure as to how each result is achieved. For instance, by what method the components are mixed, the mold is made, the reverse mold created, what a zero sandpaper is and by what method the model is cleaned and how the thing layer of acrylic covers the eye protection. MPEP 2163.03 (V) recites:
“An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved ”
Here, except for nearly the exact recitation of the claims, there is no disclosure as to how each step of a)-b) and d)-e) are achieved.
MPEP 2163.02 recites:
“Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983))”
Here, the specification does not clearly demonstrate how any of the steps are achieved except to state that they are performed. This is evidenced by the fact the detailed description is only 1 page long reiterating the same claimed steps. This does not reasonably convey, how the mixing of the alloy is preformed, how the molds are created, what is intended to be meant by zero sandpaper and by what method it cleans the alloy and finally by what process the acrylic layer is applied.
MPEP 2163 (II) 3 a recites:
“'consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification.’ It is not enough for the patentee simply to state or later argue that persons of ordinary skill in the art would know what structures to use to accomplish the claimed function."), quoting Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1380, 53 USPQ2d 1225, 1229 (Fed. Cir. 1999); Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946, 953, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) ("The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure.")”
Here, as discussed below the steps would have been known to the art, however the question is not simply whether one skilled in the art would be capable of performing the claimed method, the question is whether one of ordinary skill in the art would understand the specification itself to disclose the structure to perform the claimed manufacture.
Therefore, claim 2 fails to meet the written description requirement as required under 35 USC § 112(a).
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 are 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.
Claims 1 and 2 are vague and indefinite for reciting “personalized eye protection block” because it is not clear what is meant by personalized. The specification is also unclear. In other words, is it personalized when positioned on the patient or is it personalized by some structure.
Claim 2 is vague and indefinite for reciting “mixing of bismuth, cadmium, tin and lead in certain proportions (50% bismuth, 26.7% lead, 13.3% tin and 10% cadmium) and in this case, making easy to process and reducing the melting temperature to 70 C”. Specifically it is not clear whether the mixing results in an alloy with a melting temperature to 70 degrees C or if the claim is suggesting some unclaimed step so as to reduce the melting temperature to 70 degrees C. Since this alloy is known to the art to have the claimed melting temperature (see evidence provided in Cs Alloys attached herewith), it is interpreted that the mixing of the alloy results in the claimed melting temperature.
Claim 2 recites the limitation "the person’s eye" in line 1 of clause b). There is insufficient antecedent basis for this limitation in the claim.
Claim 2 is vague and indefinite for reciting “with zero sandpaper” because it is not clear whether this is suggesting no sandpaper is used or if this is suggesting some sort of sandpaper. No unambiguous determination can be made.
Claim 2 is vague and indefinite for reciting “a very thin layer of acrylic” because it is not clear what is meant by very thin. MPEP 2173.05 (b) recites “ If the specification does not provide some standard for measuring that degree, a determination must be made as to whether one of ordinary skill in the art could nevertheless ascertain the scope of the claim (e.g., a standard that is recognized in the art for measuring the meaning of the term of degree). For example, in Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter. 1992), the phrases "relatively shallow," "of the order of," "the order of about 5mm," and "substantial portion" were held to be indefinite because the specification lacked some standard for measuring the degrees intended”
Here, the specification provides no standard to determine what is considered “very thin” thus rendering the claim indefinite.
Claim 2 is additionally vague and indefinite because terms appear in parenthesis (i.e. ratios of the bismuth, cadmium, tin and lead, eye width, eye size, eye depth, concavity and dental jaw prosthesis material). Specifically, it is not clear whether this terms limit the claim or if they are merely examples. If they are examples, the claim is indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (Lee et al., “Low Dose Radiation Therapy for Primary Conjunctival marginal zone B-cell Lymphoma” Cancer Res Treat. 2018) (copy of publication submitted herewith) as evidenced by Caldwell (US pgPub 2014/0145097).
Regarding claim 1, Lee et al. teach a personalized eye protection block ( see figure 2) for protecting the cornea and lens in tumors occurring in and around the eyelid (fig. 2 shows customized lens shielding block over eye thus suitable for intended use), characterized in that; it is a product which is made of alloy ratios as 50% bismuth, 26.7% lead, 13.3% tin and 10% cadmium, has a melting temperature of around 70 °C (fig. 2, caption teaches composed of Cerrobend, which as evidenced by Caldwell has the claimed ratios (see table I between paragraphs [0014]-[0015] teaching the claimed ratios and noting that Cerrobend alloy is the commercially available Lipowitz alloy, which is the alloy of Lee et al.). Note: since the material ratios of the alloy are the same as claimed the melting point is inherently the same. MPEP 2112 “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” Here, since the material composition is the same, so is the melting point) and has an acrylic outer coating (fig. 2, the Cerrobend alloy is mounted on the individually made acrylic contact lens, thus the acrylic lens coats the Cerobend alloy).
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.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Shiu et al. (USPN 5,487,394) (submitted with IDS of 03/18/2024) in view of Yu (US pgPub 2020/0290119).
Regarding claim 1, Shiu et al. teach a personalized eye protection block ( see figure 1/10/14/16/18 personalized by placing on the person) for protecting the cornea and lens in tumors occurring in and around the eyelid (shielding cornea and lens as seen in figure 1), characterized in that; it is a product (tungsten 10) and has an acrylic outer coating (dental acrylic coating 18, col. 4, lines 4-6).
Shiu teaches the body of the shield is made of tungsten, therefore fails to disclose which is made of alloy ratios as 50% bismuth, 26.7% lead, 13.3% tin and 10% cadmium, has a melting temperature of around 70 °C.
However, Yu teaches which is made of alloy ratios as 50% bismuth, 26.7% lead, 13.3% tin and 10% cadmium, has a melting temperature of around 70 °C ([0004] teaches the same ratio alloy thus has the same melting point).
Yu modifies Shiu by teaching that traditional shielding material of high melting points (tungsten in addition to lead has a high melting point) are difficult to mold, therefore to facilitate molding the claimed composition is commonly used.
Since both inventions are directed towards molded shields, it would have been obvious to one of ordinary skill in the art to substitute the high melting point shielding material for the low melting point material of Yu because it would facilitate customizable shields so as to increase the comfort to the patient and improve shielding reliability, moreover simplifying the manufacture of the shield of Shiu.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shiu in view of Eichmiller (USPN 5,190,990) (submitted with IDS of 03/18/2024) alone or alternatively and further in view of Zhou et al. (US pgPub 2012/0021129).
Regarding claim 1, Shiu teaches production of a personalized eye protection block (the shield of figure 1 is inherently produced) for protecting the cornea and lens in tumors occurring in and around the eyelid (as seen in figure 1), characterized in that, it comprises the following process steps;
The shield being 3 mm thick (col. 3, lines 17-18).
e) covering the eye protection model with a very thin layer of acrylic (dental jaw prosthesis material) against the risk of tissue damage and infection (thin layer 18 is dental acrylic layer 18 over protection model of figure 1).
Shiu fails to disclose how the device is manufactured and teaches the material of the shield in tungsten.
However, Echimiller teaches a) mixing of bismuth, cadmium, tin and lead in certain proportions (50% bismuth, 26.7% lead, 13.3% tin and 10% cadmium) and in this case, making easy to process and reducing the melting temperature to 70 C (col. 2, lines 38-41 teaches molten lead or a low temperature melting alloy such as lipowitz (same composition as claimed) is poured. In order to form a liquid lipowitz metal of 50% bismuth, 26.7% lead, 3.3% tin, and 10% cadmium as disclosed by Echimiller, mixing would inherently be required before pouring. Note as above since the composition is the same so is the melting point),
b) making a mold (col. 2, lines 29-32 teaches making a plaster model of tissues via impressions), creating a reverse mold using this mold (col. 2, lines 32-37 teaches making a stent from the plaster model which is hollowed out for incorporation of a metal liner which serves as a reverse shield (i.e. reverse mold)), pouring bismuth, cadmium, lead alloy, which is formed 3 mm thick, into this mold (col. 2, lines 38-43 teaches pouring the claimed alloy into to stent to form the shielding appliance),
c) cool and harden the same (col. 2, lines 43-45)
d) cleaning the unwanted particles on this protection model thoroughly and smoothing the same with zero sandpaper (first interpretation: interpreting zero sand paper as without sandpaper. col. 2, lines 45-46 teaches polishing the completed appliance (i.e. without sandpaper, wherein polishing removes unwanted particles and smooths/cleans the surface)).
Echimiller et al. modifies Shiu by providing a means of manufacturing the eye shield to be customizable.
Since both inventions are directed towards radiation shields, it would have been obvious to one of ordinary skill in the art to use the method of manufacture as suggested by Echimiller because it would provide a shield that is well fitted to the user to better protect the eye from hazardous irradiation. That is, a low temperature shielding material alloy would facilitate a molding process to create a shield that best protects the user’s eye. Moreover, as the material of Echimiller has a low melting point it is easier to mold than the tungsten of Shiu thus simplifying the manufacturing process.
Moreover, while Echimiller does not expressly suggest the mold suitable for a person’s eye structure. Shiu teaches the shield is suitable for a person’s eye structure and Echimiller is generic to prosthetic appliances designed modeled and formed into a custom made metal on plastic shield (col. 2, lines 15-20). Therefore, the modification of Shiu with Echimiller would naturally result in the mold of Echimiller suitable for a person’s eye structure. Specifically, MPEP 2112 (IV) recites “while "inherency may support a missing claim limitation in an obviousness analysis", "the use of inherency, a doctrine originally rooted in anticipation, must be carefully circumscribed in the context of obviousness." Id. at 1194-95, 112 USPQ2d at 1952. "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). ”
Here, modifying Shiu by the manufacturing method of Echimiller would naturally result in a mode suitable for the person’s eye as Echimiller is generic to any modeled shield for a person and Shiu is directed towards an eye shield.
While Eschimiller teaches cooling the mixture, Shiu in view of Echimiller fails to expressly suggest keeping the mixture at room temperature so as to cool.
However, since the alloy has a low melting point, it would have been obvious to cool the liquid alloy at room temperature as it would simplify the cooling process by not requiring any additional equipment or steps to cool the protector, thus reducing the cost of the device.
In the second interpretation, While the combined device teaches coating the shield with an acrylic layer (see col. 4, lines 4-6 of Shiu and col. 2, lines 43-45 of Echimiller), the combined device does not teach d) cleaning the unwanted particles on this protection model thoroughly and smoothing the same with zero sandpaper.
However, Zhou et al. teach sandpaper burnishing the metal substrate before application of the coating film ([0015]) wherein the burnishing treatment [0017] is done with sand paper of particle size 20~200 microns (i.e. interpreted to be zero sandpaper as the particle size is non-visible).
Zhou et al. modifies the combined device by suggesting sanding unwanted particles on the alloy of the combined device prior to applying the coating.
Since both inventions are directed towards applying a coating to a metal substrate, it would have been obvious to one of ordinary skill in the art to sand the metal substrate of the combined device prior to coating so as to remove unwanted particles (i.e. clean) because it would improve the bonding strength between the shield and the layer of the combined device so as to form a more resilient radiation shield.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yangchen et al. (Yangchen et al. “Cerrobend shielding stents for buccal carcinoma patients”, Short communication, JCR&T, 2016) teaches a similar casting method to Echimiller, wherein the alloy is polished in a similar fashion to other metal restorations (see page 1103, left column, first bullet point).
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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